To: 5,17,37,5,101,... who wrote (201 ) 11/22/1997 7:39:00 AM From: flickerful Respond to of 756
Friday November 21 12:48 PM EST Clinton Signs FDA Reform Act WASHINGTON (Reuters) -- The Food and Drug Administration bill signed into law by President Clinton Friday aims to speed up approval of drugs and medical devices. Congress worked on FDA legislation for several years, and this bill reflects numerous compromises between Republicans and Democrats. It has broad industry support and many patient advocacy groups praise its provisions for making new drugs available more swiftly to seriously ill people. Here are some of its major provisions: -- Extension of the Prescription Drug User Fee Act (PDUFA), which passed Congress in 1992 and would have expired this year. Under PDUFA, pharmaceutical companies pay fees that the FDA uses to help speed up drug safety and efficacy reviews. Drug industry groups say it cut approval times in half and will raise another $600 million over the next five years. -- Medical devices, which cover everything from tongue depressors to pacemakers. Under an expanded pilot project, independent but accredited outside experts will review the safety of certain, relatively low risk medical devices. The FDA will still review more complex devices. -- Off-label use. Once a drug is approved for a specific purpose, doctors have been able to prescribe it at their discretion for other treatments, so called "off-label" use. The new law sets clear rules for how drug companies can disseminate authoritative published research on off-label use, but if they do so they must also start the process of getting official approval for the additional use. -- Emergency access. The bill speeds up access to new but not yet approved drugs in life-threatening situations. -- "Fast-track" drugs. Expanding a program that already applies to some AIDS and cancer drugs, the bill takes steps toward more rapid approval of breakthrough drugs for serious or life-threatening illnesses. -- Cosmetics. After a prolonged fight over whether states could enact their own labeling requirements, a compromise was reached. The states could still regulate cosmetics and other over-the-counter items, except in cases where the FDA's relatively small cosmetics program has set a national policy. -- Clinical trial data banks. The bill sets up a national data bank on clinical trials for serious diseases. It would help find experimental therapies for patients without comparable treatment. -- Pediatrics. The bill gives the incentive of a six-month patent right extension if a pharmaceutical company researches how a drug should be used for children. ------------------------------------------------------------------------ Copyright c 1997 Reuters Limited. All rights reserved. Republication or redistribution of Reuters