X-Message-Number: 18735 From: "Peter Christiansen" <> Date: Sat, 9 Mar 2002 12:32:06 -0600 ------=_NextPart_001_0001_01C1C766.6C634040 Content-Type: text/plain; charset="iso-8859-1" News Home Page Nation World Metro Business Market News Portfolio Technology Company Research Mutual Funds Personal Finance Industries Pharmaceuticals - Archive Columnists Special Reports Live Online Business Index Technology Sports Style Education Travel Health Real Estate - NEW Home & Garden Food Opinion Weather Weekly Sections News Digest Classifieds Print Edition Archives Site Index Quick Quotes: Enter symbols separated by a space Look Up Symbols | Portfolio | Index Deal to Boost Drug Approval, Oversight Industries Agree to Higher Fees So FDA Can Hire More Employees Latest news and updates Select an Industry Biotechnology Defense Energy Financial Services Food Hospitality Insurance Internet Legal Media Pharmaceuticals Retail Telecommunications Transportation E-Mail This Article Printer-Friendly Version Subscribe to The Post By Marc Kaufman Washington Post Staff Writer Thursday, March 7, 2002; Page A02 The Food and Drug Administration has reached tentative agreement with the prescription drug and biotechnology industries on a plan that would enable the agency to hire hundreds of new employees to speed drug approvals and would substantially increase oversight of drug side effects after medications reach the market. The agreement, negotiated in private but discussed publicly yesterday at a congressional hearing on reauthorization of the Prescription Drug User Fee Act (PDUFA), is being reviewed by the Bush administration and could be modified before being formally presented to Congress this month. But industry and government officials agreed yesterday that there will be a major increase in the amount drug companies pay as FDA drug-approval user fees and a resulting expansion in the FDA workforce. Already, industry user fees pay the salaries of more than 1,000 agency employees. That drug industry funding has allowed companies to have their new drug applications reviewed and approved much more quickly than before PDUFA was passed in 1992, which has made the program popular with drug producers. But some consumer groups have accused the FDA of being co-opted by the industry money, saying the agency moves too fast on drug applications while being dangerously reluctant to take drugs off the market when consumers begin experiencing serious complications. Testifying before the House Energy and Commerce Committee's health subcommittee yesterday, FDA Deputy Commissioner Lester M. Crawford said the PDUFA process has allowed U.S. drugmakers to become far more competitive and bring out many more new drugs than their European rivals. He defended the agency's safety record -- saying the percentage of approved drugs pulled from the market has not changed since 1992 -- but was also eager to report that the number of FDA employees reviewing side effects from drugs already on the market would increase most significantly under the proposed plan. Other FDA officials later said the number of agency post-marketing reviewers would double, to about 200. The FDA has been meeting regularly for several months with representatives of the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) to negotiate how much they would pay in user fees and how FDA procedures and timetables might be modified. Some members of Congress and consumer representatives complained yesterday about the private nature of the meetings, because the subject was the operations of a major government agency. There was general support in the subcommittee for reauthorization of PDUFA, which was a major initiative of House Republicans in the early 1990s. Republican members of the subcommittee stressed that PDUFA expires on Oct. 1 and that FDA employees will be laid off if it is not reauthorized in time. They said a "clean" bill should be passed so the process will go quickly. But some Democratic lawmakers asked critical questions about how aggressively the FDA regulates prescription drugs and about prescription drug pricing, and they indicated that those subjects should be part of the PDUFA reauthorization. For instance, Rep. Sherrod Brown (D-Ohio) made clear that he wants to link PDUFA to issues of drug safety and the availability of generic drugs. He also raised the contentious issue of prescription drug costs. "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," Brown said. "But we better not talk about drug pricing or the impact of direct-to-consumer advertising on health care utilization. Those topics are taboo." Sidney Wolfe of the public interest group Public Citizen, who has criticized the industry user fees for years, said the new plan is no improvement. Public Citizen has been particularly aggressive in pushing for greater post-market surveillance of drug side effects, but Wolfe said the industry-funded program is misguided. "To think this money from the industry is a free lunch, to think that it won't affect the process at FDA, is fantasy," he said. Much of the testimony yesterday about FDA expansion focused on the post-marketing surveillance, but industry officials later said their greatest concern still is getting new drug applications through the agency more quickly. Carl Feldbaum, president of BIO, said his group has concluded that the FDA's Center for Biologics Evaluation and Review is "seriously underfunded" because of the recent jump in applications for drugs created through biotechnology, and that it needs more funds from user fees. He said his group wants some of the new money to pay for consultants hired by the FDA to explain cutting-edge technologies to staff members. Alan Goldhammer, PhRMA's vice president for regulatory affairs, said his organization has also concluded that the FDA needs more user fees to support the drug approval process. While the number of agency employees working on post-market surveillance of dangerous side effects would increase by 100 under the tentative plan, he said the number of new drug reviewers would increase by "several hundred more." 2002 The Washington Post Company Related Links Latest Business News Bush Plan Puts CEOs On Notice (The Washington Post, 3/7/02) US Airways Puts Siegel In Control (The Washington Post, 3/7/02) Rich Nations Pressured for Aid (The Washington Post, 3/7/02) Full Business Section Full Washtech Section More Health News SEARCH: News Jobs AP Shopping Archives Entertain. Web/Google Search Options ------=_NextPart_001_0001_01C1C766.6C634040 Content-Type: text/html; charset="iso-8859-1" [ AUTOMATICALLY SKIPPING HTML ENCODING! ] Rate This Message: http://www.cryonet.org/cgi-bin/rate.cgi?msg=18735