Welcome to the Week in Review.

Details Emerge in FDA Voucher Program

The FDA is continuing to build out its new priority review voucher program, now formally adding “affordability” as one of the priority criteria when considering vouchers. According to new guidance, companies could potentially be eligible for a voucher if they lower U.S. brand-name drug prices to match those in comparable high-income nations – a nod to President Donald Trump’s ‘Most Favored Nation’ pricing proposal. While we are encouraged to see affordability being raised, without congressional authorization and with only five vouchers available in the pilot year, it raises serious questions about the program’s viability. As always, we know pharma will find ways to abuse even the best-intentioned programs. P4AD will continue to monitor this program as it develops. — [CNBC, Endpoints]

Pharma’s Silence Gives The Game Away

Pharma loves to claim that the popular Medicare Negotiation Program will devastate innovation – but when a CBO report found that a 10% cut to the NIH budget would result in more than four times the harm to new drug development, the industry has largely remained quiet. Why? Because pharma’s fearmongering about the IRA isn’t really about innovation – it’s about protecting their monopoly pricing power. According to the CBO, NIH cuts would result in 53 fewer drugs coming to market over the next 30 years, compared to just 13 from Medicare negotiation. — [CBO, KFF]

AstraZeneca Begins Reshoring But Patients Still Get Squeezed

With 200% tariffs on pharmaceutical products still being considered by President Trump, AstraZeneca announced a $50 billion investment this week in U.S. manufacturing. But let’s be clear; reshoring won’t happen overnight, and drugmakers will pass any increased import costs onto patients long before domestic supply chains can catch up. And while AstraZeneca is using this announcement to cozy up to the administration, its CEO is also using the spotlight for attacking potentially transformative drug pricing reforms like Most Favored Nation – a reminder that Big Pharma’s top priority remains protecting profits, not patients. — [Bloomberg, STAT News]

In Case You Missed It

A new report commissioned by the Association for Accessible Medicines claims that Medicare negotiation will harm generic competition and drive up drug prices. But a closer look reveals that their entire argument is based on faulty assumptions and ignores key facts, including inaccurately suggesting that Medicare negotiation is a substitute for market-based competition, conveniently overlooking that generic or biosimilar competition is already ineligible for negotiation.

*Introducing a new weekly patient advocate spotlight. These advocates are the heart of our movement and courageously share their stories to drive change. 

Patient Advocate Spotlight

Elaine Kniepfel, 83, Kansas

Condition: Multiple Sclerosis

Drugs: Copaxone ($100,000/year), Provigil ($8,000/month)

Background: Retired educator with 47 years of service as a teacher and administrator

In her words: “Even with Medicare, the $2,000 cap is too much for retired people on fixed incomes. It’s abhorrent that drug companies charge so much to the people who need medicine most.”

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