Wednesday, September 12, 2018
The FDA and Pharmaceuticals: From discovery to pharmacy
The FDA - FDA is an agency of the executive branch of the government reporting to The Secretary of Health Education and Welfare
- Mission of the FDA: Protect public health
- Products regulated (whole product does not need to be approved, just components) by the FDA: Food Drugs : Cosmetics/toiletries : Medical devices
- FDA regulates pharmaceutical advertisements . Violates ads for... - Broadened indication - Unsubstantiated claim
- Unapproved use/drug - Risk minimization - Overstated efficacy - Superiority claim - FDA drug responsibilities:
: Safety of drugs for clinical trials
: Protects interests and rights of patients in clinical trials
Availability of drug for general medical use . Oversees manufacturing -1906 Pure Food and Drug Act: as a result of the industrial revolution, the production of food and medicine became a large-scale enterprise, regulated by the government to protect public health, established the FDA Harvey Wiley- Head of USDA's Bureau of Chemistry
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Wednesday, September 12, 2018
American women were powerful lobbyists
: Upton Sinclair's The Jungle
1938 Federal Food, Drug, and Cosmetic Act: tightened controls over drug and food, included new consumer protection against unlawful cosmetics and medical devices, enhanced the government's ability to enforce law, introduced prescriptions
: Solvent used was diethylene glycol (DEG)
- anti-freeze
Attributed to 100s of deaths
Thalidomide
- Introduced in the 1960s
- Thalidomide (generic name)
- Advertised as SAFE
no prescription needed in Germany
: "Pregnant women can take it'
: Widespread across the world
"You couldn't overdose a rat"
- Dr. Frances Kelsey
Unsatisfied by lack of rigorous scientific studies on thalidomide
: Concerned about effects on the fetus
: Tried to keep thalidomide off the market (kept it out of the US)
- Linked to rash birth defects
- Giselle Cole
- Suffered birth defects from thalidomide (dwarf arms)
: Advocates for thalidomide surviving victims
- Some were rejected by their families (put in homes)
- Allowed thalidomide to be reintroduced to the market so it could help others (moral conscious)
Government tried to deny thalidomides linkage to the defects by blaming them on other chemicals
- German drug company only apologized 50 years after the scandal
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Wednesday, September 12, 2018
- Thalidomide eventually was banned in 1962
- Became "a drug in search of a disease"
- 1964- leprosy patient treated with thalidomide to help sleep - Thalidomide was rediscovered as a way to stave blood flow to cells (help treat cancer/ tumor cells)
- FDA begins to heavily regulate the sell of thalidomide to treat HIV/AIDS, leprosy, etc. patients
- 100 children since 2005 with birth defects from thalidomide use
- Takeways:
- Despite the detrimental effects, the drug can be used for good
We must fully understand the drug's mechanism of action, so it can be regulated properly
From discovery to market...
Drug DiscoVery and Development: A LONG, RISKY ROAD DRUG DISCOVERY PRECLINICAL CLINICALTRIALS FDA REVIEWLG-SCALEMFG WLL
5,000-10,000 250 COMPOUNDS PRE-DI