Over the past 30 years, the prescription-drug market has transformed, and generic drugs now constitute the majority of all prescriptions filled. Indeed, by the FDA’s estimate, approximately 420 drugs are now sold only in generic form. The Generic Pharmaceutical Association puts the number even higher, stating that for 45 percent of generics, no branded product is currently available.
Despite this, FDA regulation of generic labeling has remained substantially unchanged. Unlike brand-name manufacturers, generic manufacturers are not permitted to make safety updates unless the brand-name does so first. The result is a safety gap. Drug safety is threatened when market changes weaken incentives designed to motivate manufacturers’ vigilance.
The majority of new safety warnings are based on reports of adverse events by manufacturers, hospitals and others, which the FDA posts to an online database. All manufacturers, therefore, have access to the key information needed to make the majority of safety updates. The FDA has proposed just that: to allow generic manufacturers to update labeling to reflect newly discovered risks, just as brand-name manufacturers are permitted to do.
Three years ago, the U.S. Supreme Court held that, because generics are not responsible for labeling, a patient injured because of inadequate warnings on a generic drug generally cannot sue the drug’s manufacturer. The FDA’s proposal would also, therefore, restore injured patients’ ability to sue. For this reason, the generic industry is pushing hard against the proposal.
The industry incorrectly says the FDA’s proposal violates a legal requirement that branded and generic labeling be “the same.” In fact, FDA regulations allow generic labeling to “include differences in expiration date, formulation, bioavailability or pharmacokinetics.” And for months after a brand-name manufacturer updates labeling with new warnings, the generic and brand-name labeling differ. These long-standing differences have been uncontroversial, as the FDA, manufacturers and patient advocates have long accepted that “sameness” is not a literal requirement.
The industry also argues that the FDA’s proposal will cause inconsistent labeling that will confuse physicians. But under the proposal, the period in which labeling of brand-name and generic drugs differ will be shorter than under current regulations. Moreover, in the unlikely event the FDA sees confusion arising from inconsistent labeling, it can take steps to address it.
The industry has also argued that generic manufacturers will overwarn consumers. But brand-name manufacturers have been permitted to make safety updates for nearly 30 years, and overwarning has not been a problem. The proposal, however, should not be rejected based on hypothetical concerns that current practice suggests are unwarranted.
The real industry concern seems to be liability. Although a manufacturer is not responsible for every injury, when meritorious, lawsuits occur because a patient was harmed due to the lack of an adequate warning. Immunizing manufacturers from liability does not make the injured patients’ medical expenses or lost wages go away. These costs are carried by the patients, health insurers and taxpayers. In fact, the new rules would help avoid liability by preventing injuries from occurring with more timely safety updates. The FDA’s proposal is a welcome effort to fill an unnecessary safety gap.