FDA Commissioner Stepping Down After 6 Controversial Years

Dr. Margaret Hamburg, the FDA’s leader for the last six years, announced that she will be stepping down in March 2015. The FDA’s chief scientist, Stephen Ostroff, will become acting commissioner while Commissioner Hamburg’s permanent successor is appointed by the President and confirmed by the Senate. Commissioner Hamburg’s stint in the top role was one of the longest in decades. She was well-prepared for the job as a Harvard Medical School graduate and the former New York City health commissioner. While Commissioner Hamburg states that she is unsure of her next move, she says that she’s pondered leaving for some time and never planned to stay in the position for this long but found the agency “extraordinary.”

Legacy

Commissioner Hamburg’s reviews are mixed after years of FDA-centered controversy, some of which her defenders point out were not her fault or within her control. For example, in 2012, a compounding pharmacy in Massachusetts released tainted steroids that caused 64 deaths and hundreds of other illnesses from fungal meningitis. Lawmakers argued that Commissioner  Hamburg and the FDA had failed in their regulatory duties, but others pointed out that compounding pharmacies are regulated by states and not under federal purview.

Key Moments

Commissioner Hamburg led the agency through the implementation of the Food Safety Modernization Act (FSMA) (P.L. 111-353) and the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (P.L. 111-31). She was at the center of a controversy between the courts, the White House, HHS, and the FDA, regarding age restrictions on emergency contraception with the Secretary of HHS overruling her decision to make emergency contraception available to all women of child-bearing potential.

Industry Responses

Commissioner Hamburg was named to the job in 2009 by President Obama after problems at the agency grew increasingly alarming, and she describes the agency morale as “low” when she started. In years prior to her appointment, the FDA failed to publish warnings regarding the anti-inflammatory drug Vioxx®, which was believed to have caused thousands of deaths before it was pulled from the market, and a previous commissioner had hidden his investments in pharmaceutical companies regulated by the agency. Although many find that her presence stabilized the agency and allowed it to flourish, others were concerned about overreaching. The FDA approved 51 new drugs and biologics last year, the most in 20 years. Some think the agency has gotten too close with pharmaceutical companies and is approving drugs too quickly without clearly studying the effects. Others praise the expedited development and streamlined process of drug testing and approval. Many are concerned about the FDA’s lack of involvement in opioid dependency. Regardless of opinion, most agree that the FDA has many important steps to take in the future regarding obesity, electronic cigarettes, opioids, cancer treatments, and food safety.