A CDC reform scoop, Merck’s potential exit strategy, & Califf’s tough talk at BIO

An insider's guide to the politics and policy of health and medicine, from STAT's team in Washington. 

June 8, 2023 Check out STAT+

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By Rachel Cohrs Reporter, D.C. Diagnosis Writer

Happy Thursday, D.C. Diagnosis readers! Just a reminder to snag your spot for my virtual conversation with Sen. Chuck Grassley about PBM reforms on Capitol Hill on June 21 at 1 p.m. ET. News tips as usual rachel.cohrs@statnews.com, and stay safe out there!

CDC reform Republicans say CDC Covid answers aren't enough Rep. Morgan Griffith (R-Va.) at a hearing in Jan. 2022. (ANNA MONEYMAKER/GETTY IMAGES) E&C Committee Republicans aren't happy with the CDC's reorganization plans, or its efforts to explain them. In a divided Wednesday hearing on the agency's Covid-19 response, various GOP lawmakers called its four-page response to a litany of questions "insufficient" and "unsatisfactory." In the letter, which my DCD co-author Sarah Owermohle scooped, HHS Assistant Secretary for Legislation Melanie Ann Egorin denied both that a February reorganization announcement was a "large-scale" change and that it happened "behind closed doors." She insisted that the agency has shared plenty from the internal review it embarked on last spring (Republicans argue that online review reports are a "summary" and they want all the feedback from staff and external groups). Egorin also shared that Director Rochelle Walensky had held 13 all-hands meetings since her arrival, as an example that the director was embedded in the process. But Walensky leaves the agency this month and GOP lawmakers are promising more questions, and more hearings, for her replacement — reportedly former health official Mandy Cohen. drug pricing The drug price negotiation exit strategy Merck didn't mention Merck in its lawsuit against the federal government over Medicare's new drug price negotiation program complained that it would be hard to withdraw its drugs from the program, and that the monetary penalties for bucking the negotiation process would be astronomical.  But Anna Kaltenboeck, who helped write the Inflation Reduction Act as an adviser to Democrats on the Senate Finance Committee and who now is head of ATI Advisory's prescription drug reimbursement practice, told my colleague John Wilkerson that drug makers actually have another off-ramp as well that Merck didn't mention: allowing generic competition on the market. She highlighted that Merck fought tooth and nail against generic competitor Viatris in a patent dispute over its diabetes drug Januvia, which is likely to be one of the medications first up for Medicare negotiation — and the settlement happened in September, a month after the IRA passed. Merck settled with nearly two dozen drug makers who wanted to make generic versions of Januvia.  There have been mixed reviews about the new law's potential impact on the generic industry. Some, including the generics lobby, argue that it will hinder investment in generic drugs because margins would be lower and the timeline would have to be faster to market to maximize profits. But others maintain the threat of government negotiation provides a greater incentive for brand drug makers to allow generic competition on the market, my colleague John explains. congress Cassidy explores stopping FDA drug review delays Senate health committee ranking member Bill Cassidy (R-La.) is thinking about how to make sure the FDA is meeting its drug review deadlines on time, he told my colleague John Wilkerson. At issue are the product review deadlines that the FDA must meet in return for receiving industry user fees. Cassidy said the agency sometimes "technically" meets deadlines by requesting additional information at the last minute, which extends the timeline. Read on to find out which types of drugs are most affected by these deadline extensions.

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capitol hill Alzheimer's drug issues rankle Democrats Ahead of tomorrow's FDA advisory committee considering Eisai and Biogen's new Alzheimer's treatment Leqembi, a few congressional Democrats are blasting HHS over its plans to handle a full FDA approval this summer.  Senate health chair Bernie Sanders (I-Vt.) is sounding the alarm over the drug's $26,500 price tag, and calling on HHS to use march-in rights to invalidate Eisai and Biogen's patent, or create a new CMMI demonstration project to pay for the drug at a lower cost.  Reps. Anna Eshoo (D-Calif.) and Nanette Barragán (D-Calif.) criticized Medicare officials for barely releasing any details last week about how its longstanding plan to create a patient registry would work, as the drug could be approved within this month. Medicare first announced its plans to use a patient registry as a condition of coverage for fully approved Alzheimer's treatments in April 2022. fda Califf takes tough stance at BIO When FDA Commissioner Rob Califf attended BIO's conference in Boston this week, he made no attempt to apologize for the Biden administration's position on drug pricing, my colleague Jason Mast reports. "We don't agree," said Califf, referring to a conversation he had backstage with Ted Love, the new chair of the Biotechnology Innovation Organization. "I think the prices of drugs are too high in the U.S." Read Califf's full comments about how the U.S. drug pricing system is broken compared with the rest of the world. influence The digital therapeutics industry descends on Capitol Hill Often, a nascent digital therapeutics company will live or die depending on the decisions of bureaucrats in Washington. The industry's biggest trade group is taking fate into its own hands and lobbying Congress this week for a bill that would compel Medicare to create a way to pay for software-based medical treatments cleared by the FDA, my colleague Mario Aguilar writes. There's a bit of damage control, too. The coalition, which has over 100 members including startups and top pharmaceutical companies (think AstraZeneca, Novartis, and Pfizer, among others), is eager to show there's momentum behind the bill in the wake of the bankruptcy of Pear Therapeutics, a prominent digital therapeutics company that earned the first FDA clearance for a prescription app in 2017. Read more.

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Thanks for reading! More next week,

@rachelcohrs

rachel.cohrs@statnews.com

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