1. Pharma’s Legal Assault on the Inflation Reduction Act
The pharmaceutical industry’s opposition to the new Medicare drug negotiation program introduced via the Inflation Reduction Act was back in the news this week. The continued legal assault on negotiating lower drug prices for patients reveals a familiar pattern: prioritizing massive profit margins over the affordability of life-saving medications for Americans. Large pharmaceutical corporations are using whatever avenues available to protect their financial interests rather than reduce drug prices for patients. The Department of Justice’s dismissal of these challenges this week highlights the Inflation Reduction Act’s constitutional backing and Congress’s authority to enact measures to address exorbitant drug pricing. Yet, the ongoing legal battles underscore the industry’s persistent efforts to manipulate systems to their benefit and their willingness to do whatever it takes to maintain a monopoly chokehold on medicines priced in the United States. In our commitment to supporting fairer drug pricing, Patients For Affordable Drugs endorsed two amicus briefs this week as part of our ongoing efforts in defense of the Inflation Reduction Act and support of lower drug prices for patients. And in 2024, get ready for an exciting announcement from us about a new patient-centered strategy set to shake up the status quo in favor of lower drug prices for patients across the country! (Inside Health Policy)
2. AbbVie’s Tactics Highlight Need for Pharmaceutical Reforms
AbbVie’s relentless pursuit of market dominance for Humira continues to yield staggering profits at the expense of patients. The company’s efforts to maintain revenue by stifling competition through patent manipulation have drawn intense criticism, highlighting the controversial tactics prevalent among pharmaceutical giants to maintain their monopolies. These practices are emblematic of wider issues in the pharmaceutical industry and underscore the need for reforms aimed at preventing such abuse and fostering a more competitive and fair marketplace. The recent passage of the ‘Lower Costs, More Transparency Act’ in the House reflects increasing momentum toward a comprehensive healthcare package in January, where reforms aimed at tackling patent abuses and fostering competitive markets could be included. This recent op-ed by patient advocate Bob Parant in the New York Daily News similarly urges further action from Senator Schumer on these competition bills. Additionally, our community at Patients For Affordable Drugs is once again ramping up calls and letters into Senate offices, amplifying the push for these competition bills, reflecting a groundswell of support for addressing these critical issues. (Forbes, MedCity News, Politico, New York Daily News)
3. Rising Healthcare Costs and the Push for Affordable Medications
In 2022, retail spending on prescription drugs surged, accounting for about 9% of total healthcare spending and reaching $405.9 billion—an 8.4% increase from 2021, following a 6.8% growth in 2020. The Biden administration has aimed to curb some of these escalating retail drug prices through the reforms in the Inflation Reduction Act, but also through the recent announcement that the administration could break the patents on drugs funded by taxpayer money if their prices prove excessively high, and highlighting agencies have the right to “march-in” if a drug isn’t reasonably available or affordable—a critical detail and an extra too use in the battle for fair drug pricing. (Idaho Capitol Sun, White House Fact Sheet)
Patients For Affordable Drugs will be closed through January 1st. Wishing you peaceful and restorative holidays and we look forward to sharing some exciting new updates in the New Year!
My name is Grace Shults, I am 23 years old, and I am from Columbus, Ohio.
My story with high prescription drug costs started when I was just a teenager in high school. I had gotten really sick all of sudden and went undiagnosed for years, which only until later revealed I had Lyme disease – I was puking all the time and easily got sick – It wasn’t until recently that I was also diagnosed with gastroparesis, a disorder that slows or stops the movement of food from your stomach to your small intestine. Because of these health issues, I’ve had to take antibiotics and a drug called Motegrity, which after partial insurance coverage, has been an issue to afford.
I grew up in a single parent household, where my personal health issues were essentially the big elephant in the room while my mother constantly scrambled financially. Though I thankfully was covered under my father’s health insurance plan and still am today, having ongoing medical issues was a financial burden that has caused undue stress for years.
