In an article in the Pink Sheet (here, subscription required) written by Maaisha Osman and Derrick Gingery, titled “US FDA Scraps Program That Paid Bonuses For Completing Speedy Drug Reviews”, the authors note that “[T]he US Food and Drug Administration is scrapping a controversial program that offered bonus payments to drug reviewers who completed their work ahead of schedule”. It is funny that when then Commissioner Marty Makary first announced the “Reviewer Recognition and Excellence” program, I had a flashback to the generic drug scandal days where at least one aspect of the pilot rewards program had previously caused a problem.
While we all know that the FDA had in place various mechanisms for rewarding reviewers through existing incentive programs, I am not a fan of rewarding someone for being fast without a corresponding assurance that the review also a high-quality evaluation. Most FDA reward plans are based on outstanding performance and are linked back to certain quality measures.
Remembering back to the generic drug scandal days of the late 1980s, one supervisory chemist was found to have manipulated the review queue by assigning applications for review to reviewers that were “fast” and maybe not as comprehensive in their review of the CMC sections of the ANDA applications as other reviewers. To that end, some ANDAs sailed through the CMC review process, while others underwent multiple review cycles. That represented a case where speed alone through the review cycle became problematic as the supervisory chemist was found guilty of accepting bribes for his manipulation of the review queue and went to jail. While the “fix” to that problem raised in part by the scandal, was to randomly assign the review of applications in the queue, it certainly would not have addressed the potential temptation of reviewers under the “Reviewer Recognition and Excellence” to speed up reviews to assure the receipt of cash incentives while not assuring quality of the reviews. Indeed, some objections voiced to the pilot program singled out that potential problem.
While the pilot program announced by Makary was directed at NDA and BLA application reviews and not generic reviews, the opportunity for the introduction of shenanigans into the review system could occur. The Pink Sheet article notes that some payment will be made for those that participated in the pilot program. With the suspension of the pilot program, we assume that FDA will fall back to its previous recognition programs to reward reviewers for sustained high-quality work without putting the link to speed as the primary outcome.
