P4ADNow Testimony For Ways And Means Health Subcommittee
The following written testimony was submitted on behalf of David Mitchell, founder and president of Patients For Affordable Drugs Now, ahead of the House Ways and Means Health Subcommittee hearing on “Examining Policies that Inhibit Innovation and Patient Access”:
A lovely recognition from Washingtonian (and on his 73rd birthday!?) of our founder David Mitchell who was an “integral player in forcing the prescription-drug provision into the Inflation Reduction Act.” Congrats, David! Well deserved.
Welcome To The Week In Review.
1. Dozens Of Organizations Pressure Senate To Lower Drug Prices
Over 40 organizations sent a letter to the Senate urging them to advance a package of bipartisan legislation this year to lower drug prices through increased competition, transparency, and accountability. The organizations — representing patients, consumers, seniors, churches, students, and disease advocacy groups — united in insisting senators focus on strengthening the U.S. patent and regulatory systems, increasing competition, and addressing the shady practices of Pharmacy Benefit Managers (PBMs) to ensure they are serving patients first. “There is bipartisan support in Congress to pass common-sense reforms that will further improve the U.S. drug pricing system and lower prices for more patients,” said P4ADNow’s David Mitchell. AARP, who co-led the letter with P4ADNow, emphasized: “More than 80 percent of voters across party lines want federal agencies such as the Food and Drug Administration to encourage more competition in the prescription drug marketplace.” There is clearly bipartisan momentum to pass meaningful drug price reforms this year. Next week, the Senate Health, Education, Labor and Pensions (HELP) Committee will hold two hearings — one with CEOs from insulin manufacturers and PBMs and another to mark up bipartisan legislation to close loopholes in the regulatory system and accelerate generic competition. We urge the 118th Senate to keep up the good work and prioritize advancing a package of bills to the Senate floor to lower drug prices for patients. — (P4ADNow, AARP, Bloomberg)
2. More Inflation Reduction Act Savings For Patients — “It’s huge.”
Patients are seeing savings thanks to the drug price reforms in the Inflation Reduction Act. More than 37,000 Tennesseans will benefit from the $2,000 out-of-pocket cost cap when it takes effect in 2025 and many West Virginians on Medicare are better able “to buy groceries, and pay their rent and utility bills” due to the $35 monthly insulin copay caps. Members of the Biden administration continued to share how the new historic drug price law is helping patients. “Well, as you know, we pay the highest drug cost of any advanced nation in the world … but now we reduced the cost of insulin from hundreds of dollars a month to $35 a month — for anyone on Medicare,” remarked President Biden at a Democratic National Committee (DNC) reception. Vice President Kamala Harris echoed similar sentiments, saying “we were able to cap the cost of insulin for seniors at $35 a month. It’s huge.” Department of Health and Human Services (HHS) Secretary Xavier Becerra and Congresswoman Jennifer Wexton toured a senior living center in Virginia and touted the legislation, which will save Virginians who receive insulin through Medicare more than $500 per year. Becerra laid out the sizable impact of the new drug price law for American families: “The Inflation Reduction Act has now made it possible for families to be able to afford a lot of that health care that sometimes can cost a lot of money.” — (Citizen Tribune, Public News Service, The White House, The White House, Inside Nova)
3. Big Pharma’s Greed Knows No End
New numbers show that Big Pharma unsurprisingly has been cashing out on advertisements, lobbying spending, patent abuses, and huge CEO salaries. The pharma industry spent nearly $8.1 billion on ads in 2022 while patients struggled to afford life-saving medications. Health industry lobbying far outpaced any other sector with The Pharmaceutical Research and Manufacturers of America (PhRMA) spending over $8 million in the first quarter of the year. Big Pharma CEOs took home eye-bulging amounts of pay: In 2022, Biogen CEO Chris Viehbacher was compensated $30.5 million and Moderna CEO Stéphane Bancel made nearly $400 million from stock options (not to mention he raised his salary by 50% to $1.5 million). Meanwhile, Moderna announced this week that its updated mRNA COVID-19 vaccine will be priced up to $130 per shot — looks like Bancel plans to continue profiting off the backs of taxpayer funded research. Speaking of taxpayer dollars, a new study in Health Affairs shows that the U.S. government spent $143 million towards development and clinical testing of Truvada, the first approved HIV prevention pill. Yet drugmaker Gilead has hiked the price by more than 40% and made as much as $3 billion annually off the taxpayer-supported drug. Gilead’s trial — in which the federal government is suing Gilead for infringement on government-owned patents — began this week. While drug companies claim that high drug prices are needed to justify research and development, the truth is they simply want to line their coffers with more and more profit. (Fierce Pharma, Open Secrets,Fierce Pharma, Washington Post, Ars Technica, Health Affairs, Endpoints)
BONUS: Florida patient advocate Xanadu Roque eloquently speaks about her experience growing up with type 1 diabetes, issues with accessing insulin in her community, and the growing pressure from advocates to lower insulin prices. Checkitout!
