In ‘Ensuring Timely Approval Of Generic Drugs,’ Safety Must Come First

If there was ever a time for an informed discussion about the purpose and use of Risk Evaluation and Mitigation Strategies (REMS), it is now. Rather than impeding the arrival of more effective treatments to the market, Congress gave the Food and Drug Administration (FDA) authority to require REMS as a way to approve needed medicines that are also known to carry severe risks. As a result, patients now have access to new treatments for asthma, chronic obstructive pulmonary disease, blood disorders, multiple myeloma, thyroid cancer, irregular heartbeat, hypertension, multiple sclerosis, seizures, schizophrenia, bipolar disorder, Crohn’s disease and specific bowel disorders, and a number of rare disorders. Without REMS, it is unlikely most of these new treatments would ever have reached patients. Contrary to the assertions in the Health Affairs Blog post by Ameet Sarpatwari and Aaron Kesselheim, “Ensuring Timely Approval of Generic Drugs,” REMS is an integral component of ensuring safety regulations, covers a small number of drugs known to carry very high risks, and has not impeded the development of generics. At the same time, our analysis of the Fair Access for Safe and Timely Generics (FAST) Act identifies a number of provisions that, far from being reasonable solutions, would dilute the safety systems now in place under REMS to protect patient safety. High Risk Drugs Require Oversight While examining the important role of generic drugs in increasing access to medici...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Drugs and Medical Technology Featured Population Health FAST Act FDA FDAAA Patient Safety REMS Source Type: blogs