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U.S. Food and Drug Administration

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U.S. Food and Drug Administration Powered By Docstoc
					  Aimee Kelley
   Stacy Hovan
   Denise Peck
Khalid Alkadiry
   CA (Northern), NV, HI
San Francisco District Office
 1431 Harbor Bay Parkway
    Alameda, CA 94502
      (510) 337-6700
   The U S. Food and Drug Administration currently oversees
    items sold in the United States accounting for 25 cents of
    every dollar spent by consumers.
   The FDA has beginnings in the Division of Chemistry /
    Bureau of Chemistry. The predecessors of the FDA Started
    as single chemist in The Department of Agriculture in
    1862.
   The Federal Food and Drug Act of 1906 added regulatory
    function to Bureau of Chemistry.
   In July 1927 the bureau changed its name to the Food,
    Drug, and Insecticide Administration.
   In 1930 it shortened its name to FDA. June 1940 the
    Administration was moved to the Federal Security Agency.
   April 1953 the FDA was moved again to the Department of
    Health, Education, and Welfare (HEW). The Department
    soon dropped education and was renamed The
    Department of Health and Human Services.
   Original: Federal Food and Drugs Act of
    1906, (THE "WILEY ACT") : Pure Food and
    Drug Act of 1906, ch. 3915, 34 Stat. 768
    (repealed 1938).
    Current: Federal Food, Drug, and Cosmetic
    Act , 21 U.S.C.A. Ch. 9, 1938
   Ranbaxy Labs v. Leavitt,
   469 F.3d 120; 373 U.S. App. D.C. 377
    ◦ The court concluded that the FDA’s policy conditioning a generic
      applicant’s period of marketing exclusivity upon the generic
      applicant being sued for patent infringement by the NDA holder
      was inconsistent with the text and structure of the Food Drug &
      Cosmetic Act and, because it diminished the incentive the
      Congress gave manufacturers of generic drugs, was inconsistent
      with the purpose of the Act.
   Novartis v. Leavitt,
   435 F.3d 344; 369 U.S. App. D.C. 232
    ◦ The drug company Novartis argued that the FDA could not modify
      official names, dosage forms, or labeling of drugs without holding
      a notice and comment rulemaking. The court held that there was
      no basis for requiring the FDA to perform this type of rulemaking
      for this procedure.
   Where in the CFR are the FDA’s rule located?
    ◦ Title 21, parts 1-1499
   Does your agency have adjudicatory power?
    ◦ No, the FDA does not have adjudicatory power. It
      has the power to make rules and hold hearings.
The next three slides contain the recent
 proposed rules from the FDA followed by:
 ◦ the date when the comment period for the
   proposed rule ends,
 ◦ the C.F.R. citations for the proposed rules, and
 ◦ the person who you would contact for more
   information regarding the proposed rule
   Maximum Civil Money Penalty Amounts and
    Compliance With the Federal Civil Penalties
    Inflation Adjustment Act
    ◦ 73 Fed. Reg. 219, 66811 (Nov. 12, 2008) (to be
      codified at 21 C.F.R. pt. 17).
    ◦ Comments due: December 6, 2008
    ◦ For further information contact: Erik Mettler, Office
      of Policy (HF–11), Food and Drug Administration,
      5600 Fishers Lane, Rockville, MD 20857, 301–827–
      3360.
   General and Plastic Surgery Devices: Proposed
    Classification for the Tissue Expander
    ◦ 73 Fed. Reg. 246, 78239 (Dec. 22, 2008) (to be
      codified at 21 C.F.R. pt. 878).
    ◦ Comments due: March 23, 2009
    ◦ For further information contact: Nada Hanafi,
      Center for Devices and Radiological Health (HFZ–4),
      Food and Drug Administration, 520 Standish Pl.,
      Rockville, MD 20855, 240–276–8848.
    “Milk and Cream Products and Yogurt
    Products; Proposal to Revoke the Standards
    for Lowfat Yogurt and Nonfat Yogurt and to
    Amend the Standard for Yogurt,”
    ◦ 74 Fed. Reg. 10, 2443 (January 15, 2009) (to be
      codified at 21 C.F.R. pt. 131).
    ◦ Comments due: March 31, 2009
    ◦ For further information contact: Ritu Nalubola,
      Center for Food Safety and Applied Nutrition (HFS–
      820), Food and Drug Administration, 5100 Paint
      Branch Pkwy., College Park, MD 20740, 301–436–
      2371
   National, non-profit consumer advocacy
    organization
   Founded by Ralph Nader in 1971
   Represents consumer interests in Congress,
    the executive branch and the courts
   Works to strengthen the ability of citizens
    to participate in the domestic policy-
    making process
   Actively monitors the activities of the FDA
   http://www.citizen.org/
   Nonprofit, non-partisan organization
   Industry-sponsored advocacy group
    (according to the New York Times)
   Advance medical progress, reduce health
    disparities, extend life, make health care
    more affordable, preventive, patient-
    centered
   Independent scientific analysis on
    personalized medicine, food and drug
    safety, health care reform and comparative
    effectiveness
   http://www.cmpi.org/
Lawsuits                        Public Comments about
                                  Proposed Regulations
   Sued FDA for Failure to      Commented on Codex
    Act on Dangerous Drug         Alimentarius Standards, an
    (Darvon, Darvocet and all     international standard-
    drugs containing              setting body established
    propoxyphene)                 jointly in 1962 by the UN
    Complaint                     World Health Organization
                                  and the UN Food and
   Sued FDA to Force             Agriculture Organization to
    Agency to Act On Petition     facilitate international trade
    Seeking Stricter              of food
    Fluoroquinolone              Encouraged FDA to adopt
    Warnings (antibiotics can     only those Codex standards
    cause tendon ruptures)        that would improve public
    Complaint                     health and consumer
                                  protection in the U.S.

				
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