The U.S. Food and Drug Administration (FDA) recently announced a reduction in fees for new medical device applications. The FDA hopes reducing the cost of applications will help encourage manufacturers to produce more life saving medical treatments for approval.
Manufacturers will see a $26,893 reduction in fees for 2017 compared to 2016. However, the fees of an application, which includes a premarket application, premarket report, and efficacy supplement, will still cost manufacturers $234,495.
Some companies will be eligible for further reductions, including even a complete waiver of fees. The FDA would like to level the playing field for medical device manufacturers, so small businesses that report yearly earnings less than $100 million and $30 million can apply for reduced fees.
While the reduction of application fees will help manufacturers, it might hurt consumers. Making the approval process more affordable also opens up the possibility that more dangerous products could plague consumers.Although the FDA’s approval process is long and arduous, it has proven to be far from foolproof.
One of the most devastating defective medical devices was the power morcellator used in laparoscopic hysterectomies. Although approved by the FDA, the device is now known to spread cancerous cells throughout the body. It took nearly two decades for these risks of the device to become widely known and this has inspired legislation to improve the adverse event reporting system.
Power morcellators aren’t the only devices the FDA has found dangerous. After more than ten years on the market, the FDA placed a black box warning on the contraceptive device, Essure. The FDA issued the warning after receiving more than 5,000 reports of adverse events.
Inferior Vena Cava filters (IVC filters) have also proven to be extremely dangerous for patients and some products have even been subject to voluntary recalls. The tiny devices are implanted into the largest vein in the human body, the inferior vena cava, to catch blood clots, but the devices are susceptible to fracture and migration.
The FDA must walk a fine line between approving lifesaving medical treatments and protecting consumers from dangerous devices and medications, but the reduction in application fees could throw off the FDA’s precarious balance between providing new cures and protecting consumer safety.