FDA Rules Change Proposed

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WASHINGTON, D.C.: A Senate Committee approved legislation that would hasten the Federal Drug Administration's drug approval process and allow patients quicker access to European treatments. Sponsored by Senator Nancy Kassebaum, the bill would require the FDA to approve new treatments within six months or the approval process will be passed on to private companies. Drug manufacturers could sell a drug already approved in Europe -- where the approval process is easier -- if the FDA takes longer than six month to approve the drug. TIME's Christine Gorman says this could result in a greater risk to U.S. consumers. "Under these rules, thalidomide would have been approved in the U.S." Thalidomide was administered as a sedative to women who risked miscarriage and resulted in the birth of severely deformed babies. "Thanks to the FDA, the drug never made it to the U.S market," Gorman notes. The bill also calls for a three-year pilot program allowing FDA-accredited companies to review the safety and effectiveness of new treatments. The FDA would then have a 15 to 45 day period to assess the reviewing company's performance and recommendation. The test period will determine whether private companies can assess new treatments as safely and effectively as the FDA. The measure includes provisions to restrict the FDA commissioner's tenure to five years and to allow companies to advertise purported health benefits of certain foods without FDA approval. "This is part of an ongoing attack on the FDA," says Gorman. "There is a political push to fix it, but the FDA itself has already done a lot to streamline the approval rating process."