FDA’s Changes to Medical Device Approval Not Extended to Prescription Drugs

Although the FDA has announced that it is reconsidering and overhauling its current expedited approval process for medical devices, the agency has not made any similar announcements regarding updates on its drug approval process. The agency’s lack of action is concerning because the recall of medical drugs has increased, as witnessed by the 92 drugs recalled in a single quarter of 2018. According to the Recall Index, that is the highest number of medical drugs recalled since 2013.  

As the FDA changes its process for approving medical devices, it should also change its process for approving medical prescription drugs so that the medications have been better tested by the time they reach the market. That way, instead of medications being recalled only after numerous consumers have suffered severe complications, the drugs can be verified as safe before reaching the consumers.  

Recalls can occur when a medication is mislabeled, contaminated, or unsafe for consumers. Some, like the multiple sclerosis medication Zinbryta, are only recalled after patients have died, allegedly due to complications from the medication. Despite the FDA mandating a black-box warning of serious risks for Zinbryta, the medication was placed on the market and caused consumers considerable suffering before the manufacturer voluntarily withdrew it. Two other blood pressure medications containing Valsartin are being voluntarily recalled by Teva Pharmaceuticals after the ingredients were determined to potentially cause cancer. Considering the dangers that consumers have been exposed to, the FDA should take this time to make the medical prescription drugs safer for those who go rely on them.