The Wall Street Journal reports that the new U.S. Food and Drug Administration (FDA) commissioner Marty Makary faces numerous obstacles in his plans to remake the federal agency. Dr. Makary faces a reduction in staff, plummeting staff morale, and internal criticism that he is compromising scientific standards. More from WSJ:
Welcome to the new Food and Drug Administration as envisioned by Dr. Marty Makary, who is leading the agency under Health Secretary Robert F. Kennedy Jr. Both men have said they want to overhaul the agency, citing what they see as the FDA’s reputation for coziness with pharmaceutical companies.
The FDA staff is dragging their collective feet in the face of Makary’s agenda to streamline the agency partly due to bureaucratic inertia. Once procedures becomes established, bureaucrats don’t like to deviate from them. Once rules are created nobody wants to change them lest that be a sign the rules were never relevant. In the case of the FDA, the bureaucratic process became more important than the results.
The changes are coming so swiftly, and often without input from career scientists, that Makary faces declining staff morale threatening to stymie his efforts. He must also contend with the administration’s staff cuts at the FDA, which have been partly undone but shrank the workforce nonetheless. And critics say Makary is playing fast and loose with the FDA’s commitment to world-class science.
“Instead of gold-standard science, what I’m seeing is an effort to create a scientific record that supports a particular conclusion,” said Susan Mayne, a former head of a food safety division at the FDA.
Another problem is that Makary is an outsider, having never worked his way up the career ladder at the FDA. It is next to impossible to reform the drug approval system without knowing the intricacies of that system. The FDA is a huge agency with command over about 20% of the economy. That’s a difficult culture to change. On the one hand, critics complain the agency was too quick to approve Covid 19 vaccines. On the other hand, Makary hopes to streamline the approval process to make it faster and more efficient. These are seemingly impossible goals to reconcile. They are also politically charged goals. Makary had this to say:
“To reinvigorate innovation, we must become a user-friendly FDA that partners with industry,” Makary wrote in the medical journal JAMA last week. “At the same time, the FDA will guard against a cozy relationship that has characterized the agency in the past.”
In economics there is a concept known as regulatory capture, whereby a regulatory agency begins to protect the interests of the industry it regulates. Why does this happen? Industry pays far better than government service. Many FDA staffers hope to leave the agency and get far better jobs working for the very firms they once regulated. Making themselves unpopular with drugmakers while at the FDA could potentially reduce future employment potential and agency officials want to avoid that. One-quarter of the agency staff – about 600 reviewers – have already recused themselves on industry matters. Recusals indicate about 600 people are looking for another job and don’t want to risk: 1) alienating future employers, 2) being accused of conspiring with future employers while employed by the FDA.
“Recusals also occur to ensure staff not participate in engagements that have even the perception of a conflict of interest,” an FDA spokesman said.
Congress created a voucher program to fast track some drug products at the expense of others. Covid 19 is an example of a national priority. However, some observers say that if vouchers are used selectively to reward favored drugmakers for, say, for lowering prices that would be a stark agenda change for the FDA. Historically, the FDA has never cared about the prices of products the agency approves. Doing so could result in executives being ostracized by the industry they hope to join after government service.
The FDA is ripe for reform, but it’s easier said than done. The FDA is staffed with many career bureaucrats who don’t want to change the way they operate and perceive any change as an attack on the science of drug approval. The FDA is also risk averse, a standard set in 1961 by Frances Oldham Kelsey when she famously refused to approve Thalidomide. Just about every scientist at the FDA aspires to be the next Frances Oldham Kelsey. FDA regulations must serve the purpose of streamlining the approval of safe and effective drugs, while quickly rejecting drugs whose data is ambiguous or shows little better efficacy than a placebo.
WSJ: New FDA Chief Marty Makary Wants to Fast-Track Some Drugs, Use More AI