Have a great weekend, everyone!
Groups Representing Patients, Consumers, Seniors, Churches, Students, And Disease Advocacy Groups Align On Action To Lower Drug Prices
WASHINGTON, D.C. — Patients For Affordable Drugs Now and AARP, along with 39 organizations representing patients, consumers, seniors, churches, students, and disease advocacy groups sent a letter to all members of the 118th Senate urging them to advance legislation to strengthen the U.S. patent and regulatory systems, spur competition, address opaque practices of Pharmacy Benefit Managers (PBMs) to ensure they are serving patients and consumers first, and lower drug prices for millions.
“There is bipartisan support in Congress to pass common-sense reforms that will further improve the U.S. drug pricing system and lower prices for more patients,” said David Mitchell, a patient with incurable blood cancer whose drugs carry a list price of more than $900,000 per year and founder of Patients For Affordable Drugs Now. “Too many drug prices are still far too high for too many people. We must continue to push until all people can afford their medicines.”
The letter was sent ahead of the HELP Committee markup on four bipartisan bills to close loopholes in the regulatory system and accelerate generic competition. The letter follows the February passage in the Senate Judiciary Committee of five bipartisan bills to reform the patent system and improve competition. This spring, the Senate is expected to assemble a health package that includes these critical bills.
“One in four people in the United States has difficulty affording medications,” the letter reads. “We are grateful to see movement on critical issues such as access to health care and prescription drugs. We urge the Senate to immediately act on legislation to lower drug prices through increased competition, transparency, and accountability.”
Read the full letter and list of signers here and below.
May 1, 2023
Dear Members of the 118th Senate,
As organizations representing patients, consumers, seniors, churches, students, and disease advocacy groups we are grateful to see movement on critical issues such as access to health care and prescription drugs. We urge the Senate to immediately act on legislation to lower drug prices through increased competition, transparency, and accountability.
One in four people in the United States (U.S.) has difficulty affording medications, including an estimated 3.5 million adults age 65 and older. People of color are disproportionately harmed by high drug prices, which contribute to the fact that uninsured Latinos and Black Americans use 10-40% fewer medications than their White counterparts. Further, among adults 65 and older, Latino and Black adults are roughly 1.5 times more likely to have trouble affording needed medications than Non-Latino White adults and 2 times as likely not to get needed prescriptions due to cost.
Drug companies in the U.S. have unlimited, unilateral pricing power during time-limited monopoly periods awarded by the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA.) Many big drug companies prolong these monopoly periods by employing anti-competitive tactics exploiting loopholes in our patent laws to block competition, while patients, employers, and taxpayers are left paying prices that are up to four times what other wealthy nations pay for the exact same brand name drugs.
Downstream in the supply chain, three large pharmacy benefit managers (PBMs) dominate roughly 80 percent of the drug market. PBMs argue that this concentrated market share allows them to negotiate effectively with drug companies. However, there are growing concerns that some opaque business practices of PBMs may be contributing to higher prescription drug costs for consumers.
This spring, the Senate has the opportunity to advance a package of bipartisan bills that will strengthen our patent and regulatory systems, spur competition, address practices of PBMs to ensure they are serving patients and consumers first, and lower drug prices for millions. We urge the Senate to ensure inclusion of bills to:
Increase Competition: Brand-name pharmaceutical companies engage in tactics aimed at preventing competition that harm consumers and their health; these behaviors include paying generic manufacturers to delay entering the market or making trivial, non-innovative changes to medicines in an effort to avoid competition from a prospective generic. There are bipartisan bills in the Senate that strengthen the patent system by banning anti-competitive tactics such as “pay-for-delay” deals and product hopping tactics. These bills have passed House and Senate Judiciary Committees on strong bipartisan votes in the past two Congresses. Bipartisan legislation under consideration by the Senate Health, Education, Labor and Pensions (HELP) Committee can further spur competition by preventing big drug companies from manipulating FDA processes in order to thwart competitors. Beyond broad Senate support, these reforms enjoy the support of the American people. More than 80% of voters across party lines want federal agencies such as the USPTO and the FDA to encourage greater competition in the prescription drug marketplace.
