Welcome to the Week in Review.
PREVAIL Act Narrowly Clears Senate Judiciary Committee
After several delays, members of the Senate Judiciary Committee voted to pass S. 2220, the PREVAIL Act, by a razor-thin bipartisan margin of 11 yays to 10 nays. Drawing concerns from patients and public health advocates alike, this patent bill would be detrimental if enacted into law and would weaken critical mechanisms to challenge potentially invalid patents and strengthen anti-competitive tactics wielded by drug manufacturers to block generic and biosimilar competition. The bill’s narrow committee vote, coupled with significant reservations from Senators on both sides of the aisle, suggests limited support for it to advance to the Senate floor. “While amendments made to the legislation in committee attempt to resolve concerns, they barely scratch the surface of fixing the bill’s fundamental flaws,” said P4ADNow Executive Director Merith Basey in a statement issued yesterday. “We urge the full Senate to reject PREVAIL and instead focus on the bipartisan patent reform policies currently in Congress that will increase competition and lower drug prices for all Americans.” — (Inside Health Policy, IP Watchdog, P4ADNow, Axios)
Continued Push For Competition
With just weeks left in the 118th Congress, momentum continues to build towards advancing the bipartisan Affordable Prescriptions for Patients Act of 2023 (S. 150), aimed at addressing one of Big Pharma’s key abuses of the patent system. The bill, which unanimously passed the Senate in July, would limit the number of patents a pharmaceutical company can assert on biologic drugs, curbing patent thicketing and bolstering the timely entry of biosimilars into the market. According to the Congressional Budget Office (CBO), this legislation is projected to generate $1.8 billion in savings over ten years, which could serve as a timely bipartisan offset for other critical, must-pass health care priorities as lawmakers consider an end-of-year legislative package. We urge members in the House to continue advancing this cost saving measure as millions of patients nationwide urgently need relief from high drug prices. — (Politico, Axios, Congressional Budget Office)
President-Elect Trump 2025 Appointments
President-Elect Donald Trump has tapped Robert F. Kennedy Jr. to head the Department of Human & Health Services (HHS) and Dr. Mehmet Oz as administrator of the Centers for Medicare and Medicaid Services (CMS) – both unconventional appointments that introduce a level of uncertainty in the future of drug pricing policy. At P4ADNow, we’re committed to working with the new administration to lower prescription drug prices to improve the financial well-being and health of all Americans. Despite nine in 10 American voters believing that lowering drug prices should be an important or top priority of elected officials, the incoming administration has yet to outline concrete steps to address this issue. Our focus however remains the same: we will work with any elected official who champions efforts to lower drug prices for patients, hold accountable those who prioritize Big Pharma’s interests over the American people, and emphasize to the incoming administration that lowering drug prices is essential to making America healthy again. — (Becker’s Hospital Review, Reuters)
ICYMI
Listen to P4AD’s Merith Basey on WPFW-FM discuss how Black and Latino patients are disproportionately harmed by high drug prices, and face more difficulty affording their medicines. Given that Black and Latino patients are more likely to be affected by chronic conditions, including diabetes, cancer, and heart disease, Big Pharma’s relentless price hikes exacerbate existing health disparities within these communities and lead to patients disproportionally rationing or forgoing their essential medicines altogether.
