| | | |   | | | Hello, D.C. Diagnosis readers! I have some big news. This will be my last edition as an official co-author of this newsletter. It’s been a privilege to show up in your inboxes every Tuesday. I hope you’ve found this newsletter full of exclusive reporting that actually helped you better navigate – or at least understand – Washington policymaking.
Don’t worry, D.C. Diagnosis will continue. (Dare I say it will be stronger than ever!) Stay tuned for some news on Rachel’s next co-author. For the next few weeks, though, she’ll anchor the newsletter with some help from a host of other great STAT reporters.
And I’m not going anywhere: starting Monday, I’ll be STAT’s inaugural reporter on the commercial determinants of health, a new beat that will let me dig into the ways all sorts of industries shape public health — including tobacco companies, dietary supplement makers, even food marketers. Plenty of that involves D.C., so you’ll be seeing lots of my reporting in this newsletter. If you have a tip for me on this new beat, please send it my way! Bonus points for topics worth longer investigations, which will be a lot of my focus. I’m at nicholas.florko@statnews.com. | A lobbying fight to test pharma’s might  (Alex Hogan/STAT) The pharmaceutical industry is notorious for its lobbying prowess. It has deep pockets, aggressive tactics, and a nearly spotless record killing legislation that drug makers despise. But the next few weeks in Washington are going to be the biggest test of that power in at least a decade. Democrats are barreling toward a vote on major drug pricing legislation as soon as next week. My colleague Rachel Cohrs has a rundown of the tools the pharma lobby is pulling out to stop them — ad buys, campaign giving, and good old shoe-leather advocacy, to name a few. Despite the last-minute scramble, there’s a sense of impending doom among some drug industry lobbyists that their best efforts might not be enough this time to stave off defeat. “For us as an industry, the question is, ‘What can we do?’ The answer is grab some popcorn and sit on the sidelines,” one drug industry lobbyist said. Read Rachel’s full opus here. | Another last minute campaign catching our attention A group of biotech investors and CEOs has been blitzing Senate offices this week requesting a major last minute change to Democrats’ drug pricing bill. It’s not a little technical tweak: The group is pushing lawmakers to massively alter how the federal health secretary decides which drugs to target for price negotiation.
They say the bill’s current language – which allows price negotiation for so-called small molecule drugs after 9 years and biologics after 13 years – would shift research and development “from low-copay, easy-to-genericize pills to higher-copay, harder-to-copy injectables, and saddle patients with even more costs.”
More than 1,000 biotech investors, patients, and CEOs have signed onto the push, but it’s an unusual argument for most of those folks, who are known for taking big bets on the type of hard-to-copy drugs that can garner six- and seven-figure price tags. | Assessing the benefits of treatments starts with alignment on the value they bring When it comes to defining, measuring and communicating the value of our medicines, we need a framework that uses a more holistic set of attributes that are transparent and meaningful to patients, health care providers, payers and society. Learn more about how Genentech is working to help all stakeholders fully understand a treatment’s total impact to ensure we get the right treatments to the right patients. | Covid-19 was good to pharma  (Courtesy Harris Poll) Nearly three-quarters of Americans give the drug companies that developed and commercialized Covid vaccines and therapeutics credit for helping contain the coronavirus pandemic, according to a new survey conducted by Harris Poll for STAT. That’s an awfully rosy headline for drug makers, who have long been considered one of the most hated industries in America. In fact, those surveyed gave pharma more credit than organizations like the CDC and the White House, or pharma’s biggest nemesis: health insurance companies. But the poll is already chafing some drug industry critics, who argue the federal government, not companies like Pfizer and Moderna, deserve credit for developing Covid-19 drugs and vaccines. For more, check out my new story for STAT here. | First in DCD: Senators demand answers about prisons’ scant use of Covid drugs Fourteen senators, including Sens. Ben Cardin (D-Md.), Ron Wyden (D-Ore.), and Elizabeth Warren (D-Mass.) sent a letter yesterday to the federal Bureau of Prisons requesting a slew of information about the agency’s lax use of Covid-19 therapeutics.
The letter cites STAT’s exclusive reporting showing that the BOP, which houses more than 140,000 people, only prescribed roughly 350 Covid-19 drugs as of March 2022. The lawmakers wrote a similar letter to Immigration and Customs Enforcement, which has been repeatedly criticized for testing shortfalls and inadequate vaccination efforts.
For more, check out my story here. | First in DCD (Pt. 2!): FDA acknowledges challenges regulating synthetic nicotine Synthetic nicotine makers were supposed to submit applications to the FDA for their products back in May — and the FDA doesn’t currently know how many failed to do so, according to a new letter from Commissioner Robert Califf shared first with STAT. That means the agency doesn’t know how many products have been marketed illegally for the past two months. Califf writes that he is personally "deeply committed" to regulating these products and that the FDA is working to identify all the products in the category, but that it’s been a "very challenging task for a number of reasons,” including having to rely on reviewing websites and conducting inspections to gather what type of products vaping companies are actually selling. Califf’s remarks are striking given he had previously promised another lawmaker that the FDA would have a handle on this two months ago. “By mid-May we should pretty well have this cleared up with those who shouldn’t be on the market off of it – or at least getting warning letters,” Califf told Sen. Tammy Baldwin in a Senate Appropriations hearing in April. Califf also notes in his letter that his recently announced " intensive review" of the FDA's tobacco work will probe how to "optimize" the FDA's enforcement efforts, including on synthetic products. The letter went to Sen. Dick Durbin (D-Ill.), who launched a probe into the FDA’s oversight of synthetic nicotine following a STAT report that showed the FDA had not gone after any companies yet. | What we're reading - White House to launch effort to develop next generation of Covid vaccines, STAT
- Interstate abortion travel is already straining parts of the system, New York Times
- A troubling report on Cerner’s VA rollout offers a rare look into the hidden harms of health records, STAT
- Covid-19 lab companies retrench as rapid tests take over, Wall Street Journal
- GOP lawmakers seek answers about defunct NIH oversight committee, STAT
- ‘No magic bullet’: For drugmakers and the FDA, clinical trials on ultra-rare diseases pose thorny challenges, STAT
| Thanks for reading! More Thursday,  | | | |
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