Journal of Public Administration Research and Theory, 2020, 1–15

doi:10.1093/jopart/muaa009
Article

Article

Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020

Hidden Politics? Assessing Lobbying Success
During US Agency Guidance Development
Susan Webb Yackee
University of Wisconsin-Madison

Address correspondence to the author at yackee@wisc.edu.

Abstract
I test the proposition that interest groups achieve greater policy success when they lobby during
the agency guidance document development process as opposed to the notice and comment pro-
cess. Policymaking via guidance documents often receives lower levels of public attention, which
provides greater flexibility to accommodate lobbying requests. I  analyze the hypothesis during
the creation of 41 rules by one US government agency—20 of which were promulgated using the
notice and comment process and 21 via the guidance document process. I  measure regulatory
policy change using a content analysis of government documents and lobbying texts, and I also
incorporate a telephone survey of interest groups who lobbied on these same rules. I  find that
interest groups perceive—and achieve—greater policy success when lobbying during the agency
guidance process. The results yield new insights into the relationship between lobbying and regu-
latory policymaking.
  

Government agencies regulate across a broad spectrum
of important and substantive topics—from airplane
safety to animal testing, from medical devices to financial
derivatives, and from cosmetics to water quality. To give
one example, the US Food and Drug Administration’s
(FDA) policy reach is so wide that FDA-regulated prod-
ucts make up about 20 cents of every dollar spent by
US consumers (FDA 2011). Such regulatory activity
across the public sector leads Coglianese, Kilmartin,
and Mendelson (2009) to conclude that agency rules in-
fluence almost all aspects of American life. Kerwin and
Furlong (2018, 87)  similarly stress that agency rules’
“aggregate effect on the lives of Americans cannot be
exaggerated; no instrument of government exerts such
influence on the quality and conduct of our lives.”
I would like to thank the many student research assistants who
gathered data for this project over the years, as well as the Burroughs
Wellcome Fund (ID#1012523) for its generous support of the data
collection. UW-Madison’s Institutional Review Board considered the
survey data collection effort in this article to be exempt research.
In fact, more than 90% of modern public policy
decision making takes place within government ad-
ministrative agencies (Warren 2020). “Indeed, regula-
tions frequently play a more direct role than statutes
in defining the public’s legal rights and obligations,”
and this occurs in part, as Manning (1996, 615) states,
because many congressionally passed statutes con-
tain provisions that require an agency to issue a rule
in order for the statute to be fully implemented. Put
differently, statutes often need agency rules to make
clear to the general public and regulated entities how
to comply and how to benefit. Thus, it is difficult to
understand the requirements of law and policy without
understanding government rules and regulations
(Kaufman 1981).
In this article, I focus on the politics of the agency
regulatory policymaking process. Specifically, I  con-
nect the role of interest group influence during agency
policymaking to the level of public attention and
scrutiny paid to different agency policymaking tools.
Numerous scholars have suggested such a connection