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Harmful Patent Bills Stall In Senate
The Senate Judiciary Committee’s markup of two controversial patent bills, S.2220, the PREVAIL Act, and S.2140, the Patent Eligibility Restoration Act (PERA), was postponed yet again amidst ongoing concerns from patients and public health advocates. If enacted, these bills would make it more difficult to challenge questionable patents, potentially limiting competition from lower-cost generics and biosimilars – enabling pharmaceutical companies to keep prices consistently high for patients. These bills could further entrench Big Pharma’s pricing power, allowing companies to lock in monopoly prices longer and undermining recent reforms aimed at lowering costs. “We’re encouraged by the delay on S. 2220 and S. 2140, but the threat to patients isn’t over. Even with the potential amendments, the committee is unable to fix the fundamental flaws of the bill,” said Merith Basey, P4AD executive director, after yesterday’s committee meeting. In September, when the bill was originally on the calendar for markup, Patients For Affordable Drugs Now sent a letter to the Committee urging members to vote against moving the bills forward. The markup has been rescheduled for next week. As we approach the final weeks of this Congress, legislators should instead prioritize bipartisan reforms that would improve our patent system and increase competition to lower prices for millions of patients across the country. — (Inside Health Policy, Axios, patientspushforcompetition.org)
Drug Industry Trade Association’s Waning Power
The drug industry’s top trade associations, the Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) have seen notable departures from their corporate members amid continued tensions since the passage of the Inflation Reduction Act in 2022. This week, GSK became the fifth company to leave BIO in the last two years and joined Pfizer, UCB, AbbVie, and Takeda in departing the trade association. Since the enactment of the IRA, PhRMA has similarly experienced an exodus of major drug companies from its membership, including AstraZeneca, AbbVie, and Teva. The IRA drug pricing reforms have sparked significant debate within the industry, leading some companies to reassess their membership in key industry groups. — (Endpoints, STAT, Fierce Pharma, Becker’s Hospital Review)
ICYMI
In a video interview with El Tiempo Latino, P4AD’s Merith Basey detailed the significant barriers facing Black and Latino communities with regard to high drug prices that force many patients to skip or forgo their essential medicines.
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P4ADNow’s Commitment to Lower Drug Prices Under New Administration
With the 2024 Presidential Election called for Former President Donald Trump, P4ADNow reiterated its commitment to addressing the high cost of prescription drugs through working with the incoming administration and the new Congress. As an organization representing patients of all ages from across all 50 states, we know the burden of drug costs transcends party lines and affects Americans nationwide. Though it is futile to attempt to predict what President-Elect Trump will do on this issue over the next four years, he has previously voiced support for Medicare negotiation and exploring the “Most Favored Nations” model. However, he backed away from those proposals, leaving it unclear how he plans to deliver on his campaign promise of lowering prices. Proposals from Trump-affiliated think tanks, such as the America First Policy Institute (AFPI) and the Heritage Foundation, provide a possible roadmap – one that at best misses the mark and at worst could raise prices and undermine patient access to treatments. AFPI is advocating for trade policies to counter perceived foreign “free-riding” and supports making more prescription medications available over the counter, as well as other state-level initiatives. Meanwhile, the Heritage Foundation’s Project 2025 – a framework of highly conservative goals for the Trump Administration – explicitly calls for rescinding the Inflation Reduction Act (IRA). This would roll back Medicare’s authority to negotiate drug prices, a measure supported by 85% of Americans, as well as the out-of-pocket spending cap and the inflation rebate program. In a statement Wednesday, David Mitchell, president and founder of P4ADNow, emphasized that we will vigorously defend the IRA and stand against any efforts to roll back these reforms – whether through legislative, administrative, or legal means. Nine in ten Americans believe Congress should do more to lower drug prices, and P4ADNow will work with the new administration and the new Congress to keep this priority front and center. Simultaneously, we will hold accountable those who made promises to lower costs and continue advancing policies to bring relief to patients across the country. — (P4ADNow, Politico, Inside Health Policy, KFF, P4ADNow)
CAR-T: A Breakthrough Treatment Hindered by High Costs
Since the approval of the first chimeric antigen receptor (CAR) T-cell therapy in 2017, these groundbreaking treatments have transformed the landscape of cancer treatment, with six therapies now approved in the U.S. for 16 different indications. As awareness and demand for CAR-T therapies grow, so too have the challenges. The complex treatment process which currently takes several weeks, coupled with sky-high costs starting at $400,000 and often reaching seven figures, creates significant barriers to access for many patients. Efforts to reduce manufacturing costs and decentralize production models show promise in making CAR-T more affordable, but for now the price-tag remains a major hurdle. As Merith Basey, Executive Director of P4AD noted, “The conversation is currently about how we [are] going to pay for them, and not how we [are] going to lower the price.” As CAR-T becomes a more routine option, including potentially as a first-line treatment for certain cancers, it is crucial to prioritize efforts to bring down costs which is already a reality in countries like Spain and Brazil, helping to ensure equitable access for all patients. — (Managed Healthcare Executive)
ICYMI
Vertex has generated $2 million in revenue from its sickle cell therapy, Casgevy, after its commercial launch. So far the therapy is currently being administered to only 40 patients across 45 treatment centers.