Personally, the combination of Lyme disease, gastroparesis, and the other health issues it has created for me does not make life any easier. Because of my symptoms, there were times I was not eating or simply could not get myself to eat because of the pain I would later undergo. After trialing a couple of medications, I successfully landed on Motegrity, which has a list price of $505.40, which has provided consistent relief thus far at a cost of $165 per month out-of-pocket. Along with my other medications that I need, I pay on average $250 a month and try to get as many free samples from my doctors that I can. I consider myself disabled because of my health condition, am currently in school studying psychology and work remotely part time, which makes affording my medications a lot harder than most would think.
Socially, my life has also been impacted by the interconnection of my health and the medications I can afford. To put it simply, my social life is contingent on my health. I feel as if I do not have as many friends anymore while it is difficult to maintain a good social life while experiencing the many debilitating symptoms I confront on a regular basis. I am 23 years old and I should not feel alone in this way.
When faced with the question of why I believe in more affordable drugs, my answer is straightforward. I care because people need these medications to function. Affordable healthcare is not a privilege, it is a basic human right. We, the people, are not asking for crazy ludicrous things from society, we simply are asking for affordable medications to function in our society and live comfortable lives. I have seen family members before me struggle with affording their medications and now join them in this hurdle; it should not be this way at all. If Big Pharma made prescription drugs more affordable, they would still be profiting billions of dollars, all the while people would die and their health would decline.
Whenever I would imagine my future life, I never thought public health was for me, but my story has motivated me to pursue a career in this field. It is time for lower prescription drug prices.
Welcome to the Week in Review.
1. Taking Aim At Soaring Drug Prices
Yesterday, President Biden visited the National Institutes of Health, to announce that dozens of pharmaceutical companies will be required to pay rebates to Medicare for excessive price hikes on prescription drugs used by over 750,000 seniors annually. In the last quarter of 2023 alone, 48 Medicare Part B drugs surged in prices faster than the rate of inflation, leading to potential rebates under the Inflation Reduction Act. President Biden’s initiative aims to curb these exorbitant price hikes, ensuring companies repay Medicare, saving seniors between $1 and $2,786 per dose on these medications. Patients For Affordable Drugs (P4AD)’s President and Founder, David Mitchell, introduced President Biden at the event. As a patient on Medicare living with multiple myeloma, David shared his personal journey with high drug prices and celebrated the significant strides made in drug pricing reforms as a result of the Inflation Reduction Act. David is one of millions of patients whose drugs will cost him less from 2026 since Eliquis, one of his medications, is one of the first 10 being negotiated by Medicare. (The Hill, Reuters, Fortune, YouTube)
2. Enforcing Fair Drug Pricing
The White House and Health and Human Services (HHS) have also made significant progress this week towards ensuring Americans pay fairer prices for medical products they helped pay to invent through their taxpayer dollars by making fair pricing a new standard part of negotiations. The Administration for Strategic Preparedness and Response (ASPR) has integrated fair pricing criteria into recent contract agreements. Notably, contracts with organizations like Regeneron, CastleVax, Codagenix, and Gritstone Bio, as part of Project NextGen, outline provisions that require their commercialized products to be priced in the U.S. at levels equivalent to or lower than those in comparable global markets. This initiative aims to protect people from disproportionately high drug costs, ensuring that innovations backed by taxpayer dollars are affordable and accessible. (White House Fact Sheet, MedPage Today)
3. Setting the Stage For Senate Health Care Package
The House of Representatives passed the “Lower Costs, More Transparency Act” on Monday night, a pivotal step toward addressing high drug prices. The firm bipartisan passage of this legislation increases the momentum for a comprehensive healthcare package in the Senate in January and presents an opportunity to pass bills aimed at lowering drug prices by addressing patent abuses and other anti-competitive tactics employed by drug companies to delay generic and biosimilar competition. This overwhelmingly bipartisan effort paves the way for a bipartisan end of year package that can lower prescription drug prices for all patients. (MedCity News, Pink Sheet)
BONUS: Not all patient groups are what they seem! This new report from Public Citizen shows the power of Pharma dollars at work and how they leverage patient groups to do their bidding including during the fight to pass the drug price reforms in the Inflation Reduction Act. Their actions keep prices high for patients. From the report; “if a patient advocacy group expresses doubts about a drug-pricing bill, that may have a greater impact. If a local advocacy organization publishes an op-ed in the member’s local paper, that will no doubt get a member’s attention. If a new controversial drug to treat a disease gets the ringing endorsement of the patient group representing those inflicted with the disease, that could carry great weight”. Bottom line: If you’re in bed with pharma, you’re not doing enough on drug pricing. To understand the influence of Pharma on a patient group see P4AD’s The Hidden Hand and the 2023 Update Hiding in Plain Sight. (KFF Health News)
Have a great weekend!
