We noticed you're browsing in private or incognito mode.

To continue reading this article, please exit incognito mode or log in.

Not a subscriber? Subscribe now for unlimited access to online articles.

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.

This story is part of our March 2005 Issue
See the rest of the issue

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.

Discover where tech, business, and culture converge at EmTech MIT 2019

Register now
More from Business Impact

How technology advances are changing the economy and providing new opportunities in many industries.

Want more award-winning journalism? Subscribe to Print + All Access Digital.
  • Print + All Access Digital {! insider.prices.print_digital !}*

    {! insider.display.menuOptionsLabel !}

    The best of MIT Technology Review in print and online, plus unlimited access to our online archive, an ad-free web experience, discounts to MIT Technology Review events, and The Download delivered to your email in-box each weekday.

    See details+

    12-month subscription

    Unlimited access to all our daily online news and feature stories

    6 bi-monthly issues of print + digital magazine

    10% discount to MIT Technology Review events

    Access to entire PDF magazine archive dating back to 1899

    Ad-free website experience

    The Download: newsletter delivery each weekday to your inbox

    The MIT Technology Review App

You've read of three free articles this month. for unlimited online access. You've read of three free articles this month. for unlimited online access. This is your last free article this month. for unlimited online access. You've read all your free articles this month. for unlimited online access. You've read of three free articles this month. for more, or for unlimited online access. for two more free articles, or for unlimited online access.