New FDA Rules on Generic Drug Labeling Expected in September

Since the United States Supreme Court’s 2011 decision in Pliva, Inc., et al v. Mensing, people injured by generic forms of harmful drugs have been left without recourse against generic drug manufacturers for failures to warn about their drugs’ harmful side-effects. In Mensing, the Supreme Court held that federal law preempted state law requiring drug manufacturers to be aware of the dangers posed by their drugs, and to appropriately label their drugs in order to warn consumers about these dangers. The federal law at issue, the Hatch-Waxman Act of 1984, requires generic drug manufacturers to use the same labeling as those approved by the Food and Drug Administration (FDA) for the brand name version of the same drug. In other words, generic drug manufacturers cannot change their labels to warn of known risks associated with their drugs unless the brand name manufacturer changes their label first. As a result, generic drug manufacturers are under no obligation to provide warnings in their labeling about the known danger of their drugs beyond what the brand name manufacturer’s labeling provides. The consequence of Mensing and its progeny has been that consumers of generic versions of drugs are unable to bring legal action against the drug companies that injured them for failing to warn about known dangers associated with their drugs. Meanwhile consumers of the brand name versions of the very same drugs, causing identical injuries, can sue the brand name manufacturers. Thus, whether or not you have legal recourse against the drug company that injured you depends on whether you took the generic or name brand version of the drug. This affects millions of Americans taking generic drugs every year, which comprise 80 percent of all prescription drugs in the United States.

In November 2013, the FDA proposed a new rule that would allow generic drug manufacturers to unilaterally update their labels. Specifically, makers of generics would be able to submit supplements for safety-related labeling changes to the FDA, and would then be able to distribute their drugs with the most current safety warnings prior to getting FDA approval. The generic manufacturer would then be able to contact the brand name manufacturer regarding the label change. If the FDA approves the change, other generic manufacturers would follow suit with the same label changes. This would eliminate the current prohibition on manufacturers of generics from unilaterally changing their labels to warn of known harmful effects associated with their drugs. The result would be both generic and name brand manufacturers having responsibility for making sure that their products’ labels are up to date and adequately warn about the known dangers associated with their drugs. Right now, that responsibility lies solely with the name brand manufacturer. Thus, we would see increased safety labeling on all prescription drugs that would benefit both prescribing physicians and prescription drug consumers. Generic manufacturers would share the responsibility for adequately warning about dangers associated with their drugs, and they too could be held accountable for failure to adequately warn about those dangers.

Of course, generic drug companies have been giving the FDA and its proposal significant pushback. Generic manufacturers complain that, if adopted, the proposal could cause confusion amongst consumers, open their industry up to billions of dollars in legal liability, and increases the cost of their pharmacovigilance monitoring. They also complain that the FDA does not have the authority to issue a proposed rule because it conflicts with the Hatch-Waxman act. If the proposed rule is implemented, the generic drug industry has threatened to sue.

Meanwhile, the FDA has been steadfast in defending both its right to promulgate the proposed rule and its reasons for doing so. However, in December of 2014, the FDA announced that it would delay finalizing the rule until 2015. The FDA reopened the period for public comment on the proposed rule change from February 18 to April 27, 2015, and held a public meeting on the subject on March 27, 2015.

Generic drug manufacturers have argued against the proposed rule change, and have given alternative proposals that would continue to shield generic drug manufacturers from liability for failure to warn about known dangers associated with their drugs. Under the alternative proposal espoused by the generic drug industry, known as the Expedited Agency Review (EAR), drug manufacturers would shift the onus of updating drug labels onto the FDA itself. At the April 27, 2015 public meeting on the proposal, generic drug industry leaders promoted the EAR, suggesting that the FDA should be responsible for deciding whether new drug warning labels are required, and then order companies to make those changes. However, shifting the burden to the FDA would only further distance drug companies, generic and brand name, from responsibility and accountability for the harmful consequences associated with the drugs that the industry makes billions of dollars selling each year. The FDA lacks the resources to track the multitude of drugs out on the market in this way. According to the New York Times, Dr. Michael Carome, director of the health research group at Public Citizen, likened the EAR proposal to the auto industry asking the Department of Transportation to take responsibility for issuing safety updates for every type of American car. Dr. Carome said, “No other industry is so shielded from liability risk.”

As with most industries, having legal liability as a potential consequence for the drug industry puts pressure on companies to be aggressive in their efforts to monitor and track safety. If this burden is shifted to the FDA, consumer safety is likely not to be improved, and in fact, is more likely to suffer greatly. The FDA has said that it hopes to have its policy finalized by September 2015. However, the legal battle over making generic drug manufacturers responsible for the safety of their products, and holding them accountable when they do not warn consumers about risks will be far from over in light of the industry’s promises to fight back.