Legislation for Drug Safety & Efficacy

Legislation for Drug Safety & Efficacy

1. Pure Food and Drug Acts (1906) to protect from unsafe meat processing

   A. USP (U.S. Pharmacopeia) monitors drug:

   a. strength

   b. quality

   c. purity in medicine preparation

2. National Formulary (NF) sets standards for drug quality

3. Federal Food, Drug, and Cosmetics Act of 1938 (FFDCA – later became FDA) established that drugs must be tested & labeled accurately

4. Kefauver-Harris Amendment (1962) came from the tragedy of deformed Thalidimide babies – manufacturer must prove safety, efficacy, & adverse reactions & list in literature

Procedure for Drug Development and Approval – new drug molecule is subjected to:

1. preclinical trials to determine basic safety, efficacy, 3 ½ yrs.testing, of every 1000 compounds, only one make it to human test

2. clinical trials

   A. volunteers

   B. vary dosages

   C. tested on 1000 to 3000 subjects

   D. surveillance of medication (Medwatch – practitioners' reporting process)

Approval Process

1. only 10% of drugs win regulatory approval

2. long, complex, and expensive process

3. average estimation = 12 yrs & $350 million for new drug to be approved