tag:blogger.com,1999:blog-4241416962008169508.post8674293171346529574..comments2024-03-27T21:03:58.972-04:00Comments on Just A Life Sciences Blog...: More of Salmon's Cogent Observations -- on the SEAS/Cancer Issue "Dear Doctor" LetterUnknownnoreply@blogger.comBlogger1125tag:blogger.com,1999:blog-4241416962008169508.post-59584519878125177552008-07-27T11:15:00.000-04:002008-07-27T11:15:00.000-04:00Condor,I think you're overconfident in the FDA if ...Condor,<BR/><BR/>I think you're overconfident in the FDA if you think FDA will give them a call.<BR/><BR/>Things are constantly being sent out via spam and medical 'magazines' that include blatantly mislabeled material.<BR/><BR/>Having contacts at the FDA I have it on good authority that the very people at FDA who told companies no a priori to mislabeling still received these mislabelings at their FDA e-mail accounts are unable to do anything.<BR/><BR/>It's only when there's a public stink like with Singulair (Merck)will FDA do anything. (Not to pick on Merck but it's probably the best known example that I can think of.)<BR/><BR/>What people don't realize is the true impact of user fees. With the latest round of PDUFA IV approvals it's now over 50% of the FDA's total budget and was expected to rise over the next few years to over 80% of FDA's total budget. There are over 10,000 people who work at FDA yet only about 2000 work in the Center for Drugs (the rest are food etc.) Of these are not very many actual front line reviewers (maybe 1000).<BR/><BR/>Thus user fees are already paying for 100% of what FDA reviewers do. Since these are fees and not taxes they can only be used to pay for the specific things Pharma has negotiated for. So in practice these sort of things simply don't get looked at and if they do there are a million ways to game the system and drag it out for so long that it simply doesn't matter.<BR/><BR/>Look at how FDA has been giving the bum's rush to Grassley and Stupak and Rep. Stupak's is head of an FDA oversight committee and his own son died because of drug side effect that FDA appears to have been not been forthcoming on.<BR/><BR/>Recent FDA activity not withstanding typically this means the FDA is highlighting a concern in order to get patient to move to newer patented treatments, protect the company from lawsuits, mollify Congress or some other reason.<BR/><BR/>If you understand mechanisms and how things work there is so much information that FDA and companies themselves have released via the labeling itself from drugs of all classes that it tells the astute person exactly what to ask for in discovery. No inside information is needed. Just like with what you're doing it's largely right there and publicly available if you know how to read between the lines.Anonymousnoreply@blogger.com