ACTY 8103

Product Recalls
The following artefacts have been collected from various internet sources in relation to PFizer
Inc – an international drug company.

The artifacts have been selected to provide a history of a specific drug recall in 2005 (Bextra) and the
associated lawsuit that followed and settled in 2009. Artifact 7 focuses on more current practice
associated with the manufacture of a vaccine for COVID 19. Read through the material provided
from a quality management accounting perspective. You will be asked to answer specific questions
on the quality cost management perspective and Pfizer’s handling of the product recall.

Feel free to make assumptions in your answer provided you do not assume away the evidence
provided in these artifacts.

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Artifact 1
Pfizer’s Bextra Recall
Year: 2005
Cost: $3.3 billion

Pharmaceutical giant Pfizer (PFE, $34.49) was floored in 2005 when the Food and Drug
Administration forced it to pull Bextra, an arthritis painkiller, off the market because of
possible heart risks and “life-threatening” skin reactions. At the time, Bextra was one of
Pfizer’s best-selling products, with annual sales of $1.3 billion in 2004.

But that was only the beginning of Pfizer’s woes.

In 2009, Pfizer settled civil and criminal allegations that it had illegally marketed Bextra. Its
$2.3 billion payout was the largest health-care fraud settlement and the largest criminal fine
of any kind at the time. Between lost sales, fines, settlement and other costs, Pfizer took a
hit of at least $3.3 billion on the Bextra recall, according to Statista.

Long-term investors who bought the dip after the September 2009 settlement didn’t make
out so well either. Shares in Pfizer trail the S&P 500 by about 50 percentage points since
then.

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Artifact 2

Pfizer to settle Bextra, Celebrex lawsuits

By Ransdell Pierson
4 MIN READ

NEW YORK (Reuters) - Pfizer Inc said on Friday it plans to pay $894 million to settle lawsuits
alleging that its withdrawn Bextra painkiller and widely used Celebrex arthritis drug harmed
U.S. patients and defrauded consumers.

Pfizer said the money would be paid out under three separate tentative settlements --
including one that resolves claims by 33 states and the District of Columbia primarily related
to Bextra marketing practices.

“It’s good that Pfizer is settling the majority of these cases because these things tend to drag
on for five to 10 years and take a lot of focus off running the company,” said Jon LeCroy, an
analyst with Natixis Bleichroeder.

LeCroy said Wall Street has closely followed the Bextra and Celebrex cases because Bextra
was sold only briefly. Moreover, he said Celebrex has not been shown to have the same
cardiovascular risks as Vioxx, a similar drug that Merck & Co Inc withdrew in 2004.

New York-based Pfizer said it has taken a pretax charge of $894 million in the third quarter
for the proposed settlements, and that the funds should also be sufficient to cover personal
injury cases that have not yet been resolved.

The company, which still sells Celebrex, said it decided to settle to eliminate the legal
distractions, although it admitted no wrongdoing.

“Putting all these matters behind Pfizer makes good sense from the company point of view
and with respect to patients and doctors,” Amy Schulman, Pfizer’s general counsel, said in
an interview.

The charge includes $745 million to resolve personal injury claims, $60 million to settle with
the states over Bextra marketing practices and $89 million to resolve consumer fraud class-
action cases that allege Bextra and Celebrex promotions caused financial harm.

Bextra and Celebrex belong to the same class of painkillers as Vioxx, which was withdrawn
after being linked to heart attacks among long-time users. Merck has resolved claims from
most of the thousands of U.S. patients who said they were harmed by its drug with a $4.85
billion settlement.

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In 2005, the U.S. Food and Drug Administration asked Pfizer to withdraw Bextra from U.S.
drugstores, citing a possible risk of causing heart problems and reports of a potentially fatal
skin reaction called Stevens-Johnson syndrome in people taking the drug.

Pfizer’s Schulman declined to break down how much of the money being set aside would
satisfy Bextra claims or Celebrex lawsuits.

But she said federal and state courts have ruled there is no reliable scientific evidence that
Celebrex increases risk of heart attack and stroke.

At the time that Bextra was withdrawn, the FDA ordered that all prescription nonsteroidal
anti-inflammatory drugs (NSAIDs), including Celebrex, carry a “black box” warning about
potential increased risk of heart attacks, strokes and stomach problems.

The FDA also required that all over-the-counter NSAIDs, including naproxen and ibuprofen,
include more information about those risks, as well as the risk of serious skin reactions. The
label changes do not apply, however, to aspirin or acetaminophen -- the active ingredient of
Johnson & Johnson’s Tylenol painkiller.

Pfizer shares were down 3 cents to $16.94 on the New York Stock Exchange on Friday.

