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The Case for FDA Outsourcing

Tuesday, October 16, 2007

A former Food and Drug Administration official says the agency should make greater use of non-government experts.

FDA OutsourcingThe Food and Drug Administration (FDA) is currently trying to improve its efficiency by outsourcing a small number of non-critical jobs. Michigan Democrats John Dingell and Bart Stupak evidently consider this a scandal. Dingell chairs the House Energy and Commerce Committee, which oversees the FDA, and Stupak heads its Investigations and Oversight Subcommittee. They have requested all documents connected with the agency’s proposal to contract some 322 jobs to private companies, while condemning the plan as “hasty and injudicious.” It is “truly incomprehensible,” Dingell and Stupak said in a statement, “why the agency would again consider reducing the expertise and institutional knowledge of the FDA at a time when FDA’s credibility with the American people is at an all-time low.”

It may be incomprehensible to them, but it actually makes perfect sense. When something is broken, you fix it. The FDA has long been notorious for its slowness and inefficiency, and the outsourcing proposal is intended to address that problem. At least 29 independent studies over several decades have recommended transferring some tasks performed internally by the FDA to outside experts.

For that matter, there is already a successful (but largely ignored) model for the evaluation of clinical data by an independent laboratory. In a two-year pilot program that lasted from 1992 to 1994, the FDA contracted out reviews of supplements to New Drug Applications and compared the results of these evaluations to in-house analyses. The contractor was the Mitre Corporation, a non-profit technical consulting company. In all five of the supplements reviewed by Mitre, the recommendations were completely congruent with the FDA’s own actions. Moreover, the time required for the Mitre reviews was two to four months, and the cost ranged from $20,000 to $70,000—extremely fast and cheap compared to federal regulators.

This program serves as a reminder that the FDA has at one time or another delegated virtually every part of its review and evaluation functions—except for the final sign-off on marketing approval—to outside advisers, consultants, or other entities. Unfortunately, the FDA’s outsourcing has generally been piecemeal, disorganized, and short-lived. 

Neither Dingell nor his staff has the scientific expertise to evaluate drug safety. He should cease playing regulator and instead work to promote greater FDA efficiency.

Recognizing that bureaucrats cannot duplicate the level of expertise that exists in academia, many foreign regulatory agencies commonly use non-government experts for reviews and approvals. While the FDA uses non-government experts for its advisory committees, they are not permitted to do the all-important primary reviews. In 1996, the Energy and Commerce Committee considered legislation—cosponsored by nearly half of all House members—that would have allowed greater use of non-government experts. According to John J. Cohrssen, who was the majority (Republican) counsel for the FDA reform effort, “The failure to establish a way for the FDA to benefit from valuable non-government expertise has deprived American patients of products used successfully in other countries and made U.S. industry less innovative and competitive.”

In the 1980s, during an earlier stint as chair of the Energy and Commerce Committee, Dingell routinely meddled with federal agencies’ domestic policy-making and attempts to hammer out international regulatory agreements. His committee’s investigators harassed scientists from various regulatory agencies—I was working for the FDA at the time—even though they had no understanding of the subject area and were, in fact, lobbying against both sound science and U.S. interests.

In the current Congress, Dingell has demanded that the CEO of drug company Amgen “cease all direct-to-consumer advertising and physician incentives” related to the company’s anti-anemia drugs Epogen and Aranesp, citing concerns that “when used at higher than recommended doses, [the drugs] appear to cause increases in blood clots, seem to grow tumors, and are associated with significantly higher mortality rates than placebo.”  This advertising ban should remain, he said, until the FDA is able to determine whether any steps “need to be taken to protect the public from unnecessary risks to human life from these products.” Dingell made an almost identical request of Johnson & Johnson about the anti-anemia drug Procrit.

As a member of Congress, he has no authority to make such demands—which is a good thing, because neither he nor his staff has the scientific expertise to evaluate drug safety. If Dingell really wants to promote the interests of American consumers, he should cease playing regulator and instead work to promote greater FDA efficiency, even if that means outsourcing certain jobs to non-government experts.

Henry I. Miller, a physician and fellow at the Hoover Institution, was an official at the FDA from 1979 to 1994. His most recent book is “The Frankenfood Myth.”

Image by Shutterstock.

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