With Megan R. Wilson

PROGRAMMING NOTE: We’ll be off next week for the holidays but will return to your inboxes on Tuesday, Jan. 3.

The legal fallout for some digital prescribers keeps coming.

The latest: allegations from the Drug Enforcement Administration that retail pharmacy Truepill dispensed controlled substances without a legitimate medical reason and acted unlawfully in other ways when dispensing medication.

The agency said: 

— Between September 2020 and September 2022, Truepill filled more than 72,000 prescriptions for controlled substances and roughly 43,000 were for stimulants, including those used to treat attention-deficit/hyperactivity disorder.

— The pharmacy gave out prescriptions for more than the 90-day supply limit “and/or” dispensed medicine without the correct state licenses.

— Truepill must justify its actions or potentially have its controlled substances registration rescinded or suspended.

Truepill served as a pharmacy for telehealth company Cerebral, which is under Justice Department investigation for potential controlled-substances violations amid allegations it overprescribed meds for ADHD.

“DEA will relentlessly pursue companies and pharmacies that seek to profit from unlawfully dispensing powerful and addictive controlled substances at the expense of the safety and health of the American people,” DEA Administrator Anne Milgram said in a statement.

The companies respond:

— Cerebral CEO David Mou has previously said that media coverage has “distorted” the company’s “outstanding care” and denied wrongdoing.

— According to The Wall Street Journal, Truepill CEO Sid Viswanathan said his firm is cooperating with the DEA and stopped dispensing schedule 2 substances via telehealth earlier this year. “We are confident we will be able to demonstrate the absence of wrongdoing,” Viswanathan told the Journal. “Patient safety is our No. 1 concern.”

The DEA is reportedly also investigating Done, another telehealth company, for allegedly overprescribing ADHD drugs.

Why it matters: DEA’s enforcement moves come amid uncertainty about the future of pandemic prescribing rules that allow patients to be prescribed controlled substances virtually. Those waivers expire with the public health emergency, which could come as soon as April.

The DEA pledged to expand access to virtual prescribing in 2009 but hasn’t done so yet.

Some in the industry are skeptical that overprescribing virtually is a widespread problem.

“There will always be cases of startups prioritizing growth over providing high-quality clinical care,” Justin Norden, partner at investing firm GSR Ventures, told Ben. “With that said, these companies are the outliers, and this is not a universal issue.”

This is where we explore the ideas and innovators shaping health care. 

Roanoke has unveiled its plans for erecting a statue of Henrietta Lacks, who was born in the southern Virginia city in 1920. The cells of the African American mother of five, who died of cervical cancer in 1951, may have helped save your life.

Share news, tips and feedback with Ben Leonard at [email protected], Ruth Reader at [email protected], or Carmen Paun at [email protected].

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Today on our Pulse Check podcast, Megan Messerly talks with Alice Miranda Ollstein about the state abortion battles they followed in 2022 after the Supreme Court overturned the landmark Roe v. Wade decision — throwing the future of abortion access in the U.S. into flux — and what they’re looking at next year.

The omnibus spending bill released Tuesday calls on HHS’ Administration for Strategic Preparedness and Response to look into using artificial intelligence to defend against bio-threats.

The legislation calls on ASPR to report to Congress within 120 days of the legislation being enacted on how feasible it would be to develop an Al-enabled pandemic preparedness and response program. ASPR would take the lead with help from the Department of Defense and Department of Energy as needed. Congress is expected to pass the bill this week.

The AI program will: 

— Use AI to guard “against current and future bio-threats of any origin.”

— Employ the technology to develop vaccines and therapeutics more quickly and provide “global bio-threat surveillance.”

— Collaborate with HHS’ Chief AI Office.

Why it matters: The provision in the spending bill is part of a larger bid by Congress to better prepare for future pandemics.

The bill also includes provisions from legislation championed by retiring Sen. Richard Burr (R-N.C.) and Senate Health, Education, Labor and Pensions Chair Patty Murray (D-Wash.) to shore up U.S. preparedness for future pandemics.

The spending deal also seeks to improve infectious disease forecasting and modeling, establish an Office of Pandemic Preparedness and Response within the White House, and review the Strategic National Stockpile of vaccines and infectious disease treatments more frequently.

Congress settled one disagreement about the new Advanced Research Projects Agency for Health in the omnibus spending bill but left open another.

The bill says ARPA-H will be part of the National Institutes of Health, settling a dispute over whether the agency should be independent.

But lawmakers couldn’t agree on the location of the agency, which aims to fund moonshot initiatives to cure diseases like cancer and Alzheimer’s. Several states are vying for the headquarters.

According to the bill, ARPA-H must have offices in at least three geographic areas, but none can be located on NIH’s Maryland campus..

Why it matters: Rep. Anna Eshoo (D-Calif.) had led a push to establish ARPA-H outside of NIH.

Cities, states and members of Congress are lobbying the Biden administration on the location of ARPA-H headquarters. The omnibus’ language requiring multiple locations will give more of them a shot.

What’s next: Lawmakers want NIH to update Congress “no later than 30 days prior to conducting the location search on its criteria,” and tell representatives and senators about any location selections “no less than 5 days prior to a location being announced publicly,” a statement from congressional appropriators said.

The omnibus bill also provides $1.5 billion in funding for the agency.