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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: medsunman who wrote (11588)	11/25/1997 9:29:00 AM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

The new FDA legislation mentions off-label use: By Lawrence L. Knutson The Associated Press W A S H I N G T O N, Nov. 21 - President Clinton signed legislation today giving the Food and Drug Administration new authority to speed the approval of lifesaving drugs and medical devices in the battle against such killer diseases as cancer and AIDS. "The FDA has always set the gold standard for protecting the public safety," Clinton said in a ceremony in the Old Executive Office Building. "Today, it wins the gold medal for leading the way into the future." A hard-fought compromise, the FDA Modernization Act of 1997, was a major congressional accomplishment even though it took three years to hammer out its terms. "This legislation, I think, is very important because we're maintaining and redefining the public interest at a time when there are new challenges in food safety and when we have new possibilities in medicine and medical devices," the president said. He said the new law lets the FDA continue working with the medical and business communities to get new drugs and devices approved far earlier than before. "And we will offer hope to critically ill Americans by extending access to drugs and devices whose approval is still pending," he said. "For many people experimental treatment represents the best and perhaps the only chance of recovery." The changes from current practice allow third-party reviews of some low-risk medical devices to reduce the backlog in the approval process. They also provide incentives for pharmaceutical companies to develop and test medicines for children. Congress also reauthorized a successful program under which fees collected from drug manufacturers are used to hire more reviewers for new drug applications. Lots of Negotiating Supporters said the new law will help improve the nation's health by giving patients quicker access to new treatments without either undermining safety or the authority of the FDA. The bipartisan agreement that produced the final legislation came only after exhaustive negotiations on a number of thorny issues. Among them: - The final bill gave the FDA the right to request data supporting use of a medical device for a purpose other than listed on its label. In the original version, the FDA had no authority to question off-label uses of low-risk devices. - As in the original bill, drug companies can circulate reputable journal articles about off-label use of drugs. But the FDA also can review and approve those articles. - Third-party review for medical devices was limited to apply mainly to lower-risk devices. The administration, which has praised the bill as a whole, had mentioned the broad scope of these reviews as one of its last objections. - The final legislation preserves states' authority to regulate cosmetics.