Liability Looms for Generic Drug Safety Labeling Changes

FDA is proposing to revise its rules to permit generic drug manufacturers to initiate safety labeling changes, and not wait until the brand company takes that action. The aim of the new policy is to inform consumers more quickly of emerging safety concerns – but it also could create confusion by allowing prescribing information to differ among generic and brand products.

Under current law, there may be delays in adding new safety information to drug labeling if generics makers have to wait months for brands to act – a situation that may be aggravated by reduced brand marketing due to heavy generic competition. Because generics now account for more than 80 percent of U.S. prescriptions, FDA wants to make sure that their producers “actively participate with FDA to ensure that product safety information is accurate and up to date,” explained Janet Woodcock, director of the Center for Drug Evaluation and Research, in announcing the new policy Nov. 8.

The problems with the current system for updating drug labels were exposed more clearly when the Supreme Court decided in the 2011 Pliva v. Mensing case that federal law requires delays in generic drug labeling changes to prevent labeling that differs among products. And last June (2013), the Supreme Court ruled similarly in Mutual Pharmaceutical v. Barlett that FDA regulations permit generic drug manufacturers to revise labeling only to fit changes by the brand. Several federal district courts also have rejected suits filed by consumers seeking damages for generics firms that fail to warn of safety issues.

Now FDA proposes to address concerns raised by the Public Citizen Health Research Group in its 2011 citizens petition and allow generics makers to independently update prescribing information [available at www.fda.gov and published in the Federal Register Nov. 13, 2013]. Companies only have to inform FDA and other manufacturers of their action through a changes-being-effective (CBE-0) filing. To prevent confusion, FDA plans to post such information on a web page that will carry all safety-related label changes from all drug manufacturers.

Pharmaceutical companies and other parties have until mid-January to file comments on the proposal with FDA. Generics makers are not that enthusiastic, as seen in a statement from the Generic Pharmaceutical Association (GPhA) that the policy creates the potential for “unnecessary confusion” if there are even temporary differences in safety labeling for therapeutically equivalent products.  Not only could there be labeling differences between brands and generics, but among multiple marketers of competing generics.

The bigger concern for generics firms is a potential surge in liability suits, similar to those filed against brand firms, from patients claiming harm by the manufacturer’s failure to add necessary warnings to product labels. Strong safety warnings on generics, moreover, could heighten public concerns about generics being “different” or “inferior” to brand products.

Public Citizen praised the FDA proposal as likely to help prevent harm to millions of generic drug users. But generics makers already are questioning if FDA has authority to make such a change in policy through a regulatory procedure and that legislation may be needed to support labeling differences between generics and brands. Members of Congress have proposed various bills addressing this issue, and FDA’s proposal could spur action on Capitol Hill. The main aim for industry, though, is to ensure that any legislation or regulation preserves federal pre-emption of  state consumer protection laws related to prescription drug labeling.