Tag Archives: FDA

Your Government at Work (Part 2). Let’s build a community!

This is a fairly short post (for me, anyway).

If you didn’t see my post on Facebook about this earlier, I invite you to check it out now. It’s from the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA).

CLICK HERE TO FIND OUT MORE

CDRH is the group that looks at things like insulin pumps, CGMs, and artificial pancreas systems. I think the focus of this initiative is to help foster collaboration when it comes to design and improvement of devices that help us manage our diabetes (and other conditions, but since this is a diabetes blog, that’s where my focus is).

I don’t think that CDRH and FDA are saying that they’re building a community… I thiink they’re saying they’re interested in helping communities build themselves, and listening to those communities when it comes to device development, submission, and approval. How great is that?

The best part is, you can be involved. I wish I had a dollar for every time someone said to me, “I’d like to be in on something like that, but I never get the chance”.

Well, here’s your chance.

Here’s the first paragraph of the notice from CDRH, which says a lot:

One of the Center for Devices and Radiological Health’s (CDRH’s) strategic priorities for 2018-2020 is the creation of collaborative communities to bring together medical device stakeholders to achieve common outcomes, solve shared challenges, and leverage collective opportunities. CDRH believes collaborative communities can contribute to improvements in areas affecting U.S. patients and healthcare. We encourage interested stakeholders to learn more about collaborative communities and review the toolkit, which provides a collection of helpful ideas to foster strong collaborative communities that are well-prepared to take on healthcare challenges.

CLICK HERE – GET INVOLVED

If you read here often, you understand how much I believe in community-based approaches to challenges everywhere. And how much I believe in all of us being involved in said communities.

So let me ask you… why not you?

Enjoy the rest of your week.

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Not exactly Spielberg, but A.I. has arrived.

It is kinda cool, at least for starters.

Wednesday, the U.S. Food and Drug Administration (FDA) approved marketing of a device designed to use artificial intelligence to detect retinopathy in people living with diabetes.

There are several things to cover here. First of all, the FDA announcement is that it “permits marketing” of the device. In other words, it can be sold to practices as an artificial intelligence diagnostic tool. There was a fair amount of testing and back-and-forth in the development and rollout of this device, and I’ll get to that in a minute.

Simply put, this is a way for non-eye doctors to use a tool (actually, two tools) to take a photo, upload the photo, and get a retinopathy or not retinopathy diagnosis. It’s not designed to avoid the more detailed examination an ophthalmologist can perform. But it’s a way to perhaps get an early diagnosis of a potential issue with your eyes.

The tools used by the doctor (presumably, a primary care physician, or GP) are 1) The Topcon NW400 retinal camera. The doctor will take a photo with the retinal camera, then upload it to the cloud, where it will be analyzed by 2) The newly-marketing-permitted IDx-DR software to determine one of two outcomes (from the FDA press release… see link below):
(1) “more than mild diabetic retinopathy detected: refer to an eye care professional” or
(2) “negative for more than mild diabetic retinopathy; rescreen in 12 months.”

So, where’s the “artificial intelligence” angle here? I’m glad you asked.

This is the first device (the software is considered a device in FDA parlance) allowed to be marketed to provide a decision without getting a clinician involved in interpreting the results. In other words, the software, not a human, tells you whether there’s an issue or not.

How did the FDA arrive at the level of confidence needed to arrive at this decision? There were 900 diabetes patients in the clinical study, in ten different locations. The study revealed that the software made the right decision on “more than mild diabetic retinopathy” 87.4 percent of the time, and “not more than mild diabetic retinopathy” 89.5 percent of the time. That may not seem like a lot, but to this observer, that sounds pretty good for first generation software.

One of the other things I’m encouraged by is the way this rollout was handled through FDA’s De Novo premarket review pathway, designed to help new devices that are seen as being low to moderate risk get marketing approval. Through this, FDA granted the software Breakthrough Device designation, which provided a framework for greater interaction between developers and the FDA on guidance, testing, and documentation, so the developers could work more efficiently on FDA’s concerns, and the FDA could more effectively work on review.

Hey, look… I don’t know if this software and the retinal camera needed to make it work are going anywhere. But I think this story is important to pay attention to for the way it was handled by the developers and the FDA, particularly FDA’s Center for Devices and Radiological Health; and the fact that this is software that removes the human element from at least the initial diagnosis process.

How you feel about such a development is your choice.

Read the full FDA press release HERE.

Find out about the De Novo premarket submission process HERE.

Find out about the Expedited Access Pathway Program for Breakthrough Devices HERE.

Drug pricing straight talk.

I read an interesting online piece from CNN Money the other day. If you haven’t had a chance, read it HERE. I’ll wait.

Although I was surprised at first that the director of the U.S. Food and Drug Administration would weigh in on drug pricing, I have to say that his comments here are pretty much what I would expect, and it’s what I’ve been thinking for a while too.

Indeed, there have been drug companies playing fast and loose with the rules governing when their drugs could be available to be made as generics. There have been, in some cases, instances of companies restricting access to brand name drugs for makers of generics who want to use them to help develop their own products, and use them for comparison in clinical trials to help measure efficacy of their generic versus the brand name benchmark.

