“The out-of-control marketplace for stem cell interventions needs effective regulatory oversight. I therefore hope the draft guidances are more than stage props and this hearing is more than public theater. When patient safety and public health are at stake, the FDA must do more than function as a paper tiger. It is time for action.”Here is a link to the key Federal Register document laying out the process. Here is a link to the site for filing a comment electronically.
Wednesday, September 14, 2016
Folks interested in seeing more or less or different federal regulation of stem cell treatments and research have until Sept. 27 to file their arguments with the Food and Drug Administration (FDA) following two days of public hearings earlier this week.
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Patients, researchers and representatives of regulated and unregulated companies turned out personally Monday and Tuesday for FDA hearings on its new proposals. Witnesses included Randy Mills, president of the California stem cell agency. Questions were asked by an FDA panel but no conclusions reached.
For those who missed the marathon sessions, they are recorded and are available online. One big advantage of watching them in a recorded format is the ability to skip through the content rapidly instead of having to sit and wait for the whole process to unwind. The first day can be found here and the second here.
The live, online Internet broadcast chalked up about 770 views on the first day. On the second day, only about 550 were reported. The numbers seem low to this writer based on the intense, emotional interest on the part of many patients. Industry also does not seem overly interested despite forecasts of the billions of dollars to be made from regenerative medicine, which may say something about the likelihood of handsome profits.
Only 15 written comments have been filed so far, mostly from patients. That number is likely to increase as industry and academia weigh in with more details.
The FDA has not released a timetable for action which could affect many of the 570 unregulated stem cell clinics operating across the country.
The hearings generated almost no media coverage. However, the Washington Post and Stat published good pieces (see here and here) that provided an overview of the issues ahead of this week's hearing. You can find coverage by the California Stem Cell Report here, here, here and here.
California Healthline carried a piece Monday with comments from Mills that basically summarized his presentation to the FDA. Today, the agency's blog carried an item with the text of the Healthline comments. The item by Kevin McCormack, senior director of communications, also said that Mills believes that "the rules the FDA is proposing will not fix the problem, and may even make it worse."
UC Davis stem cell researcher Paul Knoepfler summed up the second day of the hearings in a blog item yesterday. He quoted Leigh Turner, a University of Minnesota bioethicist, as saying,