A bipartisan group of lawmakers grilled drug industry leaders at a House Energy and Commerce Health Subcommittee hearing on Wednesday, signaling new legislative efforts to address drug affordability. Nine witnesses representing PBMs, manufacturers, biotech firms and generic drugmakers testified as committee members explored ways to lower prescription drug costs. 

PhRMA’s Lori Reilly pointed to PBM business practices as driving independent pharmacies to close, calling the supply chain “convoluted.” David Marin, the new CEO of the PBM trade group PCMA, fired back by accusing other sectors of “wildly” misrepresenting PBMs and said his industry has “failed” to explain their role to policymakers.

Subcommittee Chair Morgan Griffith, R-Va., pressed Marin on market consolidation, noting that three PBMs – CVS Caremark, Express Scripts and OptumRx – control 80% of the market. Committee Chair Brett Guthrie, R-Ky., emphasized that “historic PBM reform is just the beginning” and more changes are needed.

Griffith said he hopes to mark up vaccine affordability legislation before Memorial Day, though bipartisan cooperation may prove difficult.

Indeed, Democrats used the hearing to raise concerns about President Trump’s “opaque” Most Favored Nation drug pricing deals with individual pharmaceutical companies, which the president would like to codify into law. Griffith agreed to work with Ranking Member Frank Pallone, D-N.J., to seek more transparency about these agreements while BIO CEO John Crowley warned that mandatory MFN pricing would impede innovation and risk bringing socialized medicine to the United States.

– Leslie Isenegger, Head, Client Development, RC Resolve

Only about 4% of applications for approval sent to the FDA are rejected without a review, usually due to the absence of vital information. However, a controversial FDA leader reportedly overruled experts at the agency to issue a “refuse-to-file” letter for an mRNA seasonal flu vaccine developed by Moderna.

Moderna shared on Tuesday that it had received the letter despite several meetings with the agency to ensure compliance with requested data on the candidate, mRNA-1010. Moderna conducted a 40,700-person clinical trial to assess the vaccine’s safety and efficacy, including data requested by the FDA that compared mRNA-1010 with an approved high-dose flu vaccine.

Dr. Vinay Prasad, director of the FDA’s biologics center, apparently issued the letter personally on grounds that Moderna failed to conduct an “adequate and well-controlled trial.” HHS issued a statement standing by Prasad, who is also facing allegations of workplace harassment and financial impropriety according to media reports.

The rejection of Moderna’s letter is considered by many to be among the most drastic actions taken by the FDA in recent months, adding to a “cloud” cast by the Trump administration that experts say could have a chilling effect on vaccine innovation.

In the past three days, Prasad and the rejection have drawn strong rebukes from editors and columnists at The Wall Street Journal, Bloomberg, STAT and BioCentury.

– Andrew Wishon, Senior Manager

We recognize the title is a loaded question, and the answer you get is entirely dependent on who you ask, what side of the aisle they sit on, and whether they have a stake in it. Since last week’s TrumpRx flashy website launch, hot (and not-so-hot) takes continue to roll in about the impact of the platform:

Democrats = unsurprisingly and unabashedly critical

• Congressional Democrats released a report pointing to cost savings of already-available generic drug options, arguing that TrumpRx may actually result in patients paying more for their medicines. Senator Maggie Hassan, D-N.H., accused the Trump administration of helping “Big Pharma line its pockets.”
• Meanwhile, Senator Ron Wyden, D-Ore., called the site a “glorified coupon book“ with “all roads in TrumpRx [leading] to Trump’s pocket.”

Business and trade media = driving narrative around limited impact

• STAT conducted its own analysis of the drugs available through TrumpRx compared to alternative DTC purchasing avenues and discovered more than half have generic substitutes that can be purchased cheaper elsewhere.
• Based on KOL commentary, other outlets report that TrumpRx’s impact will be limited to weight-loss and fertility drugs, where experts suggest these “might be a good deal.”

