Aimee Kelley

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Food and Drug Administration

• Aimee Kelley
• Stacy Hovan
• Denise Peck
• Khalid Alkadiry

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Local Office Contact Information

• CA (Northern), NV, HI
• San Francisco District Office
• 1431 Harbor Bay Parkway
• Alameda, CA 94502
• [phone]

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Hierarchy
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(No Transcript)
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FDA Origins

• 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.

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STATUTORY AUTHORITY

• 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  1906, ch. 3915, 34 Stat. 768 (repealed 1938).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

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Recent D.C. Circuit Federal Decisions

• Ranbaxy Labs v. Leavitt,
• 469 F.3d 120 373 U.S. App. D.C. 377
• The court concluded that the FDAs policy
  conditioning a generic applicants 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.

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Additional Questions

• Where in the CFR are the FDAs 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.

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The Food and Drug Administrations Most Recent
Proposed Rules

• 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

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• 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 (HF11), Food and Drug
  Administration, 5600 Fishers Lane, Rockville, MD
  20857, 3018273360.

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• 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
  (HFZ4), Food and Drug Administration, 520
  Standish Pl., Rockville, MD 20855, 2402768848.

12

• 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
  (HFS820), Food and Drug Administration, 5100
  Paint Branch Pkwy., College Park, MD 20740,
  3014362371

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Public Citizen

• 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/

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The Center for Medicine in the Public Interest

• 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/

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Public Citizens Lawsuits and Public Comments

• Lawsuits
• Sued FDA for Failure to Act on Dangerous Drug
  (Darvon, Darvocet and all drugs containing
  propoxyphene) Complaint
• Sued FDA to Force Agency to Act On Petition
  Seeking Stricter Fluoroquinolone Warnings
  (antibiotics can cause tendon ruptures) Complaint

• Public Comments about Proposed Regulations
• Commented on Codex Alimentarius Standards, an
  international standard-setting body established
  jointly in 1962 by the UN World Health
  Organization and the UN Food and Agriculture
  Organization to facilitate international trade of
  food
• Encouraged FDA to adopt only those Codex
  standards that would improve public health and
  consumer protection in the U.S.