New antibiotic development incentives in the pending House/Senate FDA user fee bill use Senate language almost exclusively, including its less prescriptive definition of pathogens that should be targeted by manufacturers who want to receive the incentives.

It was a big victory for FDA and other stakeholders who in the final days of negotiations between the two chambers pushed hard for the Senate version of the Generating Antibiotic Incentives Now (GAIN) Act.

The House plans to vote on the reconciled bill June 20 under suspension of the rules, an expedited voting procedure which it also used to pass its committee version of the legislation May 30.

The Senate has not scheduled a vote yet, but it could come within a few days, keeping the user fee renewal package on track for its goal of reaching President Obama’s desk by the end of the month Also see "User Fee Conference Cmte. Could Be Relatively Messy After Clean Floor Votes" - Pink Sheet, 4 June, 2012..

The reconciled bill, called the FDA Safety and Innovation Act, was released June 18. Its antibiotic development incentives include five years of additional exclusivity. The measure lists suggested pathogens that could be targeted to receive the incentive, but offers them only as examples.

House members had nearly the same pathogen list as the Senate but said those on the list were the ones that qualified. Additions would be allowed, but only through rulemaking.

The final measure directs FDA to finalize the list of qualifying pathogens within two years of the bill’s enactment, a new provision not in earlier versions of the legislation.

FDA was concerned the House language would not allow flexibility for the incentive to evolve. It said the list compiled in the bill is not the same as a list written two years ago, or a list that would be written two years from now ([A#00120618018]).

Allan Coukell, director of medical programs for the Pew Health Group, said the incentive will help fulfill public health goals to obtain new antibiotic treatments for life-threatening infections.

“We think they have achieved something that is workable and consistent with how drugs are approved now,” he said.

The Infectious Diseases Society of America praised the final bill in a written statement, but said additional incentives are necessary to promote research and development and public-private partnerships.

It appears FDA preferences for flexibility won out over congressional desires to give more precise instructions on which antibiotics most deserve the incentive.

Rep. Phil Gingrey, R-Ga., sponsor of the original GAIN Act, told FDA officials during a March committee hearing that the pathogens in the House bill can cause serious infections or death and noted the inclusion of a mechanism to make changes to the list, if necessary. FDA argued at that time that it wanted more general criteria for the incentive Also see "FDA Antibiotic Legislation Should Focus On Criteria, Not Bacteria, Woodcock Says" - Pink Sheet, 8 March, 2012..

Studies Eliminated, Guidance Required

The bill awaiting final votes also reduces somewhat FDA’s administrative burden related to the incentive, by removing some of the studies and reports that would have been required by earlier House and Senate versions.

A Government Accountability Office study looking at the need for an incentive to spur antibiotic development for qualified infectious diseases was eliminated. It would have compiled the costs and public and private funding levels for antibiotic clinical trials and success rates, assessed FDA management of antibiotic reviews and looked for regulatory barriers to development.

The bill still requires FDA to review at least three clinical trial guidances related to antibiotics per year, and revise them, if necessary, to “reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval.”

But it no longer requires a GAO study of the effectiveness of the guidance review, predictability of regulatory pathways and other issues.

The studies appear related to efforts by Sen. Richard Burr, R-N.C., to improve the management and efficiency of FDA. Last year, he was not pleased that the agency-industry agreement to renew the prescription drug user fee program included a fee increase, but lengthened the application review time.

The longer review for NDAs and novel BLAs is intended to allow for more first-cycle reviews, but Burr said the bill would face a tough road if acceptable FDA performance measures were not included Also see "Burr Warns User Fee Renewal Could Be Difficult Without Performance Measure Improvements" - Pink Sheet, 28 July, 2011..

Two House provisions that were incorporated into the reconciled antibiotic section would require a reassessment of the incentive in five years, including evaluation of whether products receiving the incentive are addressing the needs outlined in the bill.

The report also would include recommendations for ways to encourage more antibiotic development and stewardship programs and outline regulatory challenges.

IDSA has pushed for establishment of antibiotic stewardship requirements, such as the Limited Population Antibacterial Drug approval pathway, which would allow quicker approvals, but for narrowed indications.

The group could not get LPAD inserted into the user fee bill Also see "Antibiotic Incentives: FDA’s Woodcock Says LPAD Could Be Better Than Exclusivity, But Questions Remain" - Pink Sheet, 19 April, 2012..

FDA also would have to issue draft guidance by June 30, 2013 outlining uses for preclinical and clinical data “to inform an efficient and streamlined pathogen-focused antibacterial drug development program” and give advice on development of antibiotics targeting “a more limited spectrum of pathogens.”

Final guidance would be due by the end of 2014.

Antibiotics Not The Only Contentious User Fee Issue

FDASIA would reauthorize the prescription drug and medical device user fees, create new fees for generic drugs and biosimilars, and make several other policy changes.

Antibiotic incentives were one of several issues that generated disagreements.

The most controversial policy additions involved drug tracking standards. Negotiators did not reach an agreement to address this in the final bill ([A#14120618002]).

The final bill also used a House deficit control measure shortening the time FDA has to respond to citizen petitions, much to the chagrin of the generic drug industry. It and other stakeholders pushed for the Senate pay-for, which would have made it easier for generic companies to obtain brand drugs for testing that are subject to a Risk Evaluation and Mitigation Strategy ([A#14120618009]).

The Congressional Budget Office said June 19 the final bill will decrease the deficit $113 million between fiscal years 2012 and 2017 and $311 million between FY 2012 and 2022.

Senate Prevails On PDUFA Antibiotic Incentive As House Vote Nears

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