FDA Launching New Advisory Committee on Digital Health

Posted on October 13, 2023 by Mark Senak

FDA announced this week the formation of a new advisory committee – the Digital Health Advisory Committee – for the purpose of providing the agency with advice on matters related to digital health technologies (DHT). FDA does not form new advisory committees all that often, making it a notable development in more than one respect.

FDA stated in the agency’s press release that the committee’s subject matter jurisdiction will include helping the agency explore and assess issues regarding artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. That is a broad spectrum of subject matter. The AI/ML portion alone is growing rapidly in breadth as is its uptake.

Simultaneous to the announcement, the agency began recruiting for its membership for the nine members the agency is seeking to comprise the membership of this committee. By design there are currently none voting members – which includes the Chairperson – comprising the committee. FDA is looking for a consumer organization to fill a voting slot and nominations and self-nominations will be considered by the agency to fill both consumer and individual seats. According to the Federal Register notice, individuals should be “full-time employees of firms that manufacture medical device products, or consulting firms that represent manufacturers or have similar appropriate ties to industry.”

The agency provided examples of areas where the Commissioner may seek advice which included real world data and evidence, patient generated health data, personalized medicine and use of DHTs in clinical trials to name a few. Right now it is a stand-alone committee subject matter area, not housed under Human Drugs Advisory Committees or Medical Devices. Given the speed and span with which AI/ML is developing, it is easy to think that there will be a basis for future expansion and just as Medical Devices is sub-divided into panels by subject matter jurisdiction, one could imagine the future of the new committee taking on a similar structure given the prolific nature of DHT.

Troy Tazbaz, director of FDA’s Digital Health Center of Excellence stated in the FDA press release – “Many of these technologies are novel and tend to rapidly change; it’s our duty to seek as much knowledge on them as possible as we determine and implement appropriate regulation to encourage innovation while protecting the public health.” This is one to keep an eye on for sure – not only to see what subject matter comes before the committee, but how rapidly it grows.

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What Happens When You Talk About Adherence in Promotional Communications?

Posted on October 12, 2023 by Mark Senak

FDA has announced that the Office of Prescription Drug Promotion (OPDP) is planning a study to evaluate the influence that statements made in a promotional communication about patient adherence to a medication may have on the resulting preference for a medicine.

OPDP regularly conducts research on a wide-ranging scale to help define the agency’s perspective on how various conditions might impact a target audience of a promotional communication. In particular, the agency states in the Federal Register notice that it has previously conducted research around market claims that discuss characteristics not directly related to approved label. They give the example of past research on the use of the phrase “#1 Prescribed”, for example, assessing the impact it might have for preference. Here, you can find an overview of OPDP’s past research, on-going research and research pending peer review and publication.

For this particular research, OPDP is seeking to gain insight into how an appeal to the possibility of greater adherence or whether or not there is a statement that other patients or prescribers prefer a specific medicine might impact the outlook of the target audience. In addition, they will look at whether the inclusion of a disclosure accompanying such a claim – for example “there is no conclusive research on whether DRUG A results in better adherence” – will serve to impact the perception. OPDP notes in the Federal Register Notice that while disclosures often can help shape an outlook, they have not been studied in this particular context.

The specific questions FDA is seeking to answer in this proposed research effort is whether the presence of absence of a stated or implied adherence claim impact consumer outlook with respect to their intent or perception of risk and benefit. In addition they will explore whether the presence of both adherence and preference type of claims have an impact, as well as exploring the effect of the presence of a disclosure statement as noted above. The agency is including both patients and primary care physicians, looking for 253 and 294 participants respectively. Each participant will view various versions of a mock consumer web page promoting a fictitious medication and respond to a questionnaire.

There is a long tail to this type of research. It will have to be finalized, recruited, assessed and written up as well as undergo peer review. But in informing the agency’s perspective on a particular topic, the research undertaken by OPDP may be a window into future directions, considerations and even potential priorities for the agency in terms of enforcement. Those in promotional communications may wish to take note now.

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Drug Approvals and FDA AdComms in 2023

Posted on August 28, 2023 by Mark Senak

Having passed the mid-year point, it is always an interesting exercise to take stock of where we stand with respect to the approval of new medicines. Overall, when considering the volume of activity, things would seem to be looking up – at least in terms of the volume of activity. First let’s look at the approval of new molecular entities, and then at the number of Advisory Committee meetings being held, and compare them to the first half of 2022.

New Molecular Entity (NME) Approvals – These approvals are an important indicator of innovation coming from test tube to patients. Last year was not looking particularly good at mid-year, with only 16 NME approvals by June 30 and only 37 for the entire year – the least number since 2016. This year, however, with 26 NME approvals at mid-year. there has been a significant uptick – more in fact than any other previous mid-year check-in with the exception of 2021. It looks like we are off to a good start, and if annualized would mean that we would possibly see 52 NME approvals for the year, which is on par with the years 2019 – 2021 (2022, as you can see in the chart below was a bit anemic). But in fact, as can be seen in previous years such as 2019, 2018 and 2015, the mid-year tally (in red) is not always predictive of what we may see by year’s end (in blue). The second half could move either faster or slower. There are still many decisions and publicly available PDUFA dates with many novel treatments among them, including investigative treatments for sickle cell disease and ALS.

AdComms and Approval Votes Are Up – In addition to NME approvals, there have been an increased number of FDA Advisory committees held to discuss new treatments. That could indicate (1) more new medicines up for considerations and/or (2) more situations where FDA feels it needs the advice of consultants in the course of deliberations.

