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."

"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."

"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 report"

Marty Makary, leading the FDA, faces criticism from vaping advocates, pro-life groups, current and former FDA officials, and even drug companies. Vaping advocates cite slow progress on approvals, while pro-life groups demand tougher action on abortion. FDA officials describe turmoil within the agency, and drug companies raise concerns about its state. A plan reportedly signed off by Donald Trump would fire Makary, though timing remains unclear. Makary’s approach is portrayed as putting politics first, undermining confidence in food and drug safety. After confirmation, he launched the Commissioner's National Priority Voucher, intended to speed approvals for drugs aligned with national health priorities, but voucher awards were cleared by the White House, turning the program into a political tool.

Read at The Atlantic