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CMS Model Could Expand Access to Sickle Cell Therapy
This week, CMS announced that 33 states, DC, and Puerto Rico will join an initiative intended to improve access and lower costs for gene therapies for sickle cell disease (SCD), a condition that disproportionately impacts Black and Latino communities. A continuation of the Biden administration’s model, the Cell & Gene Therapy Access model ties payment to clinical outcomes, aiming to expand access while holding drug companies accountable. With a massive price tag upwards of $2.8 million for SCD treatments, we’re encouraged to see CMS working to make these life-changing therapies more affordable and more widely accessible for patients. — [CMS, NIH, CMS, BioPharma Dive, Fierce Healthcare, BioPharma Dive, Pink Sheet, Healthcare Finance]
Big Pharma’s Discount Won’t Cut It
Bristol-Myers Squibb (BMS) and Pfizer announced a new direct-to-patient program this week, offering a “discounted” price on their blockbuster blood thinner Eliquis. While marketed as a win for patients, the new discounted price is still higher than what patients on Medicare will pay under the new Medicare Negotiation Program and will still be too high for many patients. In the wake of growing public and political pressure, this announcement comes just weeks after the Trump administration issued an executive order reviving the idea of ‘Most Favored Nation’ pricing including calling for direct-to-consumer sales at a lower price, and at a time when patients and the majority of Americans demand more action to lower drug prices. At the same time, BMS is actively trying to weaken Medicare negotiation, asking for the “maximum level of flexibility”. Make no mistake, pharma is looking for ways to stay ahead of reforms that threaten their pricing power. — [WSJ, Reuters, Endpoints]
FDA Proposes Tying Priority Approval Vouchers to Drug Affordability
In an interview with CNBC late last week, FDA Commissioner Makary said the agency would consider drug affordability as a factor in its new priority review voucher program. This announcement comes after the department introduced the new program last month, stating that its goal is to “reduce inefficiencies” and expedite decision-making. Though some experts have claimed the new voucher program doesn’t hold up to legal scrutiny, Makary and the FDA have stated they’re aiming to use the program as an incentive for companies that commit to lowering their drug prices — though we’re always on the lookout for pharma to try and game the system here too. — [CNBC, FDA, Inside Health Policy, BioSpace]
In Case You Missed It
A new study found that just 2.5% of nearly 10,000 patents on small-molecule drugs cite government funding, despite the fact that 99% of drugs approved from 2010 to 2019 originated through NIH-funded research. It’s yet another example of a rigged system: Taxpayers fund the science, but pharma patents the profits. — [Nature Biotech, JAMA, Endpoints]
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Patients Joins HHS for a Drug Prices Roundtable
Last week, five P4AD Patient Advocates participated in a roundtable with HHS Secretary Kennedy and NIH Director Bhattacharya, focused on the burden of high drug prices and the administration’s exploration of a ‘Most Favored Nation’ (MFN) strategy. Emily, Jackie, Janet, Melissa, and Sarah shared their stories with the Secretary, the NIH Director, and HHS staff about the sacrifices they have had to make to afford their lifesaving and lifesustaining medications. MFN pricing has the potential to be a powerful tool to lower drug prices if it’s designed with patients at the center and works in tandem with the historic Medicare Negotiation Program. As the administration shapes its policy, centering patient stories independent from industry influence is critical to ensure the framework will meaningfully lower prices in the U.S., without unnecessarily raising them abroad. — [LinkedIn, YouTube, White House]
Lowering Drug Prices Doesn’t Hurt Innovation
A new report from Bentley University found that research and development (R&D) spending by 134 drug companies hit record levels after the passage of the Inflation Reduction Act, increasing from $211 billion in the 18 months before the law to $247 billion in the 18 months following its passage. This directly contradicts Big Pharma’s fearmongering that the Medicare Negotiation Program would hurt investment in new drug development. In reality, the industry has experienced steady R&D investment spending and continued strong revenue. While drug manufacturers continue to spread misinformation, 88% of Americans support Medicare negotiation to rein in pharma’s unchecked pricing power. The bottom line: the IRA has coincided with a period of record-high investment in the sector. Don’t be misled by Pharma’s cries to the contrary. — [Bentley University, Lever News, Commonwealth, Arnold Ventures]
Tariffs Are Back. And They’re Still a Bad Idea.
