the United States may double the number of innovative new medical treatments available in the next 10 or 15 years, but only if significant changes are made to the way drugs are developed and approved, says a report from the white House. This was the message in a study published today by the Council of Advisors of the President of Science and Technology (PCAST). Speaking at a meeting this morning, where the recommendations were released, Margaret Hamburg, commissioner of the US Food and Drug Administration (FDA), said: "Our job is really not complete until we have significant impact on the health of patients and the public here in this country and around the world. and I think that this report helps to move us toward that goal. "
PCAST is an illustrious group: Its 21 members include co-chair Eric Lander, president of the Broad Institute in Cambridge, Massachusetts, Eric Schmidt, the executive chairman of Google, and the presidents of Yale University and Rensselaer Polytechnic Institute. the changes pushed by the group are important and should be both additional funds for research and regulation, and perhaps action by Congress to grant more weight FDA. Among other things, PCAST of the report argues that the FDA should make more use of special track called accelerated approval, in which drugs can be given a green light on the basis of limited information. the most now granted accelerated approval therapies are drugs against cancer, and companies are required to continue the great trials of therapies after approval and report the results to ensure that products work as expected. (Indeed, a drug against cancer, Avastin, recently had its approval for breast cancer treatment revoked after studies showed it did not work as effectively as thought.) PCAST suggests that FDA to expand this fast track to include other serious illnesses and think creatively on measures to assess the effectiveness of a drug in this setting. At the same time, the ratio of PCAST admits that these new measures, the markers usually called carriers represent a "guess" whether a drug will help.
Another way to speed drugs to market, PCAST suggests, would be to limit new drugs approved for reducing populations of patients. At present, no treatment that is for sale can legally be used to treat any disease (although it is not covered by insurance or federal programs such as Medicare). For example, the report calls if a weight loss therapy may be limited to patients with morbid obesity, not only those who are 10 pounds overweight? "Drug sponsors could offer faster and smaller clinical trials for initial market approval," the authors write PCAST because people using the drug would be most at risk of health problems or death. The committee proposes a label "special medical use" that urges doctors to prescribe the drug only to those for which it is designed. Such changes, the authors acknowledge, it would be critical for the FDA to have a post-monitoring system . -strong and for that, the FDA would need something that is very hard to get these days. - more funding
the committee also calls for new economic incentives for the development of drugs and greater collaboration between stakeholders, including academics, companies and patient advocacy groups.
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