The FDA’s Productivity and Consistency Have Collapsed in a Decade

Joseph A. DiMasi, Christopher-Paul Milne, and Alex Tabarrok have written a devastating Report Card demonstrating how poorly the Food and Drug Administration (FDA) does its business. The FDA has a government-granted monopoly on deciding the safety and efficacy of new medicines. Nobody in America is allowed to choose to take a medicine not approved by the FDA without breaking the law.

The seeds of this monopoly were planted over a century ago, and they have sprouted into a thicket that is preventing Americans from benefitting from new medicines in a timely fashion. From 1993 to 2004, the FDA permitted an average of 33.4 innovative medicines annually. This dropped by 24 percent, to 25.3 innovative new medicines, in the period from 2005 to 2013.

Further, the FDA has twelve review divisions, and DiMasi and colleagues have examined the performance of each one. Not only is the FDA getting slower at permitting new medicines, but performance is inconsistent across divisions. The median time to approve a new oncology or antiviral therapy is just under 200 days, whereas it takes almost 600 days to approve a new neurology drug.

DiMasi and colleagues have added to this analysis by measuring the productivity of each review division, that is, the number of new drug applications per full-time staffer. Surprisingly, the review divisions with the largest number of applications per staffer were oncology and antiviral — the ones with the fastest approval times! Perhaps it proves the old adage that if you want something done, give it to someone who is already busy.

The FDA’s permitting of new drugs has slowed down over the years because its government-granted power insulates the agency from the demands of suffering patients. We should not be surprised to learn that FDA managers are unable or unwilling to reallocate resources to where they are most needed.

The authors recommend a number of managerial options for the FDA to improve the consistency of its performance. Unfortunately, they do not recommend abolishing or at least granting patients some relief from the FDA’s monopolist-gatekeeper role. Nevertheless, their report is a valuable contribution to the empirical evidence on the FDA’s failure to allow patients timely access to new medicines.

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Is the FDA safe and effective? Examine the evidence at FDAReview.org, a project of the Independent Institute.