Hire Don’t Fire at the FDA

As a longtime critic of the FDA, you might expect me to support firing FDA employees—not so! My focus has always been on reducing approval time and costs to speed drugs to patients and increase the number of new drugs. Cutting staff is more likely to slow approvals and raise costs.

To be fair, we’re talking about the firing of some 200 probationary employees from a total of some 20,000. Unusual but not earth shaking. But the firings are indiscriminate, and as I explain below, the FDA is a peculiar target for cost-cutting because user fees under PDUFA cover a significant share of the FDA’s budget so its workers are among the cheapest federal employees. So what is the point? Shock and awe in advance of bigger reforms for the FDA? Perhaps. Regardless, I think we should keep in mind the big picture on staff and speed.

The Prescription Drug User Fee Act of 1992 (PDUFA) provides strong evidence that with more staff the FDA works faster to get new and better drugs to patients. Before PDUFA, drug approvals languished at the FDA simply due to a lack of staff—harming both drug companies and patients. Congress should have increased FDA funding, as the benefits would have far outweighed the costs, but Congress failed. Instead, PDUFA created a workaround: drug firms agreed to pay user fees, with the condition that the funds be used for drug reviewers and that the FDA be held to strict review standards.

PDUFA was a tremendous success. Carpenter et al., Olson, Berndt et al. and others all find that PDUFA shortened review times and it did so primarily through the mechanism of hiring more staff. Thus, Carpenter et al. report “NDA review times shortened by 3.3 months for every 100 additional FDA staff.” Moreover, the faster approval times came at little to no expense of reduced safety. Thus, Berndt et al. report:

implementation of the PDUFAs led to substantial incremental reductions in approval times beyond what would have been observed in the absence of these legislative acts. In addition, our preliminary examination of the trends in the number of new molecular entity withdrawals, frequently used as a proxy to assess the FDA’s safety record, suggests that the proportion of approvals ultimately leading to safety withdrawals prior to PDUFA and during PDUFA I and II were not statistically different.

And in a later analysis Philipson et al. find that:

more rapid access of drugs on the market enabled by PDUFA saved the equivalent of 140,000 to 310,000 life years. Additionally, we estimate an upper bound on the adverse effects of PDUFA based on drugs submitted during PDUFA I/II and subsequently withdrawn for safety reasons, and find that an extreme upper bound of about 56,000 life years were lost. This estimate is an extreme upper bound as it assumes all withdrawals since the inception of PDUFA were due to PDUFA and that there were no patients who benefitted from the withdrawn drugs.

If we’re going to have FDA review, it should be fast and efficient. We need to shift the focus from the FDA’s balance sheet in the Federal budget to the patients it serves—more staff means faster reviews, better access to treatments, and a healthier society.

More generally, government regulation, not staffing, is the real problem. Cut regulation, and staff cuts can follow. Cut staff without cutting regulation, and the morass only gets worse.