Promote Transparency: By design, the U.S. drug price system is complex and convoluted, making it difficult for policymakers, patients, and health care providers to find straightforward information about drug costs. The Senate must advance bipartisan legislation that requires drug companies to disclose and justify high prices.
Hold Pharmacy Benefit Managers Accountable: Consolidation within the pharmacy benefit manager sector has given PBMs a great deal of negotiating power. However, the complicated nature of the drug supply chain can make it difficult for patients, employers, and policymakers to determine when PBM business practices are in the best interests of patients. Bipartisan legislation could require more transparency and accountability to better ensure PBMs act in the best interests of patients and consumers.
Together these reforms take vital steps to promote competition, transparency, and accountability that will lower drug prices for patients, payers, and taxpayers, including the constituencies we represent. On behalf of these constituencies, we urge the Senate to act immediately to advance a package with these reforms.
Signed:
AARP ACA Consumer Advocacy American Medical Student Association (AMSA) Americans for Democratic Action, Southern California Arkansas Community Organizations Beta Cell Action Campaign for a Family Friendly Economy (CFFE) Center for Health & Democracy Center for Medicare Advocacy Church World Service Committee to Protect Health Care Community Catalyst Consumer Action Families USA Florida Alliance for Healthcare Value Generation Patient Health Care Voices Initiative for Medicines, Access & Knowledge (I-MAK) Interfaith Center on Corporate Responsibility Lower Drug Prices Now (LDPN) Medicare Rights Center MomsRising National Committee to Preserve Social Security and Medicare National Multiple Sclerosis Society Oregonizers Patients For Affordable Drugs Now Prescription Justice Protect Our Care Public Citizen Rise Up WV Salud y Farmácos Social Security Works SPACEs in Action T1International Tennessee Health Care Campaign U.S. PIRG Unity Fellowship of Christ Church-NYC Universities Allied for Essential Medicines (UAEM) VOCAL-NY West Virginians for Affordable Health Care WV Citizen Action Group
###
Looks like PhRMA has a gold check on Twitter now, which costs $1,000 per month — an easy price for corporations to pay off the back of patients when drugs like Sovaldi are priced at $1,000 per pill.
Welcome To The Week In Review.
1. Up Next: Drug Price Reforms On The Horizon
Congress is back in session and reforms to rein in high drug prices are top of mind in both chambers. In the Senate, Finance Committee Chairman Ron Wyden and Ranking Member Mike Crapo released a bipartisanframework for legislation to target Pharmacy Benefit Managers (PBMs) that “unfairly inflate the prices patients and government programs pay for prescription drugs.” The Senate Health, Education, Labor and Pensions (HELP) Committee plans to hold its markup next week to markup legislation focused on accelerating generic drug entry, closing regulatory loopholes used by big drug companies to block competition, and reforming specific practices of PBMs. Chairman Bernie Sanders also plans to question executives of top insulin makers and PBMs at another hearing on May 10. In the House, the Energy and Commerce Committee will hold a hearing next Wednesday on transparency, competition, and PBM reform. This Congress brings a real opportunity to advance a package of bipartisan bills that will strengthen our patent and regulatory systems, spur competition, address practices of PBMs to ensure they are serving patients and consumers first, and lower drug prices for millions. Let’s do this, Congress. — (Senate Finance Committee, Endpoints, Politico, Politico, Axios, PIRG)
2. The Inflation Reduction Act Keeps Helping Patients
Patients on Medicare are saving on drug prices thanks to the reforms in the Inflation Reduction Act – and members of Congress continue to spread the word. In an op-ed, Senator Tammy Baldwin reminded her constituents that “we took on the drug industry again and we won.” She explained that “we beat Big Pharma, passing a law to lower drug prices and cap insulin costs at $35 a month for our seniors.” Senator Sherrod Brown agreed that the insulin copay caps are making a huge difference for patients in his community. He shared that Ohioans on Medicare are saving $500 a year from the new provision. “The Inflation Reduction Act finally took on the drug companies and lowered drug prices for Americans on Medicare,” Senator Brown wrote. ? — (The Madison Times, The Ironton Tribune)
3. Big Pharma Myth Busters
Big Pharma peddled lies this week about Medicare negotiation in the Inflation Reduction Act. The Pharmaceutical Research and Manufacturers of America (PhRMA) — who has been crying wolf for decades about the need for high drug prices to cover costs of research and development (R&D) — is shifting tactics now that the Centers for Medicare & Medicaid Services (CMS) is requiring drug companies to justify R&D costs as part of the negotiation process. The reality? “Drug companies know that when we see behind the curtain, the true costs of R&D won’t justify their high prices,” P4AD’s David Mitchell told STAT. CMS Administrator Chiquita Brooks-LaSure explained: “By considering factors such as clinical benefit and unmet medical need, drug price negotiation intends to increase access to innovative treatments for people with Medicare.” According to a new study published in The Journal of the American Medical Association (JAMA), 27 of Medicare’s top-selling drugs — which account for nearly $20 billion in Medicare spending — actually have “little or no therapeutic benefit over therapeutic alternatives”! Thankfully, Medicare’s new negotiation authority ensures the program can examine whether a drug is truly innovative, which will better serve patients. We won’t be fooled by Big Pharma’s big lies — we know the Inflation Reduction Act will rein in prescription drug prices for patients who need this long-awaited relief. — (STAT, Fierce Healthcare, JAMA)
BONUS: Check out patient advocate Kat Schroeder’s interview in Virginia Dogwood, where she shares her personal experience with rationing insulin due to high prices and comments on the power of advocacy to finally see the prices of insulin lowered. Thanks for your wise words, Kat!