© The Author(s) 2020. Published by Oxford University Press on behalf of the Public Management Research Association. All rights reserved. 1
For permissions, please e-mail: journals.permissions@oup.com.
2 Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX
in other realms. Studies of the policymaking process,
for instance, have long implied that interest group in-
fluence is more likely during the relatively shrouded
policy formation stage, especially compared to the
more transparent policy enactment stage (Baumgartner
and Jones 1993; Kingdon 1995; Naughton et al. 2009).
Others have theorized that interest groups attempt to
avoid attention because they are less likely to accom-
plish their goals while in the glare of the public’s eye
(Schattschneider 1975).
I draw on several new sources of data to capture
interest group lobbying activity and policy change
during agency regulatory policymaking. While sig-
nificant policy decisions are made by government
agencies, research investigating the role of interest
group influence on the US bureaucracy remains rela-
tively uncommon in part because “[t]he primary
focus of research on interest group influence, then
and now, is Congress (and occasionally other legisla-
tive bodies)” (Hojnacki et al. 2012, 385). There are
certainly exceptions to this characterization. Work
by Yackee and coauthors (e.g., 2006, 2012, 2015;
Haeder and Yackee 2015), for instance, has begun
to fill this gap by focusing on lobbying and influence
during the notice and comment rulemaking process.
Yet, given that numerous governmental reforms,
including the federal Administrative Procedure Act
of 1946 (Rosenbloom 2000; West 1995), our schol-
arly conclusions regarding the role of interest groups
during regulatory policymaking continue to be, at
best, incomplete.
This article leverages the fact that public agen-
cies make important policy decisions using pol-
icymaking tools that vary in their level of public
attention. Specifically, I focus on 41 rules developed
by the FDA. The FDA created 20 of these rules using
the well-known notice and comment rulemaking
process and the other 21 using the more obscure
guidance document process. Many readers may be
unfamiliar with the government’s guidance docu-
ment process (which provides some face-validity
of its relative obscurity). However, as I  discuss
below, guidance documents are critical agency
policy tools that Mendelson (2007, 398) states are
used on a “massive” scale across the federal gov-
ernment. Furthermore, such tools have received
high-profile attention lately. On October 9, 2019,
President Donald Trump issued the Executive Order
on Promoting the Rule of Law Through Improved
Agency Guidance Documents.1 This order, E.O.
13891, is designed, in part, to systematize—and
1 See: https://www.whitehouse.gov/presidential-actions/executive-order-
promoting-rule-law-improved-agency-guidance-documents/. On the
same day, the President also issued the Executive Order on Promoting the
make more transparent—how government agencies
develop guidance documents in the future.
I rely on two key dependent variables. The first
comes from a survey of over 200 interest groups that
lobbied during the development of the 41 rules and
taps an interest group’s Perceived Lobbying Influence.
Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020
The second dependent variable measures an interest
group’s success in achieving policy change: its Actual
Lobbying Success.2 It combines information on the
policy changes each group sought during regulatory
policymaking, with the policy changes delivered by an
agency. The main explanatory variable is whether the
policy tool is a notice and comment rule or guidance
document. I  also include several organizational- and
rule-level control variables.
In the end, this is the first study to analyze differ-
ences in perceived and actual lobbying success across
agency notice and comment versus guidance document
procedures. Overall, I  find that interest groups both
perceive—and achieve—greater policy success during
regulatory policymaking when they lobby during guid-
ance document creation. Across model specifications,
interest groups believe themselves to be more influ-
ential during guidance document creation, and these
beliefs appear well-founded: the actual policy changes
requested by interest groups find their way into the
content of government policies at a higher rate during
the guidance document process than during notice and
comment regulation.
The results hold important implications for our
practical and normative understanding of interest
group lobbying during agency policymaking. Past
accounts of interest group influence frequently cite
public attention to government decision making as a
foil to group influence. We know now that, for this
sample of regulatory policies, interest group influence
appears more impactful in a policymaking context
that, relatively speaking, garners less public scru-
tiny. Furthermore, this article advances knowledge by
introducing the importance of policy formation within
guidance documents to a broader audience, while sim-
ultaneously suggesting a largely unanticipated conse-
quence attached to guidance creation: interest group
influence.
Rule of Law Through Transparency and Fairness in Civil Administrative
Enforcement and Adjudication, which touches on guidance documents.
See: https://www.whitehouse.gov/presidential-actions/executive-order-
promoting-rule-law-transparency-fairness-civil-administrative-
enforcement-adjudication/. Accessed December 5, 2019.
2 I further the analysis of Actual Lobbying Success through employment
of a third dependent variable, Top Issue Lobbying Success, which
is a measure of positive movement on an interest group’s principal
policy goal.
Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX
Theoretical and Institutional Process
Foundations
I extend our understanding of regulatory policymaking
by focusing first on the role of interest group lobbying
during the agency regulatory policymaking process
(also called rulemaking). I then go on to highlight sev-
eral findings from the broader literature on interest
group lobbying that suggests a connection between the
level of public attention provided to an issue or policy
and the role of interest group influence on policy con-
tent. Finally, I provide important institutional and con-
textual process details on two of the chief procedures
used by government agencies to write rules: the notice
and comment process and the guidance process.
Interest Groups and Rulemaking
While the interest group literature tends to focus on
interest group policy influence within legislative bodies
(Hojnacki et al. 2012), there are key theoretical foun-
dations to build upon regarding the role of interest
groups and agency rulemaking. Chubb’s (1983) im-
portant book on interest group involvement in regu-
latory policymaking in the US energy sector in the
late 1970s emphasized—through careful theory and
the use of interview techniques—how interest group
influence frequently operates in less transparent regu-
latory environments and also tends to be biased to-
ward regulated entities over less well-organized public
interest groups. Other scholars have often explored the
relationship between interest groups and agency regu-
lation through the lens of “capture.” Rourke (1984),
building on the work of Bernstein (1955) and others,
writes that agency capture is the over-reliance on an
interest group by an agency, such that the group de-
velops a veto power over the agency’s actions. While
some more recent scholarship sees evidence of agency
capture (Bagley 2010; Barkow 2010), a number of
scholars have called into question the idea that any
particular interest group, or even collection of interest
groups or entities, holds such a high degree of con-
trol over agency regulatory decision making (Gormley
1982; Quirk 1981; Sabatier 1975; Wilson 1989).
This is not to say, however, that scholars have not
found suggestive evidence of interest group influence
during agency regulatory policymaking. Chiefly, there
is a growing empirical literature focused on interest
group impact during the notice and comment process.
This process often receives praise from researchers due
to the relatively public way in which the process un-
folds. Indeed, a key objective of the Administrative
Procedure Act of 1946 (APA) was to open up the
rulemaking process to public feedback via notice and
comment (Rosenbloom 2000). And while public par-
ticipation opportunities are known to increase the
perception of legitimacy within agency rulemaking
3
(Ruder and Woods Forthcoming), it is also widely
acknowledged that interest groups—not the general
public—are the primary commenters to most notice
and comment rules (Golden 1998; West 2004; Yackee
2006). As Kerwin and Furlong (2018, 261) conclude,
“[r]ulemaking is congenial to interest groups.” This
Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020
may occur because agencies, within notice and com-
ment rulemaking, value the technical and data-driven
arguments that are commonly made by interest groups
(Kerwin and Furlong 2018; West 1995).
We also know that interest groups perceive their
participation during notice and comment rulemaking
to be meaningful. One survey of interest groups finds
that they consider participation in rulemaking to be as
important as lobbying Members of Congress and more
important than almost all other lobbying strategies,
including campaign donations (Furlong and Kerwin
2005). Research on lobbying registrations also sug-
gests that “groups engage in substantial administrative
lobbying relative to legislative lobbying” (Boehmke,
Gailmard, and Patty 2013, 3). We know that lobbying
activity frequently occurs after Congress passes le-
gislation—suggesting that interest groups target the
rulemaking process (You 2017) and that agency offi-
cials report being responsive to interest group feedback
during rulemaking (Furlong 1998). Furthermore, ob-
servational studies of notice and comment rulemaking
frequently cite evidence of lobbying success with re-
sults obtained across a number of different govern-
ment agencies and policy domains (e.g., Haeder and
Yackee 2015; Naughton et  al. 2009; Yackee 2006,
2012). However, the size of the lobbying influence, as
well as how and when interest group influence occurs,
remain on-going topics of debate (Golden 1998; West
2004; Yackee 2019).
Influence and Public Attention
Generally speaking, prominent interest group
scholars—working primarily outside of the regula-
tory policymaking space—often posit an inverse re-
lationship between interest group influence on policy
outcomes and the public’s attention to an issue. For
instance, Schattschneider (1975) theorizes that interest
groups attempt to avoid public attention because more
public attention tends to limit the ability of an interest
group to accomplish its goals. Similarly, Browne (1990)
writes that interest groups often seek more segmented
policy “niches” in which they can lobby on increasingly
narrow issues that are more likely to be outside of the
public’s eye. Baumgartner et al. (2009) find that a large
portion of interest group activity takes place at a low
level of public visibility, and Mahoney (2007) demon-
strates that US interest groups have more lobbying suc-
cess on their key policy preferences when the salience
of the issue to the public is low.
4 Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX
A lower level of public attention may yield greater
