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Christmas came a couple of weeks late to the business sectors regulated by the Food and Drug Administration. The greatest threat to the success of America's pharmaceutical and medical device companies, FDA Deputy Commissioner Joshua Sharfstein, left his government post on Jan. 7.
President Barack Obama's appointment of Sharfstein as essentially the agency's chief operating officer--a position that does not require Senate confirmation--was significant in several ways.
First, Sharfstein was an inconceivably poor choice, boasting a long history of overt hostility toward industry dating from medical school, when he tried unsuccessfully to get his classmates to reject textbooks given to students by drug companies.
Second, during his year or so at the FDA, he was consistently confrontational, repeatedly telling regulated industries that they were going to get a thumb in the eye and like it.
Third, he acted on his prejudices, cranking up the agency's already legendary risk-aversion to unprecedented levels. The number of regulatory warning letters--many of which were for wholly inconsequential alleged deficiencies--skyrocketed. The time and expense required for clinical testing increased, and companies became increasingly uncertain about what the FDA wanted. Drug approvals dropped.
Finally, with his boss Margaret Hamburg acting largely as a figurehead (and working harder to garner frequent flyer miles than respect from the business and scientific communities), Sharfstein was really running the agency.
The FDA is desperately in need of an overhaul: It is dysfunctional, suffering from cultural, organizational and management problems that have been exacerbated by congressional mandates and meddling. As a result, U.S.-based drug and device companies are in dire straits, with costs up, pipelines stalled and regulatory approvals down.
In order to turn around the FDA's policy- and decision-making and morale, the new deputy commissioner (and the agency head as well, for that matter) needs several qualities:
--Superior management skills and experience. The agency's scope is so sweeping--encompassing cardiac pacemakers, X-ray machines, condoms, home pregnancy-testing kits, drugs, vaccines, artificial sweeteners and fat substitutes, among other products--that a single person cannot be expected to master the body of science, medicine, pharmacology, toxicology and engineering (to say nothing of the law and "regulatory science") involved. One must assume that the FDA's own professional staff can frame the issues and options; the function of the agency's chief operating officer should be primarily to manage the far-flung empire and to make the final decision on difficult policy questions.
--Unassailable integrity and honesty. The agency's decision-making must meld law, science and regulatory precedents in a way that maximizes the public interest. Its leaders need to earn the respect of those who have a stake in the FDA's policies and decisions: namely, consumers, industry and public interest groups. And in the end, science--not prejudices, public opinion or congressional grandstanding--must drive decisions. Sharfstein's oft-demonstrated bias was tantamount to a conflict of interest that should have precluded his appointment in the first place.
--Distance from politics. The positions of commissioner and deputy commissioner should not be awarded as a political plum like cabinet posts and many ambassadorships. Politics should be banished insofar as that is possible. Relevant experience and sound judgment should be the primary criteria for selection.
--Receptiveness to regulatory reform. At a time when drug development should have been spurred by huge increases in R&D expenditures--which almost quadrupled to more than $65 billion between 1995 and 2009--and by the exploitation of numerous new technologies, drug approvals have been dismal. During 1996-1999, FDA approved 176 new medicines; during 2007-2010, the number fell to 88, a decline of 50%. Bringing a new drug to market now requires on average 12 to 15 years, and costs have skyrocketed to more than $1.4 billion--in no small part because the average length of a clinical trial increased 70% between 1999 and 2006. Perhaps the most ominous statistic of all is that drug manufacturers recoup their R&D costs for only one in five approved drugs.
Without fundamental changes, these trends are sure to deteriorate further; many of the malignant effects of the Sharfstein era have yet to be fully realized.
The FDA needs more responsible, expert and wise leadership. That will require not only a strong replacement for the deputy commissioner but a further housecleaning of the zealous ideologues in various senior policy making positions and in the General Counsel's slot. I'm not optimistic. After all, Obama's response to dissatisfaction with his administration has been not that policies need rethinking, but only that the "sales job" must be improved.