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Court Watch: US v. Pharma
Combined oral arguments brought by Bristol Myers Squibb (BMS), AstraZeneca, and Janssen Pharmaceuticals were heard by the Third Court of Appeals in Philadelphia in their efforts to halt the Medicare Negotiation Program. The arguments were considered by a three-judge panel that raised issues with the drug companies’ claim that they were being forced to participate in negotiations and that the program violated their First Amendment rights. This hearing marks the first appellate-level challenge to Medicare negotiations. In September, Patients For Affordable Drugs submitted an amicus brief in the consolidated case which highlights how lower negotiated prices will deliver transformative savings to patients. First-hand testimonies from patients like Lynn, who is forced to rely on financial assistance for her Imbruvica, and Aly, who spends nearly half of his monthly income on prescription drugs, including Eliquis, illustrate the devastating impact of high drug prices and the potentially life-changing impact of lower negotiated prices. While eight cases brought by Big Pharma and its allies have been ruled against the companies, we can’t rest on our laurels. As drugmakers continue to appeal, experts anticipate that one of the cases filed in various district courts may make its way to the Supreme Court. We are steadfast in our commitment to defending this historic program against challenges both inside and outside of the courts. — (Reuters, P4AD, Politico, P4AD, STAT)
Big Pharma Reaps Big Earnings
As we enter the last stretch of 2024, the pharmaceutical industry’s earnings underscore its continued financial strength despite their fear-mongering about the Inflation Reduction Act. Novartis — one of the drug manufacturers suing to stop Medicare negotiation — reported a striking $3.2 billion in earnings during the last quarter, an 111 percent increase from the same quarter last year. Pfizer, whose CEO Albert Bourla once described Medicare negotiations as “negotiation with a gun to your head,” outperformed analyst expectations with $4.47 billion in quarterly earnings. BMS also surpassed projections, reporting $1.21 billion in third-quarter earnings — in large part due to increased sales of Eliquis, its blockbuster blood thinner which was selected for the inaugural round of Medicare negotiation. While these companies relentlessly criticize the Inflation Reduction Act’s historic drug price reforms, their strong earnings reveal a thriving industry capable of succeeding under policies that better protect patients from sky-high drug costs. — (Accountable.US, Reuters, STAT, AP News, Washington Post, CNBC)
ICYMI
The Senate Judiciary Committee held a field hearing to examine the root causes of high drug prices and the financial burden on American seniors. During the hearing, lawmakers championed legislation that would reform our patent system and increase transparency into Pharmacy Benefit Managers (PBMs) – both critical levers to reining in spiraling drug costs. As we approach the lame-duck session, we are focused on advancing bipartisan bills to curb patent abuses and increase competition to lower prices for all patients.
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Court Watch: US v. Pharma
Marking another significant upset for Big Pharma and a critical victory for patients, Novartis faced a setback last week in its lawsuit to stop the implementation of the Medicare Negotiation Program. District Judge Zahid Quraishi rejected Novartis’ claim that the program violated the Takings Clause, compelled speech protections, and the Excessive Fines Clause, underscoring, yet again, the voluntary nature of the program. Novartis’ case was the final of four cases before Judge Quraishi, and he has now ruled in favor of the government and patients in all four. This case also marks the eighth lawsuit to be ruled against the pharmaceutical industry. Next week, oral arguments will be heard as Bristol Myers Squibb, AstraZeneca, and Janssen lay out their appeals before the Third Circuit Court of Appeals. “Behind every one of these legal challenges is a story of a patient rationing their medication or going into debt to afford life-saving drugs,” P4AD’s David Mitchell said in a statement this week. “The court’s decision last week moves us one step closer to a future where no one has to make these impossible choices.” — (Bloomberg Law, Washington Monthly)
First Patient Leaves Hospital After SCD Therapy
Kendric Cromer, a 12-year-old from Washington D.C., made headlines earlier this year when he became the first patient to receive an FDA-approved gene therapy for sickle cell disease (SCD). After nearly five months of treatment, involving intensive chemotherapy and the infusion of new modified blood cells, Kendrick left the hospital this week and is now on the road to living a life without SCD. This groundbreaking treatment offers transformative potential for children, like Kendrick, who suffer from the lifelong, painful blood condition affecting 100,000 people in the United States, most of whom are Black and Latino. However, while the promise of gene therapy is life-changing, the reality is that the newly approved SCD gene therapies, Lyfgenia by Bluebird Bio and Casgevy by Vertex Pharmaceuticals, come with staggering list prices of $3.1 million and $2.2 million per treatment, respectively. These high launch prices raise serious concerns about the financial strain on patients, insurers, hospitals, and our health care system overall. While the potential benefits of gene and cell therapies are profound, the current pricing models create barriers that limit access for many patients. As we celebrate the remarkable advancements in treatment, it is crucial to address the urgent need for a sustainable pricing structure that balances fair profits for manufacturers with accessibility and affordability for patients and the health care system as a whole. — (The New York Times, CDC, CNBC)
