House Subcommittee Passes PDUFA Bill Without Preemption Language

The House Subcommittee on Health passed legislation renewing the Prescription Drug User Fee Act (PDUFA) and other provisions with few amendments after staff meetings resolved concerns including language eliminating the FDA’s preemption authority. The bill now goes to the House Committee on Energy and Commerce for a markup June 21.

The subcommittee approved an amendment that altered language in the discussion drafts related to pediatric exclusivity under the Best Pharmaceuticals for Children Act. The discussion drafts created a model that would give drug companies anywhere from three to six months of exclusivity in exchange for conducting pediatric clinical trials. The bill would have required the FDA to issue a rule outlining how much exclusivity a manufacturer would receive in different situations.

However, the subcommittee approved an amendment that removed the provision limiting exclusivity and returned the language to six months of exclusivity for all drugmakers.

The subcommittee also passed legislation renewing the Pediatric Research Equity Act, as well as eliminating a sunset provision on the act, making the HHS secretary’s authority to require drug companies to conduct pediatric studies permanent.

Reps. Edolphus Towns (D-N.Y.) and Steve Buyer (R-Ind.) introduced an amendment that would remove a provision in the bill that would allow the HHS secretary to put a ban of up to three years on direct-to-consumer (DTC) ads for new drugs. The bill violates a commercial speech doctrine outlined by the Supreme Court and is unconstitutional, Buyer said.

The subcommittee’s PDUFA reauthorization bill would add $225 million in user fees above the FDA’s proposal devoted to postmarketing safety activities over the next five years, Subcommittee Chairman Frank Pallone (D-N.J.)  said. This steep increase in user fees is “breathtaking,” and provides user fees the agency did not ask for, Rep. Joe Barton (R-Texas) said. Both Burgess and Deal introduced amendments to limit the user fees, but neither amendment passed.

The bill also contains provisions creating a clinical trial registry and a clinical trial results database and limiting the number of waivers the HHS secretary can grant to FDA advisory committee members. Pallone expects the bill to go to the House floor in July.