On March 13, Kim Witczak stood before the Senate Committee on Health, Education, Labor, and Pensions and recounted the death of her husband, Tim.
Known to his friends as Woody, Witczak hung himself from the rafters of the couple's Minneapolis garage in 2003 just five weeks after being prescribed Zoloft by his family physician. He was 37 years old. According to his wife, Woody was given the drug for insomnia and had no history of mental illness or depression.
"From the beginning," she testified, "something didn't add up about Woody's death."
In fact, increased risk of suicide had been identified as a possible side effect of anti-depressant drugs like Zoloft as far back as the 1980s, during preliminary trials. But it wasn't until 2004 that drug companies were forced to issue a warning about the side effect, and then only for patients under 18. Thus, the Witczaks were never informed of the risks.
The Senate committee Witczak addressed was gathering testimony as part of an ongoing discussion about how the Food and Drug Administration (FDA) can better ensure the safety of the drugs Americans are taking. A key issue involves the renewal of the Prescription Drug User Fee Act (PDUFA), which allows pharmaceutical companies to fast track the drug approval process by paying the FDA for their time and effort.
User fees are not uncommon in federal agencies, but critics of PDUFA say that what distinguishes it is an unprecedented level of collaboration between the FDA and the pharmaceutical industry. Through protracted fee negotiations, the industry has a say in everything from how the money will be spent to setting up timetables for a drug's approval -- the equivalent, according to one former chief editor of The New England Journal of Medicine, of "putting the fox in the chicken coop."
The legislation, enacted in 1992, was designed to help cut through red tape, to get drugs approved quicker and into the hands of needy patients. By all accounts, it has done that. Since 1993, the median FDA approval time for priority drugs has been cut in half, from 13.2 months to just over six.
But critics argue that the FDA has come to rely too heavily on the fees, with their strings attached, as federal appropriations have failed to adequately fund the agency; and while more drugs may be getting approved, there have also been more high-profile mishaps involving brand-name medications. In 2002, the General Accounting Office reported that the percentage of newly approved drugs withdrawn from the market had risen nearly five-fold since PDUFA's enactment: from 1.56 percent in the three years immediately following PDUFA to 5.34 percent between 1997 and 2000.
According to the Congressional Research Service, in 2006, user fees paid for thirty percent of salaries and expenses in the FDA's Human Drug Program, prompting some lawmakers to suggest that the program has outgrown its mandate.
"User fees were never intended to supplant appropriations, they were intended to supplement appropriated funds," said Republican Mike Enzi of Wyoming, ranking member of the Senate Committee on Health, in a March 14 statement.
The current user fee program (PDUFA III) is scheduled to expire on September 30, 2007, which means Congress will need to vote on a new act before summer's end. A vocal backlash has ensued from an alliance of scientists and legislators that want to use the act as leverage for instituting a sweeping reform of the way FDA does business.
"User fees are a reasonable way to pay for certain services, but the agency needs to be in charge of how they are spent," says Dr. David Michaels, an epidemiologist and research professor at the George Washington University School of Public Health and Health Services. "Look, if you go to the Passport Office to get a new passport, you'll pay a fee for the processing, but you aren't given the option of negotiating the terms." Michaels directs The Project on Scientific Knowledge and Public Policy (SKAPP), which, through its website, advocates for increasing federal regulatory accountability.
The day after the Senate hearing, Michaels joined 21 other medical experts in drafting a letter to lawmakers urging them to withhold approval of PDUFA IV. "PDUFA has helped to foster the public's perception that industry has become the primary client of FDA rather than the American people," the group wrote. "This perception has contributed to the erosion of trust in FDA."
Michaels says the impetus to act came out of a February 21 roundtable meeting of four former FDA Commissioners that his group hosted. "At the meeting, the former commissioners were asked if the FDA would be better off relying on user fees or appropriations, and across the board they all said appropriations," Michaels says. "There is a real belief that PDUFA is part of the problem at FDA."
Days later, at a closed door meeting of regulatory policy experts, the group decided something needed to be done. "My position is that we don't need PDUFA, but if it must be reauthorized, it must be done so the FDA has no restraints on how they use the money and no deadlines," says Michaels.
Joining Michaels in protest are members of academia, a coalition of consumer groups, and former regulatory officials, among them Dr. Susan Wood. Wood served as director of the FDA's Office of Women's Health before resigning her position in 2005 amid FDA stonewalling on the emergency contraceptive, Plan B.
"This next round of PDUFA as proposed doesn't address many of the underlying problems with having industry pay fees for specific services," says Wood. "These include lack of safety outcomes, workload pressures, lack of flexibility for the FDA to be able to respond appropriately to priorities other than rapid review of new products, and ultimately, there are still inadequate levels of funding for FDA to accomplish its overall mission."
There's no shortage of evidence to support Wood's claims. In September 2006, the Institute of Medicine (IOM) released an assessment of the U.S. drug safety system. The report found, among other things, a public perception of crisis that has compromised the credibility of both the FDA and of the pharmaceutical industry. According to the report, the FDA and the industry "do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion." The report recommended that Congress "provide oversight and enact any needed legislation to ensure compliance of both FDA and drug sponsors."
Three months earlier, in recognition of the 100-year anniversary of the founding of the FDA, Henry Waxman's office in the House Committee on Government Reform issued a landmark report on the agency, titled "Prescription for Harm -- The Decline in FDA Enforcement Activity." It found that under the Bush administration, the number of warning letters issued by the FDA for violations of federal requirements had fallen to a 15-year low, and that the agency routinely overruled field inspectors and failed to bring law enforcement actions in cases involving death and serious injury.
Since then, other lawmakers have jumped on board to speak out on the issue, including Senator Charles Grassley -- a longtime critic of the FDA -- Senator Christopher Dodd, and Representative Frank Pallone. Meanwhile, a bill introduced in the Senate on Aug 3, 2006 by Senators Enzi and now-Health Committee chairman Edward Kennedy seeks to strengthen the oversight powers of the FDA. Among other things, the Enhancing Drug Safety and Innovation Act would give the agency a stronger hand in post-approval oversight.
Meanwhile, however, on March 23 the FDA submitted its final proposal for PDUFA IV to Congress. Under a 5-year plan to continue the fees, drug-makers would pay the agency about $393 million in fiscal year 2008, or nearly 20 percent of the FDA's requested budget of $2.1 billion for the same period.
Where the chips will finally land regarding the future of PDUFA is still anyone's guess. With a Democratic Congress at the helm, it's likely the FDA will face some tough questioning in the coming months. Still, the pharmaceutical lobby has millions of dollars at its disposal. And in America you tend to get what you pay for.
Christopher Moraff is a Philadelphia-based writer and reporter who has written for In These Times and The American Prospect Online, among other publications.
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