Report From The FDA HCV Hearing On Access To New drugs

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Report From The FDA HCV Hearing On Access To New drugs

FDA HCV Hearing on Early Access to New Drugs: report from Jules Levinfrom Jules: At the hearing Friday at the Hilton in Rockville land, the relatively small hearing room, small by FDA hearing standards, was packed with I estimate about 200 people. Many drug companies were represented by high-level people, those heading their clinical and regulatory programs. Also present were some press, some community advocates, and of course other interested parties. The FDA started with 2 oral presentations including an explanation by Jeff Murray from the FDA on the traditional HIV Expanded Access Program. I was the 1st speaker in the public session and explained my proposal to provide 'early access' to needy patients (explained below). I also provided a brief report on the status of the disease stage in today's aging HCV+ patient population. Each presentation was allotted 15 minutes. published a modeling study in Dec Gastroenterology

where he said today's patients were in large numbers infected 30 years ago, the so-called HCV+ baby boomers, and today patients have aged many years and 25% today have cirrhosis, 11% have decompensation or HCC and these percentages will increase in the near future but subsequently decline due to them dying if we don't treat them. Several community advocates spoke including folks from the Hemophilia community who submitted a Citizens Petition asking for a public hearing on access about 1 year ago, also Lynda Dee and Swan spoke. All the community advocates urged the FDA and the companies to provide early access for patients at serious risk for death or progression such as they cannot wait for drugs to be approved. Most of these patients are nonresponders and some are contraindicated for pegylated inteferon/ribavirin so these latter patients are perfect to receive an oral regimen of multiple orals without peg/rbv to see if an all oral regimen could

cure HCV. Several drug companies did provide a presentation and these were Idenix, BMS, Vertex, Roche, and Merck. Also present was a senior medical official from Boerhinger Ingelheim although he did Continue Reading...........

http://Hepatitis Cnewdrugs.blogspot.com/2010/05/report-from-fda-hcv-hearing-on-access.html