Tag Archives: FDA

FDA Workshop: Engaging with FDA in the drug approval process.

Between Diabetes Blog Week and being away on vacation for the past week, I never got a chance to tell this story.

On May 12, I took the day off of work to attend a public workshop at the FDA’s sprawling White Oak headquarters in Silver Spring, Maryland. This gathering was not specifically diabetes related, but I learned a lot anyway. Officially, the workshop was called:

Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research

At this workshop, I was reminded once again that FDA officials speak using an alphabet soup of acronyms: CDER (Center for Drug Evaluation and Research), PASE (Professional Affairs and Stakeholder Engagement), DDM (Division of Dockets and Management), DDT/COA (Drug Development Tools Clinical Outcome Assessments), OHCA (Office of Health and Constituent Affairs), OSP (Office of Strategic Programs). Fortunately, the presenters, though heavy on acronyms, didn’t rely on them to convey their messages.

And the messages were significant, with a huge amount of information provided on what to know and how to engage with FDA regarding drug approvals. Want to know about diabetes drug approvals that did or did not happen? There’s a way to do that. Want to hold a meeting to bring patients together and invite the FDA to take part? There’s a way to do that. Want to stay informed on the latest news? That’s right… there’s a way to do that.



So, what was covered? A number of subjects, including the entire drug approval process, from start to finish. We learned how to “Rock the Docket” and use the Division of Dockets Management to research what’s happening in drug approvals that might affect People With Diabetes. There was an entire presentation on the various ways that FDA, and CDER in general, interact via social media.

And there were several interactive moments between FDA and attendees themselves, including question and answer sessions after presentations, and a chance to answer questions about presentations just concluded. Questions like “After this presentation, I am A) Not very confident about explaining the drug approval process, B) Somewhat confident about explaining the drug approval process, or C) Very confident about explaining the drug approval process”.
We recorded our answers using devices like these:

After lunch, there was a round of FDA Jeopardy. My team finished second out of four, but unfortunately, no prize money was awarded.

There were also a couple of presentations from representatives of patient communities who have had success interacting with FDA on drug approvals for medications that have helped the patients they represent.

I have to say that at the end of the day, I felt like the Center for Drug Evaluation and Research has a good handle on what they do, how important their mission is to people living with chronic conditions, and a valid social media strategy that keeps patients informed.

I was grateful to attend this workshop, and I walked away with a few new contacts from other patient organizations too. Not a bad way to spend my day off.

**To look at meeting presentation decks and order a transcription of the meeting, CLICK HERE.

Advertisements

Sign up for these public meetings.

Hello…. I hope everyone’s week has been grand. For me, life has been a series of meetings and appointments and lots of work. While I have a moment, I want to let you know about two upcoming meetings that offer both educational and advocacy opportunities.

On April 26 and 27, there will be a meeting at the offices of the National Institutes of Health in Rockville, Maryland. The National Institute of Diabetes and Digestive Kidney Diseases (NIDDK) is chairing an interagency coordinating committee meeting where, in this case, they will be talking about prioritizing Type 1 diabetes research.

Like so many meetings, this one is open to the public. There will not be an opportunity to make public comments in person, but there is a way to e-mail your concerns ahead of time. Then, if you are able, you can go to the meeting and be the eyes and ears of the community, so to speak. We need that sort of thing in these forums.

To find out more, and to register, CLICK HERE.

———————————————————————————————–

On May 12, there will be another public workshop at the U.S. Food and Drug Administration. This one is specifically advocacy-based. In this workshop, attendees will get direct input from FDA staff on the roadmap for approval of new drug therapies. You’ll get tips on how to make your voice heard in the approval process. And you’ll get additional information on how FDA uses the patient voice to help make informed decisions, while protecting patient safety.

This is a great opportunity to learn how the sausage is made. Metaphors! I’m full of metaphors today!

