An insider's guide to the politics and policy of health and medicine, from STAT's team in Washington.  | August 15, 2023 Check out STAT+ | | --- | | | | --- | | Sponsored By   | | --- | | By Sarah Owermohle Reporter, D.C. Diagnosis Writer | | --- | | Hello and happy Tuesday, D.C. Diagnosis readers.  Here are some resources to aid Maui residents amid the fallout from the fires. As always, send news and tips to sarah.owermohle@statnews.com. | | --- | | Medicare drug pricing Ready, set, motion The government has filed its first paperwork revealing how it plans to defend Democrats’ new Medicare drug price negotiation program from an onslaught of lawsuits filed by pharmaceutical companies. The filings came on Friday in the Chamber of Commerce’s suit in a district court in Ohio, where the Chamber had requested a preliminary injunction by Oct. 1, my colleague Rachel Cohrs reports. The government opposed the preliminary injunction, and also filed a motion to dismiss the lawsuit entirely. The Department of Justice argues that the federal government has the right to set drug prices, because other agencies, including the Department of Veterans Affairs, have similar programs. The government also implies that the Chamber doesn’t have standing to file a lawsuit and that participation in the Medicare program is voluntary,  “The public’s interests would be gravely disserved by acceding to Plaintiffs’ premature efforts to take down the entirety of the Negotiation Program—which achieves a longstanding goal of controlling skyrocketing Medicare spending and making drugs more affordable for seniors—before that program even begins,” the government attorneys wrote. FDA on food FDA salt debate peppered with racial implications Patient advocates warn that a recent FDA proposal on salt intake could inadvertently kill those with kidney disease, particularly Black Americans. The problem, they say, is a salt substitute whose use would inevitably be increased — potassium chloride. The draft regulation, unveiled in April, would let makers of a range of popular food products like ketchup, asiago cheese, and white bread use salt substitutes that were restricted before, Nick Florko reports. But kidney advocacy organizations argue that has dangerous implications for chronic kidney disease patients who can’t properly break down potassium. Too much potassium in the blood can lead to sudden heart failure. It’s especially tricky because an estimated 90% of people don’t even know they have chronic kidney disease. But experts do know that Black Americans have historically higher rates. Still, kidney advocates are up against a big public health argument: Millions of deaths worldwide are caused by excess salt intake. More from Nick. Drug shortages Paging the drug shortage panel  Lawmakers are drafting legislation to stem ongoing shortages of cancer medicines and other drugs. One problem: There’s been no contact with the White House’s group tasked with the very same problem, and it’s not clear whether that panel is prepping policy recommendations of its own, our John Wilkerson reports. President Biden formed the task force at the beginning of 2023 to deal with persistent drug shortages. The group held a rare in-person meeting with pharmacists and industry experts a little over a week ago, as John scooped. It didn’t provide much clarity. In fact, at least some lawmakers working on drug shortage policies, like Sen. Bernie Sanders (I-Vt.), don’t even know who is running the White House task force.  In the meantime, nearly every hospital pharmacy has reported shortages this summer. A third are rationing, delaying, or canceling treatments and procedures because of drug shortages as a result. More on that here. | | --- | --- | | | --- | --- | drug pricing Can drug prices be both too high…and too low?  There’s a long-running paradox in the American drug industry: High-priced, heavily patent-protected drugs are a rampant problem earning the ire of lawmakers and patient groups alike. On the other end, generic drugs can sometimes be too cheap, resulting in manufacturing gaps and shortages like the current chemotherapy crisis. What is the solution? It doesn’t quite lie with the Inflation Reduction Act’s Medicare negotiation plan, which could exacerbate the issue, STAT’s Matthew Herper theorizes. And the Hatch-Waxman Act didn’t get it right, either. Matthew lays out the problems and some potential solutions, like more steady pricing, in a new column. Read here. Speaking of drug prices, and who regulates them: Senate HELP Chair Bernie Sanders is misdirecting his drug pricing ire by holding up the nomination of Monica Bertagnolli as NIH director, University of Chicago professor Mark Ratain writes in a First Opinion essay out this morning. But NIH does have ways to reduce spending through comparative clinical trials. Read more here. | | --- | --- | More around STAT | | --- | | | | --- | | | | --- | | | | --- | | Check out more exclusive coverage with a STAT+ subscription Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles. | | --- | --- | What we’re reading In the case of a devastating disease, the FDA weighs an experimental drug’s muddled data and a desperate need, STAT Should opioid settlement money be spent on law enforcement? The New York Times Kim Kardashian sparks debate on the benefits of full-body MRI scans, STAT We’re on the cusp of another psychedelic era. But this time Washington is along for the ride, Politico | | --- | --- | # Thanks for reading! More on Thursday, | | --- | | ![](https://marketing.statnews.com/hs-fs/hubfs/email-templates/signatures/signature-sarah-owermohle.png?noresize&upscale=true&width=230&upscale=true&name=signature-sarah-owermohle.png) | | --- | | @owermohle | | --- | | sarah.owermohle@statnews.com | | --- | --- | Enjoying D.C. Diagnosis? Tell us about your experience Continue reading the latest health & science news with the STAT app Download on the App Store or get it on Google Play | | --- | | | | --- | |              STAT, 1 Exchange Place, Boston, MA ©2023, All Rights Reserved. I no longer wish to receive STAT emails | | --- | | Update Newsletter Preferences     •    Contact Us     •    Advertise with Us     •    View in Browser | | --- |