flexibility to government officials to accommodate
interest group lobbying requests, as well as lessen the
need to justify and explain their actions to the public.
This is not to say that government officials will always
be responsive to interest group advocacy within pol-
icymaking processes that have lower levels of public
scrutiny (or that they won’t be responsive in other
contexts). Instead, this intuition builds on Manning’s
(1996, 680 and 618) assertions, when writing specif-
ically about agency rulemaking, that “[r]egulatory
opacity, quite simply, makes it harder for the public to
monitor agency decision making, and leaves the agency
more vulnerable to the influence of relatively narrow
interest groups” and allows agencies at times “to mask
interest group bargains.” This intuition also aligns
with Yackee’s (2012, 2015) theorizing that interest
groups often try to take advantage of less structured
policymaking environments, which may be more re-
moved from public scrutiny. Additionally, as Garrett
and Vermeule (2006) conclude, lower public scrutiny
can encourage increased political deal-making and ne-
gotiation, whereas greater public attention can make
policy bargains prone to blowback from the public
and media and increase the need for justification and
explanation.
This may be particularly true in the context of US
agency rulemaking. We know, for instance, that interest
groups frequently make policy recommendations and
suggest policy change to government agencies, and re-
search suggests that “agencies rationally adjust their
proposals to appease interest groups” (Epstein and
O’Halloran 1995, 228). After all, public agencies
benefit at times from having close relationships with
interest groups (Yackee 2019). Interest groups help
agencies build coalitions (Carpenter 2002), commu-
nicate information externally (Rourke 1984), and in-
crease public awareness over issues the agency faces
(Hrebenar and Scott 1996). Moreover, accommodating
interest group lobbying requests during agency policy-
making may help agencies avoid unwanted political at-
tention (Epstein and O’Halloran 1995). However, such
accommodation may come at a cost. Manning (1996,
677)  suggests that, when lobbying occurs, it tends to
come “disproportionally from organized interests with
a large stake in agency policy and the resources to in-
fluence it.”
Institutional Detail—A Focus on Two Agency
Policy Tools
The APA establishes the institutional process for how
the federal government develops agency rules. The
APA defines a rule as any “agency statement of general
or particular applicability and future effect designed to
… interpret, or prescribe law or policy” (Funk 2001,
citing 5 U.S.C §551(4) (1994)). Notice and comment
rulemaking is the most well-known of the rulemaking
processes, and its use has “proliferated” over time
(Shapiro 2014, 524). When scholars of public ad-
ministration and politics write about “rulemaking,”
they are almost always referring to notice and com-
Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020
ment rulemaking, which generally requires agencies
to solicit public comments on their draft policy pro-
posal (also called a Notice of Proposed Rulemaking or
NPRM) and to consider any comments before issuing
a Final Rule.
Yet, the APA sanctions other forms of “rulemaking”
too. The APA allows agencies to promulgate rules via
guidance documents (also called guidances), which in-
clude interpretive rules and statements of policy that
are intended to clarify existing statutes or regulations.
Such policymaking is routinely discussed by admin-
istrative law scholars but rarely comes up in public
administration, politics, or public policy scholarship.
This lack of attention is remarkable, given the import-
ance of this tool to the implementation of policy in
practice.
According to a leading administrative law scholar,
“[t]hese guidances often closely resemble the pol-
icies agencies issue in ordinary notice-and-comment
rulemaking” (Mendelson 2007, 397), and the im-
pact of a guidance document can be just as signifi-
cant as a rule made through the notice and comment
process (Mantel 2009). According to Gluck, Po, and
O’Connell (2015), rulemaking via the guidance pro-
cess occurs more often than rulemaking via the no-
tice and comment process. And while an exact count
of guidance documents across the federal government
is unknown, close observers suggest that agencies fre-
quently use this tool to “set policy broadly and pro-
spectively” (Mendelson 2007, 397–8). Parrillo (2017,
34)  quotes a former senior FDA official as saying, “I
cannot imagine a world without guidance.” Unlike no-
tice and comment rulemaking, the APA does not set up
a specific process for issuing guidance. However, the
best practice standard over the past decade has been
to include a public commenting process to solicit feed-
back from affected parties during the development of
important agency guidance documents (OMB 2007).
In fact, President Trump’s recent E.O. 13891 will re-
quire, in almost all cases, cabinet-level agencies to take
public comment during the development of significant
guidance documents in the near future.3
Policies made through notice and comment
rulemaking and the guidance process have many
similarities (Mendelson 2007). Indeed, scholars use
3 The E.O.  defines “significant” in a similar fashion to how President
Clinton’s E.O. 12866 defines “significant” rulemaking with regard to
the US Office of Management and Budget’s review of notice and
comment rules.
Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX
terms like “fuzzy” (Levin 2018, 266)  and “blurry”
(Rosenbloom 2000, 60)  to describe the distinction
between notice and comment rules and guidance
documents. While another scholar, in quoting others,
suggests the distinction to be “‘tenuous,’ ‘baffling,’ and
‘enshrouded in considerable smog’” (Franklin 2010,
276). This is not to suggest that these two policy tools
are perfect substitutes. For instance, one potential dif-
ference between these agency policy tools is that guid-
ance documents are not legally binding (while notice
and comment rules are legally binding). But this dif-
ference may be more important in theory than in prac-
tice because, as many observers assert, guidances are
often considered binding by affected parties. In prac-
tice, regulated entities often comply with the policy
stipulations in guidance documents “out of fear of
that agency” (Shapiro 2014, 531). Greve and Parrish
(2014), writing about the FDA’s use of guidances,
argue that regulated entities see these guidances as
binding because they can play an important role in
agency enforcement activities against particular firms.
Indeed, some scholars worry that affected parties feel
compelled to comply with guidances (Anthony 1992).
Thus, as Graham and Broughel (2015, 2)  write, “[g]
uidance documents can have the same effects as a
regulation adopted under the APA if regulated entities
have no real choice but to comply with these agency
directives.”4
Hypothesis—Attention to Agency Policy Tools
One clear difference between these two policy
tools is the level of public attention they receive. As
Seidenfeld (2011, 337)  writes, notice and comment
rules attract “more attention” than guidance docu-
ments—suggesting a lower level of public scrutiny of
and attention to policymaking via guidance document
development. Graham and Broughel (2015, 1)  agree
that guidance documents do not have the same level
of public focus as notice and comment rules, stating
that guidance documents are often used “under the
radar” of the public. In fact, California refers to guid-
ance documents as underground regulations.5 Raso
(2010, 799–800) similarly concludes that guidance
documents receive less public attention than notice
and comment rules; yet, he adds, “[t]his comparison
is not intended to suggest that interest groups are un-
aware of guidance documents.”
Given this difference between policy tools, as well
as the earlier discussion regarding public attention and
4 Regulated entities can attempt to appeal the agency’s use of
guidance within the courts; however, achieving judicial review can be
problematic (Funk 2001; Romano 2019).
5 See: https://oal.ca.gov/underground_regulations/. Accessed March
18, 2019.
5
interest group policy influence generally, I put forward
the following: I hypothesize that interest groups
achieve greater policy success when they lobby during
the agency guidance document development process
than during the notice and comment process.
Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020
Testing the Hypothesis
This article’s research design aims to test the above
hypothesis. In doing so, I follow Kerwin and Furlong
(2018, 180), who define interest groups as “organ-
izations that attempt to influence public policy.
They include companies, business and trade asso-
ciations, unions, other levels of government, and
public interest groups.” I define lobbying as interest
group activity with the goal of influencing public
policy (You 2017). Specifically, I  study policy-
making and interest group lobbying at the FDA, and
I draw on several different data collection strategies
and methods to capture interest group activity and
policy change.
Empirical Setting: The FDA
The empirical setting for this analysis is the FDA.
The FDA has relied on both notice and comment
rulemaking and the guidance process to make im-
portant policy decisions for decades (Lewis 2011).
However, it is now the “widespread view” of FDA
observers that the guidance process is used much
more often than notice and comment rulemaking
by the agency (Parrillo 2017, 181). Evidence for this
observation occurs across 135 hour-long interviews
completed by Parrillo, which he summarizes in a
2017 government report on the guidance process. At
least 31 of Parrillo’s interview subjects—who came
from agencies, industry, and non-governmental or-
ganizations—had direct policy experience with
the FDA.
The interview data suggest that the FDA makes
policy decisions through the guidance process when-
ever possible, and generally speaking, only relies on
rulemaking via the notice and comment process when
it is required to do so by Congress. For example, one
representative from an interest group organization
told Parrillo that s/he assumes that the FDA will use
guidances—and not notice and comment rules—for
all major policy issues, whereas a congressional aide
told Parrillo (2017, 181) that the FDA “generally did
everything by guidance unless a statute forced it to
proceed by legislative rulemaking” (whereas “legis-
lative rulemaking” here denotes notice and comment
rulemaking). In the end, Parrillo’s interview evidence
on the FDA’s choice of policy tools is in line with
Noah’s (2014) similar conclusion that notice and com-
ment rulemaking appears to happen at the FDA when
6 Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX
Congress requires it, as well as Magill’s (2004) general
conclusion that agencies often have a great deal of
flexibility in what policy tool they choose when they
issue a policy decision.
Additionally, Parrillo’s interview data imply that
significant guidance documents and notice and com-
ment rules at the FDA are quite similar policy tools.
For instance, one industry official interviewed by
Parrillo (2017, 182), states that the FDA “almost
never” used notice and comment rulemaking to issue
important policy decisions anymore and instead relied
on guidance documents. While an executive in a large
health law firm told Parrillo that the FDA often used
