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Yale, 1,
University of California, 0

By Henry I. Miller - June 26, 2003 12:00 AM

This is a story of government corruption and questionable judgment in academe. Former FDA Commissioner and current dean of the Yale Medical School David Kessler has been named as dean of the medical school at the University of California, San Francisco. It is an inexplicable choice, unless one subscribes to the old inside-the-Beltway adage that no bad deed goes unrewarded. Dr. Kessler left the FDA under a cloud of legal impropriety and at Yale was known as the "invisible dean."

At the end of Kessler's seven years at the FDA, food and drug regulation were a shambles. During his regime, FDA raised the regulatory burden on drug companies by continually introducing new requirements and policies, regardless of their potential to hinder the delivery of new and innovative therapies to patients who need them. The drug development system in the United States had become by far the slowest and most expensive in the world. By the time Kessler left, in 1997, the total time required for drug development, from synthesis of the molecule to marketing approval, had more than doubled -- from 6.5 to 14.8 years -- since 1964. Bringing a new drug to market cost about $500 million, by far the highest price tag in the world (which increased by more than a third during Kessler's term).

The effects of these astronomical costs were pernicious. Concerns about costs and projected return on investment -- instead of possible benefit to patients -- began to drive drug development. Companies sought primarily financial blockbusters, fewer candidate drugs were developed, and fewer became available. The development pipeline has still not recovered from the Kessler years.

Often to the consternation of career FDA employees, Dr. Kessler has often pushed the most obtrusive and draconian regulatory approaches. Examples include home drug testing kits (the Commissioner mistrusted consumers' ability to use them correctly); and the FDA's premature and insupportable war on silicone breast implants, which laid waste to an industry and left women confused and worried. An exception that proves the rule is the female condom. Agency reviewers were dubious about the product, in view of a failure fate more than ten-fold higher than other common contraceptives. Only after Dr. Kessler's political bosses demanded that this "feminist" product be approved did FDA allow it to be marketed. (When the pols objected to other products, Kessler slowed their approval.)

Even Dr. Kessler's much-touted war on tobacco has a seamy side. Dreading the prospect of more intrusive government regulation before FDA's preemptive strike, the tobacco companies had offered to make significant concessions, including the introduction of new programs to discourage teenagers from smoking and to limit advertising. These actions could have taken effect immediately, unlike the government's initiatives, which were stalled for years in the courts.

Moreover, Kessler withdrew dozens of FDA employees from throughout the agency to work on the war on tobacco, leaving many critical jobs understaffed and undone. One office that monitors the drug industry's compliance with FDA regulations saw three of its eleven staff drafted into the war on tobacco. The result was new drugs and other products not approved -- and, therefore, unavailable to patients -- and inspections and other regulatory actions delayed.

For all of these reasons, in FDA's entire history Kessler was the agency head who was most reviled from outside, and the most disrespected within.

But here's the clincher. Dr. Kessler departed the FDA after having been caught falsifying his travel records, in effect embezzling money from the government. He was double-billing, accepting reimbursement from both the government and outside sources, and hugely over-charging the government for taxi fares. Kessler made partial restitution to the government and resigned. Not wishing to be further questioned about these issues, since his departure he has declined to testify before Congress if the committee requires swearing an oath to be truthful.

How ironic that Kessler was caught with his hand in the nation's cookie jar. His mantra was that FDA is a regulatory agency and that, by God, industry will know it. No nonsense tolerated, no quarter given. He was unnecessarily harsh toward minor, inconsequential errors by industry.

Kessler's tenure was negative for the FDA and for the consumers the agency is supposed to serve. Agency policies and decisions were politicized, regulation became more intrusive but less effective, and morale was awful. At Yale, Kessler was known as the "invisible dean," because he traveled frequently (check those records!) and absented himself from important administrative duties, such as recruiting senior faculty.

A great day for Yale; a bad one for UCSF.

Dr. Miller, a physician and fellow at the Hoover Institution, was an FDA official from 1979-1994.

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