The workshop takes place at the FDA’s sprawling White Oak campus in Silver Spring, Maryland on Friday, May 12. To find out more, and to register, CLICK HERE.
 
 
That’s what’s happening near where I am… what’s going on in your part of the world?

Sometimes, the Diabetes Community wins.

I need to take a moment to talk about last Thursday. A day like many other days, full of commutes, and workouts, and tasks to complete. Only this time, it wasn’t exactly a typical Thursday.

Sometimes, the diabetes community wins.

Four big announcements took our world by storm that day, and the news was, to me anyway, all positive.

The day began with an announcement from Type Zero Technologies and Tandem, announcing a working agreement to use Type Zero algorithms in future t:slim artificial pancreas solutions. For a pump agnostic group like Type Zero, it’s very cool to see them working with another partner in addition to CellNovo. I hope to provide more insight on this at a later date. For the official word on Type Zero and their work with Tandem, CLICK HERE.

But wait… that’s not all. There’s more!

Thursday was a big day at the U.S. Food and Drug Administration, as a hearing took place to discuss Dexcom and its latest continuous glucose monitor, the G5, to decide whether it could be officially approved for patients to make dosing decisions. That’s not the exact wording, but in simple terms, that’s it. In short, FDA approved the measure, and now we all have to decide what that means for us, individually.

For some, this decision isn’t a big deal, because they’re dosing off of the Dexcom readings they see already. For others, they’re thrilled that they see the okay from an official government agency to do this. For still others (Ally makes some points worthy of discussion here), there are questions like “Will I now be denied test strips because insurers will want me to dose off of the Dexcom?”. Again, many sides to the issue, so it will be interesting to see what the coming years bring.

Another, important side to this story: the fact that this disposition makes it so much easier to include CGM within existing Medicare framework in the future. It will probably still require Congress to act, which they haven’t wanted to do for a while, but there’s no question a major roadblock is out of the way.

This was a real success story for the Diabetes Community, as it rallied behind initiatives from Diabetes Patient Advocacy Coalitionand diaTribe to sign petitions that were seen by FDA as important influences. They really do listen to us, folks.

But wait… that’s not all. There’s more!

Bigfoot Biomedical also heard from FDA on Thursday, getting approval to move ahead with stage 1 clinical trials on their smartloop™ automated insulin delivery system. Bigfoot has been working hard, and there are so many visible, familiar, lovable faces associated with this company that it’s hard not to root for their success.

The stage 1 clinical trials will be starting shortly, in the San Francisco Bay area, in Santa Barbara, California, and in Denver, Colorado. If these trials are successful, they hope to move into stage 2 trials by the end of this year. Yay Bigfoot!

But wait… that’s not all. There’s more!

Ed Damiano, one of the main driving forces behind the iLet bionic pancreas solution, was named by Boston University as Innovator of the Year for his work on their unique dual-hormone system.

Many people have written about Dr. Damiano and his systems over the years, so there’s not much more I can add, except to say that this recognition is long overdue, and if I were to name the ten most important living scientists working on diabetes-related causes right now, his name would be very near the top. What he and his team have been doing has been influencing all of us, whether we know it right now or not.

Can you believe that all of this good news came out over a single 24 hour period? As my news feeds popped up with each new story Thursday, I could hardly contain my happiness.

Particularly gratifying to me were the many tweets and Facebook status updates from people in the Diabetes Community who feel like there’s a reason to hope again. And boy, do we need some hope. For that reason alone, Thursday was a very good day.

Sometimes, the Diabetes Community wins. Thursday was a great day. Thank you for doing your part to help make it happen.

**Note: the original draft of this post noted Bigfoot Biomedical as a non-profit. It was my mistake, which I am happy to correct.

Will my pump get hacked? Maybe not. But my phone? Maybe.

Once again, the U.S. Food and Drug Administration is inviting us to a public workshop… this time, in January, to talk about cybersecurity and our diabetes devices.

