Risk For Drugs And Medical Devices example essay topic

Business Law 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 has responsibility for protecting the rights and safety of patients in the clinical trials of investigation medical products. The FDA also has to review and approve in a timely manner the safety and efficiency of new drugs, biologic's, medical devices, and animal drugs. They have to monitor the safety and effectiveness of new medical products after they are marketed and acting on the information collected.

The FDA is responsible for seeing 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 is a big part of the FDA organization. The scientific evidence needed to back up Fda legal cases is prepared by the agencies 2,100 scientist, including 900 chemist 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, or example if products are contaminated with illegal substances. Other scientist 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.

They investigate the biological effects of widely used chemicals. The agency also runs the Engineering and Analytical Center, which test medical devices, radiation-emitting products, and radioactive drugs. Assessing risk, for drugs and medical devices, weighing risks against benefits is at the core ofF DAs public health protection duties. By ensuring that products and producers meet Goins II 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 its 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 FDA through user fees paid by the pharmaceutical industry, and the agency committed to significant performance goals in the review and approval of prescription drugs. The goal is to reduce significantly the time needed for review of new drugs, from the historic average of about to 27 months in the late 1980's to 12 months for routine drugs and six months for significant new therapies by 1997.

Whenever there is a problem with drugs, biologic's, medical and radiation-emitting devices, and special nutritional products, they should report problems to the FDA either directly or via the manufacturer. Med Watch, the FDA Medical Products Reporting Program, is an initiative designed both to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events and problems to FDA and / or the manufacturer; to ensure that new safety information is rapidly communicated to the medical community thereby improving patient care. The purpose of Med Watch program is to enhance the effectiveness of post marketing 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 2. To clarify what should (and should not) be reported to the agency 3.

To make it easier to report by operating a single system for health professionals to Goins report adverse events and product problems to the agency 4. To provide regular feedback to the health care community about safety issues involving medical products. Consumers should also report to Med Watch when a serious reaction to a medicine occurs such as: death, life-threatening situation, admission to a hospital or 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 Americas healthcare system.

Cder best-known job is to evaluate new drugs before they can be sold. The Centers review new drug applications not only prevents quackery, but it provides doctors and patients with the information they need to use medication wisely. The Center makes sure 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 that the health benefits outweigh known risk. From aspirin to cancer treatments, CDER ensures that the benefits of drug products outweigh any known risks. The Center has oversight responsibilities for prescription, and over-the-counter and generic drugs.

This responsibility includes products that many consumers usually do not associate as drugs, such as toothpaste, shampoos, and sunscreens. CDER carefully evaluates the benefits and risk of drugs and ensures that consumers have access, as quickly as possible, to promising new treatments. The Center oversees the research, developments, manufacture and marketing of drugs. CDER ensures truth in advertising for prescription drugs and monitors the use of marketed drugs for unexpected health risks. If unexpected risk are detected after approval, CDER takes action to inform the public, change a drug label, or if necessary, remove a product from the market. Goins FDA works with pharmaceutical companies to assure that all drugs marketed in the United States meet specifications for identity, strength, quality, purity, and potency.

Before approving a generic drug product, CDER requires many rigorous test and procedures to assure that the generic drug can be substituted for the brand name drug. By law, generic drugs products must contain the identical amounts of the same active ingredient as the brand name product. The FDA does not develop, manufacture or test drugs. Drug manufacturers submit full reports of a drug's studies so that the Center can evaluate its data.

This helps answer if the drug works for its proposed use. By analyzing the data, CDER reviewers assess the benefit-to-risk relationship and determine if the drugs should be approved. Once the FDA approves the drug, it does not mean it is perfectly safe. Some medicine may have side effects, but the FDA considers both the benefit and risk of all medication before approval... In addition, FDA makes the labeling outlines the benefits and risk reported in the tested population. For a drug to be approved by CDER, by current law, all new drugs need proof that they are effective and safe before they can be approved for marketing.

CDER decides as quickly as a thorough evaluation allows. When a proposed drug's benefit outweighs know risk, CDER considers it safe enough to approve. Once a drug gets the CDER approval, the drug is on the market as soon as the firm gets its production distribution system going. The FDA is prohibited from releasing information on any medicine under development, review or pending approval unless the information has been in the public.

The FDA has no legal authority to investigate or control the prices charged for marketed drugs. Manufacturers, distributors and retailers establish these prices. FDA recognizes the other factors beyond its purview, including insurance coverage and drug pricing.