Legislators Tout IRA Savings
As we anticipate the drug price reforms in the Inflation Reduction Act taking effect in 2025, patients are already reaping substantial savings this year from the provisions already underway. At an event in New Hampshire, President Biden and Senator Sanders touted a new report by the Office of The Assistant Secretary for Planning and Evaluation (ASPE) that found that because of the Inflation Reduction Act, nearly 1.5 million patients on Medicare saved nearly $1 billion in out-of-pocket costs in just the first half of 2024. The report also revealed that the annual out-of-pocket cap is delivering crucial relief for patients burdened by high cancer drug costs, which comprised nine of ten of the highest-spending medications among those who reached the cap in 2024. In two months, when the out-of-pocket cap for patients on Medicare lowers to $2,000, nearly 19 million people are projected to save roughly $400 per year on prescription drug costs. As the drug price law continues to take effect, patients stand to see substantial savings on their prescription drugs, lower out-of-pocket costs, lower average premiums for patients, and a variety of plans to choose from — ensuring access to a wide range of treatments at more affordable prices. — (PBS, ASPE, HHS, KFF)
ICYMI
The pharmaceutical industry’s top trade association, The Pharmaceutical Research and Manufacturers of America (PhRMA), closed out last quarter spending $6.9 million in health care lobbying efforts ranking the group as the top spender on health care lobbying among all health trade association groups this year.
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Court Watch: US v. PharmaI
Novo Nordisk’s legal battle against the Medicare Negotiation Program has shifted gears, with the company now focusing on challenging elements of the program’s implementation rather than broad constitutional arguments that were rejected by a federal judge in July. Novo Nordisk’s appeal, filed this week in the Third Circuit, claims that the Centers for Medicare & Medicaid (CMS) overstepped its authority by grouping six of the company’s insulin products as a single item for negotiation — Fiasp, Fiasp FlexTouch, Fiasp PenFill, NovoLog, NovoLog FlexPen, and NovoLog PenFill. These products were grouped due to their fundamental similarity, with variations primarily in delivery methods rather than in their formulations. The Third Circuit Court of Appeals will also be hearing combined oral arguments from Bristol Myers Squibb (BMS), AstraZeneca, and Janssen later this month. P4AD filed an amicus brief in the BMS and Janssen case and has signed onto seven other amicus briefs — led by led by Public Citizen and supported by AARP, Protect Our Care, Doctors for America, and Families USA — to defend the historic drug price negotiation program. — (Fierce Pharma, Bloomberg Law, US Court of Appeals)
Bringing CAR-T Closer To Patients
Chimeric antigen receptor T-cell (CAR-T) therapy, a groundbreaking immunotherapy for treatment-resistant cancers, offers the potential for long-lasting remissions without the need for maintenance therapy. However, significant access barriers hinder its potential relief for many patients. New research published in Transplantation and Cellular Therapy found that a patient’s proximity to a treatment center played a significant role in determining whether they received CAR-T therapy. According to their research, patients living 2-4 hours away from the nearest CAR-T treatment center were nearly 40 percent less likely to receive treatment compared with those living within 30 minutes. The current U.S. model often involves patients traveling significant distances to access CAR-T therapy and typically forces patients to wait several weeks to receive their personally modified therapy from remote sites. Contrasting this approach, countries like Spain have adopted a decentralized production model which has led to lower costs in part through bringing treatment closer to patients. As groundbreaking cell and gene therapies enter the U.S. market with price tags in the millions, we must prioritize strategies to make these potentially life-saving innovations accessible and affordable for both individuals and health systems. — (National Library of Medicine, AJMC)
Medicare “Smoothing” OOP Costs
