FDA – Roles and Responsibilities

The Federal Food and Drug Administration has issued many health warnings and public advisories in the past few years. Thus, the agency has come under the scrutiny of press. According to many consumer groups the agency “fast tracks” drugs. Therefore, they are unable to test the drugs adequately for their side effects and health injuries prior to the approval.

FDA claims that even the best designed and largest market studies cannot answer all the questions about the new medicine. The agency evaluates the drug even after its approval in order to ensure the public safety. This process of evaluation helps the agency to know about the benefits of the new drug.

According to the Federal Food, Drug and Cosmetic Act, FDA is not responsible for the development of new medicines.  The new drugs developed by various manufacturers and drug developers are reviewed by staff, agency physicians and scientists. FDA determines the safety of drugs so that it can be tested in humans and thereafter it decides whether it can sold in the market or not. FDA approves the warnings, direction for use and side effects.

Drug Safety Oversight Board (DSOB) is an independent body established by FDA in 2005. This body communicates to the public the risks and benefits of drugs and looks after the drug safety issues. Following are the responsibilities of Drug Safety Oversight Board:

• Drugs to be pasted on the Drug Watch Web site are selected by (DSOB)

• It conducts the timely evaluation of drug safety issues

• Ensures that experts give their views about agency

Center for Drug Evaluation and Research (CDER) is a watchdog for approximately 11000 drugs in the market. This body evaluated new drug before they are sold in the market. The review of the experts on the new drug guides the patients and doctors to use it wisely. The center ensures that effective drugs are easily available to improve the health of patients.

Moreover, products like sunscreens, fluoride toothpastes and dandruff shampoos are also the responsibility of CDERs. Monitoring the health risks, drugs marketing and ensuring true advertising for the prescribed medicines is also taken care by the CDER. The Center informs the public, if it detects some risks in the drugs.

The policies of the department are widely criticized. FDA is planning to make advisory committees. The primary work of these committees would be to give reviews on the approval and safety of the new drugs. Sixteen advisory committees will be formed under CDER.