The Diabetes Community has been known to grumble about the FDA once or twice before.
OK, fine. We've griped A LOT about the federal agency in how it handles diabetes drug and device reviews.
They don't approve devices fast enough. Why don't they have more stringent requirements for glucometer accuracy? They aren't asking the right questions. They aren't listening to the patient side of the coin enough. What gives?
But finally, they're making moves to help us start singing a different tune.
The once-impervious FDA is doing things differently these days, not only working to speed up its review process, but actually opening up its doors to listen to and interact with us patients. Of course, we were excited last November when not just one, but three senior people from FDA attended and participated in the DiabetesMine Innovation Summit at Stanford and talked candidly with our group on many different topics.
Since then, they've been hard at work helping to expand their connection with the patient community. In their new FDA Voice blog, a post from agency Director Margaret Hamburg on April 23 announced its latest move: launching an actual FDA Patient Network site!
We took some time to look through this portal, and combined with everything else we've been hearing about the "new and improved FDA" lately, we are liking what we see so far!
Here's a little video the FDA put together about the new site:
This attractive site is apparently the result of about four years' worth of research, focus groups and user-testing. The site's aimed at educating people about the federal regulatory agency and also helping people find ways to advocate within or alongside the FDA in the earliest policy-making stages. That last part has been something our D-Community knows is long overdue, as some of us have been bellowing for this type of interaction for more than a decade but haven't seemed to get very far, particularly if we don't happen to be located in the Washington D.C. area.
The FDA admits that up until now, it really has only been working with patients one-on-one by phone or email in rare cases of someone experiencing a serious "adverse effect" of some drug, or seeking clinical trial or investigational product information or access. This new site is meant to significantly broaden that interaction.
In fact, the new site is designed to be a "one-stop shop" for patients everywhere to learn about new medications, devices, or clinical trials. You should be able to enjoy easy ways to comment on issues or policies, sign up to become an advocate within the agency, or identify FDA staff that will listen to your specific concerns (!).
Browsing around the site myself, a general for the term "diabetes" brought up four main pages for me to investigate -- the FDA and Diabetes page; a contact page for the Office of Health and Constituent Affairs Patient Team; a page on an upcoming meeting by the Endocrinologic and Metabolic Drugs Advisory Committee; and a page titled "Speeding Up Drug Approval," which explains their three new approaches to fast-tracking new drugs.
Under the "Get Involved" tab on the main page, you really can find all kinds of easy-to-understand information on becoming a patient representative with the FDA, find out when a next committee or panel is meeting, listen to an FDA expert webcast or comment on a proposed regulation under consideration. You can also ask questions that might refer you to an FAQ page or even lead to a later FDA Response on the site. Also listed is an FDA email address to send more specific questions that might need a direct response. All pretty handy stuff to be able to access through one or two clicks!
It's the Law
In an article online about this new site by fellow ePatient advocate David Harlow, I learned how the FDA plans to use this site to help meet a new law passed by Congress in 2012 -- the FDA Safety & Innovation Act, which requires the agency to expand its patient advocates to roles beyond just advisory committees as it has done since the late 80s to some degree.
This includes boosting the patient perspective that's welcomed during the medical product review process. Draft procedures are expected to be made public in September about how new patient involvement will be setup -- likely in a role as consultants the same way scientific and clinical experts are currently engaged by the FDA during the review and regulatory process. Basically, that means PWDs who might be testifying about new diabetes devices or drugs would be seen as equals with an official capacity, and be paid for the time and expense. Woot!
This seems like such a a positive development to have our voices heard more broadly during this process!
More Regulatory Efficiency, Too?
Aside from this new site, the FDA seems to be making headway on just becoming more efficient overall.
Chatting with Boston University diabetes researcher Dr. Steven Russell in person recently, he told me that many of his contacts within the diabetes industry say they've had a larger amount and more productive interaction with the FDA in the past year than they recall seeing at any point in the past.
"It's feels like yesterday's argument for people to say, 'It's the FDA's fault because they move so slowly,'" Russell said.
Take Dexcom, for example. The California device maker got approval in less than 180 days last year for the new G4 Platinum CGM sensor, a timeframe virtually unheard of before. Some wonder if a contributing factor to the speed in this case was that Dexcom had originally filed its paperwork on that product back in 2010, so maybe that helped FDA have a head start. But still, it was pretty efficient turnaround from the official filing earlier this year.
There's also the agency's approval of the first outpatient studies of an Artificial Pancreas device, which it considers a positive example of its effort to expedite the device development process.
And from what industry insiders say, the process is becoming more of a continuous dialogue -- not just the "file and wait to hear back" type system of the past. Nowadays, developers often work with the agency directly to resolve issues, instead of just being required to resubmit new data for review.
Call to Action
Obviously, the proof is in the pudding. Will patients find the new FDA portal site truly interactive, or decide it's more a case of creating "consumer-friendly"-looking pages that are more for show than action?
The jury's still out on speeding up processes too. For example, we've been waiting years for the next Medtronic pump (530G), unveiled as the Veo in Europe, to be approved for use in the U.S. But the company didn't even submit the product for approval here until June 2012. So it may not be entirely fair to blame the agency alone for the delay on that one.
Point being, we can't just blame delays on the FDA anymore. We patient-consumer advocates have to work on keeping the industry accountable as well as the regulators. We ought to be looking at specific dates that products were filed with the FDA before griping too loud about how long it took and where the blame may lie.
The FDA is bringing our voices more into the process -- which is great! The least we can do is make sure they're being treated fairly -- applauded when they move quickly and questioned appropriately when the process seems bogged down or patient input seems to be missing.
Here's to hoping we are actually seeing a new day at the FDA, one where the Patient Voice matters and diabetes technology is out of the slow lane. Nice moves so far, FDA.