Proposal Calls for Sweeping Changes at U.S. Food and Drug Administration

October 9, 2006

WINSTON-SALEM, N.C. – Five current or former members of the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) called today for Congress to make sweeping changes to deal with a large number of longstanding problems at the agency.

“The current FDA system of regulating drug safety has serious limitations and is in need of changes,” they say in Archives of Internal Medicine, released today. Since Congress is ultimately responsible, “it is up to Congress to take the steps necessary to reinvigorate the FDA’s ability to assure the public that approved medical products are safe.”

Curt D. Furberg, M.D., Ph.D., professor of public health sciences at Wake Forest University School of Medicine and the lead author, said the five decided to write the analysis after becoming discouraged by the FDA’s inability to fix its own problems.

“Congress has not provided adequate funding and authority to the FDA,” he said.

The group cites eight major problems impacting FDA performance, including:

• The system of initial approval of drugs often fails to detect serious adverse drug reactions.

• The same FDA center that approves drugs also has the responsibility of taking safety actions, creating a conflict-of-interest situation.

• The FDA is overly dependant on user fees from drug companies.

• The FDA is short on expertise in drug safety and public health.

“The key features of today’s media stories about questionable drug safety are the same as with previous drug tragedies,” Furberg said. “New drugs are introduced on the market with inadequate safety documentation; serious adverse drug reactions are later reported from the marketplace, and a large number of patients are unnecessarily injured before the drugs are withdrawn or better managed. The only difference is the name of the culprit drug.”

Furberg and his colleagues recommend that Congress make five changes:

• “Give the FDA more direct legal authority to pursue violations.” The FDA’s own report says that drug companies committed to 1,231 post-marketing safety studies that are incomplete; 797 were never started.

• “Authorize the adoption of a conditional drug-approval policy, at least for selected drugs.

• “Provide additional financial resources to support the safety operations.

• “Mandate a reorganization of the agency with emphasis on strengthening the evaluation and proactive monitoring of drug safety.

• “Require broader representation of safety experts on FDA’s advisory committees.”

“Larger and longer clinical trials ought to be required for drugs that will be given for chronic conditions such as high blood pressure, diabetes and coronary heart disease,” said Peter A. Gross, M.D., chairman of medicine at Hackensack University Medical Center and professor of medicine and public health at UMDNJ-New Jersey Medical School and a coauthor. “Trials should be required to have adequate numbers to assure the tested drugs are reasonably safe.”

“Safety evaluation should be given the same priority as efficacy evaluation,” the authors wrote, calling for the creation of a Center for Drug Safety within FDA “for continuous post-marketing surveillance and regulation.” They say the center should be given adequate funding and staff to take advantage of the valuable data for safety monitoring already collected in private and public databases.

The conditional drug-approval policy could be modeled on programs in other countries for those drugs that have clear benefits but also have lingering safety concerns, requiring a re-review after two to three years. “A time-limited conditional approval status would place pressure on the sponsors to conduct and report post-marketing safety studies they commit to,” said Furberg.

Arthur A. Levin, M.P.H., director of the Center for Medical Consumers in New York, and a co-author, said the group was also calling for sufficient funding to end reliance on user fees paid by the pharmaceutical industry, calling the fees a conflict of interest. The Prescription Drug User Fee Act requires FDA to “perform something of value to industry in exchange for which industry would agree to pay the fees.”

The co-authors also include Robyn S. Shapiro, J.D., of the Medical College of Wisconsin in Milwaukee, and Brian L. Strom, M.D., M.P.H., of the University of Pennsylvania in Philadelphia.


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Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university’s School of Medicine. U.S. News & World Report ranks Wake Forest University School of Medicine 18th in family medicine, 20th in geriatrics, 25th in primary care and 41st in research among the nation's medical schools. It ranks 35th in research funding by the National Institutes of Health. Almost 150 members of the medical school faculty are listed in Best Doctors in America.

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