The Food and Drug Administration (FDA) is obligated to monitor our nation’s food supply for safety as well as evaluate and approve for sale in the United States prescription drugs and medical devices. However, recent reports of large scale outbreaks of food poisoning, dangerous drugs causing death and injury as well as tampering with chemicals imported from China that were used in the drug manufacturing process have called into question the FDA’s ability to protect consumers.
The New England Journal of Medicine recently published an article that questioned whether the FDA can adequately monitor and evaluate the prescription drugs being approved. Also, members of the House of Representatives jointly sent a letter on February 4, 2008 to an officer of the Eli Lilly Company stating that the decrease in Funding for the FDA over the past 35 years has forced a 78% reduction in food inspections and that their scientific core has been eroded to the point that they can no longer fulfill its core regulatory functions.
During the current election year cycle and while listening to the debates it is important to remember that the Federal Government has many important fundamental functions one of which is to keep its citizens safe. The FDA is currently unable to perform its functions and is therefore placing everyone at risk of death or injury from dangerous food, drugs and medical devices.
The FDA’s lack of funding is made even more dangerous by a Supreme Court that has routinely denied people the right to sue for dangerous drugs or medical devices. Currently there is a theory called preemption that is gaining acceptance by the Supreme Court. Under preemption if the FDA approves a drug or medical device you probably could not sue for damages, even if the drug or device clearly caused the injury.
The reasoning used by the pro-business court is that we cannot let 12 untrained citizens second guess scientist at the FDA. That sounds reasonable until you learn how the under funded FDA operates. The FDA often takes the information and studies provided by the drug or device manufacturer and reviews it with an under funded staff. They do not do their own studies and have to rely on the honesty and integrity of the companies that profit only if their drug or device is approved.
Needless to say if the threat of a lawsuit is taken away by preemption there will be more dangerous drugs and devices in the marketplace.