guidances as direct substitutes for notice and comment
rules. Finally, another interviewee, from a major advo-
cacy organization, suggested that the FDA uses guid-
ance aggressively, and it (i.e., the FDA) has the ability
to issue a guidance to replace an existing notice and
comment rule (Parrillo 2017).
The FDA has a well-established and more ex-
tensive process than most other government agen-
cies for issuing guidance (Lewis 2011). As part of
this process, it places guidance documents into two
tiers. There are Level-1 guidance documents, which
the FDA issues when the “agency believes there is a
major change in policy” or for “complex or highly
controversial issues” (Hwang, Avorn, and Kesselheim
2014, 772). For these rules, the FDA follows the best
practice standard of soliciting public comments.
Thus, similar to the FDA’s notice and comment pro-
cess, when the FDA publicly releases a Level-1 Draft
Guidance Document, it opens that document for
public comment before it issues its Final Guidance
Document. The FDA uses Level-2 guidance for less
policy-relevant matters and does not take public
comments.
I focus on FDA Level-1 guidance documents and
notice and comment rules in this article. In keeping
with the literature, I  anticipate that these two FDA
policymaking tools will be similar on a number of di-
mensions, with the important exception that the level
of public attention paid to guidances will be lower
than notice and comment rules.6 In the pages ahead,
6 Earlier in the article, I  detail the existing literature in support of the
conclusion that guidances, generally speaking, receive a lower level
of public attention than notice and comment rules. However, regulatory
practice at the FDA may exacerbate this relationship. This is because
notice and comment rules at the FDA—like at all federal agencies—
must provide a summary of the public comments the agency receives
to a draft rule and must detail the policy changes the agency made in
response to those public comments within the Final Rule’s preamble
(Funk 2001). These steps require the FDA to justify and to explain their
responses to the comments—in a public and open way—during notice
and comment rulemaking. However, according to the FDA’s internal
policies, this same requirement is not present for FDA Level-1 guidance
I provide suggestive empirical evidence from the data
in support of these conclusions.
Data
I gathered data from the FDA’s notice and comment
rulemaking and Level-1 guidance processes. For the
Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020
sample, each of the FDA draft policies was first is-
sued—as an NPRM or Draft Guidance Document—
and was then finalized between the dates of January 1,
2009 and December 31, 2014.7 Additionally, the FDA
had to receive at least one interest group comment
during the rule’s comment period to be included in the
sample. In focusing on comments, I follow past studies,
which focus on interest group comments to govern-
ment policy decision making as a means to measure
group lobbying activity, or as Young, Marple, and
Heilman (2017, 349) put it, interest group comments
provide “a relatively systematic ‘trace’ of interest group
mobilization.”8
I collected three types of data for the study.
Survey Data
I  hired a professional, nonprofit survey firm to im-
plement a telephone survey of the interest group
commenters to these FDA rules. The firm sent an ad-
vance letter, which explained the study and included
a five-dollar bill as a token of appreciation. The firm
administered the survey to the signed commenter or
to another organizational representative who was fa-
miliar with the group’s advocacy efforts on the rule.
The survey asked several types of questions. For ex-
ample, it asked questions specific to the interest group’s
participation in the sample rule, including its advocacy
tactics and its perceived influence on the development
of that rule, as well as demographic questions about
creation. Put differently, the FDA does not summarize the comments it
receives during the FDA Level-1 guidance process and does not go out
of its way to point out the policy changes that were made (or not made)
based on those comments in the Final Guidance Document (Lewis
2011). In fact, the FDA has expressly rejected the suggestion that the
agency needs to provide a written—and therefore public—summary
and response to the public comments it receives during the guidance
process (65 Fed. Reg. 182 (Sept. 19, 2000)). Thus, the FDA may issue
policy changes during the guidance process without calling clear and
direct public attention to the lobbying it received. The FDA’s current
practice may change as a result of E.O. 13891, however, which appears
to require that a summary of the public comments and the agency’s
response to those comments be placed in the text of all forthcoming
guidance documents.
7 For finalization actions, I  studied Final Rules and Final Guidance
Documents, as well as the FDA’s formal withdrawal of an NPRM or
Draft Guidance Document.
8 I readily acknowledge that groups can use numerous strategies in
their attempt to influence agency officials. I control for several other
lobbying strategies in the article’s analyses.
Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX
the survey respondent and his/her organization. The
firm surveyed 593 interest groups; 216 surveys were
completed, and another 11 answered all but the rule-
specific questions for a response rate of 38%.9 Thus,
the survey gathered 227 responses across 41 FDA
rules—20 of which began as an NPRM and 21 as a
Draft Guidance.10 In order to achieve a similar number
of both policy tools in the dataset, I  had to sample
the guidance documents due to the fact that guidance
documents outnumbered the notice and comment rules
issued by the FDA in these data.
Content Analysis
I  employed hand-coded content analysis to measure
regulatory policy change.11 To do so, I  hired two
graduate student coders and provided each with
training and feedback.12 They were provided the text of
the sample rules (draft and final documents), as well as
the accompanying comments submitted by the interest
group survey participants to that rule. First, the coders
read the full draft and final policy documents. Second,
the coders went one-by-one through the interest group
comments. For each comment, they first identified the
top three policy changes sought within the public com-
ment. These lobbying recommendations often came
early in the comment. In some cases, fewer than three
requests were provided, and in those cases, only the
provided recommendations were recorded. When
more than three requests were provided, coders were
instructed to code the first three mentioned. All interest
group comments were then coded in this manner.
9 Survey respondents and nonrespondents appear similar on several
key attributes. Difference in means analyses suggest no significant
differences in whether or not the interest group was located in
Washington, DC, whether the primary commenter listed any advance
degrees, whether the comment was more than 15 pages long, and
whether the commenter included attachments. Respondents were
slightly more likely to originate from rules with an NPRM than Draft
Guidance Documents than were non-respondents. All additional article
analyses are available upon request from the author.
10 Given that each policy received a different number of interest group
comments, the survey firm assigned weights so that policies with a
smaller number of interest groups comments were more likely to be
included in the sample. Consequently, a rule with 20 interest groups
commenting had a slightly higher chance of being selected for
an interview by the survey firm than a rule with 50 interest groups
commenting. Doing so encouraged more variation by rule in the
sample. The firm continued selecting potential respondents until
funding ran out.
11 This measurement approach builds on earlier work by Yackee (2006).
12 10% of the comments (22 comments) were double coded to assess
the coding procedures. There were three potential policy requests
per comment and thus 66 coding choices were recorded. The
double coding revealed that 54 of the 66 coding choices were
scored the same, which is an 82% agreement rating. Implicit
to this rating is that the coders identified the same three policy
issues, while also scoring them in the same way. Given this level
of difficulty, the percent agreement score suggests a solid level of
coder agreement.
7
Third, the coders went back one-by-one through the
interest groups’ policy requests to a rule, and asked
the question: did policy change occur on this dimen-
sion in the FDA’s final policy document? Each recom-
mendation was coded such that 0 equals no movement
toward the recommendation (or not mentioned) and 1
Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020
indicates some movement toward the interest group’s
proposed policy request.
Contextual Data
Finally, I  collected data on several other contextual
variables from other sources, such as the Unified
Agenda, Regulations.gov, and the Federal Register.13
Variables
I employ three dependent variables in this study.14
First, I use the telephone survey to develop a measure
of an interest group’s Perceived Lobbying Influence on
the sample rule. The survey question asks: “In the end,
how much did your organization influence the con-
tent of this rule: none, a little, some, quite a bit, or
a great deal?”15 Second, I quantify an interest group’s
Actual Lobbying Success as a dependent variable. As
I  describe above, this variable combines information
on the policy requests interest groups sought with the
policy changes the agency actually delivered in a rule.
It scores a 1 if there was any movement on one or
more of the interest group’s top three policy requests
for that rule and a 0 otherwise. Similarly, the third de-
pendent variable, Top Issue Lobbying Success, focuses
on whether (1) or not (0) there was any positive move-
ment on the interest group’s principal or “top” policy
change requested. For the latter two dependent vari-
ables, the measurement strategy focuses on an interest
group’s goals, as well as the potential achievement of
those goals within government policies. In doing so,
it builds on Mahoney’s work (Mahoney 2007), which
also focuses on lobbying success. Descriptive statistics
and the data sources for all variables are in table 1.
13 Federal agencies provide basic rule information on their planned
regulatory activities in the Unified Agenda of Regulatory and
Deregulatory Activities (called Unified Agenda for short). See: https://
www.reginfo.gov/public/do/eAgendaMain. Regulations.gov provides
a repository for most draft and final regulatory activities, as well as
the public comments received on these rules. See: https://www.
regulations.gov/. The Federal Register is the official daily journal of the
US Government and publishes the official version of government rules,
as well as notices regarding FDA guidance documents. See: https://
www.federalregister.gov/. Accessed December 5, 2019.
14 I use three dependent variables in an attempt to triangulate on the
phenomenon of interest, which is interest group influence on regulatory
policy outputs.
15 Respondents were also allowed don’t know and refused replies for
all survey queries. As a result of this flexibility, the sample size is
diminished for some survey questions, and some model analyses are
reduced in size as a result of these response options.
8 Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX

Table 1.  Descriptive Statistics

Model Variables Data Source Mean Low High Observations
Perceived lobbying influence Survey 2.202 1 5 198
Actual lobbying success Regulations.gov 0.600 0 1 215
Top issue lobbying success Regulations.gov 0.405 0 1 215
Guidance document Federal Register 0.181 0 1 227

Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020

Salience Survey 3.283 1 5 212
Complexity Survey 3.483 1 5 209
Comments Regulations.gov 52.670 1 99 227
Influence attempt Survey 1.877 0 4 211
Hearing Federal Register 0.053 0 1 227
Extended commenting Unified Agenda 0.379 0 1 227
Rule length Federal Register 30.626 4 45 227
Lobbying tactics Survey 10.416 5 24 202
Size Survey 2.920 1 5 226
Located in DC Regulations.gov 0.317 0 1 227
Lobbying experience Survey 3.413 1 5 223
Research and development Survey 0.044 0 1 227
Health or health care Survey 0.225 0 1 227
Legal or government affairs Survey 0.119 0 1 227
Retail or wholesale business Survey 0.057 0 1 227
Pharmaceutical Survey 0.079 0 1 227
Public interest group Survey 0.093 0 1 227

Note: See the article for a description and measurement of each variable. Overall, the variables are measured at the survey respondent level.
Some measures naturally vary at the respondent level. For instance, Perceived Lobbying Influence varies at the respondent level. Other vari-
ables are naturally rule-level constructs (such as the Hearing variable) and are included based on the number of survey respondents to that rule.
The number of observations per variable is reduced in size in some cases as a result of respondent options such as don’t know and refused.

