We Still Trust the FDA

Most of us think of the FDA as our protector, scrutinizing big pharma and all their corporate research studies on every new medication and every new medical device up for possible approval. FDA approval means something very important to us: an unquestionable level of safety, efficacy, and legitimacy. We feel sorry for people in countries that have no such high level a system of well-educated, well-trained critical inspectors and evaluators. We fear for the public health and welfare when money and profits seem to take priority. Occasionally, those of us in the medical community will hear some griping that the price for all this safety is too high. That the approval process takes too long (a year or more?), or costs too much to get through (often nearly a million dollars for a single device or medication?) and that this inhibits manufacturers from producing things that although beneficial, won't generate enough to recoup all that time and money in a timely fashion. Is it possible that these complaints and other public and political pressures have impacted upon the FDA in ways that might cause us to seriously question just how much we can trust the FDA these days? The answer is - maybe so. In August, 2015, Forbes Magazine commissioned Biomed Tracker to analyze the data on FDA approvals - this has obvious big implications for corporate direction and success. Biomed Tracker is a company well-known in the pharmaceutical industry and among big pharma investors who rely on Biomed for the tracking and reporting of pharmaceutical business data. Forbes was looking at the industry from a business performance point of view, but some rather startling information came to light about the FDA. In 2008, the FDA rejection rate was overall about 50%. But as of August, 2015 the rejection rate was about 4.0%! How rigorous, demanding and thorough would you think a final exam test for a college course to be with a pass rate of 96%? Many manufacturers look to generate more income for a drug or device by getting expanded FDA approval for additional applications or indications. These "new marketing claims" had about a 50% approval rate in 2008. But in 2015, the approval rate had jumped to nearly 90%! The odds maker would say that this is almost like insider trading - a company with a new drug or new indications up for approval has a high chance of getting it. Up for FDA approval? That stock price may be likely to go up just based on the approval odds alone - time to invest? What is going on? It kind of looks like the approval process has become more of a quick "rubber stamp" than it should be. Or could it be that the FDA is just doing its job better? There are those that say that the FDA is doing much better in advising big pharma about what they expect in the way of the submitted research, the testing requirements, etc. Sort of like telling you what's expected for a good grade on that class project or what to study for because it will "be on the test". But there is a fine line between this supportive type of help and downright actual coaching to sort of rig the game, like telling you both the questions, and the right vs. wrong answers. vqqzCqxU
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