Strong Medicine: What's Ailing the FDA?

Is America's consumer watchdog understaffed, overburdened, ethically challenged or merely misunderstood?

Crisis in the FDA

Recent headlines have uncovered one shocking lapse after another at the Food and Drug Administration: A popular diabetes drug can sharply increase the risk of heart attack, a finding the agency knew but took two years to reveal. An FDA-approved antibiotic can destroy your liver in just five days. And despite mounting concerns about the safety of Chinese-made drugs, the agency had only enough field inspectors last year to check a mere 13 of the 714 Chinese factories that produce medicines for U.S. consumers.

Many of the nation's leading doctors, scientists and lawmakers now agree that the FDA is in crisis. Lurching from one disaster to another, the 102-year-old agency learns of dangers too late and then moves too slowly to remedy them. Insiders say it's woefully underfunded, dangerously understaffed and fractured by bitter internal tensions. Instead of depending on the FDA, Americans are doubting it -- and for good reason.

The FDA is expected to regulate $1.5 trillion in food, drugs, vaccines, medical devices, blood and tissues, radiation-emitting machines, animal feeds and drugs, cell phones, dietary supplements, biotechnology and gene therapy -- and, post-9/11, sniff out any food-borne terrorist plot. Yet the agency's annual funding, $2 billion, is about what Fairfax County, Virginia, pays for its public schools.

"Think your pacemaker, heart valve, microwave oven or morning vitamin was inspected?" asks former associate commissioner William Hubbard. "Dream on."

A chilling new report commissioned by the FDA's own advisory Science Board describes an organization nearly out of control. "We were shocked at the appalling state of science at the FDA," says Garret FitzGerald, MD, chairman of the pharmacology department at the University of Pennsylvania School of Medicine and an advisor on the report. "The analogy is Katrina. But we have to fix this before the hurricane hits."

Drug safety is perhaps the greatest concern. The respected Institute of Medicine, created in 1970 by the National Academy of Sciences, recently labeled the FDA's drug branch "dysfunctional," saying it muzzles scientific dissent, inadequately monitors drug safety and relies too heavily on drug company dollars.

Even the department's champions are worried. "I don't think the FDA is at a collapse point yet, but it's getting close," says Hubbard, who retired in 2005 after 26 years at the agency. "In some places, regulation is so weak that there's nothing left."

The agency's most recent difficulties began in 2004, when officials came under fire for silencing a staff scientist who had concluded that antidepressants could increase suicidal behavior in teens. That same year, the FDA was criticized for not acting quickly to take the painkiller Vioxx off the market after it was shown to increase the risk of heart attack and stroke.

"Every generation has required some health disaster to reform the FDA," says David Graham, MD, a drug safety expert who has worked at the agency for 24 years. Today, he says, that window of opportunity has been pried open by debacles such as Vioxx. Former FDA commissioner David Kessler, MD, agrees: "These are the times when things get fixed."

Congress has begun that job. Last September, lawmakers did increase the FDA's funding by $145 million, although only about one fourth went to the drug-review branch (more on that later) and boosted its regulatory powers. Observers hope FDA officials will use their new clout to restore the agency's lost luster. But they say the public needs to weigh in to make sure that happens. Here, the five key problems, what's being done to fix them and how you can help.

• • National Health Care
• • Your Tax Dollars
• Government

• Prescription Drug Precautions
• After a trend in recalled drugs, people are losing faith in the FDA. Find out how to ensure the safety of your prescriptions.
• 
• One Drug, Many Tragedies
• A doctor blows the whistle on a dangerous new drug that wrongfully received FDA approval.
• 
• Understanding Prescription Medication
• What is the FDA doing to make prescriptions more patient-friendly?
• 
• Making Medicine Safe
• The "right" drugs kill 100,000 people a year. How to be sure your medicine won't do more harm than good.
• 
• Prescription Drug Safety
• Worried about prescription drugs? How to weigh your risk.
• 
• Medical Breakthroughs for 2008
• New hope for cancer, diabetes, dementia and more.
• 

“ Do not burn wrapping papers in the fireplace. A flash fire may result, as wrappings ignite suddenly and burn intensely. ”

• See All Tips

Toward the close of a banquet held during an Episcopal Church convention some years ago, the bishop of the diocese stood up and quite disrupted the entire affair by announcing, "We will reserve the entertainment of the evening until the waitresses have taken everything off."

-- Wilbur L. Lear