As we approach the end of 2023, we wanted to highlight the historic drug price reforms in the Inflation Reduction Act delivering relief to millions of patients on Medicare.
Medicare negotiation is critical for patients who have been forced to pay exorbitant prices for some of the most widely-used, expensive medications. Bristol Myers Squibb (BMS) blood thinner Eliquis, one of the drugs selected for the first round of Medicare negotiations, has been priced out of reach for many patients since hitting the market in 2013. Since there are no generic competitors to Eliquis, BMS is able to dictate the price to patients and taxpayers and extract increasing amounts of profit without any meaningful improvement to the drug. During periods of market exclusivity, “drug companies use their market power to set prices well above the costs of production and distribution,” said Richard G Frank, a professor emeritus of health economics at Harvard Medical School. Christen Linke Young, White House Domestic Policy Council’s deputy assistant to the president for health and veterans affairs, called out BMS at a STAT event for fending off generic competition to Eliquis and as a result “earned themselves the privilege of getting paid $16 billion by Medicare last year alone.” This long history of unjustified price hikes has hurt patients who depend on this life-saving medication. Thankfully, a lower negotiated price for Eliquis will deliver relief to millions of patients on Medicare starting in 2026. (Philadelphia Inquirer, STAT)
2. Patent Abuse Watch
In the latest Big Pharma shenanigans, AbbVie is suing potential competitors to its blockbuster drug Rinvoq, alleging that generic makers are infringing on more than 30 patents. This is a classic tactic in Abbvie’s patent abuse playbook, which also propelled its blockbuster drug Humira to earn billions of dollars of profit by obtaining dozens of unmerited patents and charging patients unjustifiably high prices. This latest example of patent abuse underscores the urgent need for reforms to our patent and regulatory systems. Johnson and Johnson’s (J&J) is attempting to exploit our patent system in a similar fashion by reaching settlements with generic makers to delay biosimilar versions of its psoriasis and irritable bowel drug Stelara. As a reminder, every additional day of market exclusivity for Stelara in the U.S. drives almost 18 million in revenue for J&J. Patients deserve lower priced competition to come to market and deliver relief from the unfettered pricing power held by profit-hungry brand name drug corporations. (Fierce Pharma, Biospace)
3. States Push For Lower Insulin Prices
There’s growing momentum within state and local governments to ease the financial burden of expensive insulin medications. Lawsuits have been filed in Utah, Arizona, New York, Virginia, and Maryland alleging that big insulin makers — Eli Lilly, Sanofi, and Novo Nordisk — worked in tandem with pharmacy benefit managers (PBMs) to price insulin out of reach for many patients who depend on this life-saving medication. These profit schemes hurt patients–too many of whom have been forced to ration their insulin supply or completely go without because of its high price tag. Taxpayers are also directly affected by the enormous costs placed on the U.S. healthcare system. The $35 monthly insulin copay cap for patients is just the start — we will keep fighting until insulin is affordable and accessible to everyone! — (STAT)
BONUS: P4ADNow salutes Senators Dick Durbin and Chuck Grassley for introducing bipartisan legislation to increase price transparency in direct to consumer advertisements on prescription drugs. Thank you Senators for prioritizing patients over the interests of Big Pharma!
