It may not feel like it to exhausted user fee negotiators, but the release of FDA’s draft commitment letter for PDUFA V signals the start of more long campaigns for the agency and pharmaceutical companies.

The draft commitment letter, released Sept. 1, is the result of nearly a year of negotiations between FDA and industry, and has at its core a new review model for drug applications.

The new review model for new molecular entity NDAs and novel BLAs will begin the day the program is expected to take effect, Oct. 1, 2012, and offers the promise of surer, if not swifter, reviews.

Under the new model, the expected review time will be extended to at least 12 months for standard applications by delaying the start of the review clock until after a 60-day filing period, but also will entitle sponsors to mid- and late-cycle meetings with agency staff during the review.

FDA hopes the system will help improve its first-cycle approval rate, but at the least should give companies a better sense of what the agency thinks of their applications while they are under review (Also see "PDUFA V Agreement Appears Set Between FDA And Industry" - Pink Sheet, 28 April, 2011.).

But while industry now has more to do upfront on applications under the new model, FDA will have a flurry of pending deadlines right at the start of fiscal year 2013, when the new Prescription Drug User Fee program cycle begins.

Guidances related to electronic application submissions, formal meetings between sponsors and the agency, and Risk Evaluation and Mitigation Strategies all are expected during the first year of PDUFA V, along with public meetings on those and other issues.

The agency also will have to hire new staff to improve communication with sponsors about rare disease drugs. Nearly as many deadlines were set for FY 2013 as the remaining four fiscal years of the program cycle (see chart, Also see "PDUFA V Implementation: A Year-By-Year Breakdown" - Pink Sheet, 5 September, 2011.).

The commitment letter attempts to further integrate REMS into the health care system and reduce their burden on industry.

The agency also is expected to further involve patients and their advocates in rare disease drug application reviews and risk-benefit decision-making, as well as develop and implement a more systematic risk-benefit assessment system for use where possible (Also see "PDUFA Commitment Letter Formalizes REMS Standardization Schedule" - Pink Sheet, 1 September, 2011.).

After a public meeting to solicit comments on the draft letter, FDA will finalize it and send it to Capitol Hill, likely in January 2012. There it likely will gain several add-ons as members attempt to make more adjustments to FDA policies and practices, but observers do not expect as many amendments as in the 2007 PDUFA reauthorizing legislation.

Even so, industry likely will have to campaign to persuade Senators and Representatives from various ideological camps that the FDA commitment letter does not need legislative tweaking – either to create more regulatory flexibility or provide more agency authority (see related story, Also see "Lilly's Field Of Dreams: "Campaign For Modern Medicines" Wants A Clean PDUFA" - Pink Sheet, 5 September, 2011.).

By Derrick Gingery

PDUFA V Commitment Letter Front-Loads Guidance, Meeting Milestones

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