SUPPORT finds support, and a calendar date

Next week, the Senate health care committee will finally consider a sweeping bill aimed at the opioid epidemic, four lobbyists and a congressional aide told my colleagues Lev Facher and Rachel Cohrs.

The proposal would reauthorize a number of programs first created by the SUPPORT Act, an addiction-focused bill that Congress first passed in 2018. Many of those expired earlier this year, but Senate HELP Chair Bernie Sanders (I-Vt.) hasn't scheduled the bill until now — much to the chagrin of addiction treatment advocates.

Among other changes, the bill would help boost funding for for community-based organizations working to address the addiction crisis, help expand access to addiction medications, and helppregnant women and, separately, incarcerated people get treatment. It's also likely a catch-all proposal wrapping in a number of addiction bills that have been introduced but haven't gained traction, Lev and Rachel write. More from them.

medical devices

The FDA's comment section on LDTs is popping off

Monday was the final day to submit comments on the FDA's controversial plan to regulate tests developed by labs in academic medical centers and hospitals, STAT's Lizzy Lawrence reports. The proposal has racked up over 19,000 comments from the public, with 2,000 posted online so far.

The FDA has been trying to regulate lab-developed tests for decades. Patient groups and non-lab test makers, who are already FDA-regulated, are generally supportive of the idea. The FDA came close to securing that power via Congress last year, but the bill ultimately failed when labs successfully convinced Republicans that FDA regulation would impede their ability to quickly test patients. In September, the FDA declared it had the authority to regulate LDTs on its own, saying the threat of inaccurate tests was too urgent to wait for Congress.

The sheer volume of comments on this rule shows how much angst it's creating in the diagnostics world, with infectious disease professionals and personalized medicine advocates sending hundreds of auto-responses condemning the rule. The American Clinical Laboratory Association submitted a 107-page comment saying that LDTs are medical services, not devices, and therefore should not be scrutinized by the FDA. The Association for Molecular Pathology took a similar stance. It seems like labs are gearing up for potential legal action. Here's more on all this from Lizzy.

drug shortages

Senate committee considers drug-shortage fixes

The Senate Finance Committee will hold a hearing today on drug shortages, opening the door to potential solutions that involve Medicare and Medicaid hospital payment policies.

It'll be an interesting hearing, because so far, policymakers haven't found a silver bullet solution. Different congressional committees are trying different things, as STAT has covered in the past, but nothing's made it through Congress.And most newsy: Even when the White House did take aim at shortages, it didn't figure out how to address the cancer drug shortages that have so alarmed patients and advocates. As my colleague John Wilkerson reports, the limited scope of Biden's latest moves actually surprised several experts on shortages.

"I see little reason why the DPA couldn't be invoked to shore up chemotherapy supply," one expert told John. Read more here.

at the fda

FDA's next phase for gene therapies

The Food and Drug Administration needs dozens more reviewers if it wants so-called Operation Warp Speed for rare disease therapies to take off, CBER chief Peter Marks said Monday. That program, dubbed the START pilot, launched this September as rare disease advocates rallied for quicker reviews and more flexible trials.

"If we were really to expand this significantly, [it] would require us to get dozens of additional staff members," Marks told listeners during a gene therapy discussion hosted by the Alliance for a Stronger FDA. More from me.

Speaking of gene therapies: Sen. Bill Cassidy (R-La.) is pressing commercial insurers for information on how they would cover a potential onslaught of pricey new gene therapies including a CRISPR approval that could come as soon as this week.

The highest-ranking Republican on the health committee is sending letters this morning to payers and supply chain intermediaries, a staffer shared with D.C.D. The letters ask them to shed light on their plans and challenges — and that responses could inform future legislation.

in the courts

SCOTUS struggles with Sackler deal

The Supreme Court on Monday at times seemed reluctant to pull apart a long-negotiated opioid settlement, but also uninterested in cutting the Sackler family any slack. As the deal with state and local governments currently stands, the Sacklers, founders of Purdue Pharma, would contribute up to $6 billion to a settlement fund and relinquish control of the company, but retain the rest of their fortune. The Biden administration has objected to that deal.

Justice Department lawyer Curtis Gannon argued Monday that governments could negotiate a better deal if the court undid the current agreement, as covered by AP News. Lawyers for thousands of victims who support the settlement — and a lawyer for victims who oppose it — also appeared.

The latter called the Sackler agreement "special protection for billionaires." The settlement would be one of the largest negotiated between a opioid crisis victims and the drugmakers, pharmacies and PBMs who supplied the painkillers. The court is expected to reach a decision by next summer. Read more from the AP.

Budget battles

HHS touts HIV record as spending cuts loom

New HIV cases in the U.S. dropped 12% from 2017 to 2021 and nine out of 10 Americans receiving HIV care were successfully suppressing the virus last year, the White House said this weekend.

The announcement coincided with World AIDS Day but also a congressional struggle over billions of dollars in HIV/AIDS programs. House Republicans have threatened to stall PEPFAR , which supports treatment access for roughly 20 million people abroad, and gut domestic HIV programs such as the Ryan White initiative.

Administration officials have argued that the proposed cuts would rip open narrowing racial disparities in care. While there are still gaps, especially with access to PrEP, HHS said that More than 87% of Black patients and 91% of Hispanic/Latino patients in the U.S. were virally suppressed in 2022, up from 63% and 74% respectively in 2010.

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