| Drug companies are really going through it. In the last several weeks, their efforts to derail Medicare drug price negotiations hit a wall at the Supreme Court, just as the Trump administration considers bolstering the program and Democrats push to expand it. Now, the administration is also one step closer to implementing a mandatory pilot that would penalize manufacturers for charging higher prices in the United States for certain drugs in the Medicare Part D program than in other wealthy nations. A finalized version of the so-called GUARD model, which is part of President Donald Trump’s most-favored-nation (MFN) drug pricing push, landed at the Office of Management and Budget for review Tuesday. It’s not clear whether the administration made any changes to the proposed version, which had garnered significant opposition from drugmakers. The GUARD model won’t hit every drugmaker equally, but it widens the government’s pricing arsenal in ways that have spooked pharmaceutical companies. In terms of how the industry is taking the most recent development, one lobbyist texted me — unprompted — with just two expletives to describe their feelings about the situation. (I’ll let you imagine which ones.) → But this is likely just the beginning. The pharmaceutical industry had thought that “the drama is over,” said Chris Meekins, an analyst at Raymond James, following the slate of most-favored-nations deals some drugmakers cut with the Trump administration and the enactment of the Medicare drug price negotiation program a few years ago. “And the reality is, with the Trump administration, there is almost always another shoe to drop,” he said. “What should have [drug companies] concerned is not just all the regulatory actions they can then try to challenge in the near term,” but the potential legislative actions from Democrats, Meekins added. → On that note: Sen. Ron Wyden (Oregon), the top Democrat on the Senate Finance Committee, released a 42-page request for information Tuesday that outlined what could become the party’s next-generation drug pricing agenda if Democrats regain power. Brian Reid, a pharmaceutical consultant, called it “one of the foundational documents we’ll talk about for the next few years.” → Democrats are floating ideas to negotiate the prices for more drugs each year, shorten the period before drugs become eligible for negotiation and incorporate prices paid in other wealthy countries into Medicare’s negotiating process — an idea Trump has frequently championed. Even if there’s not a high likelihood of an alliance between Trump and Democrats on certain drug pricing policies, Meekins said, the likelihood “is also not zero, and that’s the problem.” “The [pharmaceutical] industry and investors are going to have to navigate the reality that there’s going to be bipartisan action on this,” he tells me. BUT WAIT THERE’S MORE The Centers for Medicare and Medicaid Services last week proposed the first permanent regulations for the Medicare drug price negotiation program created under the Inflation Reduction Act. The proposal would transition the program from temporary guidance documents to a formal regulatory structure beginning in 2029, when Medicare is scheduled to negotiate up to 20 drugs each year. “We are moving from annual updates to a permanent, predictable framework,” said CMS Administrator Mehmet Oz in a statement. The administration said the move would create “a more transparent and sustainable process for lowering drug costs for millions of Medicare beneficiaries.” → CMS also proposes changes intended to prevent manufacturers from delaying negotiations through certain product reformulations, closing what the agency called a “loophole.” The industry, however, has said that this could stifle innovation. Comments are due Aug. 17. There are several other things to keep an eye on in this space. - Drug manufacturers had until last week to apply for participation in the GENEROUS model, a Trump administration voluntary pilot testing MFN-style pricing in Medicaid. It’s unclear how many companies signed up, but CMS had previously extended the deadline, citing strong interest. CMS tells me it will be announcing which manufacturers are participating this “summer.”
- CMS still needs to submit the GLOBE model, which would impose MFN pricing in Medicare Part B, to the White House for review.
- The Senate’s health committee is considering legislation Wednesday that would tighten rules for citizen petitions filed with the Food and Drug Administration, which critics argue brand-name drugmakers abuse to extend their patents and delay the release of generic versions.
- While the Supreme Court declined to hear several drugmakers’ challenges to the Inflation Reduction Act, there’s still ongoing litigation. Federal courts have repeatedly rejected claims from drugmakers that the program is unconstitutional, but if one of the ongoing cases tilts in their favor, it could create a circuit split that could nudge the Supreme Court to step in.
| “It tells us that these vaccines have actually brought beneficial effects even in people who don’t really know that they actually have contracted covid-19.” Ziyad Al-Aly, a physician-scientist and senior clinical epidemiologist at Washington University in St. Louis. | | | | That’s a quote from a story by The Post’s Daniel Wu regarding a study that showed the covid vaccine reduced the risk of major cardiovascular events linked to covid-19 by roughly 40 percent. Al-Aly is a co-author of the study. - The study was conducted among about 1 million veterans who used the Department of Veterans Affairs health system between 2024 and 2025.
- The research compared those who took the seasonal influenza vaccine and those who opted to take both the flu vaccine and the updated covid-19 vaccine that season. The research reviewed multiple types of vaccines, including mRNA shots and Novavax.
- It showed that the vaccine sharply reduced the risk of strokes, heart attacks and hospitalization from heart disease linked to covid-19.
- The evidence suggests that the shot could also modestly reduce cardiovascular conditions, hospitalizations and deaths of all causes — even ones not linked to covid.
Read the full story: “Covid vaccine linked to broad protections against heart conditions, study finds.” More than 40 medical technology CEOs and senior executives are in Washington this week for AdvaMed’s annual fly-in, scheduled to have 30 meetings with lawmakers, White House officials and federal agencies on Wednesday. → The industry plans to push for relief from medtech tariffs and policies that would speed Medicare coverage of FDA-approved technologies, arguing that lengthy coverage delays hinder patient access and discourage innovation. “Battleground Iowa House race takes bizarre turn with alleged RFK Jr. intervention,” Politico’s Samuel Benson reports. “Danone US Sues Chobani Over High-Protein Yogurt Labeling Claims,” Kristina Peterson writes at Bloomberg. “Backed by Threat of Clawbacks, Feds Wield Tight Grip on $50B Rural Health Fund,” report Sarah Jane Tribble and Arielle Zionts at KFF Health News. “Mass. wheelchair users wait months for simple repairs. Critics say private equity is to blame,” Meghan Smith writes for GBH News. This newsletter is published by WP Intelligence, The Washington Post’s subscription service for professionals that provides business, policy and thought leaders with actionable insights. WP Intelligence operates independently from the Washington Post newsroom. Learn more about WP Intelligence. | 