In true drug company and pharmacy benefit manager fashion, there is a lot of gray area in the rules governing what can be made generic when, and how. In a way, you can understand it from their point of view… they don’t want to see a lot of their profit go away because a generic (or in the case of insulin, a biosimilar) could be purchased for much less than the original product.

Yet we’ve seen generics make a huge difference in the affordability of high blood pressure and high cholesterol drugs. It would be nice to purchase our diabetes drugs for far less than we purchase them today. Can’t we make this happen?

I think that’s what the FDA Director is saying here. He uses political terms like “free market”, but at least he acknowledges that the needs of patients should trump a 20-plus year near monopoly for a particular medication.

We are seeing changes, slow changes in insulin now. Novo Nordisk’s Fiasp is a very fast-acting insulin, and over the next few years, it may change a lot of how people manage their diabetes. If it does, expect to see prices drop for Novolog. We’ve seen the first biosimilar insulin in the United States in Eli Lilly’s Basaglar, and that has already had an effect on the price of Sanofi’s Lantus, which it is biosimilaring(?). Plus, my endo suddenly has lots of free Lantus samples to pass along.

I completely believe this statement from Dr. Gottlieb, in describing the various changes under consideration by the FDA:

“All of these steps are going to have an impact, and I don’t think there’s one silver bullet,” Gottlieb said. “If anyone [thinks] there is one thing you can do with policy intervention that is going to dramatically change drug prices, that’s not true.”

It’s going to take a lot of effort on the part of regulators, advocates like you and me, and yes, industry to shepherd a change in the approach of brand name and generic drugs. We’re not going to get down to a few dollars out of pocket for our insulin prescription. But hopefully, as time goes by, we’ll see additional choice, both in medications and the cost of those medications.

I think that would qualify as making something happen.

Enlightened, but unknowing.

Even though it meant getting up very early on my day off from work, I was thrilled to go to Washington, D.C. last week for a diabetes town hall, co-sponsored by the Office of Minority Health at the U.S. Department of Health and Human Services, and the Office of Minority Health at the U.S. Food and Drug Administration.

The event, as you can imagine, was designed to facilitate discussion on ways to better promote diabetes prevention and care among the non-white populations in my country. I thought that was a terrific idea. After all, the prevalence of diabetes is much higher in non-whites than in whites here in the USA, yet many of the people affected are in vastly underserved communities, either due to socioeconomic reasons, location, or because their first language is not English. I get it, I thought. This is good.

But it turns out that there is still a lot I don’t know.

For instance… did you know that the prevalence of diabetes in the United States is highest among Native Americans and Alaskan Natives? At 15.1%, their risk of diabetes is over twice that of someone who looks like me. It turns out that 12.7% of African-Americans live with diabetes, and 12.1% of Hispanics do too. Only 7.4% of non-Hispanic Whites live with diabetes here.

But that’s not all. Eight percent of Asian Americans live with diabetes, but they are far more prone to being diagnosed with Type 2 diabetes at a lower body mass index (BMI) than other ethnicities. Those advocating for greater awareness among this population are touting an initiative called Screen at 23 to test all Asian Americans for diabetes if their BMI is at 23 or over.

As our presenters that day shared their data, it was clear that while I feel I’m enlightened, I really don’t know as much as I thought I knew. For instance, while there is data surrounding ethnic backgrounds of clinical trial participants, when we see a number that says “Asian”, we don’t know if the Asians in the study were of Japanese descent or Indian descent. When we see “non-Hispanic Black”, we don’t know if these are people of Senegalese or Jamaican descent. Those specifics could mean real differences in understanding the underlying data from a clinical trial.

How about this? Did you know that FDA has sponsored a Minorities in Clinical Trials campaign? The idea is to remove barriers to clinical trial participation for minorities, who, as a friend mentioned, may have transportation, job, family, or other special constraints that make clinical trial participation more difficult than it is for a lot of the majority population.

Did you know that people with prediabetes enrolled in a Lifestyle Change Program for a year under the National Diabetes Prevention Program at the Centers for Disease Control and Prevention (a mouthful… take a moment and breathe) showed, on average, a 5% to 7% loss in body weight, and had a 58% reduction in their risk of being diagnosed with diabetes? How do we promote the NDPP and its successes among states and tribal areas with vulnerable populations?

I learned a lot in this short, half day event. Here are a couple of nuggets that I heard more than once:

– We need additional data to understand segments of the various populations at risk for, and with higher prevalence of, diabetes. Subgroups of subgroups, if you will.

– Material and coaching rolled out to non-white populations need to be presented in a linguistically and culturally appropriate manner. One size does not fit all, and there is evidence that tailoring a message to its audience has a positive effect.

One of the words I heard mentioned a lot that day was disparities. The more we can reduce the disparities that exist in diagnosis; access to care, food, drugs, and devices; participation in clinical trials; and information that sends clear messages in terms that underserved populations can understand, the more inclusive we will be as a diabetes community, and the healthier all of us will be.

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.

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