Hundreds of products and drugs get approved by the U.S. Food & Drug Administration every year. Many people mistakenly believe that the FDA, because it has approved a device or drug, has also tested the product before allowing the sale.
But this is not the case: the FDA conducts no independent testing, but rather relies on the pharmaceutical or medical device manufacturer seeking approval of the drug or device to test its own product. The FDA submits the manufacturer’s pre-approval testing to advisory panels for review. To compound the problem, the FDA has been understaffed and has been accused of conflicts of interest with respect to FDA advisory panels. Often, the manufacturer that is seeking approval of its drug or device is paying huge consulting fees to members of the FDA advisory panel.
Following the slew of drug recalls and medical device recalls in recent years, many people wonder why the FDA doesn’t do a better job preventing defective drugs and medical devices from coming to market. The truth is that the FDA does not test products it approves.
The FDA relies on the drug and medical device manufacturers to test their own products. Indeed, many products that have been recalled were never tested, but rather were approved by the FDA because the manufacturer convinced the FDA that the product was substantially similar to an existing FDA approved product.
When the government agency in charge of food, drug, and medical device safety is more concerned with helping the manufacturers than protecting consumers, the result is serious personal injuries and wrongful death from tainted food, defective drugs, and defective devices. If you have been injured by a defective prescription drug or medical device, you need an experienced products liability lawyer.