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.

The FDA has taken a lot of political heat about meeting deadlines, and looking overall less “negative” in their approach to their important job. Has this resulted in a more efficient team, better protocols and the enhancement of streamlined efforts or has this pressure swayed the powers that be to just trim the whole process, cut a few corners and err more on the side of approval whenever possible? What do you think is the easier, less costly, and less time-consuming way to go? What do we commonly expect to see when similar issues arise with other government agencies? A recently proposed bill, the “21st Century Cures Act”, is designed to streamline FDA approval speed and decrease red tape – but who does this really benefit? Is public safety still priority one?

There has also been some not so subtle public pressure – the public perception that a drug with even marginal benefit to those in need but carrying serious side effects might be better than nothing. It’s scary to think where this type of logic could lead those deciding on the approval fate of drug X. We would not all agree on what represents a true “need” situation, and the same could be said for as to what (short of death) a “serious” side effect actually is.

Should the standards for approval be lower for a drug which treats a more rare or more serious health problem? Researchers at MIT say yes. They say the FDA is “too risk averse” for the most lethal diseases. The researchers proposed creating a “risk threshold” for each disease that would lower regulation standards based on disease prevalence, severity, lethality and available treatment limitations. But do we want a new chemotherapy drug that has a 50% mortality rate and terrible side effects, measured against a mortality rate of 60% without any treatment or the side effects? Maybe we do want that chance, even if it is a long shot. California has a “Right-to-Try Act” up for consideration which would allow patients with life threatening conditions to have the right to access experimental drugs (i.e. not approved by the FDA in any way). Perhaps it would be helpful in such situations to at least have the FDA give the drug a relative risk/benefit ratio rating based on an analysis of all available data to help patients make a more informed decision.

And if something is not for the treatment of a life threatening illness but has very marginal evidence for benefit and absolutely no side effects (perhaps some new wrinkle erasing laser, for example) does that warrant lower standards and more easy approval? Should big pharma be allowed by an FDA nod to take the public’s hard-earned money for something that really doesn’t work, but “at least it doesn’t hurt anybody”? A recent FDA proposal regarding the 510(k) approval process for medical devices suggested just that. The FDA is considering exempting more than 100 medical devices from approval requirements stating that these devices are “understood well enough” and the “risks low enough”. But won’t that create more of the possibility that we could all be spending our money on nothing more than FDA approved “snake oil”?

Do these names sound familiar: Vioxx, Accutane, Phen-Fen? These medications are in a unique group – drugs or devices approved by the FDA, then having their approval revoked when serious problems surfaced after public use. But how unique is this group? Not so much! A recent internet search turned up a list of some 30 -40 drugs that are in this “club”! More than half of these approved-then-not-approved drugs were from within the past ten years. More than half of them were pulled from the market within 5 years of their full FDA approval! How can strict testing, and research, poured over at great length and in great depth by great minds result in a drug that proves to be unsafe in so short an amount of time? One could argue that when used for many years by millions of people, a very infrequent but dangerous side effect could ultimately be revealed. But a revoking of approval within just 5 years of public use really suggests that something might have been missed in the approval process. At least three FDA approved drugs were recalled within less than a year of FDA approval! What does that alone suggest about what the strength of our trust in the approval process should be?
Dr. Lyle Back is originally from New York City, receiving his medical and surgical training at Rutgers Medical School, Cooper Hospital – University Medical Center, and Ohio State. He is Board Certified in General Surgery (ABS) and Plastic Surgery (ABPS). He is a Fellow of the American College of Surgeons (ACS), the American Academy of Cosmetic Surgery (AACS), and a longstanding member of the premier American Society of Plastic Surgeons (ASPS). He served as a Professor of Plastic Surgery at Temple University and St. Christopher’s Hospital for Children and performed reconstructive surgery with “Operation Smile” in Vietnam. He specializes in the full range of the most modern and state of the art cosmetic surgery procedures for the body and non-surgical cosmetic enhancement techniques available today.


Reposted from E-Zine Article