FDA Raises Concerns With House PDUFA Draft Legislation

The FDA is taking issue with a new version of legislation to reauthorize the Prescription Drug User Fee Act (PDUFA), telling a House subcommittee the bill goes too far in placing restrictions on new drugs.

The discussion drafts of the bill, first circulated last week call for stronger restrictions than S. 1082, the version the Senate passed in May.

The FDA is particularly concerned with preemption language in the discussion drafts, FDA Associate Commissioner for Policy and Planning Randall Lutter said. According to agency labeling rules, FDA requirements preempt conflicting state laws. However, the draft would eliminate the FDA’s preemption authority, allowing states to have different labeling requirements. 

The draft would essentially formalize a collection of state actions that could be contradictory to the FDA’s regulations, according to Lutter. “The best way to ensure safety of the medical process is to ensure there is a single authoritative voice,” he said. Lutter agreed with Rep. John Sullivan (R-Okla.) that different labeling laws would be detrimental to public health. 

The FDA is not alone in having concerns with the drafts. Some lawmakers took issue with the bill’s provisions on direct-to-consumer (DTC) advertisements. The draft would allow the HHS secretary to put a temporary waiting period on DTC advertisements of up to three years for new drugs on a case-by-case basis. Since the agency’s review of DTC advertisements remains voluntary, however, the bill “doesn’t have any teeth in it,” Rep. Anna Eshoo (D-Calif.) said.

Rep. Ralph Hall (R-Texas) said the bill’s restrictions put a “moratorium” on advertisements for new products that may violate companies’ right to free speech, exposing the agency to lawsuits. Lutter added the FDA had heard the draft’s restrictions could raise “constitutional concerns.”

However, Subcommittee on Health Chairman Frank Pallone (D-N.J.) noted the authority came on a case-by-case basis and the FDA could review whether to allow DTC advertisements after six months, one year, two years or three years.

Pallone said he did not see anything in particular he needed to address in the discussion drafts before the subcommittee markup June 14. The discussion drafts can be viewed at energycommerce.house.gov/Public Health bloc/index.shtml.