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Biotech / Medical : SNRS- Sunrise Technologies -- Ignore unavailable to you. Want to Upgrade?

To: Nanny who wrote (188)	11/11/1997 7:01:00 AM
From: BARRY ALLEN	Respond to of 4140

Monday November 10 7:16 AM EST U.S. Congress Passes FDA Reform Bill By Joanne Kenen WASHINGTON (Reuters) - Congress has passed a bill to streamline Food and Drug Administration (FDA) approval of drugs and medical devices in a carefully crafted measure that won over both the industry and patient advocates. The House followed the Senate Sunday to approve the measure, which must now be signed by President Clinton to become law. Both chambers had earlier passed separate FDA reform bills with wide bipartisan margins on once-controversial reform. The legislation being approved this weekend reconciles those bills, particularly on how medical devices are regulated. The most visible and determined critic of the initial reform initiative, Sen. Edward Kennedy of Massachusetts, ended up endorsing the final outcome, which contained many of the patient and consumer protections he had sought. "This legislation contains many needed and responsible reforms that will protect the public health while expediting the process of bringing safe and effective products from the laboratories to the marketplace to the bedsides of the patient," said Kennedy, who had delayed the bill repeatedly. "It helps the FDA get medicine and medical devices to patients and doctors sooner and safer," said Vermont Republican James Jeffords, who as chairman of the Senate Labor and Human Resources Committee spearheaded the reform effort. "It will have a positive impact on the practice of medicine for decades to come," he added. The centerpiece of the bill is extension of the successful Prescription Drug User Fee Act. Under that program, known as PDUFA, pharmaceutical companies pay fees that the FDA uses to beef up its scientific staff, getting drugs approved and on the market much more quickly. The bill expands access to potentially life-saving experimental drugs, gives drug companies incentives to do more research on drugs for children, and allows drug companies to disseminate peer-reviewed scientific information about "off-label" uses, as long as they seek additional FDA approval for these new or additional uses within three years. The medical device section was more controversial. It allows independent outside reviewers to conduct evaluations of certain devices. But the final version limits the type of devices eligible for outside review to the least risky. In a victory for Kennedy, the final bill gives the FDA some authority to evaluate medical devices if they could be used in a possibly hazardous way not specified on the label. "This agreement will result in a better and more efficient FDA. It will enhance the safety of the medicines we take, and the medical devices we use," House Commerce Committee Chairman Thomas Bliley, a Virginia Republican, said. "And those with life threatening diseases will have access to the best experimental new drugs that science can provide," he added.