[Federal Register Volume 67, Number 225 (Thursday, November 21, 2002)]
[Notices]
[Pages 70227-70228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Termination of Two Food and Drug Administration Advisory 
Committees: Medical Imaging Drugs Advisory Committee and the Pharmacy 
Compounding Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
termination of two FDA advisory committees: The Medical Imaging Drugs 
Advisory Committee, a nonstatutory advisory committee to FDA's Center 
for Drug Evaluation and Research (CDER), and the Pharmacy Compounding 
Advisory Committee, a statutory committee to the FDA's Center for Drug 
Evaluation and Research.

DATES: November 21, 2002.

FOR FURTHER INFORMATION CONTACT: Linda Ann Sherman, Director Advisory 
Committee Oversight and Management Staff (HF-4), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1220.

SUPPLEMENTARY INFORMATION: Under its current charter, the Medical 
Imaging Drugs Advisory Committee will expire on February 28, 2004. The 
Medical Imaging Drugs Advisory Committee is responsible for: (1) 
Reviewing and evaluating data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in 
diagnostic and therapeutic procedures using radioactive pharmaceuticals 
and for use as contrast media in diagnostic radiology and (2) making 
appropriate recommendations to the Commissioner of Food and Drugs. The 
Commissioner has determined that a separate advisory committee for 
these products is not necessary as these products can be more 
effectively reviewed by an existing advisory committee or a by a 
subcommittee of an existing committee with responsibility for providing 
advice and recommendations regarding the specific systemic product area 
at issue with a given product.
    The charter for the Pharmacy Compounding Advisory Committee was 
renewed February 3, 2002, for a 2-year

[[Page 70228]]

term. This Committee was created by section 503A(d)(1) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 353a(d)(1)). Section 
503a(d)(1) specifically directed the Secretary of Health and Human 
Resources to convene and consult an advisory committee on compounding.
    On April 29, 2002, the United States Supreme Court in Thompson, et 
al. v. Western States Medical Center Pharmacy, et al., 122 S.Ct. 1497 
(2002), affirmed a decision of the U.S. Court of Appeals for the Ninth 
Circuit invalidating section 503A of act. Section 503A of the act, 
enacted as part of the Food and Drug Administration Modernization Act 
of 1997, exempted drugs compounded by pharmacies from the act's new 
drug approval, adequate directions for use, and good manufacturing 
practice requirements if specified conditions, including two 
restrictions on commercial speech, were met. The Supreme Court held 
that these two speech related restrictions violate the first amendment 
to the U.S. Constitution. The Ninth Circuit had also concluded that 
these unconstitutional speech restrictions may not be severed from the 
rest of the provisions in section 503A of the act, and that section 
503A is invalid in its entirety. Because neither the Government nor the 
compounding pharmacy plaintiffs sought review of this aspect of the 
Ninth Circuit's decision, the Supreme Court did not reach the issue. As 
a result, the Ninth Circuit's invalidation of section 503A of the act 
in its entirety stands. Because the entire section 503A of the act is 
invalid, the statutory authorization for an advisory committee on 
compounding no longer exists.
    For the reasons stated previously, the Medical Imaging Drugs 
Advisory Committee and the Pharmacy Compounding Advisory Committee are 
terminated.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2)).

    Dated: November 14, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-29573 Filed 11-20-02; 8:45 am]
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