Can the FDA Get Its Bite Back?

The Government Accountability Office (GAO) is the investigative arm of Congress. It studies how the federal government spends your tax dollars.
The GAO recently evaluated the Food and Drug Administration (FDA) and concluded the FDA belongs in the doghouse. Not only does this dog not hunt, it doesn’t bark very loudly and it’s nearly toothless.
The issue is drug safety. There is growing concern that the country’s health watchdog is not protecting the public adequately. Once a medicine has been approved and made it to the market, the FDA has difficulty detecting problems and doing something effective about them. According to Senator Charles Grassley, some agency employees have been intimidated or reassigned when they raised questions about the FDA’s oversight.
This issue became evident with Vioxx. Instead of noticing an increased risk of heart attacks and strokes, the agency seemed oblivious to any problems with the drug. Although some individuals at the FDA sounded a warning, they were ignored.
In response to Senator Grassley’s concerns about the Vioxx debacle, the GAO looked at the agency’s handling of four drugs with safety issues—Arava for rheumatoid arthritis, Baycol for high cholesterol, Bextra for pain and Propulsid for acid reflux.
The report concluded, “The FDA lacks clear and effective processes for making decisions about, and providing management oversight of, postmarket safety issues.��?
This report undermines public confidence in the FDA, which was not very strong to begin with. A survey last year found only 14 percent of consumers have great confidence in the FDA’s ability to safeguard the country’s drug supply.
The report also suggests that steps the FDA has already undertaken to fix what’s broken leave too many gaps. The FDA has created a Drug Safety Oversight Board, but the agency has not figured out how to “address the lack of systematic tracking of ongoing safety issues.��?
Although the FDA frequently requests that drug companies carry out safety studies on drugs that have recently been approved, an article in the Journal of the American Medical Association (JAMA, Dec. 1, 2004) indicates that the studies often don’t get done. It’s as if a student didn’t turn in his final paper for a class but the teacher let him graduate anyway. As a result of this cavalier approach, the FDA often lacks data it needs to make informed decisions about drug safety.
Another problem facing the FDA is the objectivity of its outside experts. Frequently the agency convenes an advisory panel of specialists to consider a new medication or review safety concerns. But agency officials seem to have difficulty finding experts without financial ties to the very drug makers the agency is supposed to be regulating.
Almost 30 percent of these advisors had financial conflicts of interest (JAMA Apr. 26, 2006). Almost a quarter of the drug-company contracts were for more than $100,000.
Experts claim that these relationships do not sway their judgment. But sports fans would never tolerate having Super Bowl referees getting money on the side from one of the teams. Isn’t drug safety at least as important as the outcome of an athletic contest?
If the FDA is to regain the confidence of the American public it will need to implement the GAO’s recommendations on drug safety. For this to happen, Congress needs to beef up the watchdog’s bite.