Lawmakers Weigh FDA User Fee Agreement
The FDA's new deputy commissioner told lawmakers yesterday that the tentative deal the agency has reached with the pharmaceutical industry to secure more user fees from drug makers would both speed up the approval process and greatly expand the FDA's post-market oversight of medications, CongressDaily reports. "The need to institute a more effective program of risk management for new drugs, and thereby ensure greater patient safety, is clearly warranted by the intrinsic limitations of drug development programs and the reality that more drugs are launched for the first time in the U.S," Lester Crawford told the House Energy and Commerce Subcommittee on Health (Fulton, CongressDaily, 3/6). The subcommittee hearing marked the first step toward reauthorizing the 1992 Prescription Drug User Fee Act, under which drug makers pay the FDA to have their new drug applications reviewed more quickly. The FDA and drug industry have reached a tentative agreement under which drug makers would pay much greater user fees, allowing the agency to hire more workers for both the approval process and post-market oversight (Kaufman, Washington Post, 3/7). User fees, which totaled less than $140 million in fiscal 2001 and could reach $160 million this year, would rise to $223 million next year and $259 million in five years under the new agreement. The FDA would add 20 drug-safety workers in the first year and an additional 80 by the fifth year, which would roughly double its oversight staff (Adams, Wall Street Journal, 3/7). User fees currently pay for more than 1,000 FDA employees. The tentative agreement is still being reviewed by the Bush administration and could be altered before it is formally sent to Congress this month.
While PDUFA has significantly reduced approval times, the law has come under some criticism from consumer advocates who say the FDA has been "co-opted by the industry money" and moves too quickly to approve drugs and too slowly to take drugs that have safety or effectiveness problems off the market. Crawford defended the law, saying it has allowed U.S. drug makers to outpace their European rivals in producing new medications and that the number of approved treatments pulled from the market has not changed since 1992. The Washington Post reports that while the subcommittee expressed "general support" for reauthorizing the law, some members "complained" that the agreement between the FDA and the Pharmaceutical Research and Manufacturers Association of America and the Biotechnology Industry Organization was conducted behind closed doors. Republican members said that the subcommittee should pass a "clean" bill so that Congress can quickly reauthorize the law before it expires on Oct. 1, adding that failure to do so could result in FDA employees being laid off. But some Democrats said that the more contentious issues of how the FDA regulates drugs and drug pricing should be discussed as part of the reauthorization. "With all due respect, this committee and this Congress jump when the drug industry says 'jump'; it rushes to pass legislation when the drug industry wants it to pass legislation," Rep. Sherrod Brown (D-Ohio) said, adding, "But we better not talk about drug pricing or the impact of direct-to-consumer advertising on health care utilization. Those topics are taboo" (Washington Post, 3/7). However, House Energy and Commerce Chair Billy Tauzin (R-La.), while stating that "there are other FDA reforms [he] would like to see enacted this year," urged lawmakers to "deal with PDUFA now, and then turn [their] attention to other reforms" (CongressDaily, 3/6).
Congress should modify PDUFA to allow the FDA to use some of the fees its collects from drug makers "not just for speeding new drugs to the market but also for improving post-market surveillance" of pharmaceuticals, according to a Los Angeles Times editorial. The Times urges lawmakers to consider the "importance of continued testing, for efficacy and safety," of prescription drugs already on the market. "For too long," the editorial states, the FDA has not "wanted to bite the hand that helps feed it." And lawmakers -- who have accepted $55.3 million in contributions from drug makers since 1990 -- have "starved the agency of resources." The Times notes that consumer advocates pushing for greater post-market oversight have "gained two mighty allies": health insurers and large employers who, concerned about "runaway drug costs," also "want to give the FDA more muscle to conduct long-term post-market surveillance" to identify and "weed out" unsafe or ineffective treatments. The editorial concludes that the number of withdrawals of prescription drugs from the market in the past few years could "give Congress a new attitude about saner FDA oversight" (Los Angeles Times, 3/6).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.