Have a great weekend, everyone!
Welcome To The Week In Review.
1. HELP Is On The Way
The Senate Health, Education, Labor and Pensions (HELP) Committee is continuing to gather input in advance of their now-delayed markup on drug price legislation. The markup is expected to examine legislation focused on spurring generic drug entry, closing regulatory loopholes used by big drug companies to block competition, and reforming specific practices of Pharmacy Benefit Managers (PBMs). Chairman Bernie Sanders, in his latest effort to hold Big Pharma accountable, also says he plans to call the chief executives of the world’s leading insulin manufacturers (Eli Lilly, Novo Nordisk, and Sanofi) to testify before the Committee. “Democrats continue to push measures to lower prices after passing legislation that allows Medicare to negotiate prices, penalizes price inflation, and caps seniors’ annual drug costs,” STAT reported. Keep it up, Congress – we look forward to fighting together for further reforms when you return from recess on Monday. — (Politico, Axios, STAT, STAT)
2. More Money In Patients’ Pockets Thanks To The Inflation Reduction Act
The Inflation Reduction Act is already helping millions of people on Medicare— and members of Congress are spreading the word. At a community center in Atlanta, Secretary of Health and Human Services Xavier Becerra and Senator Jon Ossoff highlighted how “a senior in Georgia will now save between $500 and $600 a year” because of the Inflation Reduction Act which “will also provide free vaccines to seniors for illnesses like the flu or shingles.” Congressman Ruben Gallego also celebrated that the new drug price law will help more than 28,000 Arizonians “save about $500 per year on their insulin,” and Senator Debbie Stabenow and Representative Hillary Scholten held a press conference in Grand Rapids, Michigan explaining the relief that the Inflation Reduction Act will provide for seniors. Looking ahead, the new law will continue to help more people on Medicare as the rest of the provisions are implemented. Yesterday, the Centers for Medicare and Medicaid Services (CMS) closed the public comment period on its March draft of the Medicare drug price negotiation program guidance and will release final guidance in July. The agency is focused on closing potential loopholes that drug companies could use to avoid negotiation. Not so fast pharma — CMS is making sure its new negotiation authority will bring as much benefit to patients in relation to as many drugs as possible. ? — (Cure Today, Coastal Point, 11alive, Forbes, Fox17, Reuters, Bloomberg)
3. No Innovation Found Here
In the latest example of drug company shady shenanigans, one biotech company is making millions price gouging patients without ever inventing a drug. Horizon Therapeutics, along with the previous manufacturers, raised the price of gout drug Krystexxa almost every year since it came to market. Without making any changes to improve the drug, the company now charges about 10 times as much as the price of the drug when it came to market in 2011 — so six months of treatment can currently be more than $400,000. Now, the company is cashing in again by selling to pharma giant Amgen. Tim Walbert, Horizon’s CEO, who will reportedly receive around $135 million when the deal closes, “has mastered a particular kind of industry expertise: taking drugs invented and tested by other people, wrapping them expertly in hard-nosed marketing and warm-hued patient relations, raising their prices, and enjoying astounding revenues,” KFF reported. Patients deserve investments in true innovation, not spending on marketing ploys on ineffective old drugs. — (KFF)
Have a great weekend, everyone!
July is a big month for people who love pumps: The live-action comedy film Barbie comes out AND the Inflation Reduction Act’s $35 monthly insulin copay cap will extend to people on Medicare who use pumps!