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Artifact 3

Q&A on the FDA Actions for the COX-2 Inhibitors and NSAIDs
(Suspension of Sales and Marketing of Bextra)
FDA Regulatory Actions for the COX-2 Selective and Non-Selective Non-Steroidal Anti-
inflammatory drugs (NSAIDs)
FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)
The Food and Drug Administration (FDA) today announced a series of important changes
pertaining to the marketing of the nonsteroidal antiinflammatory class of drugs, including
COX-2 selective and prescription and non-prescription (over-the-counter (OTC)) non-
selective NSAID medications . A list of these products is available on the Internet at
http://www.fda.gov/cder/drug/infopage/cox2/default.htm.
After concluding that the overall risk versus benefit profile is unfavorable, FDA has
requested Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. This
request is based on:
The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along
with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery
bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.
Reports of serious and potentially life-threatening skin reactions, including deaths, in
patients using Bextra. The risk of these reactions in individual patients is unpredictable,
occurring in patients with and without a prior history of sulfa allergy, and after both short-
and long-term use.
Lack of any demonstrated advantages for Bextra compared with other NSAIDs.
Patients currently taking Bextra should contact their physicians to consider alternative
treatments. FDA is also asking manufacturers of all marketed prescription NSAIDs,
including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package
insert) for their products to include a boxed warning and a Medication Guide. The boxed
warning will highlight the potential for increased risk of CV events with these drugs and the
well-described, serious, and potentially life-threatening gastrointestinal (GI) bleeding
associated with their use. The Medication Guide will accompany every prescription NSAID at
the time it is dispensed to better inform patients about the CV and GI risks. Finally, FDA is
asking manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include
more specific information about the potential GI and CV risks, and information to assist
consumers in the safe use of the drug. This announcement does not apply to aspirin as it
has clearly been shown to reduce the risk of serious adverse CV events in certain patient
populations. 
FDA Q&A
1. What is FDA announcing today?
In follow-up to the February 16-18, 2005, joint meeting of FDA's Arthritis and Drug Safety
and Risk Management Advisory Committees, convened to discuss the safety of the "COX-2
selective nonsteroidal anti-inflammatory drugs and related agents," we are announcing our

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planned regulatory actions for Bextra, Celebrex, and the non-selective prescription and
over-the-counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs).
We have concluded that the overall risk versus benefit profile for Bextra is unfavorable and
we have requested that Pfizer, the manufacturer, voluntarily withdraw the drug from the
market. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pendng
further discussions with the agency. We are requesting that manufacturers of all marketed
prescription NSAIDs, including Celebrex, a COX-2 selective NSAID, revise the labeling
(package insert) for their products to include a boxed warning and a Medication Guide. The
boxed warning will highlight the potential for increased risk of cardiovascular (CV) events
and the well-described, serious, and potentially life threatening gastrointestinal (GI)
bleeding associated with these drugs.
We are asking manufacturers of OTC NSAIDs to revise their labeling to include more specific
information about the potential GI and CV risks, and information to assist consumers in the
safe use of the drug. This includes instructions about which patients should seek the advice
of a physician before using these drugs, stronger reminders about limiting the dose and
duration of treatment in accordance with the package instructions unless otherwise advised
by a physician, and a warning about potential skin reactions.
We anticipate that our actions will lead to careful and appropriate use of these drugs to
maximize their potential benefits and minimize their risks.
2. To what products does FDA's decision apply and what is being requested?
The decision applies to the marketed COX-2 selective drugs (Bextra and Celebrex) as well as
the non-selective NSAIDs. A detailed chart listing the chemical name and trade names for
the products affected by this announcement is attached and also can be found at
http://www.fda.gov/cder/drug/infopage/cox2/default.htm#list.
For the COX-2 selective inhibitor drugs, we have determined the following:
Bextra (valdecoxib tablets): FDA has concluded that the overall risk versus benefit profile is
unfavorable at this time and has requested the manufacturer of Bextra, Pfizer, Inc., to
voluntarily withdraw Bextra from the market. This request is based on:
the lack of adequate data on the cardiovascular safety of long-term use of Bextra, along
with the increased risk of adverse CV events in short-term coronary artery bypass surgery
(CABG) trials that FDA believes may be relevant to chronic use,
reports of serious and potentially life-threatening skin reactions, including deaths, in
patients using Bextra. The risk of these serious skin reactions in individual patients is
unpredictable, occurring in patients with and without a prior history of sulfa allergy, and
after both short- and long-term use, and
the lack of any demonstrated advantages for Bextra compared with other NSAIDs.

Heart Disease: Causes of a Heart Attack

Pfizer has agreed to suspend sales and marketing of Bextra in the U.S. pending further
discussions with the agency.
Celebrex (celecoxib tablets): We have concluded that the benefits of Celebrex outweigh the
potential risks in properly selected and informed patients. FDA has decided to allow
Celebrex to remain and has asked Pfizer to take the actions listed below:
Revise the Celebrex label to include a boxed warning containing the class NSAID warnings
and contraindication about CV and GI risk, plus specific information on the controlled clinical
trial data that demonstrate an increased risk of adverse CV events for celecoxib.

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Encourage practitioners to use the lowest effective dose for the shortest duration consistent
with individual patient treatment goals.
Include a Medication Guide as part of the labeling. It will be required to be given at the time
the drug is dispensed to inform patients of the potential for CV and GI risk associated with
NSAIDS, in general, and Celebrex specifically. The Medication Guide will inform patients of
the need to discuss with their doctor the risks and benefits of using NSAIDs and the
importance of using the lowest effective dose for the shortest duration possible.
Commit to conduct a long-term study of the safety of Celebrex compared to naproxen and
other appropriate drugs.
Vioxx (rofecoxib tablets and suspension): Vioxx was voluntarily removed from the market
by Merck in September 2004. FDA will carefully review any proposal from Merck for
resumption of marketing of Vioxx, and would likely discuss the review with the new FDA
Drug Safety Oversight Board and an Advisory Committee before making a final decision.
Non-selective NSAIDs
Based upon the available data, FDA has concluded that an increased risk of CV events may
be a class effect for NSAIDs. There are a number of non-selective NSAIDs currently approved
for marketing in the United States. Long term controlled clinical trials have not been
conducted with most of these NSAIDs. However, the available data suggests that use of
these drugs may increase CV risk.
To further evaluate the potential for increased CV risk, all sponsors of non-selective NSAIDs
will be asked to conduct and submit to FDA a comprehensive review and analysis of
pertinent available controlled clinical trial databases.
In addition, FDA is requesting labeling changes for prescription and OTC non-selective
NSAIDs. Because the use and labeling for the prescription products is different from those
available without a prescription, they are addressed separately.
Prescription Non-Selective NSAIDs
Based on the available data, the FDA will request the manufacturers of all prescription
products containing non-selective NSAIDs to revise their product labeling to include:
A boxed warning regarding the potential serious adverse CV events and the serious, and
potentially life-threatening GI adverse events associated with the use of this class of drugs.
A contraindication for use in patients who have recently undergone coronary artery bypass
surgery.
A Medication Guide for patients to help make them aware of the potential for CV and GI
adverse events associated with the use of this class of drugs. The Medication Guide will
inform patients of the need to discuss with their doctor the risks and benefits of using
NSAIDs and the importance of using the lowest effective dose for the shortest duration
possible if treatment with an NSAID is warranted in an individual patient.
OTC Non-Selective NSAIDs
The available data do not appear to suggest an increased risk of serious CV events for the
short-term, low-dose use of the NSAIDs available over the counter. FDA will request changes
to the label to better inform consumers regarding the safe use of these products.
FDA will ask the manufacturers of all non-prescription products
containing ibuprofen (Motrin, Advil, Ibu-Tab 200, Medipren, Cap-Profen, Tab-Profen,
Profen, Ibuprohm), naproxen (Aleve), and ketoprofen (Orudis, Actron) to revise their
labeling to include:
More specific information about the potential CV and GI risks,