As we approach 2025, the drug pricing provisions in the Inflation Reduction Act (IRA) are set to bring about transformative changes in how older Americans manage the cost of their medication. Two key reforms are taking effect in January: a $2,000 annual cap on out-of-pocket drug expenses and the new Medicare Prescription Payment Plan. In its first year, the spending cap promises significant savings for over 3 million recipients who do not receive the program’s low-income subsidy, addressing a critical financial burden for those with costly medications. Complementing this, the Payment Plan allows patients on Medicare to spread out their cost sharing across monthly installments, helping people who live with a chronic illness manage their out-of-pocket expenses. As implementation of these reforms nears, the growing anticipation among patients underscores the IRA’s promise of more manageable health care experience for millions of Americans. This combination of lower out-of-pocket costs and flexible payment options reflects an understanding of the complex financial challenges faced by millions of Americans who are struggling to afford the drugs they need. — (CMS, AARP)
ICYMI
Novartis recently suffered a legal setback in its effort to block a generic version of heart failure drug Entresto from entering the U.S. market. Undeterred, the pharmaceutical giant is appealing the decision, aiming to protect its lucrative franchise. In 2023, Entresto generated over $6 billion in global sales for Novartis. This case highlights the lengths brand-name drug manufacturers will go to extend their market exclusivity and stop the introduction of affordable generic alternatives that would lower costs and benefit patients.
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Projected Savings From Out-Of-Pocket Cap
Asthma and chronic obstructive pulmonary disease (COPD) disproportionately affects Black, Latino, and Native American communities, as a result of key social determinants of health – such as air pollution, limited access to care, and economic inequities. For many living with asthma, annual prescription drug costs can average up to $1,830 per person, forcing patients to choose between adhering to their treatment plans and affording other basic life necessities. In general, 30 percent of Black people and 42 percent of Latinos in the U.S. report not taking prescribed medication due to cost – driving higher rates of hospitalization and mortality for these communities. There is encouraging news however for some patients on Medicare with asthma and COPD who could see relief in January when the annual $2,000 out-of-pocket cap goes into effect. A new analysis published in the Journal of General Internal Medicine estimates that 360,000 patients on Medicare with asthma and/or COPD could save more than $1,000 per year, with total out-of-pocket savings exceeding half a billion dollars annually, helping to ease the financial burden that contributes to medication nonadherence and worse health outcomes. — (Asthma and Allergy Foundation of America, KFF, Politico, Journal of General Internal Medicine)
Rising Prices Of Cancer Therapies
Big Pharma’s exorbitantly high launch prices and consistent price gouging of cancer medications have reached unsustainable levels at the expense of patients. A new study in Nature reveals the staggering scale of this issue: in 2023, the U.S. spent $99 billion on cancer therapies, with projections soaring to $180 billion by 2028. Why is that? This surge is driven by two alarming trends: new cancer therapies are coming to market at astronomical prices, often exceeding $100,000 per treatment, and existing drugs are seeing perpetual price hikes that outpace the rate of inflation. And the consequences are dire for patients. The study highlights that 50 percent of older adults skip filling prescriptions for cancer therapy when their out-of-pocket expenses exceed $2,000. However, for cancer patients on Medicare, in 2025, the $2,000 cap on out-of-pocket costs mandated in the IRA is projected to save patients an average of $7,590 annually, with some patients saving up to $19,296. The Inflation Reduction Act, alongside critical reforms to our patent system, offer hope for more affordable cancer treatments in the future. — (Nature, P4AD, patientspushforcompetition.org)
P4AD Advocates Celebrate Relief At HHS Roundtable
From lower insulin costs to free vaccines, patients on Medicare are seeing benefits that will only continue to grow as the law is fully implemented. This was the theme of a virtual roundtable this week which included patient advocates, Department of Health and Human Services (HHS) Secretary Xavier Becerra, and Centers for Medicare & Medicaid (CMS) Director Dr. Meena Seshamani. P4AD founder and cancer patient David Mitchell shared how the cap on out-of-pocket costs has already saved him more than $13,000 this year. “The IRA is delivering lower prices, lower out-of-pocket costs, steady or lower premiums and all the while maintaining a strong innovation pipeline,” shared David at the virtual roundtable. “It’s a big win for me and millions of other patients like me.” Lisa McRipley, a patient advocate who lives with multiple sclerosis (MS), expressed the relief she felt knowing that next year, the annual out-of-pocket cap will save her up to $6,000. Patient advocates played a critical role in the passage of the IRA in 2022 and remain on the frontlines of ensuring its successful implementation, and educating the public on the historic drug prices reforms.
