Drug shortage mitigation appears to be the leading issue that could be added onto the Prescription Drug User Fee Act reauthorization, according to Rep. Michael Burgess.

Burgess, a Texas Republican and vice chair of the House Energy and Commerce Subcommittee on Health, which has jurisdiction over PDUFA, said there appears to be enough bipartisan support for dealing with the shortage problem that it almost certainly will be added to the reauthorizing legislation.

The PDUFA reauthorization is considered a must-pass bill, meaning it will attract additions from members of Congress.

Panelists at a Nov. 29 briefing, sponsored by the Center for Medicine in the Public Interest, were asked what FDA policy changes they expected to go into the bill.

Burgess said a bill he sponsored that would adjust the rules FDA uses to assess a conflict of interest for advisory committee members, could go into the PDUFA legislation.

But drug shortage legislation, which is pending in the House and Senate, can unite members on both sides of the aisle and will push the process, he said.

“What is going to drive the bipartisan aspect of this are the problems that we’re facing with drug shortages,” Burgess said. “It’s a multi-factorial problem. There’s not just one solution. I think that’s what going to pull the two … political camps together.”

Obama Also Endorsed Shortage Bills

Finding a legislative fix to combat the growing number of drugs with limited supplies due to manufacturing and other problems became a focus for Congress over the past several months.

Reps. Diana DeGette, D-Colo., and Tom Rooney, R-Fla., sponsored the House bill that would require manufacturers to tell FDA at least six months ahead of a known production disruption or permanent stoppage.

Democratic Sens. Amy Klobuchar of Minnesota, and Robert Casey of Pennsylvania, introduced similar legislation in the Senate Also see "Drug Shortage Legislation Gains Momentum With Bipartisan House Bill" - Pink Sheet, 27 June, 2011..

After gaining stakeholder support, both bills received another boost when President Obama endorsed them as part of an executive order asking manufacturers to voluntarily give more advanced warning of production disruptions. The order also allowed FDA to more than double its staff dedicated to shortages Also see "Obama's Drug Shortage Efforts Focus On Personnel, Persuasion" - Pink Sheet, 31 October, 2011..

The early warning is not required today except for sole-source manufacturers of medically-necessary drugs.

The debate now appears to be shifting to exploring economic fixes. The House Oversight and Government Reform Subcommittee on Health Care, the District of Columbia, Census and the National Archives scheduled a hearing Nov. 30 focused on whether government price controls cause shortages Also see "Drug Shortage Fixes Migrating Toward Economics" - Pink Sheet, 28 November, 2011..

GAIN, BPCA-PREA Renewals Strong Candidates For Reauthorization Bill

Burgess said there should not be many ornaments hanging on the proverbial PDUFA “Christmas tree,” but also warned Congress has only a limited number of vehicles left to get some initiatives passed.

That could mean PDUFA would be a target for other, potentially non-germane, add-ons.

Paul Kim, a partner at Foley Hoag LLP and former staff director for health policy for Sen. Edward Kennedy, said during the briefing that the Generating Antibiotic Incentives Now (GAIN) Act, an attempt to increase the exclusivity for certain antibiotics, is another likely candidate for PDUFA inclusion.

House and Senate versions of the legislation are pending and enjoy strong support from the Infectious Diseases Society of America.

An IDSA survey of the antibiotic pipeline this year showed an increase in candidates, but was expected to create more momentum for the bill Also see "Antibiotic Development Incentives Could GAIN Support From Pipeline Survey" - Pink Sheet, 24 October, 2011..

Panelists also discussed the reauthorizations of the Best Pharmaceuticals for Children and Pediatric Research Equity acts, which incentivize companies to study drugs in children, also as candidates. Both will expire in October 2012, along with PDUFA.

Kim and other panel members mentioned potentially making the laws permanent to give sponsors more certainty about pediatric requirements.

A Government Accountability Office report published earlier this year indicated sponsors could be less willing to conduct pediatric trials in part because of the laws’ regular renewals Also see "Reauthorizations Cause Sponsor Angst For PREA, BPCA Studies, GAO Finds" - Pink Sheet, 6 June, 2011..

Sen. Kay Hagan, D-N.C., is expected to introduce legislation soon proposing new Progressive and Exceptional approval mechanisms, which also could make it into the reauthorization bill Also see "FDA “Progressive Approval” And “Exceptional Approval” Pathways Possible Under Senate Bill" - Pink Sheet, 11 November, 2011..

Drug Shortage Bills Likely Drivers Of PDUFA Add-ons

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