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Inside Health Policy – FDA, Stakeholders Emphasize Importance Of Staffing To PDUFA Success

Inside Health Policy – FDA, Stakeholders Emphasize Importance Of Staffing To PDUFA Success

FDA officials, patient representatives and industry stakeholders said the hiring provisions included in the drug user fee commitment letter are critical to the other goals outlined for the sixth iteration of the program, with an industry representative saying FDA’s ability to recruit scientists is crucial to the agency keeping pace with scientific advancement.

But as the agency and stakeholders discussed the proposed recommendations for the Prescription Drug User Fee Act at a meeting Monday (Aug. 15), Avalere released an analysis saying drug approvals have not kept pace with innovation despite rapid acceleration of fees paid by manufacturers.

Drug user fees increased dramatically each year, driven primarily by higher application fees that manufacturers submit when they apply for new drug approvals, but Avalere notes that FDA reduced collections in 2017 because of significant leftover collections from the prior four years.

“While new drug approvals increased recently, they have not kept up with the number of innovative ideas entering clinical trials, and we need to consider where the road blocks are to more efficient development. FDA review timing is a critical element,” said Gillian Woollett, senior vice president at Avalere.

The group says how FDA accounts for the user fees it receives and whether industry and patients are getting access to medicines in a timely manner are important issues for stakeholders to consider.

“The significant unspent funds left over from user fee programs suggest that FDA could do more to accelerate product reviews,” said Jay Jackson, manager at Avalere. “Particularly with public concern around drug prices, speeding approval of the second-to-market products can increase competition that may result in lower net prices.”

While Avalere did not connect this trend to FDA’s hiring challenges, Sascha Haverfield, senior vice president for scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said the agency’s ability to recruit and retain scientists is crucial for FDA to fulfill its public health mission and keep pace with scientific advancement of drug development.

Theresa Mullin, FDA director of strategic programs, noted this is the first time the user fee commitment letter has provisions related to this administrative function, and expressed how FDA’s current staffing levels affect such activities as guidance development.

Director of the Bipartisan Policy Center’s Health Innovation Initiative, Janet Marchibroda, said meeting the goals to accelerate the development and delivery of treatments is “really about the capacity of the FDA.” She said the group was excited to see all the human resources related provisions in the letter.

Jeff Allen, executive director of Friends of Cancer Research, expressed similar sentiments, and noted there can be ways to address FDA’s recruiting problems through legislation, such as raising caps for eligibility to enhance salary programs and the amounts associated with those programs.

FDA’s hiring problems also recently caught lawmakers’ attention. Congress attempted to address the issue in the House Cures bill and the Senate’s complementary package. Both chambers included language that would lift hiring caps and raise salary caps for senior level scientists and researchers at the agency, as well as allow FDA to hire these staffers directly. Cures legislation passed the House last year, but continued work on the Senate’s version has been punted to September.

The PDUFA VI performance goals released last month asserted the agency’s stance that enhancements to the human drug review program require that FDA hire and retain sufficient numbers and types of technical and scientific experts to efficiently review drug applications.

The agency committed to completing the transition from the use of individual vacancy announcements for individual offices to expanded use of common vacancy announcements with open continuous posting. The agency also will engage a qualified contractor to provide continuous support through PDUFA VI to augment the existing FDA human resources staff capacity and capabilities.

“The utilization of a qualified contractor will assist FDA in successfully accomplishing PDUFA goals for recruitment and retention of human drug review program staff,” says FDA. Drug industry stakeholders in November had floated the idea of offering “third-party support” to help implement improvements to FDA’s hiring system that would positively impact PDUFA.

Additionally, FDA will complete the establishment of a new unit charged with the continuous recruiting, staffing and retention of scientific, technical and professional staff to review drug applications. “It will function as a scientific-focused recruiter conducting ongoing proactive outreach to source qualified candidates, and conducting competitive recruiting to fill vacancies that require top scientific, technical and professional talent,” says FDA.…