Tariffs are back in the news this week, after President Trump announced plans to impose rates of up to 200% on pharmaceutical products “very soon”, with new details expected at the end of the month. P4AD is cautioning that tariffs won’t hold drug companies accountable; they’ll just increase the risk of drug shortages and raise prices for patients as manufacturers pass any new costs onto patients. Price hikes will hit long before any potential benefits from reshoring or increased investment in U.S. manufacturing materialize. At a time when 1 in 3 Americans already can’t afford their prescription drugs, the last thing patients need is another policy that will make medicines even more expensive. — [The Hill, Bloomberg, Reuters]
In Case You Missed It
In preparation for the third round of Medicare negotiation, P4AD submitted comments to CMS on the cycle’s new draft guidance. P4AD will continue fighting to protect the program’s implementation as it begins to deliver savings for 9 million Medicare recipients in 2026. — [Bloomberg Law, CMS]
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Pharma Handouts, Not Patient Relief: Congress Passes The ORPHAN Cures Act
Today, the House passed a reconciliation bill that includes a nearly $5 billion giveaway to the pharmaceutical industry: the ORPHAN Cures Act, just a day after the Senate passed the same legislation, which now heads to the President’s desk. By including ORPHAN Cures, the reconciliation bill is ensuring drugs that should be included in Medicare negotiation — a program that’s supported by 86% of Americans on both sides of the aisle — won’t see lower prices in the coming years. It’s deeply disappointing that for many members of Congress, appeasing industry interests seems to come before standing with the nine in ten Americans demanding lawmakers lower drug prices and the millions of patients forced to make impossible choices because of their prescription costs. The reconciliation bill may have undermined historic affordability progress, but P4ADNow, alongside our community of patients, will continue fighting implementation of ORPHAN Cures and working to protect the Medicare negotiation program from any other attacks. — [Arnold Ventures, CSRxP, POLITICO Pro, CNBC, POLITICO Pro, Healthcare Finance, Fierce Pharma, Common Dreams, Nation of Change]
PhRMA Panics as “Most Favored Nation” Pricing Gains Traction
The pharmaceutical industry is panicking over a potential “Most Favored Nation” pricing policy. In an op-ed for STAT News, PhRMA CEO Stephen Ubl rolled out the industry’s usual fearmongering and blame-shifting to argue against aligning U.S. drug prices (which are the highest of anywhere in the world) with those in other wealthy nations. He even cites data from No Patient Left Behind, one of the pharma-funded front groups we exposed in our 2023 “Hidden Hand” report, to push the narrative that patients abroad are “freeloading.” Here’s the truth: drug companies already make huge profits in countries with lower prices. They want to keep the U.S. as their cash cow, charging Americans four to eight times more for brand-name drugs than patients elsewhere. MFN pricing threatens that status quo, which is exactly why pharma is fighting it. Aligning prices with peer nations is a path toward real relief for patients, but we must ensure it’s done right, without letting pharma raise prices abroad to protect their margins. Don’t let their talking points distract from the real problem: drug corporations, not other countries, are driving high prices in the U.S., and increasing prices internationally wouldn’t do anything to lower prices at home. — [STAT News, P4AD, HHS]
In Case You Missed It
On Monday, the FTC and DOJ held their first of three listening sessions examining how drug companies use tactics like pay-for-delay, product hopping, and rebating to block competition and keep prices high. Drug companies abuse the patent system to extend their monopolies and maximize profits, and the U.S. desperately needs increased competition and transparency if we want to see lower prices. According to the FDA, introducing one generic drug into the market reduces drug prices by 39%, while six or more result in a staggering 95% reduction in price. That’s why P4ADNow continues to fight for legislation to reduce patent abuses by drug corporations. — [FTC, FDA]
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Investors- and Lawmakers – Aren’t Buying Pharma’s “Warnings”
New reporting from POLITICO reveals that lawmakers from both parties have been snapping up stocks in the 13 largest U.S. pharma companies in recent weeks — all while the drug industry ramps up its warnings that Inflation Reduction Act reforms and Most-Favored-Nation pricing momentum will hurt innovation and slash profits. The takeaway? Behind the industry’s sky-is-falling rhetoric, Wall Street and Washington still see pharma as a safe bet. No surprise, given that analysts have long noted that drugmakers could lose $1 trillion in revenue over a decade and remain the most profitable industry sector. The gap between the industry’s doomsday messaging and investor behavior is hard to ignore, and it’s patients who are left to slip through the cracks. — [POLITICO, West Health]
