by: Jeff S. Gibson, Attorney
Rarely does a month go by without a pharmaceutical or medical device company making headline news for illegal marketing or failing to disclose dangerous side effects of its products. Many times the conduct is so egregious you are left wondering how a drug or device even made it to the market in the first place. Surely the Food and Drug Administration (FDA), the worldwide regulatory “gold” standard, would not have approved a product that was bad for us? Conventional wisdom tells us that the FDA is the gatekeeper for our safety. The FDA monitors and tests all products so its rubber stamp of approval must be absolute proof that consumers are safe? Unfortunately, this is an example where perception varies greatly from reality.
Let’s talk about what the FDA is not. The FDA is not a lab with scientists in white lab coats and Bunsen burners. The FDA is not in charge of running studies to determine the safety and efficacy of products. The FDA does not independently test the products we consume.
So, what exactly does the FDA do? The FDA is an administrative agency that oversees not only medical device and pharmaceutical products but also food safety, tobacco products, dietary supplements, over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, electromagnetic radiation emitting devices , veterinary products, and cosmetics. While the FDA oversees and monitors all of these products, it initially relies on the product manufacturer to provide data and evidence regarding safe and effective use of the products it wants to market. The FDA reviews this data to ensure a reasonable measure of product safety and allows the product to be marketed to the public. Think of the FDA as a giant filing cabinet. If a company provides accurate and truthful information and data, the process works. If a company hides or misleads the FDA, the result can be devastating. In short, junk in, junk out.
When information is omitted or modified, serious injuries can occur. After initial market approval, the FDA provides ongoing oversight for product safety in the form of data collected through its adverse events reporting system. Consumers and health care professionals are encouraged to report any adverse reactions or problems associated with products that are regulated by the FDA. These reports are then reviewed to identify any trends in injuries associated with specific products. When trends are identified, the FDA can recommend additional product testing, issue an increased safety warning, or order a manufacturer to remove its product from the market. Reports that cite serious injuries or death due to a defective product are quickly investigated to determine necessary actions to protect public health.
The FDA has a hefty job to do. To be fair, the FDA is filled with talented and dedicated employees that take their job seriously. However, the FDA is overwhelmed, overworked and underfunded. These are shortcomings that must be addressed. However, it is the responsibility of the manufacturer to act in an honest, ethical and responsible manner when they know their products are proving to be dangerous. So, the next time you read a news headline about a dangerous medical device or drug, remember what the FDA is and is not.
Debunking the Role of the FDA
by: Jeff S. Gibson, Attorney