Consumer Advocates Campaign for FDA’s Generic Labeling Proposal

Consumer and patient advocacy groups made their case for the FDA’s proposed rule to give labeling parity to generic makers, one day ahead of an FDA public hearing to again solicit comment on the plan.

Generics need the flexibility to change their labels and the accountability to ensure patients receive adverse event warnings as quickly as possible, said Michael Carome, director of Public Citizen’s health research group.

He was joined by representatives from the Massachusetts Institute of Technology and Synapse Energy and the National Women’s Health Network, among others, in heaping support on the rule at a briefing for lawmakers on Capitol Hill.

The event was designed to drum up congressional support for the proposed labeling rule, which has drawn intense criticism from generics makers, led by GPhA.

The trade group has been reaching out to reporters, lawmakers and officials in the Obama administration and the FDA in an attempt to steer them away from the proposed rule, GPhA President and CEO Ralph Neas said.

The labeling rule has also drawn ire from a number of lawmakers, although it has seen limited support from some Democrats. It was pressure from generics firms and lawmakers that helped drive the FDA to postpone finalizing the rule until the fall and reopen the public comment period.

Generics makers argue that expanding the authority currently reserved for brandmakers to change labels under certain circumstances prior to FDA approval would result in multiple labels on the same therapy all on the market at the same time. Generics also argue that granting labeling parity will open them up to product liability lawsuits in a way that they’ve largely been shielded from since the Supreme Court’s 2011 decision in PLIVA v. Mensing, precisely because generic labels cannot currently update without prior say-so.

GPhA and PhRMA are pushing an alternate plan that would make the FDA the central arbiter of all labeling changes — for NDA and ANDA holders alike — once the first generic version hits the market. That plan could in theory expand the generic failure-to-warn liability protection to brandmakers as well. Carome argued that doing so would be a responsibility the FDA simply doesn’t have the resources to accomplish speedily.

The FDA is the only entity with all the information for multisource therapies, making it the only one suited to control label changes for drugs with multiple generics on the market, Neas says. — Bryan Koenig