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Instructions about which patients should seek the advice of a physician before using these
drugs,
Stronger reminders about limiting the dose and duration of treatment in accordance with
the package instructions unless otherwise advised by a physician, and
A warning about potential skin reactions.
3. What information did FDA review to arrive at its decisions?
FDA's Center for Drug Evaluation and Research (CDER) considered the risk/benefit profile for
each of the drugs Cox-2 selective drugs, and the CV risks of NSAIDs as a class. We reviewed
the regulatory histories and NDA databases of the various NSAIDs, FDA and sponsor
background documents prepared for the joint Advisory Committee meeting, all materials
and data submitted by other stakeholders to the Advisory Committee meeting,
presentations made at the joint meeting, the discussions held by the Committee members
during the meeting, and the specific votes and recommendations of the joint Committee.
4. What offices within the Center for Drug Evaluation and Research had input into the
decisions?
Participants in the CDER decision-making process included staff from the Office of New
Drugs (i.e., the Division of Anti-Inflammatory, Analgesic, and Ophthalmic Drug Products, the
Division of Over-the-Counter Drug Products, and the Offices of Drug Evaluation II and V), the
Office of Drug Safety, Office of Pharmacoepidemiology and Statistical Science, the Office of
Medical Policy, the Office of Regulatory Policy, and the Office of the Center Director.
5. Does the Office of Drug Safety agree with the Office of New Drugs and the Divisions?
The management of the Offices of Drug Safety and New Drugs are in full agreement
regarding the actions announced by FDA today.
6. Why has FDA requested Pfizer to voluntarily withdraw Bextra from the market?
We have concluded that, from a public health perspective, we must assume that Bextra has
an increased risk of CV events with long-term use. This conclusion is strongly supported by
the significant increase in CV risk seen in those patients who had just
undergone heart surgery and the fact that other COX-2 selective NSAIDs have demonstrated
such increased CV risk in long-term studies. What is not known is how large that risk is in
outpatient long-term use, because the studies have not been done. However, the CV risk is
likely to be no less than that of other Cox-2 selective inhibitors. In addition, Bextra already
carries a boxed warning related to its increased risk of serious, life-threatening skin
reactions, which have been reported at a much higher rate than for other COX-2 selective
inhibitors. Finally, there are no data to suggest that Bextra has benefits that would outweigh
these risks (e.g., GI safety or better efficacy). Bextra has not been shown to offer any
advantages over other existing NSAIDs. Therefore, we have concluded that the overall risk
versus benefit profile of Bextra is unfavorable.

What causes tooth decay?

7. The Advisory Committee votes were split on Bextra. Why didn't FDA go with the
recommendation of the majority?
The Advisory Committees were closely divided on whether Bextra should remain on the
market (17 voted yes, 13 voted no, with 2 abstentions). Advisory Committee votes are
recommendations to FDA, and are not binding on the agency. In all cases, but particularly in
cases where its Advisory Committees are closely divided, FDA has the responsibility to weigh
all the evidence and determine what, if any, regulatory action is appropriate. After weighing

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all the evidence, as described in question 6 above, FDA decided to seek the withdrawal of
Bextra from the market.
8. It was reported in the New York Times that the members of the FDA Arthritis and Drugs
Safety and Risk Management Advisory Committees reviewing the safety risks of COX-2
inhibitors were not obligated to disclose their potential conflicts of interest. Were there
any conflicts of interest for any of the members, and did this have an effect on the
members' recommendations?
For each advisory committee meeting, the Center for Drug Evaluation and Research (CDER)
collects financial interest information for advisory committee members and consultants
prior to their participation in order to determine whether the members or consultants have
any financial interests that pose conflicts of interest.
All members of this joint committee and consultants who participated as discussants and/or
voted at the meeting responded to detailed questions regarding their interests in all entities
with a financial interest in the meeting topic. After conducting a review of the potential
conflicts of interest for all of the members on the advisory committee examining COX-2
inhibitors, conflicts of interest were found. However, these conflicts were not deemed to be
of sufficient magnitude to outweigh the need for the members' and consultants' expertise
for this meeting. Waivers were written and approved consistent with the federal ethics and
conflict of interest laws for 19 participants.
We do not believe that any of the conflicts of interest affected members' recommendations.
9. Why isn't FDA requesting that Celebrex also be withdrawn?
The Advisory Committees were unanimous in their conclusion that an increased risk of CV
adverse events has been demonstrated for Celebrex (as for all the Cox-2 selective inhibitors)
but strongly supported the continued marketing of the drug. FDA has concluded, based on
the available data, that the benefits of Celebrex outweigh its potential risks in properly
selected and informed patients. This conclusion is based on our review of the available
safety data and the long-term controlled clinical trial comparisons of Celebrex to non-
selective NSAIDs. While it appears that Celebrex is associated with an increased risk of
serious CV adverse events, the available data do not support a conclusion that Celebrex is
significantly worse than the non-selective NSAIDs. The NSAID class boxed warning regarding
increased CV and GI risks will be applied to Celebrex, and in addition the labeling will include
additional information as described in question 2 above that will inform physicians and
patients of the potential risks and allow for informed prescribing decisions.

10. Does FDA anticipate that Vioxx will return to the market at some point?
Vioxx was voluntarily removed from the market by Merck in September 2004. FDA will
carefully review any proposal from Merck for resumption of marketing of Vioxx, and would
likely discuss the review with the new FDA Drug Safety Oversight Board and an Advisory
Committee before making a final decision.
11. Will Bextra be available to patients on a compassionate use basis?
If the sponsor proposes a program to provide limited access to those patients who believe
that this drug is the best option for them, FDA would be willing to consider this.
12. Are there other examples of drug products that have boxed warnings on the
prescription indications, but are also available at an OTC dose?
We believe that this is the first time that a product with a boxed warning on the prescription
version will also be available for non-prescription use. We believe that the available data
support a conclusion that short-term use of low doses of the available OTC NSAIDs is not

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associated with any increased serious CV risk. When used according to their labeled
instructions, we believe that OTC NSAIDs continue to have a very favorable risk benefit
profile, and we believe it is important to maintain a range of therapeutic options for the
short-term relief of pain in the OTC market.
13. Who may be at higher risk when taking these products?
Those at higher risk would include patients immediately post-operative from cardiovascular
bypass surgery (CABG) and people who have coronary artery disease (people who have
known angina or who have had a heart attack), people who have cerebrovascular disease
(people who have had a stroke or who currently have episodes known as TIA (transient
ischemic attacks)), and people with a history of stomach ulcers.
14. Did FDA consult the newly identified Drug Safety Board (DSB) that was to be
established by the Agency?
No. The Board has not yet been convened.
15. Is Naproxen safe from a CV standpoint? How does it compare to the COX-2s?
Based on the currently available data FDA has concluded that the potential for increased risk
of serious CV adverse events is a class effect of NSAIDs. This conclusion applies to naproxen.
As with other members of the NSAID class, additional data from long-term, controlled
clinical trials is needed to more definitively determine the magnitude of increased risk, if
any, of naproxen over placebo and in relation to other NSAIDs.
16. Some NSAIDs have been associated with serious, potentially life-threatening skin
reactions, such as Stevens-Johnson syndrome (SJS). What is FDA doing to warn patients
about this risk?
FDA has determined that the labeling for all non-prescription NSAIDs should be updated to
warn of the potential for skin reactions. Accordingly, along with the changes to the label to
address CV risks, the agency will ask manufacturers of non-prescription NSAIDs to make
these changes. FDA also has recently received a Citizens Petition regarding the risk of SJS
with ibuprofen (received February 15, 2005). The petition is still under review. After
reviewing the data submitted with the petition, FDA will determine whether additional
labeling changes with regard to skin reactions are warranted.
17. If I'm taking Bextra, what should I do?
We encourage people taking Bextra to contact their physician to discuss discontinuing use
and alternative treatments. Any decision about which drug product to take to treat your
symptoms should be made in consultation with your physician based on an assessment of
your specific treatment needs.
18. If I have rheumatoid arthritis, what pain medication does FDA recommend?
You should consult your doctor to discuss the best course of action.
19. How can I report serious side effects with COX-2 selective and non-selective NSAIDs to
FDA?
FDA encourages anyone aware of a serious adverse reaction to make a MedWatch report.
You can report an adverse event in two ways:
Visit www.fda.gov/medwatch and click on "How to Report"
Call 1-800-FDA-1088
20. Where can I get more information?
To find out more about all NSAIDs from FDA:
Visit our Drug Information web page at: www.fda.gov/cder
Call Drug Information at: 888-INFO-FDA (888-463-6332)
FDA press release on the suspension of sales and marketing of Bextra

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Artifact 4
Source: www.fda.gov Center for Drug Evaluation and Research, MedWatch Alert, April 7,
2005

As a society, we trust that the medications our doctors prescribe will help, not hurt us. Even
though prescription drugs go through a rigorous testing and approval process, dangerous
and deadly drugs can still get through to market. Here is a look at five of the worst drug
recalls in recent history.
1. Vioxx
After five years on the consumer market, pharmaceutical manufacturer Merck recalled
Vioxx, a pain reliever for arthritis, in 2004. This recall cost close to $6 billion. As one of the
largest prescription drug recalls in history, the recall provoked a public uproar and harsh
criticisms of Merck and the U.S. Food and Drug Administration (FDA). Critics claimed that
the drug manufacturer and FDA ignored the dangers of Vioxx. At the time of the recall, Vioxx
had been prescribed to more than 20 million people. Up to 140,000 suffered from heart
attacks or strokes after taking Vioxx.

2. Bextra 
Bextra, like Vioxx, was a pain reliever meant to treat arthritis and other inflammation in the
body. Its manufacturer, Pfizer, recalled the drug in 2005 after being on the market for one
year. Also like Vioxx, but not as widely or heavily publicized, Bextra was recalled due to
increased risk of heart attack and stroke in some patients, but it was also found to cause a
fatal skin condition. Pfizer and its subsidiary, Pharmacia & UpJohn, were fined nearly $1.2
billion. It is one of the largest criminal fines imposed on a U.S. drug company.

3. Baycol
Baycol, made by Bayer, was recalled after being on the market for four years. In 2001, Bayer
recalled Baycol, a drug for patients with high cholesterol, after it was reported to be the
cause of more than 100,000 deaths and connected to a muscle disorder called
rhabdomyolysis, a condition that caused the kidneys to clog with protein from dying or dead
muscle tissue. The recall cost Bayer $1.2 billion.

4. Able Laboratories Generic Prescription Drugs

In May 2005, Able Laboratories unexpectedly recalled and removed all their generic
prescription drugs from the market due to questions about the quality of their
manufacturing process. Some of the drugs were scrutinized for being too strong, and others
were not effective enough. The FDA also found in its investigation that four of Able
Laboratories’ top-level managers falsified and fraudulently circulated misbranded and
mislabeled drugs. Able Laboratories went out of business after this recall.

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5. Rezulin
The Los Angeles Times gave the first insight into the way Rezulin was recalled in 2000 after
one year on the market. Rezulin, an anti-diabetic drug manufactured by Warner-Lambert,
was recalled after links with hepatitis and liver failure were discovered. The drug’s approval
was controversial due to an accelerated review process in 1997 and the FDA’s delayed
responses to complaints about the drug and its eventual recall.
The Attorneys at Hossley & Embry Can Evaluate Your Bad Drug Case
We know that the side effects from a recalled or inappropriately prescribed drug can be
devastating to your health and family. If you have been injured or even lost a loved one
because of a harmful or defective medication, please give the attorneys at Hossley & Embry
a call: (866) 522-9265. You can also fill out our convenient online contact form and we will
be in touch promptly. We offer free consultations, and we have the resources available
(including charter aircraft) to travel throughout Texas and the United States on short notice
to investigate your potential claim.
References
Campbell, J., Allen, A., & McIntyre, D. A. (2010 December 10). The ten worst drug recalls in
the history of the FDA. 24/7 Wall St. Retrieved
from http://247wallst.com/investing/2010/12/10/the-ten-worst-drug-recalls-in-the-history-
of-the-fda/
Rezulin recall: Fast-moving FDA hits a new speed bump. (2010 March
22). WebMD. Retrieved from http://www.webmd.com/diabetes/news/20000322/rezulin-
recall-fast-moving-fda-hits-new-speed-bump

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Artifact 5

Pfizer Whistleblower Tells His Bextra Story

September 3, 20093:30 PM ET

SCOTT HENSLEY
Twitter

In pursuing a case against Pfizer for fraudulently promoting drugs that eventually led to
the largest health fraud settlement in U.S. history, the feds leaned heavily on evidence
supplied by a half-dozen whistleblowers.

Justice Department explains its fraud settlement with Pfizer.

Chip Somodevilla/Getty Images

Perhaps the most important was West Point grad John Kopchinski, hired by Pfizer as a sales
rep when he left the Army in 1992. Kopchinski, 45, worked in South Florida until he was
fired by the company in 2003. By then he was already talking with lawyers about evidence
he had accumulated on the company's marketing of Bextra, a painkiller withdrawn from the
market in 2005 amid safety concerns.
Under a law dating back to the Civil War, Kopchinski will get $51.5 million of the money
recovered by the feds for his help. He'll also reap a share to be determined of money being
returned to various states.
What led Kopchinski, now living in San Antonio, to blow the whistle? "You have to live with
yourself when you look at yourself in the mirror," he told us in a telephone interview.

He first complained to management about aggressive promotion of Bextra far beyond the
uses approved by FDA. But his concerns were brushed aside, and, over time, the "ethical
line kept moving" in the wrong direction. He didn't want to go along with that, he said.

One of the things that bothered him most was a $50 bounty paid to reps when they got
doctors to add Bextra to the standard care for patients before and after surgery. These care
protocols would direct patients to take Bextra, often at high doses, a few days before a knee
operation, for instance, and then afterward to control pain.

The FDA rejected a company application to market the drug for uses like that because the
benefits didn't outweigh the risks, mainly cardiovascular problems. Bextra was approved to
relieve arthritis pain (10 milligrams once a day) and menstrual pain (20 milligrams twice a
day). But Pfizer touted Bextra heavily for other conditions and at higher doses anyway,
Kopchinsky said, and sales reps were expected to get doctors on board.

Check out a Pfizer manager's email to Kopchinski's team of sales reps, nicknamed "The
Sharks," asking where their results were in getting doctors to use Bextra for surgical
patients. The second page is an example of a care protocol specifying Bextra.

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These protocols and other marketing of Bextra beyond its FDA-approved uses lie at the
heart of the government's fraud case against Pfizer, and the worries Kopchinski had about
his job. "If you don't aggressively sell your products... you're labeled a non-team player,"
Kopchinski said. He said you could only achieve management's goals by selling Bextra for
unapproved uses.

Another one of the practices that bothered him: encouraging doctors to start patients at
high doses of Bextra — eight times the approved starting dose in the case of migraine
patients, he said.

Take a look at a Pfizer script from 2002 that coached reps to tell doctors Bextra was both
more effective and safer than Vioxx, a rival painkiller from Merck that was pulled from the
market in 2004 because of heart risks. FDA never approved superiority claims for Bextra.
For a fuller picture of Kopchinski's allegations, see his legal complaint, originally filed under
seal and now available online. You can also peruse more Pfizer documents about Bextra in
the exhibits here.
A Pfizer spokesman confirmed Kopchinski worked for the company during the period he
claimed but wouldn't comment on the circumstances of his departure. As for Kopchinski's
claims and those of the government, the company spokesman said:

We deny all of the civil allegations set forth in the qui tam complaints, including those in
which DOJ intervened, with the exception that Pfizer acknowledges certain improper
promotional conduct related to Zyvox and the Bextra conduct involved in the plea
agreement.
SUBSCRIBE

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Artifact 6

Office of Public Affairs

FOR IMMEDIATE RELEASE

Wednesday, September 2, 2009

Justice Department Announces Largest Health Care Fraud Settlement in

Its History
Pfizer to Pay $2.3 Billion for Fraudulent Marketing

WASHINGTON – American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia &
Upjohn Company Inc. (hereinafter together "Pfizer") have agreed to pay $2.3 billion, the
largest health care fraud settlement in the history of the Department of Justice, to resolve
criminal and civil liability arising from the illegal promotion of certain pharmaceutical
products, the Justice Department announced today.

Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food,
Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra
is an anti-inflammatory drug that Pfizer pulled from the market in 2005. Under the
provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of
a product in its new drug application to FDA. Once approved, the drug may not be marketed
or promoted for so-called "off-label" uses – i.e., any use not specified in an application and
approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the
FDA specifically declined to approve due to safety concerns. The company will pay a criminal
fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any
matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of
$1.3 billion.

In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False
Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-
psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false
claims to be submitted to government health care programs for uses that were not
medically accepted indications and therefore not covered by those programs. The civil
settlement also resolves allegations that Pfizer paid kickbacks to health care providers to
induce them to prescribe these, as well as other, drugs. The federal share of the civil
settlement is $668,514,830 and the state Medicaid share of the civil settlement is
$331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical
company.

As part of the settlement, Pfizer also has agreed to enter into an expansive corporate
integrity agreement with the Office of Inspector General of the Department of Health and

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Human Services. That agreement provides for procedures and reviews to be put in place to
avoid and promptly detect conduct similar to that which gave rise to this matter.

Whistleblower lawsuits filed under the qui tam provisions of the False Claims Act that are
pending in the District of Massachusetts, the Eastern District of Pennsylvania and the
Eastern District of Kentucky triggered this investigation. As a part of today’s resolution, six
whistleblowers will receive payments totaling more than $102 million from the federal
share of the civil recovery.

The U.S. Attorney’s offices for the District of Massachusetts, the Eastern District of
Pennsylvania, and the Eastern District of Kentucky, and the Civil Division of the Department
of Justice handled these cases. The U.S. Attorney’s Office for the District of Massachusetts
led the criminal investigation of Bextra. The investigation was conducted by the Office of
Inspector General for the Department of Health and Human Services (HHS), the FBI, the
Defense Criminal Investigative Service (DCIS), the Office of Criminal Investigations for the
Food and Drug Administration (FDA), the Veterans’ Administration’s (VA) Office of Criminal
Investigations, the Office of the Inspector General for the Office of Personnel Management
(OPM), the Office of the Inspector General for the United States Postal Service (USPS), the
National Association of Medicaid Fraud Control Units and the offices of various state
Attorneys General.

"Today’s landmark settlement is an example of the Department of Justice’s ongoing and

intensive efforts to protect the American public and recover funds for the federal treasury
and the public from those who seek to earn a profit through fraud. It shows one of the many
ways in which federal government, in partnership with its state and local allies, can help the
American people at a time when budgets are tight and health care costs are increasing,"
said Associate Attorney General Tom Perrelli. "This settlement is a testament to the type of
broad, coordinated effort among federal agencies and with our state and local partners that
is at the core of the Department of Justice’s approach to law enforcement."

"This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other
government insurance programs, securing their future for the Americans who depend on
these programs,"said Kathleen Sebelius, Secretary of Department of Health and Human
Services"The Department of Health and Human Services will continue to seek opportunities
to work with its government partners to prosecute fraud wherever we can find it. But we
will also look for new ways to prevent fraud before it happens. Health care is too important
to let a single dollar go to waste."

"Illegal conduct and fraud by pharmaceutical companies puts the public health at risk,
corrupts medical decisions by health care providers, and costs the government billions of
dollars," said Tony West, Assistant Attorney General for the Civil Division. "This civil
settlement and plea agreement by Pfizer represent yet another example of what penalties
will be faced when a pharmaceutical company puts profits ahead of patient welfare."

"The size and seriousness of this resolution, including the huge criminal fine of $1.3 billion,
reflect the seriousness and scope of Pfizer’s crimes," said Mike Loucks, acting U.S. Attorney
for the District of Massachusetts. "Pfizer violated the law over an extensive time period.
Furthermore, at the very same time Pfizer was in our office negotiating and resolving the

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allegations of criminal conduct by its then newly acquired subsidiary, Warner-Lambert,
Pfizer was itself in its other operations violating those very same laws. Today’s enormous
fine demonstrates that such blatant and continued disregard of the law will not be
tolerated."

"Although these types of investigations are often long and complicated and require many
resources to achieve positive results, the FBI will not be deterred from continuing to ensure
that pharmaceutical companies conduct business in a lawful manner," said Kevin Perkins,
FBI Assistant Director, Criminal Investigative Division.

