FDA History

Dietary Supplement and Health Education Act (DSHEA)

Passed in 1994, this act allowed the FDA to set guidelines for herbal products and dietary supplements, however; the FDA cannot regulate these products - the manufacturers hold all liability.

Kefauver-Harris Amendment

Passed in 1962, this act required that drugs be both safe and effective. This law was passed in response to the use of Thalidomide in European pregnant women.

Orphan Drug Act

Passed in 1983, this act facilitated the development of new drugs to treat rare diseases while giving manufacturers the ability to deduct 75% of clinical trial costs. There are currently more than 1000 of this type of drug on the market.

FDA Modernization Act

Passed in 1997, this allowed critically-needed drugs to move quickly through the approval process. In addition, it granted physicians the right to prescribe Phase 3 IND's.

Pregnancy Category C

Animal fetal toxicity demonstrated; human risks undefined.

OTC Drug Advisory Committee

Coming about in 1992, this group of physicians and pharmacists determined which drugs are safe for over-the-counter use.

Compassionate Use of IND

Coming about in the 1990s, this was mainly for AIDS patients. A 1-800 number provided by the FDA gave physicians, family members, and patients alike a source of information and locations of trials for AIDS research.

Pregnancy Category X

Human fetal risk present but does not outweigh benefits; contraindicated in pregnancy.

Pregnancy Category D

Human fetal risk present, but benefits may outweigh risks.

"Elixir of Sulfonamide"

In 1937 in Tennessee, this concoction was only tested by the manufacturer for taste and fragrance, when in fact the ingredient was an industrial-strength solvent. This led to over 350 deaths and lead to the Food, Drug, and Cosmetic Act.

Core Elements of Medication Therapy Management (MTM)

Medication therapy review, Personal medication record, Medication-related action plan, Intervention and/or referral, Documentation and follow-up.

Pregnancy Category B

No controlled studies show human risk; animal studies suggest potential toxicity.

Pregnancy Category A

No human fetal risk or remote possibility of fetal harm.

Food and Drug Act

Passed in 1906, this is the first federal law passed to protect the public from worthless/harmful drugs. It was amended in 1912 to require the proper labeling of ingredients.

Harrison Narcotics Act

Passed in 1914, this act introduced the word "narcotics" and established the legal framework for controlling drugs with the potential for abuse and/or dependence.

Food, Drug, and Cosmetic Act

Passed in 1938, this ensured that products were safe and gave the FDA the right to seize any drug suspected of being toxic. Manufacturers were now required to show scientific data proving that their products were safe for consumers.

Durham-Humphrey Act

Passed in 1951, this ensured that prescription drugs could only be given to patients under the care of a physician.

FDA Approval Process

Preclinical trials, IND application, NDA application, ANDA application (4 Phases).

Comprehensive Drug Abuse and Prevention and Control Act

This act replaced the Harrison Narcotics Act in 1970, and led to the formation of the DEA in 1973 as well as the idea of "schedule" drugs. Controlled substances are regulated by federal and state law, not the FDA.