The Ultimate Killer App- The FDA
In recent weeks Diabetic Investor has written about the proliferation of interconnected diabetes devices. Many of these interconnected devices not only talk with each other but also communicate with downloadable smartphone apps. The best example of this type of technology is the soon to be launched iBGStar system from Sanofi-Aventis. The IBGStar attaches to an iPhone and communicates with an app that helps the patient manage their diabetes.
In a move that really should surprise no one the FDA in their inevitable wisdom has decided they are no longer content at slowing down the diabetes drug and device approval process with ever more regulations and requirements, has decided to stick their noses into medical apps. According to the FDA’s web site; “The Food and Drug Administration (FDA) is now proposing guidelines that outline the small number of mobile apps the agency plans to oversee—medical apps that could present a risk to patients if the apps don’t work as intended. “
Now for anyone who believes the FDA will only regulate “the small number of mobile apps” has got to be kidding themselves. Unfortunately regulations are like bacteria; once they start forming it’s next to impossible to stop them from spreading. Using history as a guide it’s fair to state that the bureaucrats at the FDA have never met a regulation they didn’t like. History also tells us that regulations are the crack cocaine which the FDA is addicted too.
Diabetic Investor can only imagine how an agency that seems to think that people with diabetes are like heroin addicts who recklessly share needles will regulate medical apps. We shudder to think of the additional hurdles they will place in front of the many companies who already have apps or are developing apps. We can only imagine how these new guidelines will impact the already painfully slow device approval process.
Also posted on the agencies web site is the following:
“Joint Statement on Wireless Medical Devices – U.S. Food and Drug Administration, Federal Communications Commission
July 26, 2010
- Innovation in broadband and wireless-enabled medical devices holds significant promise for enhancing health and reducing the costs of health care for all Americans. Examples include wireless sensors that remotely monitor heart rhythm and portable glucose monitoring systems. All Americans should be afforded the opportunity to benefit from medical technology advances with improved broadband and wireless technology.
- Developing and integrating wireless and broadband communications technology with medical devices and applications requires agencies to assure that such devices operate in a safe, reliable and secure manner.
- It is important for the federal government to provide leadership and encourage innovation and investment in new health care technologies that enable patients, doctors, and other health professionals to access the highest quality care.
- The American public — including industry, providers, patients, and other interested stakeholders — should have clear regulatory pathways, processes, and standards to bring broadband and wireless-enabled medical devices to market. This includes clarity regarding each agency’s scope of authority with respect to these devices, predictability regarding regulatory pathways, and streamlining the application process, as appropriate, to facilitate innovation while protecting patients.
- The FDA and the FCC agree to build upon this initiative launched today to proactively serve the national interest in finding innovative solutions to America’s health care challenges.
|Food and Drug Administration (FDA)
Commissioner Dr. Margaret Hamburg
|Federal Communications Commission (FCC)
Chairman Julius Genachowski”
The simple and unfortunate facts are once the FDA starts getting involved with providing “leadership” and encouraging “innovation”, you can be sure we won’t have any of the former and not much of the latter. Frankly the FDA should stop using terms like leadership and innovation as they couldn’t define either one.
This move by the agency to expand their regulatory authority is also a perfect example of how backwards the agency has become. The fact is millions of people own smartphones and apps are being downloaded by the millions if not by the billions. Not surprisingly people are turning to their smartphones to help them manage their conditions and have quick access to medical information. What the FDA all of sudden had someone at the agency come in one day with an iPhone and suddenly realize what everyone else in the world already knows?
Although Diabetic Investor has been somewhat skeptical of this push towards interconnected systems, this skepticism has nothing to do with the value of this technology, frankly the technology is great. Our skepticism comes more from whether patients would actually use these systems. As we have noted on far too many occasions advanced technology is worthless if patients don’t use it. However, should these systems actually be used as intended, the possibility exists that patients would achieve better outcomes. This particularly true for patients with diabetes, who must manage multiple medications, glucose readings, carb intake, etc.
It is also somewhat ironic that just today the agency also issued new draft guidelines “on device changes that warrant new premarket review”. According the FDA’s web site:
“The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.
The 510(k) process is the most common review path to market for lower-risk medical devices. To legally market a device, manufacturers must submit a premarket notification or 510(k) demonstrating that the new or modified product is substantially equivalent to another legally marketed medical device.
Manufacturers often make changes or modifications to a device after FDA clearance such as incorporating new technology or upgrading certain aspects of the device. Many changes do not require a 510(k) submission. But when the changes could significantly affect the product’s safety or effectiveness or constitute a major change to the intended use of the device, another 510(k) must be submitted.
“We are making the regulatory process for medical devices less challenging by better describing our expectations” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “In particular, manufacturers can continue to make innovative improvements to their devices and better plan for any updated submissions. This saves time and money.”
The draft guidance clarifies the kinds of changes that trigger the need for a new submission, such as specific kinds of labeling changes, changes to the technology used in the device, changes in performance specifications, manufacturing changes, and changes in the materials used in the manufacture of the device.
This draft guidance is one of 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations launched in 2011 to enhance predictability, consistency, and transparency of the FDA’s premarket review programs.”
Now Diabetic Investor sure hopes these changes saves time and money but for obvious reasons we are not holding our breath. After all these proposed changes are just that, proposed changes, and as we have seen before just because something is proposed does not mean it will be adopted or enforced. Just as the agency is addicted to regulations they are equally adverse to change.
It’s about time everyone in the diabetes device arena comes to grips with the fact that their biggest obstacle isn’t coming up with safe, effective and innovative technologies, it’s the FDA. With innovative new diabetes devices being approved with greater speed in Europe, the FDA is doing their best to turn the United States of America into a third rate country which does not allow their citizens access to the best medical technology available. They are forcing companies to spend greater resources on foolish regulations and are making it harder for patients to manage their diabetes.
At some point one just might think with diabetes growing at epidemic rates and the exploding cost of diabetes the FDA would be moving with greater speed instead of moving in the exact opposite direction. This really does not surprise Diabetic Investor given the increasingly dysfunctional nature of our government.
John Kenneth Galbraith once wrote “All successful revolutions are the kicking in of a rotten door.” A good place to start would be the door at the FDA.