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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: BigKNY3 who wrote (7013)	2/15/1999 10:06:00 AM
From: BigKNY3	Respond to of 9523

post-market risk/benefit analysis is job of physicians, henney says February 10, 1999 Health News Daily via NewsEdge Corporation : Ultimate authority for safe use of drugs lies with physicians, FDA Commissioner Henney suggested at a National Health Council breakfast meeting Feb. 9. "Once the drug comes to the marketplace, there is a continued need for the risk management oversight...typically done by the health professionals, as he or she measures the safety equation on the risk/benefit assessment for each individual patient," Henney remarked. "We need to be very precise when...we talk about this whole issue of safety," Henney continued, "because it is really a judgement made of risk and benefit." When FDA makes a decision about drug safety "it is always weighing that issue of the risk /benefit equation for the population in which a drug is studied," she emphasized. Henney's remarks may assuage concerns of Senate Health, Education, Labor & Pensions Committee Chairman James Jeffords (R-Vt.), who has questioned FDA's authority to include "drug errors" in its jurisdiction. At his request, the General Accounting Office is convening an advisory panel of experts on adverse event reporting and prescription drug safety Feb. 24 in connection with a meeting held by the Drug Information Association. Henney also assured the audience that the clinical trial data base required by the FDA Modernization Act is "on track." Henney noted that the origins of the data base lie in part in NIH's Physician Data Query data base, which she said was "a project that I had a little bit of association with when I was at [the National Cancer Institute]." The commissioner also outlined her top priorities for the agency, listing implementation of FDAMA, enhancing the science base of the agency, improving blood and food safety and continuing the agency's tobacco initiative. Henney said that one way of strengthening FDA's ties to academia is to have professors, post-doctoral medical students and others take sabbaticals at FDA