MILLER: FDA overhaul overdue

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By Henry Miller

COMMENTARY:

The Senate Homeland Security and Governmental Affairs Committee just released the newest version of the "Plum Book."

Taking its name from both the color of its cover and the fact it lists the "plum" positions in government, the volume contains more than 7,000 jobs, 4,000 of which are political appointments (http://www.gpoaccess.gov/plumbook/2008/p65-76_healthservices.pdf ).

One of the most important of the Obama administration's political appointees will be the head of the Food and Drug Administration, which regulates products worth more than $1 trillion, 25 cents of every consumer dollar.

Finding an FDA commissioner (as the agency head is called) will be difficult. In fact, the job long has been considered not a "plum," but a "prune, "in part because the incumbent receives a constant barrage of criticism from various quarters, and the pay is far less than comparable jobs in the private sector.

The FDA is desperately in need of renewal: It is dysfunctional, suffering from cultural, organizational and management problems that have been exacerbated by congressional mandates and meddling. As a result, drug development by major U.S.-based drug companies is in dire straits, with costs up and regulatory approvals down.

Draining the FDA swamp will be one of the toughest jobs in Washington, and the nominee will need several qualities:

c 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 head, then, should be primarily to manage the far-flung empire and to make the final decision on difficult policy questions.

c Unassailable integrity and honesty. The commissioner's decision-making must meld law, science and regulatory precedents, in a way that maximizes the public interest. The incumbent needs to earn the respect of those who have a stake in the FDA's policies and decisions - consumers, industry and public interest groups. But in the end, science - not public opinion or congressional grandstanding - must dictate policy- and decision-making.

c Distanced from politics. The position should not be awarded as a political plum, as are Cabinet posts and many ambassadorships. Politics should be banished from the agency head's role insofar as that is possible, with the commissioner taking the heat for unpopular decisions. Some previous commissioners have deferred to political appointees, not only on matters of policy (which is often appropriate), but also on decisions that concerned individual products or civil service personnel. Such actions are at least unethical, and possibly criminal. A corollary is that the agency head should probably not aspire to higher political positions in government: Doing the job right makes plenty of enemies.

c Committed to regulatory reform. At a time when drug development should have been spurred by huge increases in R&D expenditures - which tripled to more than $45 billion between 1995 and 2007 - and by the exploitation of numerous new technologies, drug approvals have actually dropped. The 19 new medicines approved in 2007 was the lowest figure in 24 years, and 2008 approvals are running behind last year's. Bringing a new drug to market now requires on average 12 to 15 years, and costs have skyrocketed to more than $1.2 billion - in no small part because the average length of a clinical trial increased 70 percent 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.

These trends are likely to become even worse: Several recent developments at the FDA will further increase the time and costs of drug development - bad news for the developers of medicines and for the sick and infirm who need new therapies. The FDA needs to streamline its existing regulatory procedures and requirements, and the agency's senior and midlevel managers must be made more accountable for their decisions - especially those that delay the availability of new drugs, vaccines and medical devices to patients in need of them.

These are stringent, but not impossible, qualifications. However, early returns are not encouraging: In 2007, the Center for American Progress, dubbed "the official Hillary Clinton think tank" and headed by Obama transition team co-director John Podesta, proposed changes in regulation that would only worsen the agency's existing problems, lengthening the time required to develop a drug and further increasing R&D costs. Its report, "Prescriptions for Drug Safety," is a prescription for additional obstacles to U.S. drug development. (The think tank is the beneficiary of millions of dollars from anti-free-market billionaire George Soros.)

Moreover, the transition team for the Department of Health and Human Services (of which the FDA is a part) is headed by Bill Corr, a former senior staffer to former HHS Secretary Donna Shalala in the Clinton administration and currently executive director of the Campaign for Tobacco Free-Kids. He has long lobbied for additional authority and power for the FDA.

By appointing an FDA commissioner with the qualities enumerated above, the Obama administration can demonstrate that it puts patients' needs first and that "change" is more than a hollow campaign slogan. But for this and similar political appointments at other agencies, we are far more likely to get someone who shares the radical, pro-regulatory, anti-industry views of Mr. Podesta, Mr. Soros, Mr. Corr and Hillary Clinton.

Henry I. Miller is a physician and a fellow at Stanford University's Hoover Institution and at the Competitive Enterprise Institute. He headed the Food and Drug Administration's Office of Biotechnology from 1989 to 1993.