FDA Announces Drug Safety Oversight Board

The Food and Drug Administration (FDA) plans to initiate an independent oversight board to handle drug safety issues, but some lawmakers and consumer groups say the new panel lacks teeth. Michael Leavitt, secretary of the Department of Health and Human Services (HHS), announced Feb. 15 that FDA will create an independent drug safety oversight board. The board will be responsible for overseeing drug safety policies and resolving internal disputes over drug risks as well as approving information and content for a new government website on drug safety information. The panel will be appointed by the FDA commissioner and comprised of government officials from FDA, HHS and other government agencies. Medical experts as well as patient and consumer groups will act as consultants to the board. The panel emerged out of several recent controversies at FDA surrounding drug safety, including the discoveries that antidepressants may lead to increased suicidality in children and that patients on Vioxx faced an increased risk of heart attack or stroke. In each case, FDA was slow to act and ignored or suppressed findings from its own reviewers in the Office of Drug Safety. Aside from the review panel, the 2006 budget requests a $5 million increase in funding for the Office of Drug Safety. The office will also get an increase of $1.5 million from industry fees. The new money will allow the agency to have more access to industry drug safety information as well as pay for an additional 25 employees. Lawmakers and consumer groups responded to the news with skepticism, saying the new board needs more independence and authority to fully ensure the safety of FDA-approved drugs. Since all of the board members will come from within FDA, HHS or other government agencies and medical experts will act only as consultants, the board will lack true independence. �It�s really a cosmetic way of dealing with a much more serious problem,� Dr. Sidney Wolfe, director of the nonprofit Public Citizen Health Research Group in Washington, DC, told Newsday. �In the absence of any fundamental change, it�s a cruel hoax.� Many lawmakers believe the board does not reach to the core of the problems with drug safety reviews. Senate Finance Committee Chairman Charles Grassley (R-IA) and Sen. Christopher Dodd (D-CT) are each developing legislation that would give the Office of Drug Safety more independence from the Office of New Drugs. Congressional hearings last fall on FDA�s handling of Vioxx pointed to mounting tensions between the FDA�s Office of Drug Safety and the Office of New Drugs. Though the two offices are theoretically independent of one another, testimony revealed that the Office of New Drugs exerts considerable influence over the Office of Drug Safety. Many advocates believe such influence is inevitable when the same agency both approves drugs and evaluates their post-market safety. The agency is often reticent to release criticism of drugs already on the market, leaving patients at risk for harmful, or potentially fatal, side effects.
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