What? Who would want to hack my insulin pump?
2016Workshop
The truth is, probably no one. But as we know all too well, the world is more complicated than that. Especially lately.

Are you using a CGM? Is it the new Dexcom G5? Is it something else that is using a wireless signal to send data to an insulin pump, a watch, or a smart phone? Ever want to use something like that?

What about uploads? Do you upload data to DiaSend or some other website? Does your provider? Do they download from one of those sites?

Guess what? All of that can be hacked.

That’s what I’m worried about. Now that we have Bluetooth-enabled devices, and we’re able to start to see personal medical information on our phones, how do we protect ourselves? How do we engage both device makers and FDA to better protect us in the event something is compromised?

Let’s face it: maybe the question isn’t “can it be hacked?”; maybe the question should really be “what do we do if my device gets hacked?”.

I’m not in favor of backing up the trolley on innovative ways to view and use our data. But I think it’s smart and altogether appropriate that FDA is bringing people together to talk about it. I don’t want to not have the latest and greatest technology available to help me live a better, healthier life. But I think it makes sense to define protocols for how to react when/if someone gets access to something they’re not supposed to have access to. How do we protect ourselves? It’s a classic “fail to plan, plan to fail” scenario.

Just off the top of my head, I have questions about whether makers will be properly educating users about risks of a data breach, and how safe or vulnerable their device is to attack (while at the same time not scaring the bejeezus out of patients—it’s a fine line). Also, if my phone is hacked, what’s the protocol for how to react? What are the steps we should take in the event of someone hacking our phone and stealing our personal health information?

I know what some of you might be saying: it’s up to the phone maker to deal with that situation. True, in part. But what if a hacker is using the Bluetooth signal coming from my CGM to hack into my phone? If that happens, what is the manufacturer’s plan to address this and limit interruptions or theft of information?

I’m not really worried about someone hacking my diabetes devices. I am really worried about someone hacking my health information, either through an upload site, a smart phone, or by some other means. And really, I’m worried about whether anyone, anywhere, has any plan to deal with that if it happens.
 
 
If you want to know more about this two day public workshop, or register to attend, just click on the image above.
 

Public Workshop Alert.

After writing here for 3½ years, I can tell you that there is no shortage of people who like to add their two cents on a subject. Whether it’s insulin costs or the importance of Medicare coverage for CGM users, the Diabetes Online Community knows how to speak up when asked.

Here’s something you may not have heard of yet, and it’s tailor-made for you to learn something and speak up too.

On September 29 and 30, the U.S. Food and Drug Administration is hosting a public workshop. The workshop is geared toward the discussion of patient labeling on medical devices, like insulin pumps and continuous glucose monitors (and maybe artificial pancreas systems?). To be fair, it is not specifically diabetes related, but discussions at this event could certainly have implications for People With Diabetes.
FDA
The workshop will be held at FDA’s sprawling White Oak campus in Silver Spring, Maryland, outside of our nation’s capital. The two day agenda includes presentations from FDA staff and others, and will cover things like FDA’s development and review process, new approaches to patient labeling that aren’t necessarily paper-based, user assistance information, and more. I really like the way day two begins, with a session on Identifying the Gaps in patient labeling, followed by a session on Closing the Gaps in patient labeling.

If you live in or near Washington, D.C., this is an awesome opportunity to not only find out more about patient labeling of our devices, but actually join in the discussion too. Let me give you the link so you can find out more:
CLICK HERE to find out more and register for this public workshop
 
 
Also: Although there are no details yet, FDA says that there will be a webcast of this workshop.
 
 
So… for everyone who says, “What can I do?”, my answer is this. You can do this. You can listen in, or attend, in person, this public workshop. You can take notes. You can form your own opinion. If you are there in person, you can speak on behalf of all of us who are living with or affected by diabetes. When it’s over, you can tell everyone you know about what happened and what was discussed.

And I will be thankful you were there for me.
 

%d bloggers like this: