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Federal Register / Vol. 71, No.

49 / Tuesday, March 14, 2006 / Notices 13129

Act, as amended, 15 U.S.C. 18, and for the treatment of facial wrinkles, DEPARTMENT OF HEALTH AND
Section 5 of the Federal Trade would increase competition and likely HUMAN SERVICES
Commission Act, as amended, 15 U.S.C. reduce prices to consumers.
45, by eliminating the next most likely Accordingly, allowing Allergan to Centers for Disease Control and
entrant in the market for cosmetic control both Botox and Reloxin Prevention
botulinum toxins. The proposed would likely force customers to pay
Consent Agreement would remedy the Disease, Disability, and Injury
higher prices for cosmetic botulinum
alleged loss of potential competition Prevention and Control Special
toxin. Emphasis Panel: Occupational Safety
that would result from the merger in
this market. The proposed Consent Agreement and Health Education, PAR–05–107,
Botulinum toxin is an increasingly contains several provisions designed to and Research Center and Occupational
popular, non-surgical treatment for ensure the successful and timely entry Safety and Health Training Projects
wrinkles caused by repetitive muscle of Reloxin by requiring that: (1) Grants, PAR–05–126
movement, such as the ‘‘worry lines’’ Allergan and Inamed divest the
that appear on the forehead when a Reloxin development and distribution Correction: This notice was published
person frowns. Botulinum toxin is rights, including the ongoing clinical in the Federal Register on March 1,
uniquely effective in temporarily trials and certain intellectual property, 2006, Volume 71, Number 40, page
eliminating these ‘‘dynamic wrinkles’’ back to Ipsen; (2) Allergan and Inamed 10538. The titles for the Special
because it is the only product that can take steps to ensure that confidential Emphasis Panel meetings have been
paralyze the underlying muscles business information relating to changed.
associated with these wrinkles. Titles: Program Announcement for
Reloxin will not be obtained or used
Although there are many products and Research (PAR) 05–107, Occupational
by Allergan; and (3) Ipsen and/or its
procedures that can be used to treat Safety and Health Education and
future marketing partner have the Research Centers, and Program
facial wrinkles, such as dermal fillers,
opportunity to enter into employment Announcement for Research (PAR) 05–
topical creams, lasers, chemical peels,
contracts with certain key individuals 126, Occupational Safety and Health
and surgery, botulinum toxin therapy is
sufficiently differentiated from these who have experience relating to Training Project Grants.
other products and procedures that they Reloxin. FOR MORE INFORMATION CONTACT: Charles
are not close economic substitutes. The Commission has appointed N. Rafferty, PhD, Designated Federal
Allergan is the dominant supplier of Charles A. Riepenhoff, Jr. of KPMG LLG Official, National Institute for
cosmetic botulinum toxin in the United as Interim Monitor to oversee the Occupational Safety and Health, CDC,
States. Allergan’s Botox is the only transfer of confidential business 1600 Clifton Road, NE., Mailstop E–74,
botulinum toxin type A approved by the information back to Ipsen and to ensure Atlanta, GA 30333, Telephone Number
U.S. Food and Drug Administration compliance with all of the provisions of (404) 498–2582.
(‘‘FDA’’) for the treatment of facial the proposed consent order. Mr. The Director, Management Analysis
wrinkles. In 2002, Ipsen granted Inamed Riepenhoff has over thirty-four years of and Services Office, has been delegated
the exclusive rights to develop and experience in the health care industry. the authority to sign Federal Register
distribute a botulinum toxin type A notices pertaining to announcements of
To ensure that the Commission remains
product for facial cosmetic indications meetings and other committee
informed about the status of the
in the United States. Tentatively management activities, for both CDC
branded Reloxin, Inamed’s cosmetic proposed assets and transfers of assets,
and the Agency for Toxic Substances
botulinum toxin product is currently in the proposed Consent Agreement
and Disease Registry.
Phase III clinical trials and is expected requires Allergan and Inamed to file
reports with the Commission Dated: March 8, 2006.
to be the first serious challenger to
periodically until the divestitures and Alvin Hall,
Botox in the United States. Other
firms’ cosmetic botulinum toxin transfers are accomplished. Director, Management Analysis and Services
development programs lag well behind Office, Centers for Disease Control and
The purpose of this analysis is to Prevention.
Inamed’s Reloxin program. facilitate public comment on the
Entry into the market for cosmetic [FR Doc. E6–3564 Filed 3–13–06; 8:45 am]
Consent Agreement, and it is not
botulinum toxin would not be timely, intended to constitute an official
likely, or sufficient in its magnitude, interpretation of the Consent Agreement
character, and scope to deter or
or to modify its terms in any way. DEPARTMENT OF HEALTH AND
counteract the anticompetitive effects of
the Acquisition. Developing and By direction of the Commission, with HUMAN SERVICES
obtaining FDA approval for manufacture Commissioner Rosch recused.
Food and Drug Administration
and sale of cosmetic botulinum toxin Donald S. Clark,
takes at least two years due to Secretary. [Docket No. 2002D–0260] (formerly Docket
substantial regulatory and technological No. 02D–0260)
[FR Doc. E6–3550 Filed 3–13–06; 8:45 am]
According to the Commission’s BILLING CODE 6750–01–P Guidance for Industry on Prescription
complaint, the proposed acquisition Drug Marketing Act—Donation of
likely would cause significant Prescription Drug Samples to Free
anticompetitive harm to consumers in Clinics; Availability
the U.S. market for cosmetic botulinum AGENCY: Food and Drug Administration,
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toxin by eliminating potential HHS.

competition between Allergan and ACTION: Notice.
Inamed. The entry of Reloxin, which is
expected to be the second botulinum SUMMARY: The Food and Drug
toxin product to receive FDA approval Administration (FDA) is announcing the

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13130 Federal Register / Vol. 71, No. 49 / Tuesday, March 14, 2006 / Notices

availability of a guidance for industry Internal Revenue Code of 1954, as regulatory revisions, the agency does
entitled ‘‘Prescription Drug Marketing amended.’’ Under § 203.39, a charitable not intend to object if a free clinic fails
Act—Donation of Prescription Drug institution may receive drug samples to comply with certain parts of the
Samples to Free Clinics.’’ The guidance donated by a licensed practitioner or regulation. The guidance clarifies that
provides information for free clinics that another charitable institution for the agency’s exercise of enforcement
receive donated prescription drug dispensing to its patients, or may donate discretion with regard to certain
samples from licensed practitioners or a drug sample to another charitable requirements of § 203.39 will not extend
other charitable institutions. The institution for dispensing to its patients, to fraud or other illegal conduct
guidance discusses concerns that have provided certain requirements are met. involving drug samples, and that the
been expressed by certain individuals These requirements include, among
agency could, at its discretion, initiate
regarding regulatory requirements for other things, that a drug sample donated
enforcement action for violations of any
drug sample donations. The guidance to a charitable institution must be
announces that FDA, after reviewing an inspected by a licensed practitioner or and all applicable statutory and
independent study report analyzing the registered pharmacist, and that drug regulatory provisions implicated by
potential effects of the regulations on sample receipt and distribution records fraudulent or illegal activity. We note
free clinics, has decided to propose be maintained by the institution and also that neither this notice, nor its
revisions to those regulations. In the retained for a minimum of 3 years. corresponding guidance, affects or alters
interim, FDA intends to exercise its In the Federal Register of June 27, any requirements imposed by the U.S.
enforcement discretion and does not 2002 (67 FR 43330), FDA announced the Drug Enforcement Administration
intend to object if a free clinic fails to availability of a draft guidance entitled (DEA) on any free clinic, person, or
comply with certain regulatory ‘‘Prescription Drug Marketing Act other entity with regard to controlled
requirements for drug sample donations. Regulations for Donation of Prescription substances donated to those entities. All
DATES: General comments on agency Drug Samples to Free Clinics.’’ The draft DEA requirements relating to controlled
guidance documents are welcome at any guidance announced that FDA, in the substances remain fully in effect.
time. exercise of its enforcement discretion,
This guidance is being issued
ADDRESSES: Submit written requests for did not intend to object if a free clinic
failed to comply with the requirements consistent with FDA’s good guidance
single copies of this guidance to the practices regulation (21 CFR 10.115). It
Division of Drug Information (HFD– in § 203.39. The draft guidance defined
the term ‘‘free clinic,’’ which is not represents the agency’s current thinking
240), Center for Drug Evaluation and on this topic. It does not create or confer
Research, Food and Drug otherwise defined in the Federal Food,
Drug, and Cosmetic Act or regulations, any rights for or on any person and does
Administration, 5600 Fishers Lane,
as a charitable institution or not operate to bind FDA or the public.
Rockville, MD 20857. Send one self-
organization, under § 203.3(f), that An alternative approach may be used if
addressed adhesive label to assist that
office in processing your requests. actually provides health care services such approach satisfies the
Submit written comments on the and relies in whole or part on drug requirements of the applicable statutes
guidance to the Division of Dockets donations and volunteer help to achieve and regulations.
Management (HFA–305), Food and Drug its goals. Thus, charitable institutions
that receive donated drug samples but II. Comments
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit do not provide health care services, or Interested persons may submit to the
electronic comments to http:// that provide health care services but do Division of Dockets Management (see See not rely at least in part on drug
ADDRESSES) written or electronic
the SUPPLEMENTARY INFORMATION section donations and volunteer help to provide
comments regarding this document.
those services, would not be considered
for electronic access to the guidance Submit a single copy of electronic
free clinics. According to the draft
document. comments or two paper copies of any
guidance, FDA intended to exercise
FOR FURTHER INFORMATION CONTACT: enforcement discretion while the agency mailed comments, except that
Meredith S. Francis, Office of studied the potential impact of the individuals may submit one paper copy.
Regulatory Policy (HFD–7), Center for regulation on the ability of free clinics Comments are to be identified with the
Drug Evaluation and Research, 5600 to receive and distribute prescription docket number found in brackets in the
Fishers Lane, Rockville, MD 20857, drug samples. Interested persons were heading of this document. Received
301–594–2041. given the opportunity to submit comments may be seen in the Division
SUPPLEMENTARY INFORMATION: comments on the draft guidance by of Dockets Management between 9 a.m.
September 25, 2002. and 4 p.m., Monday through Friday.
I. Background Since issuing the draft guidance, FDA
FDA is announcing the availability of has received a completed study report III. Electronic Access
a guidance for industry entitled from Eastern Research Group (ERG) Persons with access to the Internet
‘‘Prescription Drug Marketing Act— analyzing the burden imposed on free
Donation of Prescription Drug Samples may obtain the document at either
clinics by the requirements in § 203.39
to Free Clinics.’’ Section 203.39 (21 CFR
and the potential regulatory alternatives.
203.39) of the agency’s regulations sets According to the ERG study report, index.htm or
forth requirements for donation of implementing § 203.39 as written could dockets/default.htm.
prescription drug samples to charitable impose a significant financial burden on Dated: March 6, 2006.
institutions. ‘‘Charitable institution’’ or free clinics. Based in part on the study Jeffrey Shuren,
‘‘charitable organization’’ is defined in report’s conclusions, FDA is
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Assistant Commissioner for Policy.

§ 203.3(f) as ‘‘a nonprofit hospital, announcing today that it intends to
[FR Doc. E6–3532 Filed 3–13–06; 8:45 am]
health care entity, organization, exercise enforcement discretion while
institution, foundation, association, or the agency proposes revisions to BILLING CODE 4160–01–S

corporation that has been granted an § 203.39 as applied to free clinics.

exemption under section 501(c)(3) of the Specifically, as FDA works to propose

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