policy
Yep, DEA poised to extend controlled substance policies again
The Trump administration seems set to once again extend the Covid-era policies that allow clinicians to prescribe controlled substances like ADHD medications and treatments for opioid addiction over telehealth. While the details aren't public, the title listed on the government website that tracks pending regulatory changes says it all: "Fourth Temporary Extension of Covid-19 Telemedicine Flexibilities for Prescription of Controlled Medications."
A new extension would kick down the road long-awaited rules from the Drug Enforcement Administration on how it will allow telemedicine prescribing in the future. The flexibilities during the public health emergency prompted a proliferation of businesses focused on remote prescribing, illustrating both the benefits of increasing access as well as the potential for abuse.
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AI chatbots face Congressional scrutiny
The House Committee on Energy and Commerce plans to hold a hearing on the risks associated with AI chatbots. A handful of lawsuits filed in the recent weeks and months allege that ChatGPT and other products encouraged conversations that led to mental breakdowns and suicides among users. The use of bots designed to provide therapy has grown recently and will surely be a topic of lawmaker inquiry. The FDA's digital health advisors recently held a meeting to guide the agency's effort to clarify how regulation applies to these products. The new Congressional hearing, titled Innovation with Integrity: Examining the Risks and Benefits of AI Chatbots, will be held by the subcommittee on oversight and investigations on Nov. 18.
Pfizer job posting casts fresh light on digital plans
A new Pfizer job posting for a digital medicine & PDURS strategy lead offers a glimpse of where the pharma giant may be going with some of its digital health work. The new role would be charged with heading up a PDURS Center of Excellence at Pfizer and "will guide cross-functional teams to design, validate, and launch drug-digital solutions that meet regulatory requirements."
What is PDURS you may reasonably ask? In 2023, the Food and Drug Administration issued draft guidance on Prescription Drug Use-Related Software, which is of particular interest because it offers the agency's thinking on what drugmakers are supposed to do when they have software, like an app, that when used with a drug offers "meaningful improvement in a clinical outcome" as compared to use of the drug alone. With evidence of this benefit, it could be added to a drug's label, and that opens the door to new marketing and reimbursement opportunities.
PDURS is viewed as a crucial opportunity for the digital therapeutics industry, which up until now has had a lot of trouble marketing disease treatment apps as standalone products — uptake has been slow and reimbursement minimal. Pfizer's job posting sends the clearest signal yet that the drugmaker is working on PDURS, which could prompt others to do the same.
Pfizer has offered bread crumbs here before. The company co-chaired a Digital Therapeutics Alliance committee on PDURS. DTA was acquired by the American Telemedicine Association earlier this year, which has continued the work. Edward Cox, Pfizer's head & general manager of digital health & medicines, was recently spotted on Capitol Hill with ATA bigwigs talking about PDURS. In October, ATA submitted comments to FDA asking, among other things, that finalized guidance "capture the de-regulatory intent" of previous FDA thinking on PDURS by loosening evidentiary requirements.
Pfizer hasn't said much that I'm aware of about what kinds of PDURS or digital medicines it might be working on. However, in comments on Medicare fee schedules it's weighed in on the reimbursement for digital mental health treatments by asking the government insurer to consider a broader swath of apps including for "high-burden disease areas such as oncology and cardiometabolic management." Pfizer is steadfast that "CMS should restrict reimbursement to FDA-cleared products that meet established safety and effectiveness thresholds." If you have thoughts about this and wants to chat, get in touch: mario.aguilar@statnews.com
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