Government agencies face labor cuts, including the U.S. Food and Drug Administration (FDA). The New York Times reports that new hires, who were supposed to beef up departments reviewing food safety, artificial intelligence, robotic surgical devices and insulin delivery systems, among many others, were cut this week. This is arbitrary because the medical device and drug industry pays user fees that support the operations of the FDA, not taxpayers.
In recent years, the Food and Drug Administration hired experts in surgical robots and pioneers in artificial intelligence. It scooped up food chemists, lab-safety monitors and diabetes specialists who helped make needle pricks and test strips relics of the past.
Trying to keep up with breakneck advances in medical technology and the demands of a public troubled by additives like food dyes, the agency enticed scores of midcareer specialists with remote roles and the chance to make a difference in their fields.
In one weekend of mass firings across the F.D.A., much of that effort was gone. Most baffling to many were the firings of hundreds whose jobs were not funded by taxpayers. Their positions were financed through congressionally approved agreements that routed fees from the drug, medical device and tobacco industries to the agency.
The result of firing hundreds of FDA specialists is a slowing of approvals for new drugs and medical devices. Industry groups (whose user fees pay for the services) are lobbying the Trump Administration to rehire many of those laid-off. As is the case with some other agencies, there seems to be little consideration for who should go and who should stay. The last hired are the first fired in most cases.
Dr. Robert Califf, the F.D.A. commissioner under President Biden, said the personnel cutbacks seemed scattershot. Taking a not-so-subtle aim at Mr. Musk’s Department of Government Efficiency, which is reducing the federal work force, Dr. Califf said the layoffs were, in effect, “anti-efficiency.”
For example, one division director was working on a pet project of the new HHS secretary, Robert Kennedy Jr. That is, food safety and the safety of food additives. Then many of the staff were laid off, and the director resigned in protest.
Nine people from that food-chemical-safety staff of 30 are gone, including specialized toxicologists and chemists, Mr. Jones said in an interview.
The layoffs include not people newly hired within the past two years but also long-time employees who were promoted to take on new roles.
Just to be clear, the FDA is in dire need of reform. In recent years new regulations have proliferated, as have guidance documents (many of which contradict each other). During this time, inspections and enforcement actions have fallen. More needless regulations make it harder for medical device manufacturers and drug makers to understand and follow those regulations. The proliferation of regulations also makes it harder for the FDA staff to understand the regulations and know what needs to be done. Slowing enforcement provides industry with little incentive to fix problems. Remember three years ago when the largest baby formula manufacturer was shut down. Its problems could likely have been averted before they became dire. Two years ago eye drops contaminated with bacteria required warnings from the FDA. There are numerous other examples where the FDA dropped the ball, due to inaction or indecisive actions.
The Government Accountability Office has highlighted problems with FDA’s lax inspection of food safety operations. Indeed, the GAO advised the FDA to take steps to retain its inspectors. In recent years it seems in lieu of physical inspections that find easy-to-spot-problems with safety, the FDA has conducted inspections from industry conference rooms (assuming regulatory compliance is a paperwork exercise) or, worse, over Zoom. Gone are the days when inspectors walked the production floor and talked to rank & file workers, who are often very willing to spill the beans about what’s wrong. Instead of physical inspections, the FDA just added more regulations.
The FDA needs a leaner, meaner workforce who gets the job done in a timely manner. Slash & burn cuts will likely make the situation worse. What needs to be done is a wholesale evaluation of which regulations are redundant, ineffective, cumbersome and contradictory. The FDA needs is fewer regulations, with the ones that remain meaningful, effective, simple-to-follow (or at least straight forward) and enforced.
Read more in the NYT: Firings at FDA Decimated Teams for AI and Food Safety. Those Hires Are Now Gone.