Have a great weekend!
Patients Thank Senator Schumer For Leading Historic Reforms To Lower Drug Prices And Push For Bills To Curb Anti-Competitive Practices And Boost Generic Competition
NEW YORK — Over 100 patients from New York who depend on essential, high-priced medications sent a letter to Senate Majority Leader Chuck Schumer thanking him for his work to lower drug prices and urging him to continue his efforts to make medicines more affordable by including legislation that would curb patent abuse and increase competition in a January health care package.
The letter to Senator Schumer endorses a package of bipartisan bills, which, having received committee approval, address the anti-competitive tactics employed by drug companies to delay the entry of generic competition necessary to reduce drug prices. These legislative reforms are anticipated to substantially decrease prices and out-of-pocket expenses for millions of patients and result in significant savings for taxpayers.
“We stand in support of the bipartisan bills aimed at curbing these anti-competitive practices,” the letter reads. “We know that you and Senators on both sides of the aisle have been working to advance these measures. It’s critical that we take action now to improve competition and address the loopholes exploited by Big Pharma. Doing so will lead to lower out-of-pocket costs for millions of people and substantial savings for taxpayers.’
The bills included are:
S. 142 to curb pay-for-delay deals in which brand name drug makers pay would-be generic and biosimilar competitors to keep them from bringing their products to market.
S. 150 to crack down on patent thickets and product-hopping, which are used to build a patent wall around existing brand name drugs and block lower-priced competition.
S. 148 and S. 1067 to stop drug company abuse of citizen petitions before the Food and Drug Administration (FDA) which drug companies use to delay generic and biosimilar market entry.
S. 775 to improve the ability of the FDA to disclose information generic companies need for speedy approval.
S. 79 to establish a task force between the U.S. Patent and Trademark Office and FDA in order to improve each agency’s patent-related activities.
“As your constituents in New York, we are committed to supporting your efforts to make progress on these critical bills,” the letter continues. “We laud your dedication to this cause and we are eager to see you build on the work you’ve already achieved to ensure these bipartisan bills are enacted to further lower prescription drug prices for patients nationwide.”
Read the full letter and list of signers here and below.
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Senator Chuck Schumer Majority Leader 322 Hart Senate Office Building Washington, DC 20510
Dear Senator Schumer,
As patients from New York who rely on expensive medications to treat our illnesses or conditions we are particularly impacted by the high price of prescription drugs. We are writing to express our gratitude for your tireless efforts in championing vital prescription drug reforms to make medications more accessible and affordable for all.
The Inflation Reduction Act was instrumental in securing historic reforms such as drug price negotiation under Medicare, an out-of-pocket cap in Medicare Part D, and inflation-based rebates for drugs in Medicare Part B and D. These initiatives will significantly alleviate the burden of high prescription drug costs for many of us in our community and millions across the country. The actions you’ve taken are positively impacting the lives of seniors, people with disabilities, and many others relying on Medicare for essential medications.
Despite all that progress, we recognize that you are well aware that more work is needed to ensure continued progress to combat exorbitant prescription drug prices. As you know, Big Pharma uses anti-competitive practices, like patent thickets, product hopping, and pay-for-delay arrangements, to hinder the entry of generic and biosimilar medications into the market, obstructing market competition that would reduce drug prices for patients across the country.
We stand in support of the bipartisan bills aimed at curbing these anti-competitive practices. We know that you and Senators on both sides of the aisle have been working to advance these measures. It’s critical that we take action now to improve competition and address the loopholes exploited by Big Pharma. Doing so will lead to lower out-of-pocket costs for millions of people and substantial savings for taxpayers.
