As I mentioned earlier, today marks a huge day in the diabetes community’s collaboration with the FDA, the government agency in charge of regulating America’s drugs and medical devices: Courtney Lias, the director of the division at the FDA that regulates blood glucose meters, insulin pumps, continuous blood glucose meters and other diabetes-related technologies just did a live-chat with the inimitable Bennet Dunlap, creator of Stripsafely.com and tireless patient advocate. The moderator was Helene Clayton-Jeter, one of the masterminds at the FDA’s Office of Health and Constituent Affairs, which is responsible for the FDA’s Patient Network website — a cool resource which houses the agency’s diabetes web page, among many other things.
The subject? How people with diabetes can work with FDA to ensure that we all have access to safe, high quality blood glucose meters and supplies.
Here’s a quick recap:
First, if you missed the live-chat and want to see it, it will be available soon from the FDA’s patient network site for diabetes — which is also where you should go to sign up for updates on how the FDA is collaborating with patients about diabetes-related issues. As noted, it’s definitely worth checking out.
Second, if you think this chat was a good idea (spoiler alert: I think it was an AWESOME idea), please please let the FDA know. (They like affirmation, too!) You can do so by sending a tweet to @FDADeviceInfo (and perhaps use the hashtag #DOCasksFDA). Also please comment on this post. This was a really innovative and unusual thing for them to do, and it’d be nice for them to hear our feedback. (Over 500 people signed up to watch/participate in the chat, which hopefully will also send a positive message!)
A bit more info: I have written about the FDA’s proposed draft guidance for meters and test strips before, so please check out that story (or visit StripSafely or see Mike Hoskins’ summary of the issue) if you want the background. In short, a “draft guidance” document is basically the FDA’s thoughts on what factors it will consider before deciding whether or not a particular meter (or other diabetes technology) will be cleared for sale. The last (and, incidentally, first!) guidance on the subject was published way back in 2003 — and was developed with very little direct patient input. So it’s now our chance to make our voices heard.
The deadline for commenting has been extended to May 7th. So please, PLEASE submit your comments to the FDA’s draft guidance! You can find out how to do so (and read some suggestions of what to say) here.
In addition to those suggestions, I also suggest that you consider requesting that the FDA do something about the accuracy of meters currently on the market. At the moment, the draft guidance is written in such a way that today’s meters would be grandfathered in, regardless of whether they have accuracy issues. During the call, Lias made it clear that if the patient community wants the FDA to incorporate more proactive language — that is, take affirmative action on today’s meters, rather than simply let them “sunset” out, we need to say so.
I also anticipate that the FDA might get a lot of push-back about its proposed requirement for accuracy information to be published on the front of the box. This is a HUGE deal for people with diabetes, since it would a. make clear that not all meters are equally accurate, and b. provide an incentive for manufacturers to prioritize accuracy when developing new meters. It may also be possible to leverage this information to influence which meters are (and are not) covered by insurance payers. If you agree, PLEASE make this clear in your comments to the FDA. Consider including something like “I applaud FDA for its proposed front-of-box labeling requirements for blood glucose meters. This will allow customers to make educated decisions, and motivate manufacturers to improve the accuracy of their products. This is an essential part of the proposed draft guidance and should be included in the final version.”
Likewise, if you believe that the FDA should have a system to ensure that meters and strips continue to meet accuracy standards even after they’ve been cleared for sale (i.e. that there should be a post-market surveillance program), please indicate that, too! (“I believe that there should be a post-market surveillance program to ensure that meters and strips continue to meet the accuracy standards on which their FDA clearance was based.”) The FDA is trying to work with the patient community on this issue, and the more we can emphasize this issue and support the FDA in its attempts, the better.
And also: please be sure to praise the parts of the draft guidance that you like. This is not just a request from the FDA for praise; it’s essential in order to make sure that the stuff we like doesn’t get stripped out. As Lias said during the chat, “First and foremost if you agree with something in guidance document please include it. If someone else disagrees we’ll only hear their side.”
Lastly, be sure to add your personal story! It may seem strange to do so, given the formal tone that many comments can take, but the FDA really, really wants to know how the drugs and devices it regulates affect the lives of patients. So if there’s anything you wish the FDA knew about how you use your blood glucose meter, or which features are most important, or what you wish the draft guidance had said, speak up! Just as there are no stupid questions, there are also no stupid comments. Make it personal.
In the interest of brevity, I’ll end this (so you can go comment on the draft guidance — it takes two minutes!). If you have additional questions on this issue, leave them in a comment to this post and I’ll try to answer them.
In closing, I’ll leave you with these comments from the FDA’s Courtney Lias:
“It’s really been great to hear how engaged the patient community is on this issue. We [at FDA] want to get a good sense of what you want so we can try to get devices out there for you that meet your needs better than the ones you’re getting now. . . . We want patients to tell us what they want and what they need.”
The ball is in our court. Submit your comments NOW. And let’s extend a huge thank you to StripSafely.com’s Bennet Dunlap and the FDA’s Courtney Lias and Helene Clayton-Jeter for putting together such a revolutionary and inspirational event. It’s great to be working together.