| | | |   | Hello, D.C. Diagnosis readers. If you’re in the nation’s capital, I hope you had a lovely sunny weekend … and that you didn’t already put your winter coat away like I did. May I suggest you check out this new piece from the New York Times editorial board on the need to reform the patent system? Talk about a scathing rebuke of drug makers. I’m at nicholas.florko@statnews.com. | | | Your quarterly dose of lobbying gossip It's almost the best day of the year for pharma reporters: tomorrow is the deadline for lobbyists to file their first quarter reports with Congress, and disclosures are already starting to trickle in. Here’s what’s catching our attention:
Biogen’s head-scratching hire — and other Alzheimer’s advocacy moves
Biogen, the company behind the embattled Alzheimer’s drug Aduhelm, has hired a new lobbyist focused on Alzheimer’s advocacy, but he’s not necessarily the type of expert you’d expect. In fact, he doesn’t represent any other drug makers.
The lobbyist, William Clyburn Jr. of Clyburn Consulting, focuses primarily on telecommunications and transportation, according to his biography, (though it’s also worth noting that his father is the cousin of House Majority Whip Jim Clyburn). His current clients include a Virginia-based IT company that has gotten into the business of Covid-19 testing, the advocacy arm of the Campaign for Tobacco-Free Kids, the cities of Charleston and Aiken, South Carolina, and the operator of the airport in Jackson, Mississippi. It’s hard to know what Clyburn will be lobbying on exactly — Biogen’s disclosure lists a single, cryptic topic: “Alzheimer's disease and treatment.”
UsAgainstAlzheimer’s also hired Fulcrum Public Affairs. Genentech and Eli Lilly, which are working on similar Alzheimer’s drugs, are both paying Bryant Hall of Tiber Creek Health Strategies to lobby on Medicare’s recent Alzheimer’s coverage decision, according to new disclosures. Hall was already on both drugmakers’ payroll, but he previously was only listed as lobbying on issues related to drug pricing, more generally.
The latest biotech to spend big in Washington
Lantheus Holdings, which makes some injectable radiopharmaceuticals used in medical imaging procedures, spent $250,000 on lobbying in the first three months of 2022. That’s nearly $100,000 more than it spent on lobbying over the same period last year.
Why? It looks like they’re having some trouble with the FDA. For the first time, the company listed “Possible legislation to clarify FDA regulatory status for imaging contrast agents” as one of its advocacy issues.
Alnylam hires on Covid-19 vaccines
Alnylam, the Cambridge-based biotech, has also hired a crew of lobbyists from Tiber Creek Group to advocate on “issues related to Covid-19 vaccines.” Though Alnylam doesn't actually have a Covid vaccine, the company recently sued both Pfizer and Moderna claiming the companies’ vaccines infringe on Alnylam’s patents. | The 6 big Covid-19 mysteries scientists are still trying to unravel Curious about what the next Covid wave will look like? Or whether we will ever have a pan-coronavirus vaccine?
You’re not alone. Those are some of the mysteries scientists are still grappling with more than two years into the Covid-19 pandemic.
Five of STAT’s star science reporters made a valiant effort to answer those questions and more in a new story for STAT. As they write, the “eventual answers will determine our relationship with Covid and and how we’ll fight a future pandemic.”
Check out the new story here. | Drug manufacturers are giving more in rebates to payors, annual pricing report reveals Responsible pricing action is at the heart of patient-centricity. In its annual U.S. Pricing Principles report, Sanofi disclosed it gave back 49% of its gross sales in rebates to payors in 2021 — and delivered lower net prices for its prescription medicine portfolio for the sixth consecutive year — but those discounts aren’t reaching patients. Read the report to learn more. | Hospitals are drastically marking up the prices of cancer drugs I thought I had heard every drug pricing horror story imaginable. But this statistic even made my jaw drop: Some of the nation’s top cancer hospitals jack up the price of the prostate cancer drug leuprolide by a whopping 600%, my colleague Bob Herman reports in a new story for STAT.
And that’s not the only drug seeing massive markups: Fifteen other drugs carry markups of at least 200%, according to an analysis recently published in the Journal of the American Medical Association.
For more from STAT’s wizard on all things hospitals and insurance, check out Bob’s new story here. | An in-depth investigation into the FDA’s breakthrough device program Lawmakers set up a new program five years ago that was supposed to help speed innovative new medical devices to market, but as my colleagues Katie Palmer and Mario Aguilar write in a new investigation, “while the program has delivered big benefits to companies making devices, its value to patients is still far from clear.”
Katie and Mario spent months digging into the FDA program and uncovered some eyebrow-raising facts, including that the FDA doesn’t actually require breakthrough devices to prove they are superior to existing devices before granting them approval. But we at D.C. Diagnosis were particularly tickled by how much device companies swarmed to the new program after the Trump administration proposed having Medicare automatically cover any device approved through the pathway — a proposal now being actively considered as part of the Cures 2.0 legislation. It’s not everyday you get an industry executive to call a regulatory perk a “golden ticket.”
Check out Katie and Mario’s investigation here.
And want to do some digging into the companies that have benefited from the breakthrough designation? STAT has also compiled the first comprehensive tracker of devices receiving the designation here. | | | Thanks for reading! More next week,  | | | |
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