The main explanatory variable is Guidance
Document, which scores a 1 if the underlying rule is a
guidance document, and a 0 if it is a notice and com-
ment regulation.
I also include four key control variables within the
multivariate analyses. Salience is collected from the
survey question: “How important was this rule to the
general public: not at all important, slightly important,
somewhat important, very important, or extremely im-
portant?” I  also employ an alternative measurement
strategy to capture rule salience. To do so, I use Google
News searches around the time of the draft proposal
on the rule’s subject.16 As a sensitivity analysis, I sub-
stitute this Google News measure for Salience in each
of the article’s models. The results yield no substantive
differences in terms of the sign or significance of the
article’s key predictor variable, Guidance Document.
The second control variable Complexity measures,
“How technically complex was this rule: not at all,
slightly, somewhat, very, or extremely?” These vari-
ables are responsive to Gormley’s (1986) observation
that rule salience and complexity can drive varying
16 I rely on Regulations.gov to identify the subject of the rule. Specifically,
Regulations.gov provides information on the “topics” of the draft rule,
and if no “topic” is provided, then I  use the draft rule’s “keywords,”
which are found on Regulations.gov. I focus on an 8-month window of
time around the draft rule’s issuance.
regulatory participation. Comments is a count of the
total number of interest group comments to the rule—
with rules that have more comments being, arguably,
more contentious. Additionally, Influence Attempt
comes from the survey question: “How much of the
content of the rule did your organization attempt to
influence: none, a little, some, quite a bit, or a great
deal?” It provides information on the degree of policy
change sought by the interest group, which is an im-
portant control variable in the analyses, especially
those employing the Perceived Lobbying Influence de-
pendent variable.
In other model specifications, I  incorporate a
number of additional rule-level characteristics, which
provide contextual and political controls in the ana-
lyses. Rule Hearing equates with a 1 for rules that list a
hearing during regulatory development and a 0 other-
wise. Extended Commenting captures whether the
FDA extended the rule’s public commenting period.
These variables control for augmented participation
opportunities, whereas Rule Length is the page length
of the draft policy document, and Lobbying Tactics
acknowledges that interest groups may use numerous
strategies when attempting to influence agency offi-
cials. It is an additive scale that combines five survey
questions measuring how much the interest group
used the following tactics: contacts with Members
of Congress on the rule; contacts with FDA officials
Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX
before the draft rule’s issuance; coalition lobbying;
provision of specific rule text to the FDA; and contacts
with Office of Management and Budget officials on
the rule. Choice categories include: not at all, a little,
somewhat, quite a bit, and a great deal, and the alpha
for the scale is 0.75.
I also include a number of organizational character-
istics regarding the interest group participants, which
may impact their perceived or actual policy influence.
I incorporate group Size, measured via its number of
employees, with the survey question reading: “Does
your organization have 20 or less full-time employees,
21–50, 51–150, 151–500, or more than 500 full-time
employees?” Located in DC is whether or not the ad-
dress on the interest group’s comment is within 15
miles of Washington, D.C. Lobbying Experience is
drawn from the question, “In the last 5  years, how
often has your organization participated in federal
rulemaking: never, rarely, sometimes, very often, or ex-
tremely often?” Finally, I  use a set of indicator vari-
ables to identify an organization’s field of work. The
survey question reads: “Which of the following best
describes your organization’s main field of work? Is
it R&D (research and development), health or health
care, legal or government affairs, retail or wholesale
business, agriculture, pharmaceutical, public interest
group, academia, or something else?” Due to a small
number of respondents, agriculture and academia were
combined with the “something else” response.
Descriptive Patterns
A number of important descriptive patterns can be
discerned from the data. For instance, analysis of
these FDA notice and comment rules and guidance
documents suggests that these two policy tools are,
in fact, similar on a number of dimensions. For in-
stance, difference of means analysis at the rule level
suggests no differences in the average page length of
NPRMs and draft guidance documents in the sample.
Similarly, the time between the announcement of the
draft rule and the final agency action are also quite
similar—with notice and comment rules taking, on
average, 1.9 years, whereas guidance documents take,
on average, 1.8 years to complete. As predicted by the
hypothesis, however, differences do emerge regarding
the level of public attention. Using difference of means
analyses at the respondent level, I  investigate differ-
ences between these policy tools with regard to the
public salience of the rule (Salience). I find a statistic-
ally significant difference, with guidance documents
having a lower average level of perceived importance
to the general public than notice and comment rules.
Difference of means tests also demonstrate that the
number of Comments submitted by interest groups is
significantly lower for guidance documents than notice
9
and comment regulations, which implies some sup-
port for the idea that guidance documents receive less
attention.
Figure  1 provides further contextual information
by displaying the distribution of the rules across the
different FDA centers and suggests the range of the
Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020
FDA’s policy work from food to drugs to medical de-
vices etc.17 As the figure displays, the largest number of
rules in the article’s sample came from the Center for
Devices and Radiological Health (CDRH), followed by
the Center for Drug Evaluation and Research (CDER),
and the Center for Tobacco Products (CTP). Moreover,
there was a good mix of guidances and notice and
comment rules across each FDA center. For instance,
of CDRH’s 15 study rules, nine were guidances (60%)
whereas six were notice and comment rules, while of
CDER’s 10 rules, five were guidances (50%), and of
CTP’s six rules, two were guidances (33%).
The study’s data also provide several interesting de-
scriptive patterns regarding the interest group respond-
ents, as well as their organizations’ characteristics. For
instance, I focused on the respondent’s answer to their
organization’s main field of work question (detailed
above) for insights into the types of interest groups
participating in the survey. The results suggest that 9%
of the respondents worked for a public interest group
and 8% for a pharmaceutical organization. As shown
in table  1, 12% of respondents stated that “legal or
government affairs” best described their organization’s
main field of work, whereas “health or health care”
was chosen by 23% of the sample.
Another useful way to describe the survey data is
to focus on two respondent categories: public interest
groups and industry. While the public interest groups
identify themselves in the sample, “industry” is a more
difficult category to characterize. As a result, I, again,
rely on the main field of work survey question and com-
bine the categories of research and development, retail
or wholesale business, and pharmaceutical to represent
“industry.” I  then run a series of difference of means
analyses to analyze whether public interest groups have
different characteristics in the data. Specifically, I study
whether public interest groups versus all other survey
respondents look different in terms of the Lobbying
Tactics, Size, Located in DC, and Lobbying Experience
variables. Of these, only Size is statistically significant
and suggests that respondents at public interest groups
work for smaller organizations than other survey re-
spondents on average. I then undertake a similar ana-
lysis for industry organizations. In it, three factors are
statistically significant: industry groups are more likely
17 Given the FDA’s present organization, only one FDA center, the
Oncology Center of Excellence, is not represented. It was created in
2017—after the data collection for this project ended.
10 Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX
Figure 1.  Study Rules by FDA Center. Note: See the Article’s Text for a Detailed Description of the Study’s Sample.
to be larger in Size, less likely to be Located in DC,
and use fewer Lobbying Tactics, on average, than other
survey respondents.
Model Results
This article provides the first empirical results
investigating the differences in perceived and actual
lobbying success across agency notice and comment
versus guidance document procedures. To do so, I use
logistical and ordered logistical regression analyses,
depending on the nature of the dependent variable, to
assess the article’s research question. Robust standard
errors clustered by the rule are included in all specifica-
tions. Standard two-tailed cutoff levels establish statis-
tical significance.
Table 2 displays the results, beginning with the basic
models for the Perceived Lobbying Influence dependent
variable. Overall, the findings in Model 1 provide ini-
tial support for the conclusion that interest groups
Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020
believe that they exert more influence over government
policymaking when they lobby during FDA guidance
development. The coefficient for Guidance Document
is statistically significant and positively signed. In
terms of its substantive effect, Model 1 results dem-
onstrate that the probability that an interest group be-
lieves that it had “some, quite a bit, or a great deal” of
influence over the content of the underlying rule in-
creases from 33.56% for a notice and comment rule to
63.24% for a guidance document.18 Model 2 provides
similar results; however, this specification incorpor-
ates additional rule and organizational characteristics
as control variables. After doing so, the statistical sig-
nificance and direction of Guidance Document re-
main the same, and the substantive significance is also
analogous to Model 1. A number of control variables
are significant across Models 1 and 2.  For instance,
18 For all predicted value calculations, other variables are held constant
at their mean or mode.
Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX 11

