Advice to the New FDA Commissioner

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Writing in The Hill, Mercatus Senior Research Scholar Robert Graboyes discussed ways to boost the U.S. Food and Drug Administration’s productivity.  He and coauthor Jordan Reimschisel discussed seven things the FDA could do to speed approval of drugs and medical devices.

His recommendations:

1) Shift from regulation to certification. This process would involve educating patients and providers about risk. Or as he phrased it, “commend and cajole in place of command and control.”

2) Dial back the risk-aversion. The FDA’s risk-aversion has gotten out of control. The agency worries more about preventing hypothetical worst-case scenarios, when it should be focused on promoting best-case solutions.

To that end the FDA should:

3) Return to a safety-only posture. The FDA should leave efficacy to the market to sort out. Currently the FDA requires objective endpoints to be stated ahead of time. Even if a drug is found to be beneficial on several clinical metrics, it will still not gain approval if it failed at its stated endpoints. Drugmakers may not know the best metrics to measure until conducting the clinical trials.

4) Grant approval in stages. An alternative to the yes/no votes that are currently made, the FDA could grant approval in stages. For example, Graboyes explains “patients with time-critical illnesses could gain access before a drug was approved for general usage, for example, through right-to-try rules expediting access to terminally-ill patients. Data from these users could inform later stages of the process.”

5) Introduce foreign reciprocity. If a drug or device is approved in Europe or certain other advanced countries, firms should have an avenue to have that approval recognized in the United States.

6) Restructure. In the European Union private organizations approve drugs with mutual reciprocity, with safe faster results. According to Graboyes this is not unlike how Underwriters Laboratories works in providing independent assessments of safety.


7) Become more predictable. Despite advances in information technology, the number of years it takes to approve a drug has about doubled every decade. Physician care using drug therapy and devices is cheaper than most hospital care, nursing home care and many other labor intensive form of care. Yet it’s becoming harder to get drugs approved. One by-product of this is more patients treated in expensive environments like hospitals. Another is drugs that are so hard to get approved that each is its own monopoly that costs patients anywhere form hundreds per month to tens of thousands per month.

The entire article is worth a read here.

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