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Federal Food and Drugs Act of 1906, (THE "WILEY ACT") : Pure Food and Drug Act of 1906, ch. 3915, 34 Stat. 768 (repealed 1938).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.