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.