As your constituents in New York, we are committed to supporting your efforts to make progress on these critical bills. We laud your dedication to this cause and we are eager to see you build on the work you’ve already achieved to ensure these bipartisan bills are enacted to further lower prescription drug prices for patients nationwide.
Thank you for your unwavering commitment to lower drug prices for all Americans. We stand with you and eagerly anticipate this package of crucial bills being brought to the floor so we can enhance competition for prescription drugs and reduce costs for patients.
Sincerely,
[Patient Signatures]
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Vote Sets Stage For Negotiation On Bipartisan Bills Promoting Competition Making Their Way Through The Senate
The following statement was issued by Merith Basey, executive director of Patients For Affordable Drugs Now, after the House of Representatives passed the “Lower Costs, More Transparency Act”:
“The House’s decisive bipartisan action tonight in passing the “Lower Costs, More Transparency Act” including measures to increase transparency and further tackle high drug prices by improving the generic drug approval process, is highly encouraging and moves the Congress in the right direction. This development boosts the momentum for the Senate leadership to move forward with a comprehensive health care package, encompassing bills aimed at lowering drug prices by addressing patent abuses and other anti-competitive tactics employed by drug companies to delay generic and biosimilar competition. This action helps to pave the way for a bipartisan end of year package that can lower prescription drug prices for everyone.”
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Wishing everyone a restful and restorative Thanksgiving break! Here’s a roundup featuring P4AD patient advocates at the virtual CMS Listening Sessions for the Medicare Negotiation Program
David Mitchell, a cancer patient and founder of Patients For Affordable Drugs whose drugs carry a combined list price of more than $900,000 per year, kicked off the first day of the Centers for Medicare & Medicaid (CMS) patient focused listening sessions with remarks on taking blockbuster blood thinner Eliquis and the relief to come from its negotiated drug price. “Negotiation on Eliquis is going to help millions of patients like me have both better health and improved financial well-being,” David explained. The following day, longtime P4AD patient advocate Judy Aiken shared her experience from her home in Maine at the Enbrel listening session: “Enbrel’s high cost has been a real burden, a constant anxiety. A lower price for this drug will be life changing for me and thousands of other patients.”
P4AD patient advocate Bob Parant, who lives with type 1 diabetes and introduced the President in September last year following the passage of the Inflation Reduction Act, spoke at the listening sessions about his high out-of-pockets costs for Entresto — a heart failure medication that keeps him alive following a recent triple bypass surgery. “I am always on high alert with all of my meds. Many do not realize what additional stress this presents besides living with the disease itself,” remarked Bob at the patient listening session for Entresto. Thankfully, in 2026, he won’t have to worry so much about managing the high costs of his life-saving medication due to Medicare negotiation. Lynn Scarfuto, a P4AD advocate who takes oral chemotherapy drug Imbruvica for her leukemia, celebrated the announcement that her anticancer medication will be eligible for Medicare negotiation in 2026. She shared at the Imbruvica listening session that the monthly list price of her medication is hugely cost prohibitive at $17,000 a month and hopes that “future negotiations will make these meds more affordable” for patients like her on Medicare.
P4AD patient advocate Steven Hadfield, who lives with a rare blood cancer and type 2 diabetes, and who introduced the President when the first 10 drugs selected for negotiation were announced, shared the relief he felt when his diabetes medication, Januvia, was announced as one of the first drugs that Medicare will negotiate a lower price for in 2026. “I know Medicare negotiation is a blessing not a detriment for patients like me, as a decrease in price would allow working class Americans to feel some well needed financial relief and enjoy access to more affordable medications,” said Steven during the Januvia listening session. At the Stelara listening session, P4AD patient advocate Doug Lusty commented on the financial burden caused by the high cost of Stelara in addition to his other expensive medications that he depends on to treat his Crohn’s disease and diabetes. “I am already on a fixed-income and have been hit financially hard with medical expenses between my wife and I, which means lower drug prices will ultimately let us enjoy some savings and give us more breathing room that we desperately need.”
