The leader of the Food and Drug Administration division responsible for regulating prescription and over-the-counter drugs is leaving her post, a senior FDA official confirmed to CBS News, marking the latest high-level shake-up at the FDA.\u00a0<\/p>\n
Dr. Tracy Beth H\u00f8eg had served as acting director of the FDA’s Center for Drug Evaluation and Research (CDER) since December, helming an office that reviews applications for new drugs. She previously advised former FDA Commissioner Dr. Marty Makary.<\/p>\n
A Health and Human Services spokesperson did not immediately respond to a request for comment. The news of H\u00f8eg’s departure was first reported by\u00a0Reuters<\/a>.<\/p>\n H\u00f8eg is leaving her job three days after Makary\u00a0resigned<\/a>\u00a0as FDA commissioner following a flood of news reports about internal tensions within the agency, including disagreements over a recent decision to\u00a0approve flavored e-cigarettes<\/a>. A source familiar with the matter told CBS News that Makary left due to the e-cigarette dispute, adding that the commissioner didn’t want to approve flavored products but had been forced to do so by other members of the administration.<\/p>\n The former head of the FDA office responsible for vaccine approvals, Dr. Vinay Prasad, also\u00a0departed the agency last month<\/a>. Prasad\u00a0briefly left the agency<\/a>\u00a0last summer, but was reinstated less than two weeks later.\u00a0<\/p>\n H\u00f8eg’s appointment as the head of CDER had drawn controversy and sparked alarm among senior FDA officials due to her history of vaccine skepticism, CBS News previously reported. She\u00a0helped write a memo<\/a>\u00a0last year linking several children’s deaths to the COVID-19 vaccine, without providing data to back up the claim, and she was\u00a0involved in<\/a>\u00a0a controversial effort to reduce the number of recommended childhood vaccines.<\/p>\n “Putting Tracy Beth in charge is like dropping an atom bomb,” one agency source told CBS News in December.<\/p>\n H\u00f8eg has acknowledged the effectiveness of some vaccines, including the\u00a0measles<\/a>\u00a0vaccine. She\u00a0said<\/a>\u00a0when she was confirmed that she was “committed to transparency, honesty, and decisions based on rigorous science and ensuring important changes happen efficiently.” \u00a0<\/p>\n