TCS Daily

What's Needed at FDA

By Henry I. Miller - August 23, 2006 12:00 AM

Even in the dog days of August, a lot of attention has been paid to Senate confirmation hearings for FDA commissioner nominee Andrew von Eschenbach. Most of it has focused on a hold placed on his confirmation by two Democratic senators unhappy about the FDA's years of dithering over whether to permit the Plan B emergency contraceptive to be purchased without a prescription.

During almost a year heading the beleaguered agency in an acting capacity, Dr. von Eschenbach has been something less than a house afire. That's not a good sign.

A leaderless - and therefore, more diffident and risk-averse - FDA spells trouble for both the pharmaceutical industry and for public health, and the agency has been without a confirmed commissioner for all but 20 months of the Bush administration. As acting commissioner, however, Dr. von Eschenbach has shown little ability to discipline the troops or to moderate the agency's tendency toward excessive risk-aversion.

In spite of increasingly more powerful and precise technologies for drug discovery, purification and production, during the past twenty years development costs have skyrocketed, with direct and indirect expenses now exceeding $800 million to bring an average drug to market. And the trends are ominous: the length of clinical testing for the average drug is increasing, fewer drugs are being approved, and the number of applications to FDA by industry for marketing approval has been decreasing for a decade.

FDA is largely responsible for these worrisome trends. Regulators keep raising the bar for approval, especially for innovative, high-tech products. Human gene therapy and other treatments tailored to individual patients have been hit especially hard, and the agency has made it more difficult for badly needed new antibiotics to be licensed. FDA's demands for post-marketing clinical trials have proliferated wildly, and "risk management" plans for newly approved drugs have been punitive and designed more to protect regulators' derrieres than patients.

Ideally, the FDA commissioner should be equal parts consummate manager, technocrat, reformer and Lord High Executioner. Dr. von Eschenbach, a distinguished surgeon and former head of the National Cancer Institute, hasn't shown that he has what it takes to turn around a failing enterprise. One senior agency official offered this assessment: "He is smart and pays attention. . . [but] I have the strong impression that no one is running FDA, and that even if anyone were, no one is running [the Department of Health and Human Services] and so nothing remotely controversial, which seems to include any decision on anything that hasn't been decided before, can get done."

FDA needs to streamline its existing regulatory procedures, enhance the monitoring of the safety of marketed drugs, eliminate unnecessary requirements and work with Congress on new approaches that offer non-governmental alternatives to some of the agency's functions. The latter could include greater reliance on extramural expert advisory committees, contracting out product reviews and the accumulation of safety data, and the creation of extra-governmental oversight mechanisms.

For example, the regulation of medical devices in the European Union relies heavily on various sets of product standards and normally does not involve government regulators directly in product oversight. For low-risk devices, manufacturers themselves are allowed to certify that their products meet the necessary standards. For higher risk products manufacturers must obtain third-party review from private-sector, profit-making entities -- "notified bodies" -- that test products, inspect manufacturing systems, and ultimately verify that EU standards have been met. Another apposite model is U.S. Nationally Recognized Testing Laboratories, the prototype of which is Underwriters Laboratories, a private, non-profit entity that crafts standards and certifies compliance with them for tens of thousands of categories of consumer products which range from lighting fixtures and flame retardant chemicals to bulletproof glass.

In addition, the FDA's senior and mid-level managers must be made more accountable -- especially for scientifically insupportable policies and needless delays in getting new drugs, vaccines and medical devices to patients who need them. One way to achieve that would be to create an independent, strong ombudsman mechanism that could impose negative sanctions on civil servants who are incompetent, indolent or insubordinate.

Politics should be banished from FDA policies and actions insofar as that is possible, with the commissioner doing what is in the public interest and taking the heat from all quarters for unpopular decisions. But all we've gotten are platitudes about a commitment to "good science" and the need for a "modern, efficient and effective FDA."

Dr. von Eschenbach has failed to take a firm stand on important issues, including such ill-advised congressional initiatives as public databases of clinical trials and the institution of "limited" or "conditional" approvals of new drugs. On the contrary, the agency itself recently floated the idea of new "user fees" -- which are a discriminatory tax on one industrial sector and are particularly harmful to small, innovative companies -- for the review of medical devices.

The FDA, which regulates more than a trillion dollars worth of products annually, is omnipresent in Americans' lives. For too long the agency has put public relations before public health, trying to look good instead of doing good. We need an FDA leader who believes in science-driven public policy, data as the basis for regulatory decisions, the right of patients and physicians to assume more responsibility for the risk of medical interventions, and the banishment of politics from regulation.

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

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