FDA Stuggles to Fullfill its Mission

The Food and Drug Administration (FDA) is responsible for researching and approving new medicines, staying abreast of those medicines on the market, regulating medical devices, and monitoring and ensuring the safety of approximately 80% of our food supply. Most people don’t realize the FDA also regulates many devices that emit radiation such as cell phones, computer monitors, as well as a host of other products. The FDA also regulates cosmetics and many products used in the production of food, including animal feed.

With the globalization of food and drug production it is no surprise to find that the FDA has been unable to do its job as mandated. The FDA’s budget has essentially been flat for years even though many managers and administrators in the FDA have called for a doubling of their budget. Recently an article published March 14, 2009 in the New England Journal of Medicine pointed out the difficulties faced by the FDA. The article entitled “A To-Do List for the New FDA Commissioner” points out many of the difficulties faced by an increasing workload at the FDA and suggests many changes that need to be addressed.

The primary focus of the FDA is the protection of the United States consumer. It is obvious that the FDA is not capable of monitoring all of the products under its umbrella that are made in the United States and certainly not those entering the U.S from foreign countries such as China. With the FDA stretched beyond its limit and the Federal Budget unable to fully fund the FDA an obvious choice is to remove the private lawsuit protections that medical device makers and drug manufacturers have taken advantage of in the past. Congress originally attempted to essentially grant immunity to drug and device manufacturers in many circumstances, if the FDA had approved a product. Inasmuch as the FDA cannot properly research and evaluate every product, private consumer litigation is the only avenue to seek redress from harmful drugs and devices. Legislation has been introduced in the current session of Congress to accomplish this task. We as a country need to either fully fund the FDA or allow consumer protection lawsuits. Innocent people are being harmed or killed by unsafe food, drugs or medical devices and many of those harmed currently have no relief in the courts.