One has to wonder

One has to wonder

This past Friday GlaxoSmithKline (NYSE:GSK) announced that the FDA has moved back the PDUFA date for albiglutide, their once-weekly GLP-1, to April 15, 2014. According to a company issued press release the delay will “provide time for a full review of information submitted by GSK in response to the Food and Drug Administration’s requests.”

Also late last week when Sanofi (NYSE:SNY) reported their second quarter results which contained some interesting comments by the company. In his prepared remarks Christopher A. Viehbacher, Chief Executive Officer, Director and Member of Strategy Committee, stated – “Obviously, the differing profile of U300, which is not bioequivalent to Lantus, largely because of the size of the depo when you inject it, which changes the rate of degradation in the body, and when you look at the middle part of that slide, you see that it does 2 things: It has a flatter PK profile, but also the pharmacodynamic profile is more prolonged, so you get even better 24-hour coverage. And of course, the clinical benefit of that is 21% lower hypoglycemic events.” (The entire presentation can be downloaded from the Sanofi web site

During the Q&A he added; “In terms of the U300, for us, this is a next-generation insulin. This isn’t for a subsegment of the population. We know that there tends to be in all insulin products somewhat of an under-dosing because even though hypoglycemia — glycemic events are rare, they still can sometimes have an impact on caution on dosing. So we believe that all insulin patients will benefit from the U300. And so we would be actively seeking to switch Lantus patients, as well as other analog patients to U300. This is a brand-new product that we believe will be for all patients.”

So it’s pretty obvious that the company is very excited about this new insulin and see’s it helping offset the coming patent cliff facing their blockbuster insulin, Lantus.

Yet later on during the Q&A he states this – “So let’s take the growth platforms, let’s look at diabetes. I mean, I think diabetes is growing about 16%, 17% versus our high-single digits. We’re clearly easily surpassing that. Personally, I don’t see anything that really is slowing that down. Clearly, the delay of degludec in the U.S. only helps us….”

Now the delay of GSK’s albiglutide and the high expectations held by Sanofi for their U300 insulin may seem like unrelated events but in our eyes they are for the very reason noted by Mr. Viehbacher who himself attributed some of the success of the Sanofi diabetes franchise to the troubles Novo Nordisk (NYSE:NVO) in getting degludec through the FDA.

The linking factor between these three events – the delay of albiglutide, the delay of degludec and the high expectations for the U300 insulin – is the influence the FDA has on the future of diabetes management and to a larger extent how the decisions made the agency can make or break a company’s future. While were delighted Sanofi is is excited about the U300 insulin, we wonder what makes them think their experience with the FDA will be any different than what Novo and now GSK is dealing with.

As we noted just yesterday the FDA is agency that has strayed from their stated mission of using scientific based evidence to approve new drugs and devices; becoming instead a rogue agency whose mission seems to be preventing patients with diabetes from getting the best possible drugs and devices.  The harsh reality is if things don’t change and change in a hurry, diabetes patients in the United States will become second class citizens. As Diabetic Investor has stated consistently we understand the goal of making sure that new drugs and devices are as safe as reasonable possible. However, we also understand, as most reasonable people do, that there is no such thing a drug or device that 100% adverse event free.

To paraphrase what Spock said, the FDA is allowing the needs of the few to outweigh the needs of the many. They have lost all touch with reality and unfortunately are not just standing in the way of innovation but actually preventing innovation from happening. Listen drug development is risky enough as it, a process which takes years and costs billions. The FDA with their ultra-conservative approach to approving new drugs and devices has now increased both the time it takes to bring new drugs and devices to market plus added substantially to the cost of doing so. We are quickly approaching the point where a company with a promising early stage compound might just decide the process time and costs just aren’t worth it. Again to paraphrase a line from one of the Star Wars movies; this is how innovation dies.

One has to wonder how long this can go on.