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Monday, May 7 2018

Full Issue

'We've Been Planning For It': FDA Braced For Tsunami Of Retirements From Its Senior Level Staff

FDA Commissioner Scott Gottlieb emphasized the need to cut hiring time when it comes to rank-and-file staff positions. At the annual meeting of the Reagan-Udall Foundation for the FDA, Gottlieb also countered criticism of the agency's "breakthrough" designation for certain drugs.

The Food and Drug Administration is undaunted by the fact that many of its top staff are nearing retirement age and the agency has a plan to continue to buttress its ranks, both among the leadership and rank-and-file, Commissioner Scott Gottlieb said Friday. 鈥淚t is the case that about 50 percent of all the people in senior roles in [the Center for Drug Evaluation and Research] right now are nearing retirement age, where they can retire with benefits,鈥 Gottlieb said. 鈥淲e鈥檝e been aware of that. We鈥檝e been planning for it.鈥 (Swetlitz, 5/4)

Food and Drug Administration Commissioner Scott Gottlieb defended his agency鈥檚 鈥渂reakthrough therapy鈥 program, which speeds review of drugs that show signs of benefit early on, amid criticism from academics that the therapies aren鈥檛 actually breakthroughs at all. A study published in late April in the Journal of Clinical Oncology showed that, on average, cancer drugs designated as 鈥渂reakthrough鈥 don鈥檛 help patients more than drugs that aren鈥檛 designated as 鈥渂reakthrough.鈥 And a study published earlier in April in the New England Journal of Medicine pointed out other examples of 鈥渂reakthrough therapies鈥 that really weren鈥檛 scientific breakthroughs. (Swetlitz, 5/4)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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