FDA and industry appear to have reached an agreement to on recommendations for the reauthorization of the Prescription Drug User Fee Act.

Minutes of a March 31 negotiating session, released April 28, stated a "final review" and "minor clarifying edits" were made to the draft PDUFA V commitment letter, the document sent to Congress for approval that indicates how the user fee program will be structured. Both sides had worked throughout March on it, according to other sets of minutes released the same day.

The agency appears to have gained most of the changes it wanted at the beginning of negotiations, with a few exceptions. Industry gained significant improvements to the application review model, one of its major focuses for the reauthorization.

FDA would not confirm an agreement had been reached. The agency said in an e-mailed statement the proposals will be published in the Federal Register following clearance by the full administration, likely by late summer or early fall this year. Final recommendations are due to Congress by January 2012.

Following clearance and a public review, the agreement would go to Capitol Hill, where congressional hearings had been projected to begin as early as this fall, so a bill could be passed by June 2012 and avoid legislative entanglements. PDUFA is scheduled to sunset in October 2012.

FDA wants the PDUFA agreement packaged in an omnibus bill with the reauthorization of the Medical Device User Fee and Modernization Act, as well as new user fee programs for generic drugs and biosimilars (Also see ""Mega-UFA" Is Behind Schedule; Combined User Fee Bill Will Be Difficult, But Still Expected" - Pink Sheet, 14 February, 2011.).

Nine Program Enhancements Included

Within the letter are what were characterized as "tentative agreements" on nine program enhancement areas. Chief among them is a new review model for new molecular entity new drug applications and novel biologics license applications that will allow for mid- and late-cycle meetings between sponsors and the agency.

The issue has been the most-debated topic of the negotiations since they began last year, as industry demanded more communication with the agency during the review process and FDA wanted to improve its first-cycle approval rate (Also see "NDA Review Pilot Will Be Mandatory, Assuming Program Flies At All" - Pink Sheet, 7 March, 2011.).

User fees also will help FDA grow its biomarker and pharmacogenomics teams. Workforce capacity in both departments already has been exceeded and submissions are expected to increase during PDUFA V (Also see "PDUFA V: Sentinel, Regulatory Science Upgrades Could Gain User Fee Funding" - Pink Sheet, 28 February, 2011.).

In addition, systems that will require electronic submissions and standardized electronic drug application data were included in the letter. Measures that will further standardize and integrate Risk Evaluation and Mitigation Strategies into health care system also were approved along with expanded development of patient-reported outcomes and study endpoint assessment tools.

The agency already had reached agreements to add patient and advocate views to its risk-benefit decision-making processes, create a dedicated meta-analysis team, increase staff for rare disease drug development efforts and launch pilot projects to determine the feasibility of using the Sentinel Initiative to look at drug safety issues. They rounded out the commitment letter (Also see "PDUFA V Agreement Set In Four Areas, But Broad FDA/Industry Talks Continue" - Pink Sheet, 7 March, 2011.).

There did not appear to be any agreement on a proposal to allow first-time applicants to ask clarifying questions of the agency.

Both sides had offered proposals related to the idea, which is intended to help inexperienced sponsors more easily navigate the agency. The idea was expected to increase the workload of FDA staff, but industry said it was willing to pay for the service (Also see "PDUFA V: FDA Relaxes Pre-Submission Meeting Requirement" - Pink Sheet, 28 March, 2011.).

An agency request to extend the review goal for prior-approval manufacturing supplements to six months also has not gained industry support.

Some Statutory Changes Were Included

Statutory changes also were reviewed during the March 31 meeting as part of agreements on user fee revenue levels for PDUFA V and the various adjustment formulas.

Both sides have been negotiating changes to the PDUFA inflation adjuster, which increases the amount collected each year based on changes in labor and other costs.

Industry had argued for changes that would make the formula more responsive to cost factor changes, meaning it would be more beholden to the short-term whims of the U.S. economy, by shortening the number of years used to determine an average for cost increases.

It potentially had become an issue because of the recession and a federal wage freeze instituted last year, which would adversely affect how much FDA collects (Also see "PDUFA Formula Could Better Incorporate Present Economic Conditions" - Pink Sheet, 18 April, 2011.).

Changes to the law also were agreed to clarify the assessment of product fees when a product is approved as both a new drug application and abbreviated new drug application, according to the minutes.

-Derrick Gingery (d.gingery@elsevier.com)

PDUFA V Agreement Appears Set Between FDA And Industry

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