By my count, during the first half of 2022 there were only 4 advisory committee meetings held to discuss new drug applications (NDAs), compared to 17 held during the first half of 2023 – which is kind of a whopping 300 percent increase. In fact, by mid-2023, there were 17 AdComms held, outpacing the number held during all of 2022 when there were 14 for the year (19 had been scheduled, but 5 of them did not take place).

But there is another important contrast between last year and this and that is in regard to outcomes – of the 4 meetings held in the first half of 2022, the vote was negative in 100 percent of them. In fact, in 2022, there were only 4 approval recommendations out of the 14 meetings held that year. In other words, 71 percent of the 2022 outcomes were negative. By contrast, in 2023, of the 17 meetings held to discuss NDAs during the first half of the year, the vote was positive in nearly all of them – 16 recommendations for approval – or 94 percent approval recommendations – also a rather eye popping reversal in trend.

Individual AdComm Frequency – The AdComm that met more than any other was the Antimicrobial Microbial Drugs Advisory Committee with a total of four meetings, followed by the Oncologic Drugs Advisory Committee with 3, and the Peripheral and Central Nervous System Drugs Advisory Committee with 2 meetings. All the other meetings held during the first half of 2023 – Cellular Tissue and Gene Therapy, Endocrinologic Drugs Advisory Committee, Gastrointestinal Drugs Advisory Committee Obstetrics, Reproductive and Urologic Drugs Advisory Committee, the Psychopharmacologic Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee all had a single meeting. The committee that had the sole negative recommendation was from the Gastrointestinal Drugs Advisory Committee which did not recommend approval for an NDA involving a treatment for pre-cirrhotic liver fibrosis due to NASH.

Other Approvals – Of course, there are many drugs approved that are not NMEs and which do not have Advisory Committee meetings. One last indicator is to review the number of press releases about drug approvals this year compared to last. During the first half of 2022, FDA issued only six press releases about drug approvals compared to 13 during the first half of this year.

There are other approvals not included here that occurred as well. But looking to these indicators – NME approvals, AdComm recommendations and FDA press releases, 2023 is carving its own unique profile. If 2023 continues at this pace, it looks to be shaping up as a banner year for both the volume of FDA advisory committee meetings well as for the proportion and number of approval recommendations.

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FDA’s OPDP Issues Third Letter of 2023

Posted on August 22, 2023 by Mark Senak

For the second time this month and the third time this year, FDA’s OPDP has posted notice that it has taken an enforcement action. Last week, a Warning Letter was posted regarding a sales aid. This week it action came in the form of an Untitled Letter (NOV) sent to a company regarding a paid social media posting. Enforcement this year was non-existent until June when the agency posted its first letter in a year. This week’s action makes a total of three letters sent this year, all within a three-month period.

The Untitled Letter posted this week involved an oral birth control pill which has a specific of contraindications contained in the label as well as a list of warnings and precautions and of the most common adverse events. The communications vehicle in question was a social media sponsored posting.

OPDP took issue with three specific aspects of the promotional communication. First, while presenting the indication in the posting, there was no risk information included in the communication. Second, a claim was made in the communication that OPDP said was not supported by the clinical studies section of the package insert. And third, the communication was not submitted under form FDA-2253 for review.

It would seem that the omission of any risk information combined with the review issue would have been enough to trigger action by OPDP. But as discussed last week, previous to this letter there were four letters in a row that held efficacy claims up against studies that might support the claims and found them wanting. This is now the fifth letter in a row that took issue with an efficacy claim with OPDP scrutiny of the underlying data that may or may not exist to support the claim. Pharma communicators take note.

Last year the agency only issued a total of four letters. Enforcement trends are impossible to predict but certainly it has picked up and there could be more to come. After all, back in 2016, the agency issued six letters in the month of December alone. Stay tuned.

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FDA’s OPDP Issues Second Regulatory Action Letter of 2023

Posted on August 16, 2023 by Mark Senak

In what has been a long period of relative low activity, FDA’s OPDP has taken the opportunity to remind us that low enforcement does not mean no enforcement when it comes to promotional speech by pharmaceutical companies.

This past June FDA posted an Untitled Letter, the first regulatory action letter in a year, reported on here regarding a website communication. This month FDA posted another letter, this one a Warning Letter involving a Sales Aid. This second letter of 2023 makes a total of six letters for the combined years of 2022-2023, two of which were Warning Letters and four of which were Untitled.

With so little activity, trends are often difficult to discern, but one does appear to emerge.

In examining four of the last six regulatory action letters issued by OPDP, one discerns that there is possibly an emergent sensitivity the agency has in looking at communications that make claims about a product, even when citing published papers as evidence.

The last four letters from OPDP:

Each of these letters have a common thread – in each of the last four letters issued by OPDP the agency was taking issue with the support that existed for efficacy claims being made in the communication about the medicine. In each situation, OPDP closely analyzed the studies for their applicability to the claim being made, assessing whether or not they were adequate to the task from the perspective of the agency.

With four in a row, that would seem to signal that promotional communications that deal with efficacy claims may be speech that is of special interest to the agency right now, and that enforcement actions are sending that signal. Future letters will indicate if this persists as a point of interest.

By the way, for those who want to follow or examine the letters, FDA now separates the reporting of Untitled Letters from Warning Letters. To view the former, you can go to this page and see the Untitled Letters issued each year. If you want to see Warning Letters, you must go the Warning Letters page and perform a search specific to the issuing office – Office of Prescription Drug Promotion.

Photo by Goh Rhy Yan at Unsplash

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