Thursday, October 12, 2006

Experts Urge Major FDA Overhaul

Institute of Medicine report says the agency lacks oversight, independence.

By Amanda Gardner
HealthDay Reporter

MONDAY, Oct. 9 (HealthDay News) -- Cries for major changes in the current U.S. drug regulatory system are getting louder.

Five current or former members of the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) are now calling for Congress to step in and engineer an overhaul of the beleaguered agency. The article was published in the Archives of Internal Medicine.

"Congress cannot leave them on their own," said Dr. Curt Furberg, lead author of the article and professor of public health sciences at Wake Forest University School of Medicine. "We would have to have oversight and some strong people that drug safety as a priority."

At the same time, a report from the Institute of Medicine in the Oct. 26 issue of the New England Journal of Medicine, advocates for better post-marketing surveillance of approved drugs.

Both articles follow years of well-publicized problems at the agency. As one example, in 2004, Vioxx was withdrawn from the market after reports of increased risk of heart attack and stroke. Experts close to that case accused the FDA of ignoring key data that could've prevented the debacle.

And the multiple sclerosis drug Tysabri was pulled from pharmacy shelves in early 2005, after several patients in clinical trials developed a rare but deadly viral infection in the brain. Tysabri was returned to the market in 2006, but under much stricter guidelines.

Meanwhile, criticisms of the FDA have been coming at a furious pace, including one from Harvard researchers in the pages of the New England Journal of Medicine which stated that the federal government allows "a minimal standard that would be unacceptable anywhere else in research." This week, an editorial in the same journal stated that "definitive action must be taken" at the agency.

The authors of the Archives of Internal Medicine paper identified four types of problems and solutions:

Organizational problems, including a high turnover in leadership. "What's missing is a strong, dynamic leadership to make some changes," Furberg said. "The main problem is the voice of drug safety is not heard. Drug safety is sort of the stepchild." The authors recommended elevating the status of drug safety by establishing an office of drug safety reporting directly to the commissioner.
Operational problems. "There's a lot of unhappiness, low morale, people don't communicate," Furberg said. "The leadership does not get the message. They don't see the big picture." Here Congress needs to step in, he said, because the FDA can't do it on its own." Operational solutions would include a condition period of approval for drugs and an updated surveillance program.
Lack of authority. "Industry is not adhering to the regulations," Furberg said. "As of now, there are 1,200 unsatisfied commitments, studies that were never started or were delayed. So, in other words, they just ignore the regulations." The agency needs to have enforcement tools at its disposal.
Under-funding. The FDA currently is dependent on user fees coming directly from pharmaceutical companies. "That puts FDA and industry in a close relationship," Furberg said. "There should be a wall between them." Instead, the FDA should receive general funds allocated by Congress.
The article also recommended streamlining the current MedWatch system and changing the composition of FDA advisory committee to reduce the number of experts receiving industry support.

The Institute of Medicine report focused largely on the post-marketing period, which it called an "evidence-free zone." After drugs are approved, there seems to be no real impetus to follow through on post-marketing studies, the IOM said.

Instead, the authors advocated a sort of provisional period. Drugs labels would carry a new symbol for up to two years after approval "to signify the uncertainty associated with new drugs." There should also be a moratorium on direct-to-consumer advertising during that period and a re-review of the drug's risk-benefit ratio five years after approval.

While the IOM report basically calls for internal changes within the FDA, Furberg said his article calls for outside intervention.

"We don't believe the FDA can do it," he said. "For a decade, they've had problems, and they've done very little. They deny their problems, and they can't fix them. We're saying Congress has to step in to give them authority, give them money, oversee their operations and make sure drug safety is a priority.

In their related article, three NEJM editors called the IOM report "a crucial starting point, and we urge Congress to implement its recommendations and give them the highest priority."

The FDA did not respond to requests for comment.

More information

The U.S. Food and Drug Administration ( ) has more on the existing drug approval process.

SOURCES: Curt D. Furberg, M.D., Ph.D., professor, public health sciences, Wake Forest University School of Medicine, Winston-Salem, N.C.; Oct.5 ,2006, Archives of Internal Medicine; Oct. 26, 2006 New England Journal of Medicine

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