| | | |   | Hello, D.C. Diagnosis readers. Hope you all enjoyed Washington’s favorite – completely asinine – tradition yesterday. I’m speaking, of course, about Budget Day, where federal agencies compile thousands of pages of budget requests only to have Congress ignore that work and punt enacting any budget legislation till the government is on the verge of a shutdown. I’m at nicholas.florko@statnews.com. | | | The NIH’s long Covid research is a mess Last February, the NIH launched an ambitious multi-year initiative to better understand the disease now known as long Covid. But my colleague Rachel Cohrs reports that the initiative is moving at a glacial pace – infuriating researchers and study participants. Rachel’s story is chock-full of eye-opening tidbits. Including that the NIH has recruited just 3% of the 40,000 patients it intends to recruit and that more than $1 billion of its funding was temporarily transferred to help house unaccompanied children at the border. You won’t want to miss this one. After all, NIH’s work could have massive implications. As Rachel writes, “the success of the NIH’s research into long Covid will shape the trajectory of the long-term burden of the pandemic on health care systems around the world for years to come, as millions of patients grapple with debilitating symptoms.” Read more. | Pelosi to Becerra: Save ARPA-H Health secretary Xavier Becerra is suddenly the target of a frenzied, last-minute lobbying campaign aimed at ensuring the independence of ARPA-H, the new high-stakes research agency that President Biden has said will “end cancer as we know it.” In a bizarre turn of events, it’s lawmakers themselves who are doing the lobbying, my colleague Lev Facher reports in an exclusive new story for STAT. Last week, Reps. Anna Eshoo (D-Calif.) and Rosa DeLauro (D-Conn.) met with Becerra to warn him that placing ARPA-H under the auspices of the NIH could have disastrous results. Speaker Nancy Pelosi is in on the action, too: She’s communicated with the White House directly, and deployed her top domestic policy aide, Wendell Primus, to back up Eshoo and DeLauro at their meeting with Becerra. The extraordinary fight has pitted the House against the Senate; Nancy Pelosi against Francis Collins; and the NIH establishment against an array of researchers who say the agency’s entrenched bureaucracy and risk-averse culture could doom the ARPA-H experiment before it even begins.
Read more here. | Known and unknown unknowns: Nearly half of all 2021 drug shortages had undetermined root causes Figuring out the root causes of drug shortages requires transparency and a cross-functional approach to solve this complicated challenge. GPOs, their members and suppliers are working together to uncover the why behind drug shortages, and to use insights gained to make supply chains more resilient. Learn more here. | Our favorite budget nugget: The FDA endorses accelerated approval reforms The White House budget almost never becomes law, but it does give policy wonks a glimpse of what agencies want from lawmakers. This year, one pitch from regulators caught our attention: The FDA is asking Congress for more authority to crack down on drug makers abusing the so-called accelerated approval pathway. FDA’s request, if enacted into law, would allow the agency to condition their approval on drug makers demonstrating that the required follow-on studies are “adequately designed … and can be completed in a timely manner.” The proposal would also give the FDA clearer ways to pull accelerated approval drugs off the market. The FDA’s proposal isn’t as far reaching as a new bill from Rep. Frank Pallone (D-N.J.), which would automatically pull a drug off the market if it didn’t complete its follow-on studies. Nonetheless, it is the latest sign of the growing push for reforms of the pathway – and one of the clearest signs to date that even the FDA believes reforms are needed. | The FDA’s ongoing spat with ALS advocates is about to get a lot more contentious For years, ALS advocates have accused the FDA of keeping promising new drugs for the deadly condition off the market. And surprise, surprise: An FDA meeting scheduled for this Wednesday is about to reignite that long-simmering feud. Briefing documents for the meeting, which is focused on whether to approve a new ALS drug from Amylyx Pharmaceuticals, reveals that the agency isn’t giving the drug its ringing endorsement. While ALS advocates are convinced the drug should be approved, the agency is concerned that the company’s Phase II data “may not be sufficiently persuasive” to grant an approval. Already, advocates are calling foul. Brian Frederick, a spokesperson for the ALS Association, told STAT in a statement that the group was concerned by the new documents. He also argued that the company’s existing clinical trial data should be enough for the FDA to let ALS patients access the drug. You can also expect the FDA will get an earful from ALS advocates during the hour and a half “open public hearing” period of Wednesday’s meeting. My colleague Adam Feuerstein and I will be live blogging the meeting for STAT, so stay tuned. | What keeps CMMI Director Liz Fowler up at night Want to get inside the head of Liz Fowler, the director of the Center for Medicare and Medicaid Innovation? Check out my colleague Rachel Cohrs’ interview with Fowler on the heels of her selection as part of the inaugural STATUS list.
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