A Political End for an Unusually Political FDA Commissioner

Marty Makary, the Johns Hopkins surgeon who has led the FDA for the past year, is facing criticism from all sides. Vaping advocates are angry because of the FDA’s slow progress on green-lighting their products. Pro-life groups have called for Makary’s firing because he has not been tough enough on abortion. Current and former FDA officials have repeatedly warned that the agency is in turmoil. Even drug companies, typically cautious about criticizing regulators, have raised concerns about the state of the agency. Donald Trump has now reportedly signed off on a plan to fire Makary—although when, exactly, that axe might fall is unclear. On Friday evening, the president told reporters gathered at the White House that he knew nothing about Makary’s future.Traditionally, FDA commissioners have been less dramatic figures; they have approached their role as steward of an organization whose strength stems from its independence. The logic of that position is simple: Putting a drug on the market simply because of a commissioner’s or a president’s preference, or burying politically inconvenient research, doesn’t inspire much confidence in the safety of America’s food and drugs. But Makary has shown again and again that he’s willing to put politics first, a strategy that may have created the conditions for his own fall from power. (Neither Makary nor the White House agreed to comment for this story.)The problems began shortly after Makary’s confirmation. In June, he announced the launch of the Commissioner’s National Priority Voucher, a pilot program meant to dole out speedy approvals for drugs that “align with one of five critical U.S. national health priorities.” The program quickly became a tool for political influence. The FDA frequently does speed up review for important drugs, but drugs that are given a golden ticket must address a serious, unmet medical need. For the new program, all decisions to award vouchers were cleared by the White House, STAT News reported. As such,