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FDA Action Handbook



Federal Drug Law Timeline

 1813 Federal statute to ensure purity of small pox vaccine.
 1848 Congress bans adulterated imported drugs.
 1879 First bill to protect against adulterated processed foods introduced to Congress.
 1886 First bill to protect against bogus medicines introduced.
 1902 Congress passes Biologics Act requiring pre-market approval for vaccines and serums; administered by Public Health Service (PHS), transferred to FDA in 1972.
 1906 Pure Food & Drugs Act bans from interstate commerce adulterated & misbranded foods and drugs, assigns enforcement to Agriculture Department's Bureau of Chemistry, which could seize illegal substances and prosecute manufacturers.
 1911 Supreme Court rules Bureau of Chemistry may not ban products sold under false pretenses unless deliberately fraudulent.
 1912 Congress bans "false and fraudulent" advertising, in Sherley amendment written by Parke, Davis & Co. pharmaceutical lobbyists; it is legally difficult to prove intent to defraud.
 1927 Congress creates Food, Drugs & Insecticide Administration.
 1933 Bill to amend & extend 1906 bill introduced in Congress.
 1937  "Elixir of Sulfanilamide" episode: wonder drug mixed with antifreeze equals 108 dead Americans and pressure for reform. FDIA becomes Food & Drug Administration (FDA)
 1938 Food, Fug & Cosmetic Act passed; FDA powers expand; cosmetics and therapeutics devices come under its control; drugs must be proven safe before marketing; drug companies must provide adequate warning of side effects and must pay damages whether harm was intentional or not. Sherley Amendment repealed. Tolerance levels set for unavoidable poison substances, factory inspections authorized. FDA can seize, prosecute and obtain court injunctions.
 1940 FDA transferred from Department of Agriculture to Federal Security Agency.
 1949 New drug introduction reach all-time peak of 559.
 1951 Durham-Humphrey Amendment requires, for the first time, that drugs be labeled "for sale by prescription only." Defined prescription drugs as unsafe for self-medication, only to be used under a doctor's supervision.
 1953 FDA's personnel and budget shrink under Republicans. FDA transferred to new Department of Health, Education & Welfare (HEW)
 1954 Pesticide Chemicals Act.
 1955 Responding to Republican commission's suggestion that FDA abandon enforcement for persuasion, Democrats in Congress raise FDA budget; it has risen steadily since.
 1958 Food Additives Amendment.
 1959 - 1962 Senator Estes Kefauver (D-Tennessee) conducts hearings on drug company malfeasance and FDA laxity.
 1960 Color Additives Amendment.
 1961 Kefauver introduces amendments mandating FDA require proof of efficacy, forcing companies making more than 500% profit on drugs to license them to other companies after 3 years, requiring clearer labeling of generic drugs and expanding FDA oversight of drug advertising. Pharmaceutical Manufacturers Association (PMA), American Medical Association (AMA) and craven Senators try to gut bill in committee.
 1962 Thalidomide causes birth of thousands of limbless babies in Europe & Japan. Kennedy comes out for drug reform. Kefauver amendments pass, minus anti-profit provision. FDA begins retroactively assessing efficacy of 6,000 drugs approved since 1938. Adverse reaction reports must be sent to FDA. Medical journal advertisements must be complete about drug risks as well as benefits.
 1966 FDA begins efficacy review of over-the-counter (OTC) drugs approved between 1938-1962 (of sample 512 OTC products, 75% lacked such proof). There are 300,000 such products, combined from 700 ingredients. Between 1972-1981 outsiders reviewed the 700 elements; FDA review of these reports continues, final monographs having been issued for 18 of the 81 overall categories. Thus the FDA is still processing a 50-year backlog of efficacy studies.
 1972 Oversight of biologics (vaccines, serums) transferred from NIH to FDA.
 1974 Kennedy Health Subcommittee uncovers harassment of FDA whistle-blower by FDA chiefs, hearings culminate in Review Panel of New Drug Regulation.
 1976 Congress passes Vitamin Amendments, removing control of vitamins, minerals and food supplements from FDA. Another law mandates pre-market testing of therapeutic devices. National emergency swine flu vaccination program discredits CDC and Federal intervention in epidemics. Legionnaire's Disease fells 26 old white men in Philadelphia; by December, the CDC has isolated a rare bacteria as the cause.
 1977 Congress overrules FDA saccharine ban.
 1978 Drug Regulation Reform Bill introduced in Congress, mandates extensive post-marketing surveillance ("Phase 4"); it never passes.
 1981 First reports of immune deficient gay men & Haitians reported by CDC.
 1982 FDA's blood advisory committee scoffs at CDC reports of blood-transfused AIDS transmissions. FDA sets up Office of Orphan Drug Products Development.
 1983 Orphan Drug Act passed, Jan. 4; companies can deduct 75% of clinical trials costs from taxes and get 7 year monopoly. French team isolates HIV. FDA resists CDC call for screening blood supply for Hepatitis-B antibodies, which CDC feels could detect 80% of AIDS-contaminated blood.
 1984 FDA task force votes in March to do nothing on blood supply; in April FDA officials stoutly maintain there's no danger to it. FDA blocks access to HPA-23 in clinical trial, so people with AIDS go to Paris for treatment with HPA-23. FDA approves testing of Isoprinosine. Gallo re-isolates HIV. IV-pentamidine approved by FDA and granted to LyphoMed under Orphan Drug Act. Drug Price Competition & Patent Term Restoration Act signed, enabling generic drug sponsors to file abbreviated NDA's; length of drug patents extended by 5 years since clinical trials took up such a period during original patented period.
 1985 HIV-antibody test released; FDA declines to put testing under existing confidentiality guidelines. FDA criticized for un-availability of substances available abroad such as Ribavirin, Isoprinosine and HPA-23. Revised NDA regulations issued.
 1986 FDA approves Burroughs-Wellcome trial of AZT;' from February - June it's placebo-controlled, then until September, open-labeled (everyone gets it), when trial is suspended because of favorable data; AZT is approved for marketing within 3 1/2 months of NDA submission.
 1987 March: aerosol pentamidine assigned "high priority" by NIAID. Nothing happens for 13 months. ACT UP hangs FDA Commissioner Frank Young in effigy. Treatment IND is redesigned to allow release of experimental drugs of proven safety and indicated efficacy to people with severe or life-threatening conditions.



