The Federal Food and Drug Administration (FDA) has come under scrutiny in the press due to the large number of public advisories and health warnings the agency has released in the last couple of years. Some consumer groups claim that the agency “fast tracks" too many drugs, therefore not permitting sufficient time for potential side effects or long term ill health effects to surface prior to the approval of a new drug.

According to the FDA even the largest and best-designed pre-market studies cannot reasonably answer all of the important questions that may arise about new medicines. The agency states that it is committed to continuing the evaluation of drugs after their approval and that it is an important part of ensuring public safety. The FDA also states that this ongoing process helps to learn new things about the drug’s benefits. The agency has recently hired outside consultants to conduct an evaluation of their post marketing study commitment process for collecting medical information in order to make improvements.

The role of the FDA does not include the development of new drugs under the Federal Food, Drug, and Cosmetic Act. Therefore, agency physicians, scientists, and other staff review drug test results that are submitted by large numbers of different drug developers and manufacturers. The FDA does determine whether the drug is safe enough to test in humans and after all the human testing is completed decides whether the drug can be sold to the public. The FDA also directs the labeling requirements of the drug and approves the directions for the use, side effects, and warnings.

In 2005 the FDA established an independent Drug Safety Oversight Board (DSOB) to oversee the management of drug safety issues and communication to the public about the risks and benefits of medicines. The board's responsibilities include conducting timely and comprehensive evaluations of emerging drug safety issues, selecting drugs to be placed on the Drug Watch Web site for health professionals and patients, and ensuring that experts give their perspectives to the agency..

The FDA’s Center for Drug Evaluation and Research (CDER) is a consumer watchdog in the health care system for the roughly 11,000 drugs currently on the market. CDER's primary job is to evaluate new drugs before they are sold. The Center's review of new drug applications provides doctors and patients with the information they need to use medicines wisely. The Center also has the responsibility for making sure that safe and effective drugs are available to improve the health of consumers and ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks.

In addition to prescription medications, CDER’s responsibilities include products such as fluoride toothpaste, dandruff shampoos and sunscreens. The Center oversees the marketing of drugs, ensuring truth in advertising for prescription drugs and monitors the use of marketed drugs for unexpected health risks. If unexpected risks are detected after approval, CDER takes action to inform the public.

Even with these departments in place and the accelerated approval process for new drugs (through a series of regulations that provide incentives to pharmaceutical companies to develop new drugs more rapidly and to expand clinical trials) the agency’s policies have been widely criticized. Controversies surround the accelerated approval process, the legal concerns about unsafe drugs and the incentive program for the pharmaceutical companies' use of the accelerated approval process.

Partly in response to these concerns over the next year, the FDA is planning reforms to the operations of the agency’s advisory committees. These committees make recommendations on prescription drug approvals and safety. Initially, the reforms will involve the sixteen committees under CDER. In most cases, the FDA accepts committee recommendations on whether and under what conditions to approve prescription drugs. The committees have standard financial disclosure guidelines and generally act in a similar manner but it has been noted that they differ in certain practices, such as the conduct of discussions and votes. The agency is seeking to improve the consistency and predictability of the operations of the committees, as certain committees seem to operate more effectively than others do. The agency is seeking to apply the best practices from each committee to all committees in order to provide greater protections to the public and improve industry standards.