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PDUFA: A lot of talk

Details on FDA-industry deal for PDUFA V: it's about meetings, not money

After ten months of negotiations, FDA, BIO and PhRMA have agreed on a PDUFA V formula that trades a $100 million increase in fees over five years and an additional two months of review time for new drugs in the hope that the time and money will make it possible to complete a higher percentage of reviews on schedule.

High quality reviews performed on a predictable timetable has been the industry's primary objective for PDUFA since the program's inception in 1992. But as user fees have exploded over the decades and have been allocated to a widening range of activities, success in achieving their principal goal has been elusive.

FDA has consistently managed to approve about 60% of priority NDAs for new molecular entities (NMEs) and original BLAs within a single review cycle, but has done so only by pulling staff away from standard reviews.

Although about 80% of all NDAs and BLAs are eventually approved, there has never been much more than a one-in-three chance that a standard NME or BLA would be approved in the first cycle (see "First Cycle Approval Rates vs. User Fees," A2).

To increase first-cycle approval performance, the PDUFA V agreement adds a two-month "filing period" to the start of the review process for NME NDAs and original BLAs, establishes a mid-cycle meeting to allow sponsors to attempt to get errant reviews back on track, and sets up a late-cycle meeting to smooth any advisory committee meetings or negotiations over labels or risk evaluation and management strategies (REMS).

Indeed, commitments for more meetings runs throughout the PDUFA V agreement, and when FY13 starts in October 2012, there will be a lot more meetings and discussions among agency officials and drug sponsors, patients, physicians, and academic scientists.

All of the talking is integral to a number of process changes intended to expand and improve FDA's interactions with drug sponsors, patients and the scientific community along the regulatory continuum from IND filing through NDA and BLA reviews and the postmarket period.

In addition to improving

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