Trimetrexate, an anti-PCP agent, becomes first AIDS drug released under Treatment IND protocol so restrictive only 89 people receive it.


FDA branch offices clamp down of buyer's clubs supplying AL-721 and Dextran Sulfate. FDA lobbies against Federal funds for Community Research Initiatives (CRI's), but fails. Americans traveling to Japan for dextran sulfate find Kowa, Inc., won't sell them the drug.


ACT UP zaps Kowa in New York. FDA announces it won't prohibit PWA's from importing a 3 months' supply of a foreign substance for personal use, if endorsed by a doctor.
July  Act-Now begins mobilization for national October actions at HHS and FDA. Kowa resumes sale of dextran sulfate to Americans in Japan. Frank Young heckled at Boston Lesbian & Gay Health Conference. Young meets Bush on 8.29.


Young meets with Lambda representatives, indicates new policies will attempt (once again) to speed approval of AIDS drugs, possible endorsing an end to placebo trials in AIDS when other effective treatment is available, the expansion of trimetrexate availability, the release of DHPG under Treatment IND and possible modeling of a national AIDS registry after the ATR. Now they claim to support CRI's.


2nd: FDA Consumer Affairs meets 4 people from ACT UP/NY. __ 20th: Dr. Paul Parkman to meet with ACT UP/NY's ATR (AIDS Treatment Registry).


11th: ACT UP / ACT NOW takes over the FDA





APPENDIX: Federal AIDS Bureaucracies
__and AIDS Drug Development Flowchart



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