Role of the FDA in Pharmaceuticals

The Food and Drug Administration (FDA) is the federal agency responsible for, among other things, regulating and reviewing the pharmaceutical industry. In order to perform this duty, the organization oversees a number of programs and systems to tests and monitor human consumption of drugs.

Function

One of the primary roles of the FDA is to approve new drugs for consumption by humans. This process is known as the New Drug Application (NDA). Initially, all new drugs are available only through prescription.

Features

All prescription drug advertising and promotion is reviewed and regulated by the FDA. However, all over-the-counter drug advertising is handled by the Federal Trade Commission.

Significance

Once a drug is approved through the NDA process, the FDA continues to monitor any adverse reactions by patients reported by the medical industry. All fatalities need to be reported within 15 days.

Misconceptions

The FDA is challenged by the fact that many doctors do not report minor harmful side effects of the drugs. In response to this, the FDA utilizes a program called MedWatch, a system of easily accessible reporting tools.

Considerations

On occasion, the FDA will require additional clinical trials for drugs after approval. This usually occurs when new information about the pharmaceuticals arises. The program is called Phase IV testing.

References

• New Drug Application
• FDA Considers Tightening Regulations for Direct-to-Consumer Advertising
• MedWatch

Resources

• FDA: Drugs