Proposed FDA Rule Change on Generic Drug Labeling Essential for Patient Safety

In November 2013, in response to a Public Citizen petition, the Food and Drug Administration (FDA) proposed a rule change that would allow generic drug manufacturers to promptly update the safety information on their product labels. Under the proposed change, generic drug companies could, for example, add additional warnings about newly recognized risks without first obtaining FDA approval for the changes, as brand-name manufacturers can now do.

Three key factors together make the proposed rule change necessary to ensure patient safety. First, many potential hazards from prescription drugs are not discovered until many years after the products have been on the market — and, often, long after generic versions become available.

Second, generics now dominate the prescription drug market, constituting 84 percent of all prescriptions filled in the U.S. (More than 400 drugs are now available only in generic form.) As a result of these market shifts, brand-name drug companies have little or no incentive to be vigilant about ensuring product labels are up to date after competing generics come to market.

Third, in 2011, the U.S. Supreme Court ruled that because of the FDA regulations, generic drug manufacturers cannot be held liable to patients injured because of inadequate product warnings. As the FDA noted when issuing its proposed rule, this Supreme Court decision “alters the incentives for generic drug manufacturers to comply with current requirements … to ensure that the labeling for their products is up-to-date.” Moreover, it denies compensation to patients injured by drugs lacking adequate warnings on the arbitrary basis of whether the prescriptions were filled with a brand-name or generic version.

In a desperate attempt to prevent the FDA’s rule from being finalized, representatives of the generic drug industry have posed several unfounded objections to it. For example, industry representatives argue that the law requires brand-name and generic drug labeling to be “the same.” However, the FDA has never required such “sameness.” Rather, current FDA regulations already allow differences in drug labels with respect to information on a drug’s expiration date, formulation and metabolism. In addition, after brand-name drug companies make safety updates, the labels for generic versions of the drug differ from those of the brand-name version for months.

The FDA is now reviewing comments on the proposed rule. Public Citizen submitted detailed comments highlighting its benefits and rebutting the many flawed objections made by industry representatives. It is imperative that the FDA move swiftly to finalize the rule and close a safety gap that threatens the health and welfare of tens of millions of patients.