Table 2.  Results

1 2 3 4 5 6
Perceived Perceived Actual Actual Top Issue Top Issue
Lobbying Lobbying Lobbying Lobbying Lobbying Lobbying
Key Predictor Variable Influence Influence Success Success Success Success

Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020

Guidance document 1.269 1.665 1.633 2.554 1.248 1.926
.009 .019 .012 .012 .072 .010
Rule characteristics
 Salience 0.363 0.423 0.331 0.506 0.134 0.219
.058 .068 .017 .026 .398 .239
 Complexity 0.264 0.126 0.070 −0.092 0.053 −0.127
.161 .419 .729 .635 .803 .516
 Comments 0.006 0.010 0.015 0.037 0.009 0.020
.311 .302 .013 .017 .127 .073
  Influence attempt 0.702 0.591 0.332 0.471 0.259 0.474
.000 .002 .060 .009 .158 .007
 Hearing . 1.531 . −0.038 . 0.128
.009 .952 .912
  Extended commenting . 0.010 . 0.635 . 1.738
.000 .125 .002
  Rule length . −0.046 . −0.074 . −0.079
.007 .015 .001
  Lobbying tactics . 0.171 . 0.004 . −0.087
.032 .928 .035
Org. characteristics
 Size . 0.107 . 0.180 . −0.082
.122 .101 .323
  Located in DC . 0.786 . 0.089 . −0.402
.029 .835 .138
  Lobbying experience . 0.178 . −0.207 . −0.056
.158 .367 .695
  Research and . −0.435 . −0.302 . 0.594
development .595 .772 .371

  Health or health care . −0.112 . −0.679 . −0.079

.814 .153 .791
  Legal or government . −1.403 . −0.332 . 0.148
affairs .020 .567 .772

  Retail or wholesale . −1.168 . 0.508 . 0.066

business .036 .488 .934

 Pharmaceutical . −0.285 . −1.936 . −2.441

.628 .012 .041
  Public interest group . 0.305 . −1.033 . −0.077
.519 .139 .884
Constant . . −2.517 −1.509 −2.162 0.319
.011 .293 .009 .776
Sample size 191 178 192 180 192 180
Wald χ 2/F; Prob > χ 2/F 37.38; 0.00 348.32; 0.00 14.97; 0.00 80.52; 0.00 10.44; 177.39; 0.00
0.00

Note: All specifications include robust standard errors, which are clustered by rule. Coefficients and p-values are shown. Standard two-tailed
cutoff levels establish statistical significance. Models 1 and 2 employ ordered logistical regression analyses techniques, whereas Models 3 to 6
use logistical analyses. The cut points are: Model 1: 2.74, 4.49, 6.55, and 8.94; Model 2: 4.12, 6.26, 8.68, and 11.18.

