Business Impact

Dear FDA: Get Well Soon

What’s wrong with the regulatory agency and how to fix it.

Last December, the U.S. Food and Drug Administration warned doctors that a drug widely prescribed to children for attention deficit hyperactivity disorder carried with it “the potential for severe liver injury.” The FDA demanded that the manufacturer, Eli Lilly, relabel the product with a new bold-letter warning. Since the drug was introduced in 2002, some two million people have taken it. The FDA discovered that two of these patients had suffered subsequent liver problems.

So far, so good. Perhaps a little overzealous. But the FDA had been less vigilant about more serious safety concerns related to the pain relievers Vioxx, Bextra, and Celebrex. An FDA whistleblower told the U.S. Congress that tens of thousands of patients may have died needlessly because of the FDA’s misjudgments about Vioxx alone. Perhaps the whistleblower overstated the influence of drug manufacturers on the FDA’s hesitation to warn the public about these drugs. Nevertheless, a thorough examination is in order.

As Stephan Herrera explains in a review of Philip J. Hilts’s book Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation, there is talk in Washington of overhauling the FDA to ensure that such mistakes don’t recur (see “Who Needs the FDA?”). Some are ask­ing for the creation of an independent product-safety review board to oversee the FDA’s own product-safety review board. The FDA itself has asked the National Academies’ Institute of Medicine to conduct a review and vows to act on its recommendations.

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Other critics, particularly those on the right who are ideologically antago­nistic to all regulation, argue the agency must be destroyed altogether. They say it is a kind of tyranny to tell sick citizens they cannot use risky thera­pies, so long as the risks are clearly explained. They believe a U.S. drugs agency should limit itself to describing the efficacy of medicines.

In this rush to review and restructure the agency, the root cause of all that ails the FDA is being overlooked. Despite being responsible for the health and well-being of 300 million Americans – and the proper working order of close to $1.5 trillion worth of products and services – the agency must make do with an annual budget of $1.5 billion. No other government agency is required to do so much with so little. The FDA needs more money and more guidance in how to spend it for the greater good. It won’t be easy for a Republican-dominated Congress to give the FDA more money and power, but the public and media will surely back those who lead the charge.

If something must be scrapped, let it be the “user fee” system. Hundreds of millions of dollars in product-review fees paid by drug companies go to the FDA. Congress and the FDA will say that they can’t afford to ditch the user fee system, but it creates intolerable conflicts of interest.

Failing all of this, surely the FDA at least deserves a real commissioner. We recommend the White House look at Stanford University’s president emeritus, Donald Kennedy. Now the editor in chief of Science, Kennedy served as FDA commissioner from 1977 to 1979. There is some precedent for rehiring commissioners. Kennedy is wiser now and even more highly regarded by scientists and the biopharmaceutical industry. Another good choice would be David Kessler, dean of the University of California, San Francisco, School of Medicine, who was an effective and powerful commissioner of the FDA under both President George H. W. Bush and President Bill Clinton. The FDA again needs this type of expertise and strong leadership.

With the proper remedy and the right physician, the FDA can be healed.

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