The Role of the FDA
The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. It's responsible for regulating food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.
And just like every other government agency, the FDA is a bureaucracy whose rules, regulations, and requirements continue to expand. In 1980, the typical drug underwent 30 clinical trials involving about 1,500 patients. By the mid 1990s, the typical drug had to undergo more than 60 clinical trials involving nearly 5,000 patients.
Ongoing Oversight
The FDA continues to monitor the drugs for which it has granted approval. It gathers safety information on side effects and potential hazards as they arise. Occasionally, the FDA will recommend changes in labeling that reflect these new concerns.
The FDA also releases periodic news bulletins to alert the public when a serious problem has arisen. The FDA reserves the authority to withdraw a drug from the market if the drug proves to be harmful when used as prescribed.
Alert
The most severe FDA alert, short of withdrawing a drug from the market, is the “black box” alert. This warning provides additional cautions for use of the drug in question. After concerns about potential risks of suicide in teenagers and children who used antidepressant medications, the FDA issued a black box advisory, cautioning about antidepressant use in these populations.
Shortening the Process
Everything seems to be moving faster in our technologically driven world, and the FDA is no exception to this. In January 2006, the FDA announced plans to streamline the process of getting a drug through the earliest stages of clinical development.
The Secretary of the Department of Health and Human Services pointed out that nine out of 10 experimental drugs fail in the clinical trials because researchers cannot accurately predict how these drugs will affect people based solely on animal and lab studies. To address this problem, the FDA will permit small amounts of experimental drugs to be tested on human subjects before Phase I trials begin. This will not only cut time, it will also cut back on expense.