People involved in TrumpRx = best thing since sliced bread

• Administration officials have taken to conservative outlets to tout the initiative. HHS Secretary Kennedy told Fox News that “President Trump took on Big Pharma – and delivered.” CMS Administrator Oz told NewsNation that “everyone could benefit from TrumpRx.gov” and highlighted how the site mitigates the game-playing of middlemen.
• Wendy Barnes, CEO of GoodRx (the “integrated pricing source on TrumpRx for Pfizer), praised TrumpRx for “shining a spotlight on the idea that consumers do have power when it comes to shopping for drug pricing is a lesson that we’re learning as Americans.” She said, “At present, I rate it positively from our perspective because it expands our reach and aligns with our mission.”

While none of the industry reactions are shocking, we drug pricing nerds appreciate the nuance (and pithiness) that some lawmakers and media are bringing to the dialogue. As for this duo, we will be watching closely for the president’s inevitable middle-of-the-night Truth Social clapback at Mark Cuban. (Mark, never change.)

– Terri Pollock and Regan Thompson, CPPA

• Feb. 16 – a U.S. federal holiday since 1879, Presidents’ Day

• “For now, TrumpRx looks less like the disruptive change it was marketed to be and more like window dressing on a system the administration prefers to operate within rather than overhaul.” – Jeffrey Sonnenfeld et al., Fortune
• “A well-intentioned but misguided crackdown on generics produced in foreign manufacturing facilities won’t make Americans safer. It will simply make essential medicines harder to obtain for most Americans.” – Ken McEldowney, The Well News
• “The weight-loss market is a special case shaped by conditions that don’t exist elsewhere in the drug industry, not least of which is the mass appeal of the product. But it also reveals what happens when consumers have more agency and more transparent prices. It is a lesson pharmaceutical companies are unlikely to forget.” – David Wainer, The Wall Street Journal

• German pharma lobby group Pharma Deutschland warned that new U.S. drug price regulations could prompt drugmakers to demand higher prices in Germany or delay launches there. Reuters: German drugmakers lobby says US price rules will challenge domestic market.
• AstraZeneca CEO Pascal Soriot said the recent drug pricing deal between the U.S. and UK is a “very positive step” but will not be sufficient to restart a paused £200m investment in Cambridge, England. The Guardian: AstraZeneca CEO hails NHS drug price deal but keeps pause on £200m UK investment.
• Pharma’s 2026 Super Bowl ads focused on building trust and cultural relevance over direct clinical claims, with Novo Nordisk’s star-studded Wegovy pill spot and Novartis’ prostate cancer awareness campaign scoring high in engagements and likability. Fierce Pharma: Pharma’s 2026 Super Bowl ads: Novo’s Wegovy pill spot is engagement MVP, while Novartis scores ‘likeability’ touchdown.
• Pharma companies excluded from Trump’s initial drug pricing deals are reaching out to the White House and CMS to craft their own agreements to avoid potential tariffs and Medicare price-setting demos. Reuters: Pharma companies left out of Trump’s drug-pricing deals look for way in.
• Nearly a dozen mature biotech companies formed the Midsized Biotech Alliance of America to protect their interests amid the Trump administration’s drug pricing policies, arguing they face existential threats from MFN pricing requirements. STAT: Biotechs, wary of being tied to Big Pharma, form new industry group as hedge against Trump policies.
• Sen. Bill Cassidy, R-La., requested information from Apexus about its profits and business practices related to the 340B program after a media investigation found the firm had $227 million in revenue with profit margins above 80%. The New York Times: Senate Questions Health Care Firm for Profiting Off Program Meant for Poor.
• Lawmakers signaled additional actions on the horizon following recent PBM reforms, with legislators on the table taking aim at group purchasing organizations. Modern Healthcare: Congress just whacked PBMs. Some want a second shot at GPOs.
• As of late 2025, about 39% of commercially insured lives were enrolled in plans with copay accumulators or maximizers, which divert manufacturers’ copay support away from patients and toward plans and PBMs. Drug Channels: Copay Accumulators and Maximizers in 2025: Popular, Profitable, and Problematic.