HHS Announces Creation of Board To Monitor Drug Safety Information at FDA
In response to concerns that FDA has mishandled information about some drugs' potential safety risks, HHS officials on Tuesday announced the creation of the FDA Drug Safety Oversight Board, which will be charged with monitoring and reporting information about potentially dangerous drug reactions, the Philadelphia Inquirer reports (Mondics, Philadelphia Inquirer, 2/16). The board's role will be advisory, and members will not have authority to remove a drug from the market or make changes to a drug's sales practices (Harris, New York Times, 2/16).
The oversight board will include government medical experts and chairs of outside committees (Rubin , USA Today, 2/16). The board is expected to include about 15 members, one of which will come from NIH and one of which will be from the Department of Veterans Affairs. Two board members also are expected to come from areas of FDA "not involved with drugs," the Wall Street Journal reports. Other members will include representatives from the FDA Office of New Drugs, which oversees drug approvals, and the Office of Drug Safety, which monitors drugs already on the market. The board is expected to meet monthly, and its conclusions will be made available to the public on a Web site, the Journal reports (Mathews/Abboud, Wall Street Journal, 2/16).
According to the Washington Post, FDA Acting Commissioner Lester Crawford said that pharmaceutical companies will not be permitted to address the board directly unless the board requests them to do so (Kaufman, Washington Post, 2/16). Some experts said the cost of monitoring large medical databases could be "tens of millions of dollars each year," according to the Times. President Bush's proposed 2006 federal budget does not include additional money for such an effort. The board is expected to be fully funded by FDA (New York Times, 2/16).
In another part of its effort to increase transparency, Crawford said the agency will be more proactive in providing information to the public, including releasing data that might not be complete or that might displease drug companies. Crawford -- nominated on Monday as permanent head of FDA -- said, "There are legal restrictions on releasing confidential and commercial information; however, that is not something the FDA should hide behind" (Washington Post, 2/16).
In addition, Crawford said that the agency soon will begin reviewing large databases, including those at CMS, to identify harmful side effects in drugs already on the market, the Times reports (New York Times, 2/16). The agency will work to develop information sheets for health care professionals and patients about drugs, which will be available on the agency's new Drug Watch Web site (Pugh, Miami Herald, 2/16).
HHS Secretary Mike Leavitt said, "If we have information and there's not a reason legally for it to be protected, we need to put it in the public domain" (Rubin , USA Today, 2/16). Currently, FDA relies on drug companies and physicians to report issues of drug safety. The agency also does not currently monitor off-label prescribing patterns (Miami Herald, 2/16). Crawford said that the agency does not plan to ban consumer drug advertising, although he added that the agency will continue to target misleading ads (New York Times, 2/16).
Scrutiny of FDA has intensified in recent months after questions about the safety of COX-2 inhibitors arose when Merck in late September 2004 withdrew the COX-2 inhibitor Vioxx from the market, citing concerns over possible cardiac risks. FDA recently announced that Bextra -- a COX-2 inhibitor manufactured by Pfizer -- could increase patient risk for heart attack and stroke, and recent studies have found that the safety concerns associated with Vioxx could apply to all COX-2 inhibitors.
Members of the FDA arthritis and drug safety and risk management advisory committees on Wednesday will begin a three-day meeting to determine whether to remove COX-2 inhibitors from the market over safety concerns (California Healthline, 2/14). Concerns over COX-2 inhibitors have "fueled a debate about whether the FDA adequately monitors the safety of drugs once they hit the market," USA Today reports (Rubin , USA Today, 2/16).
"The public has spoken, and they want more oversight and openness," Leavitt said in a statement. "They want to know what we know, what we do with the information and why we do it. We will address their concerns by cultivating openness and enhanced independence" (Philadelphia Inquirer, 2/16).
Crawford said, "Our culture, which has received some criticism in recent months, is not to alarm the public when we get a signal. That era is sort of past. What the public, we think, is demanding is to know as soon as we know what's going on. And they're fully prepared and adult enough to interpret whether or not this is a final decision" (New York Times, 2/16). He added, "Our goal is to prepare the agency for these new demands" (Kerr, Long Island Newsday, 2/16).
The Washington Post reports that the board and Web site will "constitute a major shift for [the] agency" (Washington Post, 2/16). According to the Journal, it is "unclear if the moves will satisfy the FDA's critics in Congress and elsewhere -- or address their concerns about whether the agency is aggressive and independent enough" (Wall Street Journal, 2/16).
Sen. Chuck Grassley (R-Iowa), who has criticized FDA's oversight practices, said, "It is always better to have more watchdogs and more checks on government agencies. ... A new drug safety board may contribute to oversight at [FDA]. It also remains necessary that the drug safety office within the FDA be made a truly independent entity" (Philadelphia Inquirer, 2/16). Grassley also said that he is preparing a bill that would establish "independence" for the Office of Drug Safety and provide it with "the authority needed to do its job" (New York Times, 2/16).
The Pharmaceutical Research and Manufacturers Association said in a statement, "It is important that regulatory decisions and communications be based on sound science and reflect carefully considered judgments regarding both benefit and risk" (Philadelphia Inquirer, 2/16).
Timothy Franson, Eli Lilly vice president of global regulatory affairs, said, "There must be a balance of properly warning people of safety concerns without frightening them, or inadvertently making them stop taking medicines that are helping them. ... It's a tough tightrope to walk" (Wall Street Journal, 2/16).
Public Citizen Director Sidney Wolfe called the board a "substitute" for "fundamental change" that is "unlikely to make any difference." He added, "It is a cruel hoax and a frantic reaction to congressional disapproval" (New York Times, 2/16).
Consumers Union representatives questioned the real independence of a board composed of government officials appointed by the FDA commissioner, the Baltimore Sun reports (Baer, Baltimore Sun, 2/16).
University of Washington professor Bruce Psaty, who co-wrote an editorial on drug safety published Tuesday in the New England Journal of Medicine, said, "FDA lacks authority ... to do some basic things that are necessary to protect the public health" (Rubin , USA Today, 2/16). He said, "I think this sounds like a good initial step, but it's not a solution to the problem. And anyone that thinks this is a solution to the problem misunderstands the problem" (Miami Herald, 2/16).
Sen. Christopher Dodd (D-Conn.) called the board a "step in the right direction" but added that it "doesn't go nearly far enough" (Alonso-Zaldivar, Los Angeles Times, 2/16).
Several broadcast programs reported on the new FDA drug-monitoring board:
- ABCNews' "World News Tonight": The program includes discussion of the new board (Jennings, "World News Tonight," ABCNews, 2/9). The complete segment is available online in RealPlayer. The complete segment is available online in RealPlayer.
- NPR's "All Things Considered": The program includes discussion on the new board (Silberner, "All Things Considered," NPR, 2/15). The complete segment is available online in RealPlayer.
- NPR's "Day to Day": The program includes discussion on the new board and other recent FDA news (Rovner, "Day to Day," NPR, 2/15). The complete segment is available online in RealPlayer. Expanded NPR coverage is available online.