Pharma Front Groups Working Overtime For Big Drug Companies
It’s been a month since P4AD released The Rampant Reach of Pharma’s Hidden Hand, exposing six major pharma-funded front groups masquerading as patient advocates while quietly pushing Big Pharma’s agenda. Since then, these groups have continued their efforts to protect drug industry profits. The Center for Medicine in the Public Interest (CMPI) — whose entire board has pharmaceutical industry ties — is now pushing a new report blaming high U.S. drug prices on so-called “global freeriding”, a classic pharma talking point that deflects blame and distorts reality. Meanwhile, Pacific Research Institute (PRI) President and CEO Sally Pipes is parroting similar messaging in a new op-ed, dismissing Most Favored Nation (MFN) as “a distraction” — no surprise given PRI’s deep financial ties to pharma. The problem isn’t that other countries pay too little, it’s that we’ve failed to hold pharmaceutical corporations accountable at home. The drug industry is one of the most profitable industries in the world, and its network of front groups continues to spread misinformation to protect its bottom line. Patients and policymakers deserve to know whose interests these groups serve. — [P4AD, CMPI, Newsmax, West Health]
P4AD Patient Advocate Speaks Up in New Op-Ed
The U.S. is experiencing a drug pricing crisis, and Latino communities are among those hit the hardest. 11% of U.S. adults have been unable to afford or access quality healthcare — its highest level since 2021 — and the most notable increases have been among Hispanic adults, rising 8% to 18%. This week, the Latino Newsletter published an op-ed from P4AD patient advocate Sonia Vega about her struggles to afford the Ozempic needed to manage her diabetes. Despite Ozempic costing less than $5 to manufacture, Sonia’s “out-of-pocket cost is over $1,000 a month” — and she’s not alone. P4AD is committed to fighting for equitable and affordable medication access in the Latino community, because no one should be forced to skip prescription doses or avoid treatment just to make ends meet. You can read Sonia’s full op-ed at the link here. — [Gallup, Latino Newsletter, CNBC]
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Patient Victory: ORPHAN Cures Act Excluded from Reconciliation Text
This week, patients scored a key victory as the Senate Finance Committee released reconciliation text that excluded the harmful ORPHAN Cures Act – a pharma-backed proposal that would have weakened the Medicare Negotiation Program and protected drug company profits at the expense of patients. Over the past several weeks, P4ADNOW patient advocates mobilized to oppose the provision: sending 13,326 letters to Congress, meeting with lawmakers, and telling their powerful stories – including an Alabama patient advocate, Beth, who spoke with her senators. Beth takes Jakafi, an orphan drug that costs $17,500 every month, and she spoke out about how the Orphan Cures Act would exempt Jakafi and other orphan drugs from eventual price negotiations. Last Thursday, P4ADNOW and AARP joined forces to send a letter to Senate offices opposing the inclusion of ORPHAN. We’re proud to stand with the patients who made this happen, and we’ll keep fighting to ensure no version of ORPHAN resurfaces and every patient can get the medications they need at prices they can afford. — [P4ADNow, InsideHealthPolicy, POLITICO, Endpoints, Fierce Pharma, FirstWord Pharma, AInvest, Global Genes, The Pharma Letter]
I-MAK Releases New Report on Pharma Patent Abuse
On Tuesday, I-MAK published a new report chronicling how drug companies continue to manipulate the patent system to extend monopolies and keep drug prices artificially high. The report, which is part of I-MAK’s Overpatented, Overpriced series, focuses on the top-selling blood thinner Eliquis and the blockbuster family of diabetes and weight-loss drugs, including Ozempic, Rybelsus, and Wegovy — all of which are included in the second round of Medicare negotiations. By stacking patents to block competition, the report found that Bristol Myers Squibb and Pfizer have raked in an estimated additional $50.7 billion off Eliquis alone. Novo Nordisk is projected to make a staggering $166 billion over five years in additional profits by extending monopolies on its GLP-1 drugs. The report reinforces why patent reform is one of P4AD’s top priorities — and why Congress must act to stop pharmaceutical companies from using monopoly tactics to keep drug prices high for patients. — [I-MAK]
In Case You Missed It
The administration’s termination of over $1 billion in National Institute of Health (NIH) research grants was overruled by a federal judge this week. The NIH plays a critical role in drug development. In fact, 99 percent of drugs that received FDA approval between 2010 and 2019 received federal funding during their R&D. — [NIH, NBC News, Reuters, The Hill, Axios]
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P4ADNOW and AARP Send Letter on OPRHAN Cures to Senate
To safeguard hard-fought and cost-saving drug price reforms, P4ADNow and AARP sent a joint letter to all Senators to oppose the inclusion of the ORPHAN Cures Act in the reconciliation bill. At a time when nine in ten Americans want further action from Congress to lower the price of prescription drugs and an overwhelming majority support giving Medicare the power to negotiate lower drug prices for ALL drugs, including this policy in the reconciliation package would be a step backward. The Congressional Budget Office (CBO) found that the ORPHAN Cures Act would increase federal spending by $4.87 billion over the next 10 years. That’s billions of dollars going straight into the pockets of big drug companies. We’re urging Congress to put patients first rather than bend to the whims of greedy drug manufacturers. — [P4ADNow, AV, CBO]
Most Favored Nation: One Month Out
This week marked 30 days since President Trump issued his executive order to align U.S. drug prices with other high-income nations through the “Most-Favored-Nation” (MFN) approach. In the U.S., drug companies charge Americans between four and eight times what patients in other high-income countries pay for the very same brand-name drugs because the current system lets them. If done right, international referencing pricing could help lower prices in the U.S. But as expected, Big Pharma is already pushing back hard. Pfizer and other drugmakers met with the administration, but failed to make any commitments to lower prices. Instead, Pfizer CEO and PhRMA Board Chair Albert Bourla said he hopes prices in Europe increase, even threatening to pull drugs from some countries if they don’t pay more. We’ve said it before: any proposal that seeks to raise prices abroad is a nonstarter. The real problem is that the U.S. has failed to rein in the pharmaceutical industry. Americans know who the drivers of high drug prices are, and pharma’s recent comments make it even clearer where their priorities lie. — [White House, P4ADNow, Quartz, Reuters]
Spotlight on Cell and Gene Therapies
The heads of HHS, FDA, NIH, and CMS came together for a roundtable discussion on the future of cell and gene therapies, where NIH Director Jay Bhattacharya emphasized the importance of making these life-saving treatments both scalable and affordable. Treatments like these have been critical for patients like Janet Kerrigan, whose CAR-T therapy put her multiple myeloma into remission. But no one should be saddled with the enormous price tags these innovations currently carry, which can reach nearly $3 million for disorders like sickle cell. Lowering this cost is a priority, and we’re encouraged to hear that affordability might also be on the radar for federal leaders as they chart the path forward. — [Endpoints News, P4AD, Ortho]
In Case You Missed It
On Monday, the FDA announced it would be reinstating the internal team responsible for advancing generic drug approvals, reversing its controversial decision to dismantle the office earlier this year. As Endpoints News noted, the team played a key role in driving the agency to a record number of new generic drug approvals before its elimination in April. — [BioSpace, Endpoints News, Pink Sheet]
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Fighting ORPHAN Cures in the Senate
As the Senate considers the House-passed reconciliation package, P4ADNow is urging lawmakers to reject the inclusion of the ORPHAN Cures Act — an unnecessary Pharma handout that would weaken the effective and popular Medicare Negotiation Program. At a time when nine in ten Americans want further action from Congress to lower drug prices and an overwhelming majority support giving Medicare the power to negotiate lower drug prices for every drug, including this policy that would reduce the number of drugs eligible for negotiation would be a harmful step backward. The Congressional Budget Office (CBO) found that the bill would cost taxpayers $4.8 billion over the next 10 years. That’s nearly $5 billion in lost savings — not to support innovation or new treatments, but to allow drug companies to keep prices high for longer at the expense of patients. Americans know that Pharma is to blame for their high drug prices, and over the coming days, P4AD patient advocates who would be impacted by this legislation will be speaking to their Senators to express their strong opposition to the ORPHAN Cures Act. — [Axios, CMS, CBO]
The Tide Continues to Turn Against PBMs
Arkansas is taking on PBMs with its first-in-the-nation law barring PBMs from owning pharmacies in the state. The profitability of PBMs has risen in recent years as a result of vertical mergers between PBMs, insurance companies, and pharmacies, leading to higher prices for patients. Arkansas’ law represents a major step toward dismantling these vertically integrated monopolies that contribute to keeping prices artificially high. While PBMs claim to be utilizing their bargaining power on behalf of patients, they’ve simultaneously fought to ensure their rebate practices stay hidden from view. As Axios reported, “the ramifications are nationwide, with many other states weighing new restrictions, including prohibitions on steering business to affiliated pharmacies.” — [Axios, Axios, Reuters, Pharmacy Times]
Supporting Transparency in Drug Advertisements on Capitol Hill
On Thursday, Reps. Dave Taylor (R-OH) and Jan Schakowsky (D-IL) introduced the Drug-Price Transparency for Consumers Act of 2025, companion legislation to the Senate version that would mandate pharmaceutical companies disclose the cost of their drugs in all direct-to-consumer (DTC) advertising. This joins the growing trend against DTC Pharma advertising, after Senators Josh Hawley (R-MO) and Jeanne Shaheen (D-NH) introduced the bipartisan and P4ADNow-endorsed No Handouts for Drug Advertisements Act last month. The U.S. is one of only two countries that allows DTC advertising for pharmaceutical drugs, and the least patients deserve is transparency on the cost of what’s being advertised to them. P4ADNow endorsed this bill, and is supportive of efforts to bolster transparency at all steps of the pharmaceutical process. — [Washington Examiner]
In Case You Missed It
This week, P4AD attended Latino Magazine’s LATINO 100 luncheon. Latino patients are more likely to report difficulty affording prescription medications, and Gallup polling earlier this year found that Hispanic adults are reporting the greatest increase in lack of ability to afford or access quality healthcare. P4ADNow is working closely with organizations and groups who serve the Latino community as part of our push to expand our community in the fight to lower drug prices.
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Expanding Medicare Negotiation with the SMART Prices Act
The Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act has been re-introduced by Senators Amy Klobuchar (D-MN) and Peter Welch (D-VT) — legislation that will expand Medicare price negotiation and strengthen HHS’ tools to lower prescription drug prices. One in three Americans can’t afford their prescription drugs, and we hear from patients every day who are rationing medication or skipping doses because of high drug costs. The SMART Prices Act builds on the 2022 prescription drug law’s historic drug price reforms by increasing the number of drugs subject to Medicare negotiation — a proposal that has broad support from Americans on both sides of the aisle. Patients For Affordable Drugs NOW endorses this legislation, and we support efforts to expand Medicare negotiation to secure a better deal for even more Americans. — [Senator Klobuchar, Senator Welch]
Trump’s “Most Favored Nation” Proposal Keeps Moving
The administration’s “Most Favored Nation” (MFN) policy begins to take shape this week, with President Trump tapping CMS administrator Dr. Mehmet Oz to lead the negotiations process. Americans pay the highest drug prices in the world, and international reference pricing frameworks like MFN are worth exploring — but only if they’re done right. The policy must meaningfully lower prescription drug prices for U.S. patients, without driving up costs in other countries or creating new loopholes for drug companies to exploit. This also means a policy that’s developed in conjunction with Congress to ensure reference prices are enforceable and stand up to legal scrutiny. P4ADNow will continue monitoring as this policy develops. — [Endpoints News, BioSpace, JAMA Health Forum, Axios]
RFK Jr. vs. Big Pharma’s TV Ads
The U.S. and New Zealand are the only two countries in the world that allow direct-to-consumer (DTC) advertising by drug manufacturers. HHS Secretary RFK Jr. has long criticized this practice, and his renewed calls to ban pharma ads from TV gained fresh attention this week. Making matters worse, taxpayers are subsidizing these ads through a longstanding tax break that has allowed Big Pharma to flood the airwaves for years. Earlier this month, Senators Josh Hawley (R-MO) and Jeanne Shaheen (D-NH) introduced the bipartisan and P4ADNow-endorsed No Handouts for Drug Advertisements Act, which would eliminate that tax break — a common-sense step toward curbing pharma’s outsized influence. — [X.com, Bloomberg, Senator Hawley]
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