Despite the presence of pharma talking points saturating the sessions, we want to express our deepest thanks to all P4AD patient advocates, whose stories illuminate the urgency and impact of Medicare negotiations. It’s undeniable that the success of the historic drug price reforms within the Inflation Reduction Act is due to the power and dedication of these patient advocates speaking out in direct opposition to pharma interests.
Have a great holiday!
Welcome to the Week in Review.
1. Deflating Big Pharma Lies
We know that Big Pharma will go to extreme lengths to preserve its monopoly pricing power and egregious profits. It turns out that their fear mongering claims about the Inflation Reduction Act are falling flat. Compared to last year, drug company research & development (R&D) spending is increasing and mergers and acquisition (M&A) is on the uptick, according to a study by ATI Advisory. Big Pharma is flush with cash! Despite Big Pharma’s constant spewing of misinformation, patients are able to steer through this shroud of propaganda and are already feeling relief from the drug price reforms in the Inflation Reduction Act. “Innovation is meaningless if no one can afford it,” wrote Jim from Minnesota in a letter-to-the editor. “Medicare negotiation will finally allow the program to look at whether drug prices are justified and move toward a system that rewards meaningful advances, leading to more innovation.” The historic drug price law is prioritizing patients’ health and financial well-being, while also continuing to enable innovation. — (ATI Advisory, Duluth News Tribune)
2. Patients Need Competition To Lower Prices
There was more evidence this week that drug companies game our patent and regulatory systems to maintain market exclusivity and charge patients high prices. According to analysis published in JAMA, between 2004 and 2021, a U.S. appeals court found 36 cases in which companies failed to disclose accurate information to the U.S. Patent and Trade Office (USPTO). More than 60 percent of those invalidated patents were attributed to medical products covered by the Food and Drug Administration (FDA). This draws attention to the question of the genuine “innovation” being brought by these patents filed by drug companies. One of the study’s authors, Sean Tu, argued that the USPTO should improve communication with the FDA to prevent patent abuse. “If somebody asked me how many people are speeding on the highway? I would say I‘ve no idea, but I can tell you how many are caught speeding. And if 50% are driving red Corvettes, then maybe we should look at red Corvettes. In this instance, the companies with FDA-approved products are red Corvettes,” Tu told STAT. “Perversely, patents can also create incentives for innovations that create very little value,” wrote James and Robert Rebitzer in a STAT opinion. They continue to explain that Big Pharma uses secondary patents and other tactics that “offer little benefit to patients and society” and exist purely to extend monopoly periods. That’s why we’re pushing for bipartisan bills that will fix our rigged patent system and close regulatory loopholes to encourage competition and lower drug prices. — (JAMA, STAT, STAT)
3. Insulin Affordability Crisis
On Monday, the Congressional Black Caucus convened to discuss how diabetes disproportionately affects Black Americans and called for more action to help provide relief for insulin costs. Rep. Shontel Brown cited a study last year that found 23 percent of Black people were rationing their prescribed insulin due to high costs. This devastating reality for many patients who depend on insulin is enabled by rampant patent abuses from the drug corporation cartel that controls the world’s insulin market. Drug companies making insulin products regularly file for multiple patents after FDA approval and extend market exclusivity, according to a study published in PLOS Medicine. While the $35 insulin copay cap in the Inflation Reduction Act for patients on Medicare represents a significant step in the right direction, many people in the U.S. are still facing high costs and can be forced to ration or go completely without their insulin which can be deadly. We will keep fighting to ensure that everyone can access insulin at prices they can afford. — (Cleveland.com, PLOS Medicine)
BONUS: P4AD’s David Mitchell was one of several co-authors on this new paper in Nature that examines the ways that universities and academic medical centers, which receive large amounts of funding from taxpayers, can better ensure medicines including novel gene therapies are priced to maximize public health and lessen the burden that high drug prices impose on patients and society.
