FDAOctober 11, 2000The FDA has many responsibilities which include overseeing the production ofsafe foods and the manufacture of safe and effective drugs and medical devices. TheFDA has responsibility for protecting the rights and safety of patients in the clinicaltrials of investigation medical products. The FDA also has to review and approve in atimely manner the safety and efficiency of new drugs, biologics, medical devices, andanimal drugs. They have to monitor the safety and effectiveness of new medicalproducts after they are marketed and acting on the information collected.
The FDA isresponsible for seeing that the public has access to truthful and non-misleading productinformation by: monitoring the promotional activities of drug and device manufacturers,and regulating the labeling of all packaged foods. Science is a big part of the FDA organization. The scientific evidence needed toback up FDAs legal cases is prepared by the agencies 2,100 scientist, including 900chemist and 300 microbiologist, who work in 40 laboratories in the Washington, D. C.
,area and around the country. Some of these scientist analyze samples to see, orexample if products are contaminated with illegal substances. Other scientist reviewtest results submitted by companies seeking agency approval for drugs, vaccines, foodadditives, coloring agents and medical devices. The FDA also operates the NationalCenter for Toxicological Research. They investigate the biological effects of widelyused chemicals.
The agency also runs the Engineering and Analytical Center, whichtest medical devices, radiation-emitting products, and radioactive drugs. Assessingrisk, for drugs and medical devices, weighing risks against benefits is at the core ofFDAs public health protection duties. By ensuring that products and producers meet Goins IIcertain standards, FDA protects consumers and enables them to know what they arebuying. 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 mustdetermine that the new drug produces the benefits its supposed to without causingside effects that would outweigh the benefits.
In 1992, the U. S. Congress passed the Prescription Drug User Fee Act. Thislegislation provided additional resources for FDA through user fees paid by thepharmaceutical industry, and the agency committed to significant performance goals inthe review and approval of prescription drugs.
The goal is to reduce significantly thetime needed for review of new drugs, from the historic average of about to 27 months inthe late 1980s to 12 months for routine drugs and six months for significant newtherapies by 1997. Whenever there is a problem with drugs, biologics, medical andradiation-emitting devices, and special nutritional products, they should reportproblems to the FDA either directly or via the manufacturer. MedWatch, the FDAMedical Products Reporting Program, is an initiative designed both to educate allhealth professionals about the critical importance of being aware of, monitoring for, andreporting adverse events and problems to FDA and/or the manufacturer; to ensure thatnew safety information is rapidly communicated to the medical community therebyimproving patient care. The purpose of MedWatch program is to enhance theeffectiveness of postmarketing surveillance of medical products as they are used inclinical practice and to rapidly identify significant health hazards associated with theseproducts. The program has four goals:1. To increase awareness of drug and device-induced disease2.
To clarify what should (and should not) be reported to the agency3. To make it easier to report by operating a single system for health professionals to Goins IIIreport adverse events and product problems to the agency4. To provide regular feedback to the health care community about safety issues involving medical products. Consumers should also report to MedWatch when a serious reaction to amedicine occurs such as: death, life-threatening situation, admission to a hospital or alonger than expected hospital stay, a permanent disability, a birth defect, or the needfor medical or surgical care to prevent permanent damage.
The FDA also has a department called CDER( Center for Drug Evaluation andResearch). The Center is a consumer watchdog in Americas healthcare system. CDERs best-known job is to evaluate new drugs before they can be sold. TheCenters review new drug applications not only prevents quackery, but it providesdoctors and patients with the information they need to use medication wisely.
TheCenter makes sure that safe and effective drugs are available to improve the health ofconsumers. CDER ensures that prescription and over-the-counter drugs both brandname and generic, work correctly and that the health .