America’s Innovation Agency?

America’s Innovation Agency?

In today’s Wall Street Journal Dr. Margaret A. Hamburg, the commissioner of the Food and Drug Administration, penned an op-ed piece entitled America’s Innovation Agency; The FDA.  While nearly everyone living in the real world and not the fantasyland more commonly known as Washington D.C., would disagree with this assertion, Dr. Hamburg believes that the ultra-conservative, never meet a regulation we did not like agency, more commonly known as the FDA is driving innovation.

Here are just a few selections from today’s piece:

“Despite common criticisms that our agency impedes innovation by being slow and bureaucratic, we actually play a proactive role in promoting innovation by ushering new products through the approval process and to market—while making sure they meet the standards of safety and effectiveness that have served the American people well.”

“But misconceptions about our effectiveness as an agency could derail these efforts. One prevailing misconception is that the FDA lags behind Europe in approving medical products. The truth is that the FDA consistently approves the vast majority of priority drugs and medical devices as fast as, or faster than, our European counterparts.”

“Another misconception is that the demands of the FDA’s approval process cost jobs and undermine U.S. global competitiveness. The opposite is the case. By instilling confidence in American products and technologies, the FDA stimulates economic growth, creating jobs at home and opening markets overseas.”

In an ironic twist in the very same issue of the Journal another article states:

“An influential outside panel called Friday for a broad overhaul of U.S. medical-device regulation, saying the Food and Drug Administration should give more intense scrutiny to thousands of devices that currently receive only a quick review before going on the market.

If the FDA follows the advice of the Institute of Medicine committee, it could lead to the some of the biggest changes in decades in the system that decides how thousands of products ranging from artificial joints to heart-surgery devices reach U.S. patients.”

The article goes onto state:

“The report calls for revising the system under which the FDA approves medical devices without human studies if the device is “substantially equivalent” to others already on the market. That simpler approval process, known as a 510(k) approval, generally doesn’t evaluate the safety and effectiveness of a product in the way that is required for most drugs.

“Reliance on substantial equivalence cannot assure that devices reaching the market are safe and effective,” the IOM study said. The report estimated that about one-third of devices entering the market are approved this way. “

It’s even more ironic that the same day these two pieces were published Intuity Medical, Inc. announced they had closed a Series D financing round securing $76 million. According to a company issued press release; “Intuity Medical will use the funds to obtain FDA clearance and to prepare for U.S. commercialization and distribution of the POGO All-in-One System.”  The irony here is that the POGO is almost the perfect poster child for what’s wrong with the FDA and how badly the device approval process needs to be reformed, but not in the way the IOM report purposes.

For those who are unfamiliar with the POGO, it’s a conventional blood glucose monitor that incorporates an automatic lancing system.  Unlike conventional monitors where a patient needs to lance their finger and then apply the blood sample to a test strip, POGO users would simply place their finger on the device which automatically lances their finger and draws the blood onto the test strip. While the POGO is not a revolutionary device, it is a huge advancement in patient convenience.  Rather than make the patient carry around a monitor, test strips and lancing device the POGO combines all these elements into one nice neat easy to use device.

According to survey data provided by Healthy Outcomes, a web site devoted to educating patients with diabetes, more than two-thirds of patients would prefer such a device. Very simply it would make their lives just a little easier and when you’re a diabetic who monitors their glucose levels regularly it can be a real pain in the rear carrying around all the stuff you need to perform a simple glucose test.

One just might think since the POGO is not really a new product and really a combination of a bunch of already existing FDA approved products into better packaging it would fly through the FDA with relative ease. That is unless you’re the FDA who can find issues with new and innovative products the way new puppies find newspaper. As Diabetic Investor has noted before the FDA seems to believe that patients with diabetes act like heroin addicts recklessly sharing their glucose monitors just as heroin addicts share needles. In their crazy way of thinking the FDA believes that in the one in a billion chance that a POGO user has a disease like Hepatitis or is HIV positive, diseases which can be transmitted through blood transfers, that somehow these users would use the POGO, leave blood on the device then somehow that blood would be transferred to some unsuspecting patient who uses the device and the infected blood left on the device would somehow be transferred to this unsuspecting patient. (No we are not making this up.)

