Subject: Plan to Speed Drug Approvals Clears Congress Date: Published: 10/8/92 (113 lines) Source: Wall Street Journal. Copyright Dow Jones & Co. Inc. Medicine: Plan to Speed Drug Approvals Clears Congress ---- By Bruce Ingersoll Staff Reporter of The Wall Street Journal WASHINGTON -- The Food and Drug Administration got clearance from Congress to sharply accelerate approval of new drugs, especially for patients with life-threatening diseases. In a final legislative push before adjourning, lawmakers adopted an industry-endorsed plan -- widely considered a milestone in FDA history -- aimed at breaking a logjam of new-drug applications at the understaffed agency. The action is part of a bill that also delays health-claim rules for the rapidly growing industry in nutritional and vitamin supplements, which has annual revenue of $4 billion. The bill cleared the House Tuesday and the Senate yesterday by unanimous consent. President Bush is expected to sign it. Under the new drug-approval plan, the nation's drug makers will pay the government $330 million in fees over the next five years -- enough for the FDA to hire 600 new staff members to evaluate the safety and effectiveness of new pharmaceutical products. The agency, in return, has promised to cut product review times in half by October 1997. "This is a crucial turning point for the agency," says FDA Commissioner David Kessler. "It means extra people coming on board at the Center for Drugs and the Center for Biologics. We're talking about a commitment to approve drugs in six to 12 months. That's a radical change." Economists say the resulting savings on drug research and development costs are likely to result in lower drug prices for consumers. One drug maker, Eli Lilly & Co., says it intends to cut its prices if the measure cuts review times as advertised. Among other things, the bill also gives the dietary-supplements industry a reprieve from tighter FDA regulation of health claims on the labels of vitamins and other nutritional products. The measure had been held up in the Senate by Sen. Orrin Hatch of Utah until lawmakers consented to a moratorium on new dietary-supplement labeling regulations until Dec. 31, 1993. Under the 1990 Nutrition Labeling and Education Act, the FDA was to have issued such regulations by Nov. 8, 1992. Mr. Hatch, the ranking Republican on the Senate Labor and Human Resources Committee, represents several Utah manufacturers of nutritional supplements that are at odds with the FDA. They fear that the agency will set unreasonably high scientific standards for making claims about supposed disease-preventing attributes of their products. The industry sees the moratorium as a chance to "carve out a proper place for dietary supplements in the regulatory scheme of things," says Kenneth Murdock, president of closely held Nature's Way Products Inc., a maker of dietary supplements and herbal products in Springville, Utah. The focus of the legislation, however, is the faster drug approval. The drug industry, including makers of prescription and over-the-counter drugs, backed the drug-approval plan after lawmakers provided statutory assurances that user-fee revenues would be added to congressional appropriations for the FDA and would be used only for drug-evaluation purposes. The bill "will increase FDA resources without using the appropriations process," says Democratic Rep. Henry Waxman of California, "and it will speed up the approval process without watering down the safety and efficacy standards." Rep. Waxman was one of the bill's authors, along with Sen. Hatch, Democractic Rep. John Dingell of Michigan and Sen. Edward Kennedy of Massachusetts. The FDA has committed itself to meeting a series of interim and five-year performance goals, including eliminating the current backlog of drug applications within two years. Half of the 600 additional drug reviewers are to be hired by the first quarter of fiscal 1995, which begins Oct. 1, 1994, and all are to be on board by the end of fiscal 1997. Last year, it took the FDA more than 23 months on average to clear new drugs and more than 11 months to clear high-priority drugs urgently needed by patients with AIDS and cancer. The plan calls for reducing review times to 12 months and six months, respectively, which will save the industry hundreds of millions of dollars, according to the Pharmaceutical Manufacturers Association. The trade group, which speaks for prescription drug makers, has long complained about the backlog of new drug applications. The agency usually has 300 applications under review, as well as thousands of amendments and supplements to amendments. Only one in five drugs makes it from company laboratory to the pharmacy. Development costs currently average $274 million per drug, according to a study by the Center for Drug Development at Tufts University. Expediting the review of a high-priority drug could save as much as $65 million. "Review times are one of the main factors in drug pricing," says Edward West, a spokesman for Eli Lilly, Indianapolis. "This could well result in lower prices for consumers." Lilly, which plans to spend $10 billion on drug research and development this decade, will pass on savings from shorter review times in the form of lower prices, he adds. Under the bill, prescription-drug makers will pay a one-time fee for each drug application, as well as annual fees for each drug on the market and each manufacturing plant in operation. The size of the fees will increase each year. The application fee, for example, will rise to $233,000 in fiscal 1997 from $100,000 in fiscal 1993. Similarly, total fee revenue will rise to $84 million a year from $36 million. The FDA will be empowered to waive or defer fees if they threaten to stifle innovation by small, start-up companies. The measure also will impose a $100,000 application fee on manufacturers who want to turn prescription drugs into over-the-counter products. But they won't have to pay annual fees for their over-the-counter manufacturing facilities and products. [This article is made available here by Dow Jones Co. for the personal and non-commercial use of callers to this bbs, in the hope that it will be of some help to those who are suffering from the disease and others who are seeking to help them.]