Years ago, I used to think of the FDA as a big, monolithic mystery agency that regulated my diabetes devices from some dark back room in the nation's capitol, weighing in on the importance and safety of said devices like the Gods from Olympus.
More often than not, they seemed to throw lightening bolts of denial and delay. And no, you didn't get to question or interfere in that decision-making, lest you be cast out into "off-label" exile.
That used to be how I felt about the FDA, but not anymore.
'Mine editor AmyT summed it up at the recent DiabetesMine Innovation Summit in three simple words: the once-evil empire regulatory has gone from "zero to hero" in our patient community over the past few years.
The agency is listening to us, weaving our voices into the decision-making process and working to address those issues we find important. It's simply outstanding to see how much the FDA's approach has changed, and how the devices branch is now pretty much embracing interoperability in policy and attitude.
And get this: The FDA is now looking to weave our patient voices into the regulatory process even more, and they need to hear from us in the next three days on how best to do that! Read on for details...
Soliciting Patient Perspectives
Thanks to a law change about two years ago called FDASIA (Food and Drug Administration Safety and Innovation Act, or Pub. L. 112-144) that President Obama signed into law in July 2012, the FDA's authorities have been expanded and the agency is able to increase stakeholder involvement in FDA regulatory processes.
Specifically, one section of that law directs the Secretary of HHS (Department of Health & Human Services) overseeing the FDA to "develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions, including by (1) fostering participation of a patient representative who may serve as a special government employee in appropriate agency meetings with medical product sponsors and investigators; and (2) exploring means to provide for identification of patient representatives who do not have any, or have minimal, financial interests in the medical products industry."
For many years, the FDA (and other federal government agencies) only heard these voices through the category of Special Government Employee -- more of an official role that we've seen some D-Advocates take on, including fellow PWDs Rebecca Killion and Aliza Chana Zaleon. That has been great, but access was obviously restricted to the lucky few who were local in Washington, D.C., and/or had the right connections to nab these spots.
Now finally the agency is working to put more a broader patient perspective infrastructure into place. The agency wants to hear from us on this, specifically:
FDA is opening a docket for 30 days to provide an opportunity for interested stakeholders to submit comments on "strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions." FDA is interested in comments on both current and new activities that would involve patient participation in regulatory discussions, as well as comments on ways to assess patient participation activities.
We have until this Thursday, Dec. 4 to send in our comments. Don't worry, it's easy! You can leave a comment on the FDA docket directly, writing your own or even relying on the help os some great fellow D-advocates who've prepped draft comments that can be copied and pasted or personalized for submission. Check those out from Stephen at Happy Medium or at the StripSafely campaign site , where Stephen joins the awesome advocacy efforts of Christel Aprigliano and Bennet Dunlap.
In a word, this is HUGE. It's your chance to tell the FDA what exactly you want and how your voice can be better included in the regulatory process!
Looking Beyond A1C
We've also been overjoyed to hear the FDA say they are looking beyond A1C as a "gold standard" for approving diabetes meds and technology, to include important quality of life measures including hypoglycemia, glucose variability and in-range trends when making decisions. We're also pleased to hear they are cautiously working with industry and encouraging companies to send in human factors and outcomes data, and also urging caution on third-party products that may not be as reliable or high-quality as some of the bigger brand names. Many of us have been concerned about device vendors just "coasting along" and barely meeting older guidelines without aiminig for increased accuracy. So we appreciate the FDA doing all it can to push on this front.
There is a delicate balance between safety and access, and it's well-known that the regulatory environments tends to pendulum back and forth on risk adversity. We feel the FDA is more closely striking a good balance these days.
And now, we get the chance to tell them so.
On Interoperability (and Bolus Calculators)
We can thank the FDA for all it's done to date, from opening up conversation with the Diabetes Online Community twice this year already in March and November, how it's been engaging with us at events like the Friends For Life conference, the Diabetes Technology Society meeting and our own DiabetesMine Innovation Summit, to how it's working on guidelines ranging from glucose meter and strip accuracy to diabetes data and interoperability for embracing new mHealth tools.
It's now no secret the FDA sees the benefits of devices and software being able to communicate and makde dataaccess better for us, and I saw that clearly during our recent DiabetesMine Innovation Summit where FDA branch chief Stayce Beck gave an excellent presentation that dispelled many myths.
During their Nov. 3 public workshop webinar (the one that crashed their system) the FDA spent a day listening to public feedback, and it was very interesting hearing the agency talk about the need for the right balance between safety and innovation. Our friends at diaTribe have a good recap of some of the key sentiments expressed there, but to me what stood out the most was how bullish the agency seemed to be on diabetes device interoperability.
Early on, the FDA's director for the office of In Vitro Diagnostic Device Evaluation and Safety Dr. Alberto Gutierrez had a spot-on comment: "Too much regulation can slow down innovation, but the risks of not regulating are patient harm."
And hitting the nail on the head was FDA reviewer and fellow Type 1 Dr. Alain Silk, who compared contemporary tech like wireless networked speakers that can communicate and play music throughout his entire house to his insulin pump and CGM that can't communicate the same way or talk to his smartphone. "The better these systems can work together, the better the outcomes for the patient," he said.
Silk says the FDA is creating policies to encourage companies to collaborate more and coordinate their diabetes data strategies, and it's encouraging to see that happening with efforts like Tidepool on the open data front, whom FDA met with recently as well, along with the Nightscout/CGM in the Cloud inventors.
These past few months have indeed been a critical time for the FDA in terms of diabetes mHealth, with the agency working on new medical device and data guidelines and their recent Dexcom SHARE approval that is the first big regulatory approval of a smartphone-connected CGM device.
There is still debate on the value of some tech tools, of course. For example, in an afternoon discussion at the Nov. 13 FDA workshop, bolus calculators came into question. Dr. Howard Wolpert of the Joslin Diabetes Center for Translational Technology cautioned that these calculators might not be accurate and could be dangerous, while fellow type 1 and D-Advocate Adam Brown pointed out how it could be more dangerous playing the guessing game than having some guidance from these calculators.
I don't know what to make of all that discussion, but it does my heart good knowing the FDA got a first-person chance to hear from people who live with these devices, and not just the docs who may have never used a particular device or program before.
It is the age of #WeAreNotWaiting, after all.
That's reassuring, and we can't say thank you enough to the FDA for opening these discussions and welcoming patient perspectives within their ranks and official channels.
Personally, I have found myself more often trusting the decisions this FDA is making because of this new transparancy and willingness to listen to our patient voices.
.@fda has gone from zero to hero at #dbminesummit - embracing patient voice & innovation in #diabetes ! -AT
— DiabetesMine (@DiabetesMine) November 21, 2014
If and when delays or denials come through from regulators, it no longer seems like the ill-informed choices of out-of-touch officials sitting off in an ivory tower somewhere. And that is something to be thankful for.
Stay tuned for tomorrow's post that continues the diabetes tech conversation with coverage of our Nov. 20 DiabetesMine D-Data ExChange event.