What's Wrong with the FDA?
Hawthorne, Fran, Chief Executive (U.S.)
Either too fast or too slow, the agency can't find the right balance. BY FRAN HAWTHORNE
It is February 2004 and the scene is the Holiday Inn in Bethesda, Md.: One by one, parents, grandparents, siblings and friends tell a committee of scientists advising the U.S. Food and Drug Administration how teenagers they loved had committed suicide, or tried to, while taking antidepressants such as Paxil, Prozac and Zoloft that were approved as safe for adults. They demand that the FDA get tough about restricting new drugs.
How the wheel doth turn. A year later at the Hilton in nearby Gaithersburg, Md., a dozen patients tell a different FDA advisory committee about the excruciating pain, stiffness and helplessness they had suffered until they started taking the Cox-2 pain relievers Vioxx, Celebrex and Bextra. These drugs had been withdrawn or were at risk of being withdrawn because of the potential for heart attacks and stroke - and these patients were begging the FDA not to ban their drugs. "I feel like Celcbrex was created for me," says Judy Kogel of Ithaca, N.Y., who has osteoarthritis.
At least snice the early 1990s, the FDA has been stuck on a seesaw, alternately criticized as either a bureaucratic obstacle to industry, or the lapdog of industry-too slow in getting desperately needed druigs to the public, or too fast in rushing dangerous drugs onto pharmacy shelves. In 1992, when a drug application could take two years to be cleared, the agency was "too slow." By 2001, after more than a dozen drugs had been recalled in less than six years for serious safety problems, it was "too fast." In 2002, as approval times were lengthening, it was "too slow" again; now, with headlines about Vioxx and the others, it's again "too fast."
But the issue for CEOs who depend on the FDA for product approval is this: Is there something fundamentally wrong with the FDA regulatory process?
The FDA oversees more than one-fourth of the U.S. economy, including prescription and over-the-counter drugs, packaged food, animal drugs and food, biological products and blood banks, and a wide range of "devices," from cell phones to pacemakers to airport X-ray-scanners. Only drugs and medical devices need to be approved before they can be sold, but the FDA can order the others to change their labels or even pull them off the market.
These products, often essential for life, can have dangerous side effects. That presents the FDA with a tough choice-speed vs. safety. It needs to weigh the risks and benefits of new products, get the good ones out fast, then yank back the dangerous ones just as fast. The FDA may never get the balance completely right. But with more money, new scientific technology and a stronger CEO of its own, the agency could do a better job, especially in postmarket review, where it is now weakest.
No one expects the FDA to catch all side effects before approving any new drug or device. Although products typically are tested on several thousand people over about six years, some side effects become apparent only when a patient takes the drug in conjunction with another medication, or only after a drug has been in use for years, or only in cases of rare genetic defects. Perhaps most problems could be discovered if drugs were tested on a million people over 20 years, but then industry and patients would really scream about speed. "We try to set the bar for approval somewhere in the middle, between knowing everything you could possibly know versus society's need for new drugs," says Dr. John Jenkins, director of the FDA's Office of New Drugs.
To speed up the review process, pharmaceutical makers in 1992 reluctantly agreed to pay user fees to hire more reviewers under the Prescription Drug User Fee Act (PDUPA). In return, the agency had to meet strict deadlines, which are tightened each time the law is renewed.
Critics say PDUPA pushed the balance too Far in the speed direction. …