ICYMI
CMS unveiled a preliminary list of 101 generic prescription drugs for which the agency expects to cap monthly prices at $2. The drug list, which is part of a voluntary model proposal, includes common drugs for cholesterol, high blood pressure, and other chronic conditions. Serving as a companion to the drug price reforms in the IRA, this initiative would stabilize prices of widely-used generic medicines, curb rationing, and increase medication adherence.
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CMS Guidance On 2nd Round Of Medicare Negotiation
The next round of the Medicare drug price negotiations has been designed to be more patient-centered, according to the Centers for Medicare & Medicaid Services (CMS). The next 15 drugs selected for negotiation will be released by February 1, 2025, with negotiated prices taking effect in 2027. Key elements of the new guidance include:
Last year, P4AD patient advocates participated in CMS listening sessions to share their experiences with high drug prices. Their testimonies were a crucial counterweight to pharma representatives who infiltrated the sessions with industry talking points. Along with other stakeholders, P4AD submitted comments on draft guidance for the inaugural round of Medicare negotiation, contributing to the chorus of patient voices that influenced these positive changes. We applaud CMS for including patient perspectives in this critical process and ensuring that the program truly serves the needs of those who are most harmed by high drug prices. — (CMS, Fierce Healthcare)
Medicinas Vitales, No Lujos
The high cost of prescription drugs for Latino communities takes center stage in a new P4AD ad campaign developed by Espacio, a creative collective out of El Tiempo Latino. The campaign, entirely in Spanish, is titled “Medicinas Vitales, No Lujos,” (Essential Medicines, Not Luxuries) and underscores the urgent need for reforms to lower the price of critical medicines, such as inhalers and chemotherapy drugs, used to treat chronic illnesses that disproportionately affect Latinos. The ads also draw attention to lawsuits from the pharmaceutical industry and its allies aiming to undermine the historic Medicare negotiation program. Our recent report highlighted that Latinos are more likely to require prescription medications for chronic illnesses — such as diabetes, high blood pressure, and cancer — and as a result of high drug prices set by pharma, 42 percent of Latinos report not taking their medications as prescribed due to cost. These shocking disparities are the catalyst behind the ad campaign to mobilize Latino communities to share their experiences with high drug prices and demand reforms to ensure patients can access life-saving treatments at affordable prices. The campaign includes a series of videos and digital print ads. — (El Tiempo Latino, P4AD, El Tiempo Latino)
Big Pharma CEOs Rake In Cash
Big Pharma executives continue to line their pockets as one in three Americans report difficulty affording their medicines. According to a new STAT News analysis, in 2023, health care industry CEOs averaged $11 million in annual compensation, with the median pay hitting $4.1 million – a staggering 51 times the median American household income. Topping the list, Moderna CEO Stephane Bancel, whose company amassed its huge fortune from taxpayer-invested COVID-19 vaccines, pocketed a whopping $305 million last year, which included salary, bonuses, vested stock, and other perks. And ranking among the top ten highest-paid industry executives, Eli Lilly CEO David Ricks took home an executive pay package of $73.9 million. These outrageous executive payouts are undoubtedly boosted by taxpayers who fund early development of blockbuster drugs. It’s a vicious cycle: taxpayers fund early drug development, then American patients pay inflated prices for years, all the while Big Pharma executives rake in millions of dollars in compensation. — (KFF, STAT)
ICYMI
In a new video, P4AD’s Merith Basey illustrates how Big Pharma games the patent system to block competition and keep prices high, and how we can curb these abuses and lower drug costs. Watch here.
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