So in their infinite wisdom the FDA has delayed approval of the POGO and the iBGStar, a glucose monitor from Sanofi-Aventis (NYSE:SNY) which attaches to an iPhone, because they want Intuity and Sanofi to come up with methods for cleaning their respective devices to insure that infected blood is not transferred to an unsuspecting patient who just happens to use these devices right after the infected patient has used it. Something that happens in the real world about as often as the Chicago Cubs win a World Series, or about once every hundred years or so.

Now Diabetic Investor isn’t quite sure which world Dr. Hamburg lives in but in the world Diabetic Investor lives in we’re seeing medical device companies receive approval for their new and innovative devices in Europe well before they receive approval here in the US. The InsuLinx from Abbott (NYSE:ABT) and OneTouch Verio from LifeScan, a unit of Johnson and Johnson (NYSE:JNJ) are just two recent examples of simple glucose monitors which were approved overseas first. The same can said for insulin pumps as the  Animas Vibe™ which combines an Animas insulin pump with the Dexcom (NASDAQ:DXCM) continuous glucose monitoring system recently received approval in Europe but has yet to receive FDA approval. In fact a consistent theme in the diabetes device world has been the regularity devices receive approval in Europe only to languish here in the US.

Yet the FDA isn’t just stifling innovation in the diabetes device arena and as their ultra-conservative nature has infected the new drug approval process as well. For reasons only the FDA understands they will approve a me-too drug like Tradjenta which offers limited, if any, advantages over the two existing DPP-4’s already on the market and will delay a truly innovative first in class drug like Bydureon. It’s ironic, and yes irony is becoming redundant here, that Tradjenta is not yet approved in Europe while Bydureon is.  This fact alone proves beyond a shadow of doubt just how screwed up the FDA really is.

Keep in mind this is the agency that listens to zealots like Dr. Steven Nissen, that famous crusading cardiologist and his merry band of marauders, who seem to believe that there is something wrong with every diabetes drug and now diabetes devices. The good doctor and his minions are in sync with the FDA as they too cannot seem to find a regulation they don’t like. As Diabetic Investor noted previously now that the good doctor has decimated the new drug approval process, slowing this process to a crawl, he’s turning his attention to doing the exact same thing for medical devices.

Dr. Hamburg claim that “the FDA remains the regulatory gold standard throughout the world” holds about as much truth as stating that the US government is the model for fiscal discipline. If as she believes Americans have access to the safest drugs and devices, how does she explain the Avandia controversy or the numerous device recalls. How can she believe America is leading the way to better health when the FDA is preventing new and innovative drugs and devices from making their way into the hands of the patients who need them most? Is she not aware that diabetes is growing at epidemic rates and that diabetes is not just a healthcare crisis but an economic crisis as well?

The stark reality is the FDA has strayed from their stated mission of using scientific evidence when approving drugs and devices. The agency instead seems more interested in suspect meta-analysis and the mistaken belief that there is such a thing as a completely adverse event free drug or device. The agency has become preoccupied with “protecting” the public from issues that occur so infrequently that it boggles the mind they would even merit the agency’s attention. They have lost all perspective that in their attempt to “protect” the public they are doing the exact opposite as by preventing new drugs and devices from reaching the market, patients continue to needlessly suffer. They fail to see what is staring them in face as nearly two-thirds of all patients are not properly controlling their diabetes, a fact which leads to devastating and costly consequences. At a time when the public needs more and better drugs and devices, the agency is moving 180 degrees in the other direction.

This is not innovation by any stretch of the imagination. The reality is the agency and it’s commissioner are delusional if they think they are part of the solution when they really are the source of the problem. As Henri Amiel wrote; “Our greatest illusion is to believe that we are what we think ourselves to be.”