FDA, October 11, 2000. The FDA has many responsibilities, which include overseeing the production of safe foods and the manufacture of safe and effective drugs and medical devices. The FDA is responsible for protecting the rights and safety of patients in the clinical trials of investigational medical products. Additionally, the FDA has to review and approve the safety and efficiency of new drugs, biologics, medical devices, and animal drugs in a timely manner. They also monitor the safety and effectiveness of new medical products after they are marketed and act on the collected information.
The FDA is responsible for ensuring that the public has access to truthful and non-misleading product information by monitoring the promotional activities of drug and device manufacturers and regulating the labeling of all packaged foods. Science plays a significant role in the FDA organization. The agency’s 2,100 scientists, including 900 chemists and 300 microbiologists, who work in 40 laboratories in Washington, D.C., prepare the scientific evidence needed to support FDA’s legal cases.
Scientists work in various areas around the country. Some analyze samples to determine if products are contaminated with illegal substances. Others review test results submitted by companies seeking agency approval for drugs, vaccines, food additives, coloring agents, and medical devices. The FDA also operates the National Center for Toxicological Research, which investigates the biological effects of widely used chemicals.
The agency also runs the Engineering and Analytical Center, which tests medical devices, radiation-emitting products, and radioactive drugs. Assessing risk for drugs and medical devices, weighing risks against benefits, is at the core of FDA’s public health protection duties. By ensuring that products and producers meet certain standards, FDA protects consumers and enables them to know what they are buying. In deciding whether to approve new drugs, FDA does not itself do research, but rather examines the results of studies done by the manufacturer. The agency must determine that the new drug produces the benefits it’s supposed to without causing side effects that would outweigh the benefits.
In 1992, the U.S. Congress passed the Prescription Drug User Fee Act. This legislation provided additional resources for the FDA through user fees paid by the pharmaceutical industry. The agency committed to significant performance goals in the review and approval of prescription drugs.
The goal is to significantly reduce the time needed for the review of new drugs, from the historic average of 27 months in the late 1980s to 12 months for routine drugs and six months for significant new therapies by 1997. Whenever there is a problem with drugs, biologics, medical and radiation-emitting devices, or special nutritional products, they should report problems to the FDA either directly or via the manufacturer. MedWatch, the FDA Medical Products Reporting Program, is an initiative designed to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events and problems to the FDA and/or the manufacturer. The program also aims to ensure that new safety information is rapidly communicated to the medical community, thereby improving patient care. The purpose of the MedWatch program is to enhance the effectiveness of postmarketing surveillance of medical products as they are used in clinical practice and to rapidly identify significant health hazards associated with these products. The program has four goals: 1. To increase awareness of drug and device-induced disease.
To clarify what should and should not be reported to the agency, to make it easier to report by operating a single system for health professionals to report adverse events and product problems to the agency, and to provide regular feedback to the healthcare community about safety issues involving medical products. Consumers should also report to MedWatch when a serious reaction to a medicine occurs, such as death, a life-threatening situation, admission to a hospital, a longer than expected hospital stay, a permanent disability, a birth defect, or the need for medical or surgical care to prevent permanent damage.
The FDA also has a department called CDER (Center for Drug Evaluation and Research). The Center is a consumer watchdog in America’s healthcare system. CDER’s best-known job is to evaluate new drugs before they can be sold. The Center’s review of new drug applications not only prevents quackery, but also provides doctors and patients with the information they need to use medication wisely.
The Center ensures that safe and effective drugs are available to improve the health of consumers. CDER ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and promote good health.
