Eurogene

It’s nearly 10 years now and still there is no clarity about the position of personal genetics in the regulatory framework. Maybe that’s going to change soon with the FDA activity and the recently published HGC Principles . It would be good to get it settled one way or another, the uncertainly doesn’t help anyone except those who exploit it to exploit the gullible. Some elements: DTC vs. DTMD (via physician) – I will argue that DTMD is actually higher risk and needs closer scrutiny Is it medicine? I think this question is a waste of time, it will not be resolved, the definition is too broad, medicine is practised everywhere by everyone - if I take my son’s temperature, put a plaster on a cut or administer medication I am practising medicine. What is the FDA duty bound to do and what will they decide? No regulation – more or less the current situation Tight regulation – medium/high risk requiring pre market approval (PMA) Somewhere in between ...

Mary Carmichael (General Editor, Newsweek) has this week been running a very interesting series of articles about the “dilemma” of whether or not to undergo a 23andMe type DTC genetic test. As part of that she interviewed the FDA and with journalistic cunning recorded the whole interview and published the full transcript ( here ). It was a very good thing too that she has the tapes because the interview was in some places quite revealing. Mary asked me to comment/dissect the interview and I have done so below – I look forward to seeing the comments of others that Mary has asked on their blogs as well. In a sentence the interview came over to me as unnecessarily vague and evasive (unless for some reason it was necessary!) – certainly lacking in clarity and not answering some of the questions asked but giving up some useful information. DNA Dilemma: The Full Interview With the FDA on DTC Genetic Tests NEWSWEEK: During the recent congressional hearing, 23andMe’s general counsel...