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FDA's Woes Will Grow Under New Leadership

By Henry I. Miller - April 20, 2009 12:00 AM

The FDA, which regulates products worth more than $1 trillion -- a quarter of every consumer dollar -- has over the past two decades become a dangerous impediment to patients' getting the medicines they need. Drug development costs are up, approvals are down. Reforming a demoralized and chaotic FDA will require leadership that manages competently, is science-driven, is untainted by ideology, and is sufficiently strong to deflect congressional brickbats.

That's why the Obama administration's selections for the leadership at the FDA are especially disappointing. Although Dr. Margaret Hamburg, the nominee for commissioner (as the agency head is called), boasts significant experience in government and is highly thought of in the public health community, her new deputy, Dr. Joshua Sharfstein, is an inconceivably poor choice.

The selection of Dr. Sharfstein -- who is acting agency head while Dr. Hamburg awaits Senate confirmation -- is particularly bad, given that he will reportedly be entrusted with oversight of the most important sector of FDA-regulated products, and is apparently being groomed to head the agency.

FDA commissioner has long been one of the most difficult jobs to fill in the federal government. On most high-profile issues, the incumbent is subject to intense criticism from a number of quarters, and the position has never been a stepping stone to fame or fortune. He or she needs to be equal parts scientist, technocrat, and Lord High Executioner (the latter, in order to keep balky bureaucrats in line).

The new leadership will face the added challenge of addressing the legacy of recent incumbents who imposed excessive and expensive burdens on those trying to bring new medicines to consumers, pushed drug development costs into the stratosphere, damaged agency morale, permitted the drug approval process to become politicized, and allowed drug-safety zealots to dominate agency policymaking and decisions.

The new FDA leadership must also confront a trend -- especially among members of Congress and the media -- toward vilifying drug companies, and even alleging that regulators have become too cozy with industry. In response, the FDA has battered the pharmaceutical industry with overly risk-averse, burdensome new policies, as well as erratic and dubious decisions on individual products. As a result, Sharfstein will need to establish credibility and rebuild trust with a variety of stakeholders -- including drug companies and their investors, patient groups, consumer activists, and members of Congress from both parties.

The probability of that happening approaches zero. Sharfstein has a long history of dubious associations and hostility toward the pharmaceutical industry. While a medical student at Harvard, he led a campaign urging classmates to return textbooks donated by a pharmaceutical company (the project failed -- apparently, most of Sharfstein's classmates were less radical than he). Also, while in medical school, he was an intern for FDA Commissioner David Kessler, whom many consider to be the most disliked and disreputable leader of the FDA within memory. (Kessler, who was unceremoniously fired last year as Dean of the medical school at the University of California, San Francisco, has bragged lately about his close ties to the new FDA leadership.)

Of course, it wouldn't be fair to predict an official's future approach to issues based only on his youthful activism, but Sharfstein's early "us versus them" view of the pharmaceutical industry has persisted throughout his career. He went on to work for anti-drug and anti-industry zealot Sidney Wolfe, and as health policy advisor to Rep. Henry Waxman (D-Calif.), who personifies the divisive approach that castigates and persecutes innovative pharmaceutical companies.

These are difficult times for both the drug industry and its regulators. Leadership at the FDA will demand nuance and the ability to weigh benefits and risks -- including the risks of excessive regulation that inhibits innovation and investment in R&D. Federal regulators should not be collaborators with industry, to be sure, but they must cooperate with drug manufacturers in order to get new drugs to patients in a timely and cost-effective way. Sharfstein has shown no willingness to do so, nor does he have any experience with the arcane and high-risk business of developing and regulating prescription drugs.

The aging American population is literally dying for regulatory reform at the FDA -- but not the kind that is in store.


Henry I. Miller, a physician and fellow at the Hoover Institution and the Competitive Enterprise Institute, was an official at the FDA from 1979 to 1994. He is the author of To America's Health: A Proposal to Reform the FDA.
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