Morning Briefing
Summaries of health policy coverage from major news organizations
'We've Been Planning For It': FDA Braced For Tsunami Of Retirements From Its Senior Level Staff
Stat: FDA Is Ready To Cope With Wave Of Retirements, Gottlieb Says
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. “It 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,” Gottlieb said. “We’ve been aware of that. We’ve been planning for it.” (Swetlitz, 5/4)
Stat: Gottlieb Pushes Back Against Criticism Of 'Breakthrough' Designation
Food and Drug Administration Commissioner Scott Gottlieb defended his agency’s “breakthrough therapy” program, which speeds review of drugs that show signs of benefit early on, amid criticism from academics that the therapies aren’t actually breakthroughs at all. A study published in late April in the Journal of Clinical Oncology showed that, on average, cancer drugs designated as “breakthrough” don’t help patients more than drugs that aren’t designated as “breakthrough.” And a study published earlier in April in the New England Journal of Medicine pointed out other examples of “breakthrough therapies” that really weren’t scientific breakthroughs. (Swetlitz, 5/4)
