Prescription drugs and medical devices are supposed to improve our health. Prescription drugs and medical devices are regulated and approved by the Food and Drug Administration (FDA) before they reach the consumer. However, even with this oversight, there are large deficiencies in the FDA process for introducing certain drugs and devices to the market.
According to the Centers for Disease Control and Prevention (CDC), pharmaceutical drugs kill over 40,000 people every year. In 2011, it was reported that prescription drug deaths outnumbered traffic fatalities in the United States. Recent studies highlighted by the CDC estimate that more than 50% of all the drugs marketed to the American consumer have injurious effects, despite testing and FDA regulation.
Unfortunately, FDA recalls of many dangerous and medical devices have occurred after thousands of people were injured occurred.
Prescription drugs and medical devices are a multi-billion dollar per year industry. Big pharmaceutical and medical device manufacturers spend huge amounts of money to design products for our use. If a product shows promise, a company will invest even more money to push it through human testing. Sometimes, in a rush to gain FDA approval, danger signs are overlooked or ignored. Because so much money is involved, manufacturers have been known to hide potentially damaging information and hope the negative findings.
According to the Federal Food and Drug Administration (FDA), a recall will lead a firm to remove one of its products from the market. Recalls may be conducted by a firm’s own initiative, or on the request or order of the FDA. The FDA will order a recall of a drug if it is defective and/or potentially harmful.
A recent study conducted by Brigham and Women’s Hospital in Boston counted more than 1,700 drug recalls listed in the FDA’s enforcement reports between 2004 and 2011. During that time, the FDA issued approximately 2,900 announcements through the Recall Alert System.