History of Drug Regulation in the USA.txt
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1. First United States Pharmacopeia (USP) in USP
2. Import Drug Act of 1848
- (Story: Due to US Mexican War)
- It mandated inspection prior to admission to the country
3. The Bureau of Chemistry founded (1862)
The predecessor of the FDA
4. Upton Sinclair wrote about unsanitary conditions (1901)
5. Biologics Control Act (1902)
- (Story: deaths of children caused by contaminated vaccines. diphtheria)
- Safety, purify, and effectiveness of biological products (Led to formation of CBER--Center for Biologics Evaluation and Research, a predecessor of the FDA)
6. Food and Drugs Act (1906)
Prohibit interstate commerce of misbranded and adulterated food, drinks, drugs. Precursor to FDA formation. Prevent people from mislabeling ingredients.
7. Sherley Amendment (1912)
Prohibit false therapeutic claims.
9. Federal Food, Drug, and Cosmetic Act (1938)
- (Story: deaths due to diethylene glycol was used to dissolve sulfanilamide meds to make a liquid form)
- Required animal tests. Law has been amended many times.
10. Durham-Humphrey Amendment to the Act of 1938 (1951)
- (Humpty Dumpty fell on a pile of prescriptions.)
- "Prescription Amendment". Differentiate between OTC and prescription drugs. Phone prescription and refill.
11. Kefauver-Harris Amendment (1962)
(Story: Thalidomide disaster) Need to prove effectiveness to FDA before marketing a drug.
12. Drug Listing Act (1972)
Give FDA a list of all their drugs by NDC, a unique product identifier.
13. Orphan Drug Act (1983)
- Designed to facilitate the development and commercialization of drugs to treat rare diseases.
- -7 years exclusivity after approval
- -Special financial incentives
- -Protocol assistance
14. Drug Price Competition and Patent Restoration Act (1984)
Provides for a period fo exclusivity such that once a New Molecular Entity (NME) is approved, a generic version cannot be approved for 5 years.
15. Revision of New Drug Application (NDA) regulations (1985)
These changes provide for safety reports after an application for a new drug is submitted, more focused and better organized data, use of summaries and tables for easier review, etc
16. Drug Exports Amendments (1986)
Can export meds to other countries even if it's not approved by the FDA.
17. Prescription Drug Marketing Act (1987)
- Prevent illegal diversion and sale of prescription drugs from legitmate distributors.
- -Require state licensing of wholesale distributors
- -Ban on re-importation of products produced in the USA
- -Ban teh sale, trade, or purchase of drug samples
- -Ban trafficking in or counterfeiting of drug coupons
- -Require practitioners to request drug samples in writing
- -Prohibit the resale of prescription human drug products
18. Revision of Investigational New Drug (IND) Regulations (1987)
19. Treatment use of INDs (Investigational New Drug) (1987)
Made promising new drugs available to desperately ill patients as early in the drug development process as possible. (before clinical trial)
20. Generic Drug Enforcement Act (1992)
"ANDA" (Abbreviated New Drug Application) -- impose debarment and penalties for illegal acts involving ANDA. Authorizes FDA to prevent companies from manufacturing generic drugs if the FDA deems they are corrupt or in violation of the law.
21. Prescription Drug User Free Act (PDUFA) (1992)
- -User fees will be collected only if taxpayers dollars supporting the review process remain constant
- -Establish performance goals for drug reviews
- -Speed up approval of drugs and devices
- (FDA now has companies pay for the review of their drugs)
22. The FDA Modernization act (FDAMA) (1997)
- -Allows pharmacists to compound drugs.
- -Disseminate literature of off-labeled indications of a product
- -Access to experimental tehrapy
- -Biological product
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