FDA confirms: It’s considering rule change for generic labels

February 13, 2013

Last month, when I wrote about the Obama administration’s apparent flip-flop on the question of federal pre-emption of product liability claims against generic drugmakers, I mentioned a curious footnote in the Justice Department’s Supreme Court amicus brief in Mutual Pharmaceutical v. Barrett. All the wrangling over liability for generics, which are required by law to use the same labels as the brand-name drugs they replicate, could be unnecessary, Justice hinted. “This office has been informed that Food and Drug Administration is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances,” the brief said. “If such a regulatory change is adopted, it could eliminate pre-emption of failure-to-warn claims against generic-drug manufacturers.”

I should have given the footnote more attention. In the last couple of weeks, it has prompted speculation by a number of pharma websites about whether the FDA really intends to upend longstanding policy barring generics from altering their labels, and, if so, what that portends for their product liability exposure. On Wednesday, I emailed the FDA to ask. In an email response, an FDA representative confirmed what the Justice Department footnote suggested: “FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances,” the agency said. “FDA intends to provide an opportunity for public comment with respect to any such proposed changes to its regulations.”

The FDA email, according to Kurt Karst of Hyman, Phelps & McNamara (and the FDA Law Blog), is the first confirmation of what FDA watchers have been anticipating since the U.S. Supreme Court’s 2011 ruling in Pliva v. Mensing freed generics from liability for failing to warn consumers about dangerous side effects.

So, will generics welcome the opportunity to provide consumers with more information about potentially dangerous side effects of their drugs? Not bloody likely.

As Karst points out, the FDA still isn’t giving much away about its intentions, so it’s premature to speculate on how a policy change would impact liability for generics. Still, the Justice Department was pretty clear that if FDA policy imposes labeling responsibility on generics, generic drugmakers won’t be able to rely on pre-emption as a defense. And the last time generics faced that prospect, when Congress was considering legislation introduced last year in response to the Supreme Court’s Pliva ruling, the trade association for generic pharmaceutical companies was squarely opposed to any increased responsibility for drugmakers.

If Congress enacted a law tasking generics with the responsibility of strengthening warning labels, the Generic Pharmaceutical Association argued, “the legislation could create a situation in which one drug could have multiple different warning labels. Massive consumer and provider confusion would result.” (I reached out to the trade group for a reaction to the FDA’s confirmation that it’s considering a policy change. Claire Sheahan, a representative, said the group didn’t yet have a response.)

In fairness to the generics, there are reasons why revisions to drug-labeling policy could end up doing more harm than good to consumers. Robert Pollock, a former FDA official who is now a senior advisor at the pharmaceutical consultant Lachman, said that the Hatch-Waxman Act’s mandate that generics carry the exact same FDA-approved labels as their brand-name counterparts is an acknowledgement that generics don’t engage in safety testing of their products. Generics manufacturers rely on the testing conducted by brand-name makers, who are rewarded under Hatch-Waxman with an extended monopoly on the drugs they develop. A policy change, Lachman said, could upset the delicate balance Congress created.

And because multiple generic drugmakers often produce the same product, Pollock said, the FDA could face different labeling requests from different companies for the exact same drug. That could create regulatory bottlenecks and marketplace confusion, Pollock said – precisely the impediments to low-cost pharmaceuticals that Hatch-Waxman was supposed to eliminate.

Like regulatory lawyer Karst of Hyman Phelps, Pollock told me he’s eager to see exactly what the FDA is proposing. “This has caught everyone by surprise,” he said. “This is going to be interesting.”

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