Welcome to the Week in Review.

New FDA Move Set To Hinder Big Pharma’s DTC Advertisements

The FDA is expected to strengthen transparency and warning requirements for direct-to-consumer (DTC) prescription drug advertisements as part of the administration’s 2026 regulatory agenda – a move that could make ads increasingly difficult and costly to air – even if it falls short of an outright ban. That shift is significant given how effective DTC advertising is: even small increases in ad spending are associated with major jumps in drug sales. At the same time, lawmakers have advanced proposals like the bipartisan, P4ADNow-endorsed No Handouts for Drug Advertisements Act, which would eliminate tax breaks that subsidize this marketing. Together, these efforts signal growing momentum to rein in a practice – unique to the U.S. and New Zealand – that prioritizes industry profits by encouraging the overprescribing of expensive brand-name products, often while downplaying potential side effects. — [POLITICO, OMB, Axios, TIME, Washington Examiner, Sen. Hawley]

Judge Blocks Colorado PDAB and Enbrel Price Relief

A federal judge has temporarily blocked Colorado’s Prescription Drug Affordability Board (PDAB) from implementing a price cap on Enbrel, halting a first-in-the-nation effort to rein in the cost of high-priced prescription drugs through upper payment limits. The policy would have capped the drug at $600 per week, compared to a monthly list price of over $7,000. The ruling comes as the pharmaceutical industry continues to challenge state-level affordability efforts, with Enbrel manufacturer Amgen praising the decision. For Colorado patients who rely on Enbrel, the pause means continued exposure to high and unaffordable prescription drug costs while the case moves forward. The decision underscores the ongoing legal and political barriers facing efforts to lower drug prices – even as states attempt to take action. — [STAT News, CMS, Colorado Sun, Endpoints News]

HIV Drug Costs Set to Surge for Medicare, EPIC Would Make It Worse

The cost of HIV drugs for Medicare is projected to nearly triple over the next decade, rising from $6.4 billion in 2026 to $17.8 billion by 2035, according to a new study. The analysis finds that the high cost of antiretroviral therapy — not other health conditions — is the primary driver of spending for older Americans living with HIV. These findings reinforce concerns previously raised by P4AD: drugmakers continue to raise prices on HIV treatments while pushing policies that would delay cost-saving reforms. Tools like Medicare drug price negotiation would significantly reduce costs, but many HIV drugs could face delayed eligibility under pharma-backed proposals like the EPIC Act — which would extend the timeline before negotiation could begin. As more people with HIV age into Medicare, the stakes are clear: without protecting and strengthening Medicare negotiation, patients and taxpayers will be left to absorb the rising cost of lifesaving medications. — [JAMA, P4AD]

Bipartisan Push for Broader Insulin Price Caps

Sens. Collins (R-ME) and Shaheen (D-NH) highlighted their bipartisan INSULIN Act this week, which would expand Medicare’s $35 monthly insulin cap to private and employer insurance. While out-of-pocket caps don’t address the root cause of high list prices and instead shift costs away from patients to the government, growing GOP support signals meaningful bipartisan momentum. The proposal was recently folded into a broader drug pricing bill and could see action in an upcoming markup. — [Johns Hopkins, Sen. Shaheen, P4AD]

ICYMI: The FDA approved a new sickle cell disease gene therapy, Casgevy, for children over 2, providing a lifeline for families dealing with this debilitating disease, but it comes with an enormous price tag — Casgevy has a list price of over $2.2 million. Gene therapies are often customized and transformative, but the cost barrier in the United States severely limits patient access, particularly when the same drugs often launch at significantly lower prices in countries like Spain and Brazil.

Patient Advocate Spotlight: Doug Lusty

Condition: Crohn’s disease

Drugs: Stelara ($2,641.09 per injection every eight weeks)

Background: Retired state auditor living in Kaysville, Utah

Read more about Doug in his new Deseret News profile: 

“‘Between my wife and I, we were on five of the first 10 medications to get negotiated for Medicare,’ he said. He added that the negotiated prices can still be expensive, but not as expensive as before.”

“Doug retired after 32 years with the state government due to health and meeting his medical needs — not just prescriptions — on a fixed income is challenging.” 

“Both of them have at times in recent years skipped medication doses because of the cost. And they’re not alone.” 

“Doug Lusty said the bright spot has been that some of the medication costs for them have gone down, thanks in large part to the ability Medicare now has to negotiate the prices on some of the more expensive drugs the program covers.” 

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