"This resolution protects the FDA in its vital mission of ensuring that drugs are safe and
effective. When manufacturers undermine the FDA’s rules, they interfere with a doctor’s
judgment and can put patient health at risk," commented Michael L. Levy, U.S. Attorney for
the Eastern District of Pennsylvania. "The public trusts companies to market their drugs for
uses that FDA has approved, and trusts that doctors are using independent judgment.
Federal health dollars should only be spent on treatment decisions untainted by
misinformation from manufacturers concerned with the bottom line."

"This settlement demonstrates the ongoing efforts to pursue violations of the False Claims
Act and recover taxpayer dollars for the Medicare and Medicaid programs," noted Jim
Zerhusen, U.S. Attorney for the Eastern District of Kentucky.

"This historic settlement emphasizes the government’s commitment to corporate and

individual accountability and to transparency throughout the pharmaceutical industry," said
Daniel R. Levinson, Inspector General of the United States Department of Health and Human
Services. "The corporate integrity agreement requires senior Pfizer executives and board
members to complete annual compliance certifications and opens Pfizer to more public
scrutiny by requiring it to make detailed disclosures on its Web site. We expect this
agreement to increase integrity in the marketing of pharmaceuticals."

"The off-label promotion of pharmaceutical drugs by Pfizer significantly impacted the

integrity of TRICARE, the Department of Defense’s healthcare system," said Sharon Woods,
Director, Defense Criminal Investigative Service. "This illegal activity increases patients’
costs, threatens their safety and negatively affects the delivery of healthcare services to the
over nine million military members, retirees and their families who rely on this system.
Today’s charges and settlement demonstrate the ongoing commitment of the Defense
Criminal Investigative Service and its law enforcement partners to investigate and prosecute
those that abuse the government’s healthcare programs at the expense of the taxpayers
and patients."

"Federal employees deserve health care providers and suppliers, including drug
manufacturers, that meet the highest standards of ethical and professional behavior," said
Patrick E. McFarland, Inspector General of the U.S. Office of Personnel Management.
"Today’s settlement reminds the pharmaceutical industry that it must observe those
standards and reflects the commitment of federal law enforcement organizations to pursue
improper and illegal conduct that places health care consumers at risk."

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"Health care fraud has a significant financial impact on the Postal Service. This case alone
impacted more than 10,000 postal employees on workers’ compensation who were treated
with these drugs," said Joseph Finn, Special Agent in Charge for the Postal Service’s Office of
Inspector General. "Last year the Postal Service paid more than $1 billion in workers’
compensation benefits to postal employees injured on the job."

Component(s): 

Civil Division

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Artifact 7 – Vaccine for COVID 19
Pfizer’s Newest Vaccine Plant Has Persistent Mold Issues, History of
Recalls
By Sarah Jane Tribble, Kaiser Health News

Wednesday, March 10, 2021 (Kaiser News) -- Pfizer’s management knew last year there was “a
mold issue” at the Kansas facility now slated to produce the drugmaker’s urgently needed
covid-19 vaccine, according to a Food and Drug Administration inspection report.
This story also ran on The Daily Beast. It can be republished for free.
The McPherson, Kansas, facility, which FDA inspectors wrote is the nation’s largest
manufacturer of sterile injectable controlled substances, has a long, troubled history. Nearly a
decade’s worth of FDA inspection reports, recalls and reprimands reviewed by KHN show the
facility as a repeat offender. FDA investigators have repeatedly noted in reports that the plant
has failed to control quality and contamination or fully investigate after production failures.
The 1970s-era manufacturing site has had persistent mold concerns over the years and been
the focus of at least four intense FDA inspections since Pfizer took over its operations in late
2015, when it acquired Hospira. At the end of the January 2020 inspection, FDA investigators
appeared to be growing frustrated.
Pfizer’s plant managers told investigators they knew they had either bacteria or mold
throughout the facility at various times of the year. In a Jan. 17, 2020, establishment inspection
report obtained by KHN, one of three FDA experts who visited wrote that Pfizer said it
addressed problems and added “more cleaning activities in response to mold” after a 2018
inspection and “yet, there are still unexplained discrepancies.”
After the January 2020 inspection report, Pfizer immediately developed and put in place a
corrective action plan, company spokesperson Eamonn Nolan told KHN. Neither Pfizer nor the
FDA responded to requests to provide a copy of the plan.
Nolan, in an email last week, said “significant investments have been made” in resources,
equipment and the facility. He stated all improvements related to covid manufacturing would
be completed before vaccine production begins. He declined to provide details on when
production of the vaccine would begin, but said the site is currently operating in a state of good
manufacturing, which means it has met a regulatory standard enforced by the FDA.
“We are confident in the McPherson site’s ability to manufacture high-quality COVID-19
vaccine,” he wrote.
Large clinical trials have found Pfizer’s vaccine to be safe and 95% effective against covid.
News that the plant will be a fill-and-finish site for the Pfizer-BioNTech covid vaccine means
more watchful eyes focused on the facility. “That alone should be helpful,” said Barbara Unger,
a former pharmaceutical industry executive who now does manufacturing audits for
companies.

