April 23, 2012 — The House and Senate both issued draft legislation last week to reauthorize the Prescription Drug User Fee Act and with mark-ups imminent, Congress appears to be on track for passing the PDUFA V legislation by mid-year.

“The news from Capitol Hill on PDUFA V reauthorization of the FDA is great,” said Coalition for Healthcare Communication Executive Director John Kamp. “Even in the face of federal deficits, members of Congress understand that FDA must have the people and resources necessary to carry on its business, including approving drugs. Indeed, the discussions are months ahead of previous such debates, enabling possible passage well before the election recess and avoiding distracting layoff contingency plans by agency heads.”

In addition to provisions for user fees for drugs and devices, the discussion drafts from the House and the Senate address fees relating to generic drugs and biosimilar biological products as well as protection for the drug supply chain.

The draft Senate bill, “The Food and Drug Administration Safety and Innovation Act,” includes a provision creating a new review channel for breakthrough treatments and includes the Generating Antibiotic Incentives Now (GAIN) Act, which would extend the market exclusivity period for drugs treating antibiotic-resistant pathogens by five years.

The draft House bill also incorporates the GAIN Act and adds a six-month extension for any therapies approved with a companion diagnostic. Both the Senate and House drafts include provisions that would require the FDA to track drug shortages.

Further, the House legislation includes language that would permanently authorize two laws that provide incentives for conducting clinical trials for pediatric therapies: the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Separate legislation covering this issue was introduced in the Senate and most likely will be integrated with PDUFA V during mark-up.

Interestingly, what is not included in the bills so far is any specific drug marketing language, despite consumer and other groups pressing for this during the FDA phase of the legislation process. During a Feb. 1 House Energy and Commerce Committee Subcommittee on Health hearing to discuss PDUFA V issues, medical marketing was raised in only one exchange, between Rep. Jan Schakowsky (D-Ill.) and Commissioner of Food and Drugs Margaret Hamburg, M.D.

In that exchange, Schakowsky inquired about the agency’s resources to monitor direct-to-consumer (DTC) advertising. Hamburg stated that although advertising was considered in previous PDUFA negotiations, “it is not a part of PDUFA V.”

Efforts by the Pharmaceutical Care Management Association (PCMA) to suppress the use of branded drugs and eliminate advertising tax deductions and by

consumer groups to add marketing rules to PDUFA V – including expanded capacity for DTC monitoring – to date have not yielded results in the legislation.

“But the devil is in the details,” Kamp said, “and last-ditch efforts to revive these issues could emerge during the mark-ups. We must continue to track the progress of the legislation carefully and be prepared to explain the value of drug marketing to U.S. patients.”