FDA delays generic drug label warning update
The U.S. Food and Drug Administration’s final rule on generic drug label warning regulations won’t be published until late next year, according to last month’s announcement from the federal agency. Since late 2013, FDA officials have collected feedback on a proposal to 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. Due to intense interest and a great deal of public input from various industry groups, the FDA pushed the decision back from this month until September 30th, 2015. The proposal has ignited heavy debate between plaintiff’s lawyers and the pharmaceutical industry, since the decision would overturn the U.S. Supreme Court’s 2011 ruling in Pilva v. Mensing, which limited the liability of generic manufacturers. Under the Mensing decision, generic drug labels are required to match brand name products, which shields generic makers from failure-to-warn suits since they have little control over what safety information is 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 with the ruling 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. With the delay, all eyes will be on action on Capitol Hill, as the GOP takes full control of Congress and opponents of the proposal try to rally support against the FDA’s action on the issue. WGA will continue to provide updates on this issue as the FDA’s final announcement draws nearer.
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.