The Role of the US Food and Drug Administration

The Food and Drug Administration (FDA) is a government entity which oversees and regulates the safety standards for most foods, pharmaceuticals, medical devices, and cosmetics. The FDA was created in 1927 from a reorganization of the Bureau of Chemistry. Over the years, the FDA has seen several changes in the scope of its regulatory powers, most importantly the Food, Drug, and Cosmetic Act of 1938, which significantly expanded its authority. Since that time, many amendments have been added to the FD&C Act, some which strengthened the organization, others which attempted to expedite the approval process (particularly for drugs intended to treat terminal illnesses).

Today, the FDA has two major jobs. First, it has the authority and duty to examine new food, medical, and cosmetic products for potential health and safety risks, to approve products which are safe, and reject those which carry unacceptably high risks. Second, the FDA has the authority to order recalls of products which prove to be unsafe on the market.

The Food and Drug Administration, like many government agencies, is almost constantly surrounded by controversy. Certain groups accuse the FDA of being too slow to approve important drugs, thus driving up prices and harming patients in need. Others, ironically, fault the FDA for being influenced by major corporations and failing to carefully examine the products they approve.

Recently, a proposal to ban lawsuits over FDA-approved products has been brought before Congress. If approved, the measure would prohibit states or consumers from suing companies for problems with their products, as long as the product has already gained FDA approval. This doctrine, known as preemption, is highly controversial.

To learn more about the FDA and its role, contact a Racine product liability lawyer by calling Habush, Habush, & Rottier, S.C. at 262-554-6200 today.