FDA proposal could give generic drug makers independent labeling rights
Earlier this month the FDA proposed a new rule that would grant generic drug manufacturers permission to update product labels independently with new safety information, without having to wait until the brand-name counterpart drug makes similar changes. The ruling would permit generic makers to submit a “changes being effected”(CBE) supplement to the FDA; the agency could either accept the changes or reject them at a later time. The proposal comes on the heels of several U.S. Supreme Court rulings that limited the liability of generic manufacturers. Those previous decisions, which required generic labels to match brand name products, protected generic makers from failure-to-warn suits since they had little control over what safety information was provided to patients.
Supporters say the proposal encourages generic manufacturers to participate more directly with the FDA to ensure that patients and health care providers receive the latest safety information on medications they use. Over 80 percent of prescriptions filled in the U.S. are for generic forms, and the ruling would manufacturers would create enhanced transparency between consumers and providers.
On the other hand, critics say the ruling adds a duty on behalf of generic companies and leaves them facing an unlimited amount of liability. They worry that the obligation to update products independently could lead generic makers to engage in defensive labeling. Generic companies that are less accustomed to evaluating drug safety reports and warnings, may be more inclined to update labels every time a warning is reported, including those that turn out to be irrelevant or inaccurate. This could lead to confusion and conflicting information from different companies and throughout the marketplace. The FDA is already said to be in the process of sorting through a backlog of 2,500 supplement labels.
The FDA plans to publish the proposed rule in the Federal Register this week and interested parties may submit feedback to the agency for 60 days.
About the Author
Amy Sinclair is an Executive Vice President and co-leader of the Life Sciences Practice in WGA’s Property and Casualty Group. She negotiates, implements and manages comprehensive insurance programs for a variety of clients, ranging from venture-backed start-up organizations up to publicly traded companies.