Welcome to the Week in Review.
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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Welcome to the Week in Review.
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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WASHINGTON, D.C. — Today, the House passed a reconciliation bill that includes a nearly $5 billion giveaway to the pharmaceutical industry: the ORPHAN Cures Act. Despite outrage from tens of thousands of patients on Medicare to halt its progress, ORPHAN Cures was included in the reconciliation bill, was passed by both chambers this week, and now heads to the President’s desk. Its inclusion defies the will of American patients and, if implemented, will diminish the savings due to be generated for patients via the historic and wildly popular Medicare negotiation program.
“When nine in ten Americans want Congress to go further to lower prescription drug prices, there is no good reason to hand Big Pharma a new loophole to exploit — and stick taxpayers with a $5 billion bill,” said Merith Basey, Executive Director of Patients For Affordable Drugs Now. “This unnecessary carveout keeps prices high on drugs that should be negotiated, weakening Medicare negotiation before it even begins to deliver savings. It sends a clear message to the 1 in 3 Americans struggling to afford their prescriptions: a majority of Congress chose Big Pharma over patients. Patients across all 50 States fought too hard for the historic progress we’ve made to watch this legislation undermine it at the last moment. We will keep fighting the implementation of ORPHAN Cures and any bills like it that would weaken Medicare negotiation, a program supported by 86% of Americans across party lines.”
The ORPHAN Cures Act creates a new loophole allowing some of the most profitable drugs with multiple orphan indications to avoid Medicare price negotiation, even as these drugs generate massive sales. The CBO estimates this carveout would cost taxpayers nearly $5 billion over the next decade while weakening the Medicare Negotiation Program just as it’s set to deliver savings to 9 million seniors starting in January.
P4ADNow patient advocates have sent 19,545 letters to Congress, met with Members of Congress, spoken out publicly, and talked to the media demanding lawmakers reject the ORPHAN Cures Act. While this bill now heads to the President’s desk, Patients For Affordable Drugs Now will continue to fight its implementation, protect the Medicare negotiation program, and work to secure lower prices for patients who need relief now more than ever.
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Patients For Affordable Drugs Now, is the only national, patient advocacy organization focused exclusively on policies to lower drug prices. We empower and mobilize patients and allies, hold accountable those in power, and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4ADNow is bipartisan and does not accept funding from organizations that profit from the development or distribution of prescription drugs. To learn more visit; PatientsForAffordableDrugsNOW.org.
WASHINGTON, D.C. — Just days after patients won a critical victory to keep the ORPHAN Cures Act out of the Senate reconciliation bill text, lawmakers have reinserted this harmful, pharma-backed proposal into the proposed final text. P4ADNow is calling on Congress to remove the ORPHAN Cures Act once and for all and protect the historic Medicare negotiation program that patients fought to secure.
“Patients are infuriated to see the Senate cave to Big Pharma by reviving the ORPHAN Cures Act at the eleventh hour,” said Merith Basey, Executive Director of Patients For Affordable Drugs Now. “This is a blatant giveaway to the pharmaceutical industry that would keep drug prices high for patients while draining $5 billion in taxpayer dollars. We call on lawmakers to remove this unnecessary provision immediately and stand with an overwhelming majority of Americans who want the Medicare Negotiation program to go further. Medicare negotiation will deliver huge savings for seniors and taxpayers; this bill would undermine that progress.”
The ORPHAN Cures Act would create a new loophole allowing some of the most profitable drugs with multiple orphan indications to avoid price negotiation under Medicare, even as they generate massive sales. The CBO estimates this carveout would cost taxpayers nearly $5 billion over the next decade while diminishing the popular and effective Medicare negotiation program that is poised to deliver savings to millions of seniors starting next year.
P4ADNow patient advocates have sent over 13,000 letters to Congress demanding lawmakers reject the ORPHAN Cures Act, met with legislative offices, spoke out publicly, and talked to the media to make it clear that patients should not have to pay more just to pad pharma’s bottom line. Once again, patients are mobilizing to push back against this dangerous provision.
P4ADNOW urges Congress to protect patients and taxpayers by removing the ORPHAN Cures Act from the reconciliation package now.
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Patients For Affordable Drugs Now, is the only national, patient advocacy organization focused exclusively on policies to lower drug prices. We empower and mobilize patients and allies, hold accountable those in power, and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4ADNow is bipartisan and does not accept funding from organizations that profit from the development or distribution of prescription drugs. To learn more visit; PatientsForAffordableDrugsNOW.org.
Welcome to the Week in Review.
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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Welcome to the Week in Review.
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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WASHINGTON, D.C. — Patients For Affordable Drugs Now is applauding a patient-driven victory as the harmful ORPHAN Cures Act was excluded from the reconciliation text released by the Senate Finance Committee today – protecting the Medicare Negotiation Program from a pharmaceutical industry carveout that would have driven up drug prices and padded Big Pharma’s profits at a time when one in three Americans still cannot afford their prescription drugs.
“The exclusion of the ORPHAN Cures Act from the Senate Finance Committee’s reconciliation text is a victory powered by patient advocacy and a direct rejection of the pharmaceutical industry’s greed-driven agenda,” said Merith Basey, Executive Director of P4ADNOW. “This decision helps protect the popular and effective Medicare Negotiation program and its promise of lower prescription drug prices for millions of Americans on Medicare. We remain vigilant against any effort to revive this harmful proposal, or anything like it, and will continue fighting to ensure every patient can get the medications they need at prices they can afford.”
Over the past several weeks, P4ADNOW patient advocates sent over 13k letters to the Hill, met with congressional offices, and spoke out publicly to oppose the ORPHAN Cures Act – legislation that would have allowed some of the most profitable drugs with multiple orphan indications to avoid price negotiation, despite being widely used and costing Medicare hundreds of millions of dollars each year. Last week, P4ADNow and AARP sent a joint letter to the Senate opposing ORPHAN Cures.
An “orphan” drug designation is meant to incentivize treatments for rare diseases affecting fewer than 200,000 people. But too often, pharmaceutical companies abuse the system by stacking multiple orphan indications to extend monopolies and keep prices high for as long as possible. The ORPHAN Cures Act would have enabled those abuses while weakening Medicare negotiation. To make matters worse, the Congressional Budget Office (CBO) found that this would cost the federal government nearly $5 billion over the next 10 years, an unnecessary gift to drug companies at the direct expense of patients and taxpayers.
Thanks to the leadership of champions in Congress and the groundswell of advocacy from patients nationwide, this proposal has been removed.
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Patients For Affordable Drugs Now, is the only national, patient advocacy organization focused exclusively on policies to lower drug prices. We empower and mobilize patients and allies, hold accountable those in power, and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4ADNow is bipartisan and does not accept funding from organizations that profit from the development or distribution of prescription drugs. To learn more visit; PatientsForAffordableDrugsNOW.org.