in Model 2, interest groups perceive greater influ- that use more Lobbying Tactics perceive greater influ-
ence on rule when those rules have a Hearing or an ence. Another pattern is that groups who describe their
Extended Commenting period. Additionally, groups organization’s field of work as Legal or Government
12 Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX
Affairs report lower levels of perceived influence over
rule content.
Models 3 and 4 move away from an interest
group’s perception of regulatory policy influence to
the interest group’s success in achieving its stated
lobbying goals. These models display the results at-
tached to Actual Lobbying Success, which is a dichot-
omous measure of whether or not the FDA moved
policy toward one or more of the top three policy
changes sought by the interest group in its public
comment. Guidance Document is significant in both
models and is positively signed. The substantive ef-
fect of Guidance Document in Model 3 suggests that
the probability that an interest group receives some
movement toward one of its top lobbying requests in-
creases by almost 30% when that group is lobbying
on a guidance document rather than on a notice and
comment regulations. However, it is notable that
lobbying appears quite successful across both policy
tools (with the probabilities being 56.97% for a notice
and comment rule and 85.70% for a guidance docu-
ment). Model 4 returns a slightly larger substantive
effect size for this relationship. Other control vari-
ables are occasionally statistically significant across
both Models 3 and 4.  For example, Rule Length is
significant and negatively signed, suggesting that there
is a lower level of interest group lobbying success on
longer rules. Interest groups that attempt to influ-
ence a larger portion of the rule are more successful,
whereas groups who describe their organization’s field
of work as Pharmaceutical appear to have lower levels
of actual lobbying success.
Models 5 and 6 focus on an interest group’s ability
to achieve policy movement on its top lobbying re-
quest. Across both model specifications, there is a posi-
tive and statistically significant relationship between
Top Issue Lobbying Success and Guidance Document.
The substantive effect of the Guidance Document co-
efficient in Model 6 implies that the probability of
securing some movement toward the interest group’s
top policy change increases from 23.15% for a notice
and comment rule to 64.69% for a guidance docu-
ment. Several other control measures are also signifi-
cant. For instance, a larger number of Comments to a
rule is associated with greater policy change in Model
6, as is Extended Commenting. Interestingly, other
analyses (which are not shown) reveal that an interest
group’s lobbying success on its top issue is not strongly
correlated with its success on the second or third policy
requests made within the interest group’s public com-
ment. This finding is consistent with the conclusion
that agencies frequently accommodate some of an
interest group’s top lobbying recommendations but
rarely satisfy all of an interest group’s top lobbying re-
quests during rulemaking.
When taken together, the findings across table  2
support the article’s hypothesis. The results suggest
that the policy changes pursued by interest groups
often find their way into government regulatory pol-
icies, and this appears to occur at a higher rate during
guidance document creation than notice and com-
Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020
ment rulemaking. Thus, I  find that interest groups
both believe and achieve greater lobbying success
when lobbying during guidance document creation.
In doing so, the results imply that the specific policy
changes pursued by interest groups are realized at a
higher rate during guidance document creation than
notice and comment rulemaking. To be clear, I am not
suggesting that interest groups hold no influence over
the notice and comment rules in this sample. Instead,
the results contextualize our overall understanding of
lobbying success during rulemaking—providing new
evidence that interest group influence may be particu-
larly impactful during guidance development. I  am
also not evaluating the degree to which interest groups
may be active, and potentially influential, outside of
the notice of proposed rulemaking or guidance pro-
cess phases. Overall, we can expect that lobbying does
occur on the topics underlying these rules both before
and after the regulatory development stage. Instead,
this article asks whether during this consequential
stage in the regulatory policymaking process—i.e., the
stage which purposefully encourages public participa-
tion and comment—does lobbying via the submission
of public comments matter? The answer appears to be
“yes,” and even more so for agency policies that are
promulgated via the more obscure guidance document
process.
Conclusion
I test the proposition that interest groups achieve
greater policy success when they lobby during the
agency guidance process, as opposed to the notice and
comment rulemaking process. In keeping with the lit-
erature, I  suggest that one of the key differences be-
tween these two policy tools is that guidance documents
tend to attract lower levels of public attention than no-
tice and comment rules. Some scholars may not have
been acquainted with the government’s guidance docu-
ment process until reading this article. Yet, as I suggest
above, guidance documents are believed to be used at a
“massive” scale across government (Mendelson 2007,
398) and are understudied by scholars within the fields
of public administration, politics, policy, and interest
groups.
This article draws data and insights from one of the
most consequential American policymakers: the US
Food and Drug Administration. The FDA is a public
sector agency whose broad policymaking mandate
Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX
includes tobacco, nutritional labeling, cosmetics, med-
ical devices, prescription and over-the-counter drugs,
and animal testing. I employ a research design strategy
where I  compare FDA policy decision making across
two similar policy tools. I draw on existing interview
evidence to suggest that guidance documents are the
primary policy tool of choice at the FDA, as well as
to suggest that guidance documents are often used to
regulate on major policy topics and frequently as sub-
stitutes for notice and comment rules (Parrillo 2017).
In this article, I employ a multi-faceted data collection
effort to tap interest group lobbying activity and policy
change, including a content analysis of lobbying texts
and FDA policy documents, and a telephone survey of
the groups who lobbied on the sample rules.
We now know that, for this sample of FDA policies,
interest groups perceive—and achieve—greater policy
success when lobbying during the agency guidance
process than during notice and comment rulemaking.
Specifically, I find that interest groups believe that they
exert more influence over government policymaking
when they lobby on guidance documents. I then inves-
tigate the actual lobbying success these interest groups
achieve during FDA decision making, and the data re-
turn solid evidence that interest groups frequently see
policy movement on one or more of their top lobbying
goals. While rates for lobbying success are also high
for notice and comment rulemaking, interest group
lobbying during the guidance process appears more
impactful.
These results hold particular importance given
President Trump’s recent policy announcement.
Beginning in 2020, E.O. 13981 will require that a
public comment process be used for all significant guid-
ance documents promulgated by cabinet-level agen-
cies—making the conclusions drawn from the FDA
process in this article particularly timely. Given the
FDA’s long experience with taking public comments on
important guidance documents, the findings in this art-
icle ought to provide insights into future influence pat-
terns in other agencies as the executive order spreads
a similar commenting requirement across most of the
federal government. Moreover, recent developments in
the US Supreme Court augment the significance of this
article’s results, as well. In Kisor v. Wilkie (No. 18-15,
588 U.S. ___ (2019)), the Supreme Court upheld the
long-standing precedent that courts ought to defer to
a government agency’s reasonable interpretation of its
own regulations (Talbot 2019). Such a ruling may pro-
vide further cover for the use of agency guidance as a
means of future policymaking, while also serving as
a potential step toward greater judicial oversight of
agency guidance use in the future.
Although the findings move the literature forward,
it is also important to be clear about their limitations.
13
For instance, the results are derived from one agency
and within one time window. Future work must collect
data that expand the analyses to new policymaking set-
tings and over a longer time period. For instance, other
agencies, including the US Environmental Protection
Agency (Mendelson 2007) and US Consumer Financial
Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020
Protection Bureau (Romano 2019), which also use
guidance at a high rate, would be opportune settings to
explore these trends further. This type of additional ana-
lysis is even more important because, while numerous
experts see similarities across guidance documents and
notice and comment rules promulgated by the FDA,
as documented by Parrillo (2017), such as a relation-
ship may not be as clear in other public agencies. This
suggests the need for additional research dedicated to
understanding how, when, and why agencies, including
the FDA, address some policy issues via the guidance
process while others go through the more traditional
notice and comment rulemaking, as well as more work
that explores how answers to these questions vary by
agency. Doing so will improve our understanding of
agency practice, as well as provide additional evidence
regarding how and why the public’s attention to spe-
cific agency policy tools may interact with an agency
choice of policy tools.
Another limitation is that the article’s findings are
primarily identified within an observational study, and
as a result, this limits what can be said about caus-
ality. This caveat is important. Nevertheless, several
things mitigate it. For instance, the article’s research
design takes advantage of the close proximity between
the interest group’s lobbying requests made in public
comments and the agency’s policy modifications.
Additionally, the results occur within model specifica-
tions that control for a variety of other factors that
may drive regulatory policy change—including the
complexity of the rule. Finally, I attempt to be careful
in the attribution of “lobbying success” (as opposed to
“influence”). Here I follow Mahoney (2007, 44), who
argues that “[l]obbying success does not prove influ-
ence. An advocate could see an outcome on their issue
that is in line with their preferences but may have done
nothing to bring about that outcome.” Nevertheless,
as Mahoney (2007) argues, studies of lobbying suc-
cess are important because they allow scholars to track
winners and losers within policy debates.
The article’s research design and findings point
the way for future research. First, they further dem-
onstrate the promise of moving beyond traditional
policymaking venues to examine interest group
lobbying success (Baumgartner et  al. 2009; Hojnacki
et al. 2012). Second, the article’s results are consistent
with the conclusion that agencies rarely satisfy all of
an interest group’s lobbying requests; however, agen-
cies frequently appear to accommodate some of the
14 Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX
requests. Such a strategy may allow for the partial
accommodation of a larger number of external partici-
pants. Future research will need to explore the agency’s
intentions, constraints, and goals. Third, the article
advances knowledge by introducing the importance
of policy formation within guidance documents to a
broader audience. In the end, this article’s findings—
when taken together with these “next steps” for future
research—suggest a ripe area for students of public ad-
ministration and politics to explore.
References
Anthony,  Robert  A. 1992. Interpretive rules, policy statements,
guidances, manuals, and the like-should federal agencies use
them to bind the public. Duke Law Journal 41: 1311–84.
Bagley,  Nicolas. 2010. Agency hygiene. Texas Law Review 89:
1–14.
Barkow,  Rachel  E. 2010. Insulating agencies: Avoiding capture
through institutional design. Texas Law Review 89: 15–79.
Baumgartner, Frank, Jeffrey Berry, Marie Hojnacki, David Kimball,
and Beth Leech. 2009. Lobbying and policy change: Who wins,
who loses, and why. Chicago, IL: Univ. of Chicago Press.
Baumgartner,  Frank  R., and Bryan  D.  Jones. 1993. Agendas and
instability in American politics. Chicago, IL: Univ. of Chicago
Press.
Bernstein, Marver. 1955. Regulating business by independent com-
mission. Princeton, NJ: Princeton Univ. Press.
Boehmke, Frederick, Sean Gailmard, and John Patty. 2013. Business
as usual: Interest group access and representation across policy-
making venues. Journal of Public Policy. 33: 3–33.
Browne, William P. 1990. Organized interests and their issue niches:
A search for pluralism in a policy domain. Journal of Politics 52:
477–509.
Carpenter, Daniel P. 2002. Groups, the media, agency waiting costs,
and FDA drug approval. American Journal of Political Science
46: 490–505.
Chubb, John E. 1983. Interest groups and the bureaucracy: The pol-
itics of energy. Stanford, CA: Stanford Univ. Press.
Coglianese,  Cary, Heather  Kilmartin, and Evan  Mendelson. 2009.
Transparency and public participation in the rulemaking process.
Georgetown Law Review 77: 924.
Epstein, David, and Sharyn O’Halloran. 1995. A theory of strategic
oversight: Congress, lobbyists, and the bureaucracy. The Journal
of Law, Economics, and Organization 11: 227–55.
FDA. 2011. Advancing regulatory science: Strategic plan for regula-
tory science. http://www.fda.gov/ScienceResearch/SpecialTopics/
RegulatoryScience/ucm267719.htm.
Franklin, David L. 2010. Legislative rules, nonlegislative rules, and
the perils of the short cut. Yale Law Journal 120: 202–407.
Funk,  William  F. 2001. A primer on nonlegislative rules.
Administrative Law Review 53: 1321–52.
Furlong, Scott R. 1998. Political influence on the bureaucracy: The
bureaucracy speaks. Journal of Public Administration Research
and Theory 8: 39–65. https://doi.org/10.1093/oxfordjournals.
jpart.a024373
Furlong, Scott, and Cornelius M. Kerwin. 2005. Interest group par-
ticipation in rule making: A decade of change. Journal of Public
Administration Research and Theory 15: 353–70. doi:10.1093/
jopart/mui022
Garrett,  Elizabeth, and Adrian  Vermeule. 2006. Transparency in
the budget process. Univ. of Chicago Law & Economics, Olin
Working Paper. doi:10.2139/ssrn.877951.
Gluck,  Abbe  R., Rosa  Po, and Ann  Joseph  O’Connell. 2015.
Unorthodox lawmaking, unorthodox rulemaking. Columbia
Law Review 115: 1789–65.
Golden, Marissa Martino. 1998. Interest groups in the rule-making
process: Who participates? Whose voices get heard? Journal of
Public Administration Research and Theory 8: 245–70.
Gormley, William T. 1982. Alternative models of the regulatory pro-
Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020
cess: Public utility regulation in the states. The Western Political
Quarterly 35: 297–317.
———. 1986. Regulatory issue networks in a federal system. Polity
18: 595–620. https://doi.org/10.1093/oxfordjournals.jpart.
a024380
Graham, John D., and James Broughel. 2015. Confronting the problem
of stealth regulation. Mercatus Center. https://www.mercatus.
org/publication/confronting-problem-stealth-regulation.
Greve,  Michael, and Ashley  Parrish. 2014. Administrative law
without congress. George Mason Law Review 22: 501–47.
Haeder,  Simon, and Susan  Webb  Yackee. 2015. Influence and the
administrative process: Lobbying the U.S.  president’s OMB.
American Political Science Review 109: 507–22.
Hojnacki,  Marie, David  C.  Kimball, Frank  R.  Baumgartner,
Jeffrey  M.  Berry, and Beth  L.  Leech. 2012. Studying organiza-
tional advocacy and influence: Reexamining interest group re-
search. Annual Review of Political Science 15: 379–99.
Hrebenar, Ronald J., and Ruth K. Scott. 1996. Interest group politics
in America, 3rd ed. New York, NY: Routledge.
Hwang,  Thomas  J, Jerry  Avorn, Daniel  Carpenter, and
Aaron S Kesselheim. 2014. Lifecycle of medical product rules is-
sued by the US food and drug administration. Journal of Health
Politics, Policy, and Law 39: 751–80.
Kaufman, Herbert. 1981. The confines of leadership. In The admin-
istrative behavior of federal bureau chiefs, 91–138. Washington,
DC: Brookings Institution.
Kerwin,  Cornelius  M., and Scott  R.  Furlong. 2018. Rulemaking:
How government agencies write law and make policy, 5th ed.
Washington, DC: CQ Press.
Kingdon, John W. 1995. Agendas, alternatives, and public policies,
2nd ed. New York, NY: HarperCollins College Publishers.
Levin, Ronald M. 2018. Rulemaking and the guidance exemption.
Administrative Law Review 70: 263–356.
Lewis, Kevin Michael. 2011. Informal guidance and the FDA. Food
and Drug Law Journal 66: 507–50.
Magill,  Elizabeth  M. 2004. Agency choice of policymaking form.
University of Chicago Law Review 71: 1383–447.
Mahoney, Christine. 2007. Lobbying success in the United States and
the European Union author. Journal of Public Policy 27: 35–56.
Manning,  John  F. 1996. Constitutional structure and judicial def-
erence to agency interpretations of agency rules. Columbia Law
Review 96: 612–96.
Mantel,  Jessica. 2009. Procedural safeguards for agency guidance.
Administrative Law Review 61: 343–406.
Mendelson,  Nina. 2007. Regulatory beneficiaries and informal
agency policymaking. Cornell Law Review 92: 397–452.
Naughton,  Keith, Celeste  Schmid, Susan  Webb  Yackee, and
Xueyong  Zhan. 2009. Understanding commenter influence
during agency rule development. Journal of Policy Analysis and
Management 8: 258–77.
Noah,  Lars. 2014. Governance by the backdoor: Administrative
law(lessness?) at the FDA. Nebraska Law Review 93:89–138.
Office of Management and Budget. 2007. Final bulletin for agency
good guidance practices, No. 07-02. http://www.whitehouse.gov/
omb/inforeg/good{\_}guid/c-index.html.
Parrillo, Nicholas R. 2017. Federal agency guidance: An institutional
perspective. Administrative Conference of the United States
Report, October 12, 2017.
Journal of Public Administration Research and Theory, 2020, Vol. XX, No. XX
Quirk, Paul J. 1981. Industry influence in federal regulatory agen-
cies. Princeton, NJ: Princeton Univ. Press.
Raso, Connor N. 2010. Strategic or sincere? Analyzing agency use of
guidance documents. Yale Law Journal 119: 648–847.
Romano,  Roberta. 2019. Does agency structure affect agency
decisionmaking? Implications of the CFPB’s design for adminis-
trative governance. Yale Journal on Regulation 3: 273–358.
Rosenbloom,  David  H. 2000. Framing legislative centered public
administration: Congress ’s 1946 response to the administrative
state. Tuscaloosa, AL: Univ. of Alabama Press.
Rourke, Francis. 1984. Bureaucracy, politics, and public policy, 3rd
ed. Boston, MA: Little Brown.
Ruder, Alexander I., and Neal D. Woods. Procedural fairness and the
legitimacy of agency rulemaking. Journal of Public Administration
Research and Theory, Forthcoming. doi:10.1093/jopart/muz017
Sabatier,  Paul. 1975. Social movements and regulatory agencies:
Toward a more adequate—and less pessimistic—theory of ‘clien-
tele capture’. Policy Sciences 6: 301–42.
Schattschneider, Elmer E. 1975. The semisovereign people: A realist’s
view of democracy in America. Revised. Hinsdale, IL: Dryden
Press.
Seidenfeld,  Mark  B. 2011. Substituting substantive for procedural
review of guidance documents. Texas Law Review 90: 331–94.
Shapiro, Stuart. 2014. Agency oversight as whac-a-mole: The chal-
lenge of restricting agency use of nonlegislative rules. Harvard
Journal of Law and Public Policy 37: 523–52
Talbot,  Margaret. 2019. The pivotal justice. The New Yorker,
November 18, 2019.
15
Warren, Kenneth F. 2020. Administrative law in the political system,
6th ed. New York City, NY: Routledge Press.
West,  William  F. 1995. Controlling the bureaucracy: Institutional
constraints in theory and practice. Armonk, NY: M.E. Sharpe.
———. 2004. Formal procedures, informal processes, account-
ability, and responsiveness in bureaucratic policy making: An
institutional policy analysis. Public Administration Review 64:
Downloaded from https://academic.oup.com/jpart/article-abstract/doi/10.1093/jopart/muaa009/5810413 by University of Exeter user on 26 June 2020
66–80.
Wilson, James Q. 1989. Bureaucracy: What government agencies do
and why they do it. New York, NY: Basic Books.
Yackee,  Susan  Webb. 2006. Sweet-talking the fourth branch:
Assessing the influence of interest group comments on federal
agency rulemaking. Journal of Public Administration Research
and Theory 26: 103–24. doi:10.1093/jopart/mui042
———. 2012. The politics of ex parte lobbying: Pre-proposal
agenda building and blocking during agency rulemaking. Journal
of Public Administration Research and Theory 22: 373–93.
doi:10.1093/jopart/mur061
———. 2015. Invisible (and visible) lobbying: The case of state
regulatory policymaking. State Politics and Policy Quarterly 15:
322–44.
———. 2019. The politics of rulemaking in the U.S. Annual Review
of Political Science 22: 37–55.
You,  Hye  Young. 2017. Ex post lobbying. Journal of Politics 79:
1162–76.
Young, Kevin, Tim Marple, and James Heilman. 2017. Beyond the
revolving door: Advocacy behavior and social distance to finan-
cial regulators. Business and Politics 19: 327–64.