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It is unclear whether FDA investigators have returned to check on production practices in
McPherson or plan to visit before vaccine production begins. The FDA did not respond to
specific questions. FDA spokesperson Abigail Capobianco wrote in an email that the public “can
be assured that the agency used all available tools and information to assess compliance.”
Pfizer’s emergency use authorization letter for its mRNA vaccine includes safeguards, such as
quarterly reports to the FDA and a quality analysis from the company for each manufactured
drug lot at least 48 hours before it is distributed.
The plant’s manufacturing issues can be traced in FDA reports dated from 2011 to last year.
Several former FDA staffers and industry experts said the ongoing challenges in McPherson
highlight how agency officials must balance aggressively going after a company’s
manufacturing practices with the need to keep the supply of medications flowing to patients.
“I do not envy the FDA choices,” Unger said, describing a balancing act. “Which has the more
significant public health risk?”
The site produces a wide array of sterile, generic medications used in hospitals, and its troubles
have played a role in some big health system shortages, specifically for injectable opioid
analgesics, according to a 2018 FDA statement.
The FDA rejected Pfizer’s biosimilar version of Amgen’s anemia drug Epogen because of
concerns about the fill/finish plant in 2017. The same year, John Young, who was a group
president at Pfizer, told investors the company had submitted a “corrective and preventative
action plan” for the facility.
That is the same language used after the January 2020 inspection, which said there were
contamination concerns for the site but not in the medicines. And it was Young, now Pfizer’s
chief business officer, who last month told Congress that Pfizer had added production lines at
the McPherson site to help meet covid-19 vaccine demands.
The facility’s record of recalls and field alerts include vials of medication that contained glass
and cardboard particles and, as one customer complained, a “small insect or speck of dust.”
A 2017 FDA warning letter — which is a strong rebuke for the agency — said the contaminants
such as cardboard and glass found in vials posed a “severe risk of harm to patients” and
indicated that the facility’s process for manufacturing sterile injectable products was “out of
control.”
FDA records show that multiple batches of vancomycin hydrochloride, a drug injected into
hospital patients who have an infection that penicillin won’t treat, were recalled in 2016 and
2017.
John Avellanet, an FDA compliance expert and principal at Cerulean Associates, reviewed the
2020 inspection reports. He said he fears the fixes have been little but “window dressing.”
“They may have solved it in one instance, like the cardboard particles. But for some reason,
they were never able to solve the contamination,” Avellanet said. “Whatever they are doing for
quality control testing doesn’t appear to be working, because if it was working they wouldn’t
continue to have these contamination problems.”

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Pfizer shut down McPherson’s manufacturing in December 2017 even though the FDA had
visited two months earlier and improved the facility’s inspection rating. McPherson’s
management suspended production and rejected batches of finished products after finding
mold on equipment in a filling area, according to an FDA inspection report. The facility returned
to production weeks later.
When the FDA came back to inspect in late summer 2018, it found that procedures to prevent
microbiological contamination of drugs were lacking. It also noted a lack of employee training,
employees not following procedures, obstructed surfaces and in-house testing that did not
guarantee drugs met standards.
In 2019, when CEO Albert Bourla took the helm at Pfizer, he told analysts it would be another
hard year for U.S. hospitals to get their hands on sterile injectables because of ongoing work at
the McPherson plant.
Since then, the coronavirus pandemic has taken a toll on the FDA’s ability to inspect plants,
according to a recent report from the U.S. Government Accountability Office. The agency
halted non-urgent foreign and domestic inspections in March 2020 out of concerns for staff
safety and has since resumed select visits to domestic plants.
John Fuson, a partner at the law firm Crowell & Moring and former associate chief counsel at
the FDA, said the agency has sent surveys to manufacturers to help it prioritize inspections.
While not speaking directly about the Pfizer plant, Fuson said the FDA lacks the resources to do
all the inspections “we might like it to do.”
It is unclear what oversight Pfizer’s McPherson facility has had in the past year. In 2020, the
pharmaceutical company Gilead Sciences signed a multiyear agreement with Pfizer to produce
its covid treatment remdesivir in the Kansas plant. Gilead spokesperson Arran Attridge wrote in
an email that Gilead “evaluates our manufacturing partners’ facilities” to make sure they follow
regulations.
FDA inspectors visited the McPherson plant annually before the pandemic, according to public
FDA records. The plant was given ratings of VAI, or voluntary action indicated, or OAI, official
action indicated, depending on the inspection. John Godshalk, a former FDA investigator who
worked on vaccines, said a VAI is one of the most common inspection ratings given. That
means the FDA is “trusting the company to fix” the observations made during the inspections,
he said.
The FDA assigned Pfizer’s McPherson facility a VAI rating in January 2020 — and company
executives were so pleased they reported in their third-quarter financial filing that the agency
had “upgraded” the plant.
Before January 2020, the McPherson plant appears to have been operating with the more
severe OAI rating since its 2018 inspection, according to FDA reports. Former FDA investigator
Godshalk said an OAI puts the company on notice. It’s “what you don’t want as a company,” he
said.
Pfizer employs about 1,500 people at the McPherson plant, plus contractors. Kasi Morales,
executive director of McPherson Industrial Development Co., said the facility is the largest
employer in the industrial town about an hour north of Wichita, Kansas, and not far from
Interstate 70, a major east-west thoroughfare across the country.

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The 2020 inspection report that led to McPherson’s “upgraded” rating listed repeat
observations that involved quality control procedures not being fully followed and
“contamination” with mold and bacteria on surfaces because of humidity and cleaning
practices.
No contamination was found in the medications themselves during the inspection, but
investigators described seeing operators “leaning over and talking over sterilized items being
unwrapped.”
Notably, the 2020 inspection report states early on that Pfizer had made “significant
management changes” since the previous inspection in 2018. That latest inspection spanned
three weeks from December 2019 to January 2020 and inspectors wrote “management was
cooperative and no refusals were encountered.”
Christopher Smith, vice president of quality operations for Pfizer’s U.S. and European Union
sterile injectables, was at the McPherson facility periodically during the visit. In the end, he
“expressed discontent” with several of the 2020 observations made by investigators and
“repeatedly sought clarifications.”
WebMD News from Kaiser Health News

©2013-2020 Henry J. Kaiser Family Foundation. All rights reserved.

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