[Federal Register: November 21, 2002 (Volume 67, Number 225)]

[Notices]               

[Page 70227-70228]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr21no02-84]                         



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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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