The U.S. Food and Drug Administration recently published a draft proposal that would remedy an injury the Supreme Court dealt to generic-drug consumers two years ago in a case known as Pliva v. Mensing.

In that decision, the court held that federal law prevented generic manufacturers from independently revising inadequate, inaccurate and out-of-date warning labels on their products, as the manufacturers of brand-name drugs are able to do. The ruling had the net effect of taking away any legal recourse from consumers who were harmed by those drugs because of poor safety labels.


In part, this situation was created by a lack of parity in the way federal labeling requirements apply to the manufacturers of brand-name and generic drugs. The Food and Drug Administration enables brand-name manufacturers to unilaterally alter their products' safety warnings in light of newly acquired information. In contrast, generic manufacturers are required to maintain product labels that are, at all times, identical to their brand-name counterparts. This requirement persists even when generic manufacturers discover life-threatening side effects in their products or when brand-name manufacturers have stopped producing the branded drug. Conscious of the peril posed to consumers by the Pliva ruling, the Supreme Court in its decision encouraged Congress or the FDA to change the existing regulation to better protect consumers.

It appears the FDA is moving in that direction — a move long overdue. Its draft proposal would allow generic manufacturers to unilaterally include newly acquired safety information in their product warning labels through the FDA's standard "Changes Being Effected" mechanism, even when the revised safety information differs from the generic drug's brand-name counterpart.

Currently, generic manufacturers can use the mechanism only to bring a label into conformity with the branded counterpart. If a generic manufacturer believes that its label is inadequate and a stronger safety warning is warranted, the manufacturer must notify the FDA and then wait for the agency and the brand-name drug maker to determine whether and how to revise the warning. Because of constraints on FDA resources, this review process can be lengthy and may prevent pertinent safety information from reaching health care providers and consumers in a timely manner.

A primary goal of the FDA's proposal is to increase the speed at which new safety information is disseminated to the public. In addition, the proposal would recalibrate the rights of consumers and the obligations of generic manufacturers. Consumers and prescribing health care providers would have a right to receive, and generic manufacturers would have an obligation to provide, labels containing the latest safety warnings.

Up-to-date, accurate warning labels on medications play an important role in reducing the incidence of injury and death. Therefore, generic manufacturers should be required to ensure that this information is placed on their products and is made available to consumers, patients and health care providers.

Extending the Changes Being Effected requirements to generic manufacturers would also mean that those manufacturers could no longer avoid compensating patients for injuries caused by inadequately labeled drugs.

The FDA's proposal is not perfect, however. Several practical aspects need refinement. For example, as the FDA acknowledges, consumers may be confused by differing language in the safety warnings on drugs that are supposed to be the same. There is also concern that the change could cause an explosion of litigation that will drive up the cost of generic drugs. And some observers have questioned whether the FDA has the legal authority to make the proposed changes without congressional involvement. During the proposed rule's 60-day comment period, which ends in mid-January, these and other concerns will be addressed.

The Supreme Court's ruling in Pliva left consumers vulnerable. Since that time, people who take generic drugs have had no assurance that the safety warnings on their medications are accurate. Moreover, patients harmed by inadequately labeled drugs have had no legal recourse. But now the FDA has taken a long-awaited first step toward protecting consumers and holding manufacturers of generic drugs accountable for their products.

Stacey Lee is an assistant professor at the Johns Hopkins Carey Business School, where she teaches courses on legal issues in medicine and business. Her email is staceyb.lee@jhu.edu.

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