Welcome To The Week In Review.
1. Momentum For Bipartisan Drug Price Reforms
Congress may have been in recess this week, but bipartisan momentum continued to grow with regard to looking into the practices of Pharmacy Benefit Managers (PBMs) and reforming our rigged patent system. Politico reported that on April 19th, the Senate Health, Education, Labor & Pensions (HELP) Committee will mark-up a yet to be seen bipartisan drug price bill that is related to PBMs and generic drugs. Further, Axiosreported that Senate Majority Leader Chuck Schumer holds prescription drug reform as a top priority and plans to bring a health care package to the Senate floor that could include the five bipartisan bills from the Senate Judiciary Committee that address key fixes to our rigged patent system and reforms to the practices of PBMs. Following the Senate Finance Committee PBM hearing last week, Raymond, a patient in Washington, wrote an opinion piece urging legislators to continue bipartisan collaboration on reforming the PBM industry: “As a patient adversely impacted by benefit managers, I can confidently say that these reforms must remain a federal priority for the 118th Congress.” Tahir Amin, co-founder of the Initiative for Medicines, Access, and Knowledge (I-MAK) shared how patent reform is essential in the fight to lower drug prices on the Public Health On Call Podcast: “I think the first step we have to do is get the agencies like the FDA and USPTO to get on board and change some of the rules that allow companies to build these thickets of patents — and I think that’s happening at the moment.” We’re looking forward to working with lawmakers across the aisle on these reforms as they come back from recess next week! — (Politico, Axios, The Daily Herald, Johns Hopkins Bloomberg School of Public Health)
2. “How Long Can We Go Through Our Savings To Pay For A Drug?”
Patients continuously face high drug prices that push the medicines they need out of reach. Kentucky patient Sue Lee wrote a letter about the blockbuster drug Humira, which she took to treat painful sores caused by her chronic plaque psoriasis. Once on Medicare, the drug cost her $4,000 out of pocket monthly and she was forced to stop taking Humira completely. Florida patient Sydney, 18, lives with Crohn’s disease and was also forced to stop taking Humira, which improved her health significantly, because of its high cost. Sydney’s mother, Holly, explained the hardship of paying for the expensive drug to the Washington Post: “How long can we go through our savings to pay for [a drug]?” Trudy, a respiratory therapist in Washington, told the Post how she witnessed seniors with chronic lung disease forgo their medications and inhalers for years because of high drug prices set by Big Pharma. In addition, patients who rely on EpiPens shared that they are currently paying in excess of $600 a year, an increase from the original $100 per year, for the life-saving drug. We clearly need meaningful policy solutions to fix our rigged system. Drug corporations won’t stop padding their bottom line — with no regard for patients’ health and financial security — unless we stop them. — (Lexington Herald-Leader, The Washington Post, Vox)
3. Popular Provisions In The Inflation Reduction Act
There’s no denying the popularity of the drug price provisions in the Inflation Reduction Act. A new survey reports that 83 percent of people over the age of 65 support the president’s budget proposal to expand on drug price reforms in the Inflation Reduction Act including Medicare negotiation. Lawmakers have been singing a similar tune about the savings in the new drug price law. Senator Jacky Rosen proudly reminded the Nevada Legislature about the success of the Inflation Reduction Act: “After years, years of obstruction, Medicare can finally negotiate lower drug costs for our seniors.” Senate Judiciary Committee Chairman Dick Durbin shared that 50,000 people in Illinois will see savings due to the $35 monthly insulin copay caps. Rep. Jared Golden wrote in an op-ed that the Inflation Reduction Act will “lower prescription drug prices for the more than 262,000 older Mainers enrolled in Medicare Part D,” and that, contrary to Big Pharma’s lies, “using the purchasing power of the government to negotiate lower drug prices for seniors is the right thing to do.” Senator Peter Welch also debunked Big Pharma myths about the new law: “All of the fear mongering — that it was going to ruin innovation — has been proven to be false. Keep in mind, these high drug prices are brutal whether you voted for Trump or you voted for Biden. All of us are hearing about that from our constituents.” Well said! Regardless of political background, patients know the Inflation Reduction Act will bring drug prices down while maintaining innovation we need. — (Morning Consult, Framingham Source, WFLA, KUNR, Fox Illinois, Bangor Daily News, Roll Call)
Have a great weekend, everyone!
Drugs work best when people can’t afford them … APRIL FOOLS!?
Welcome To The Week In Review.
More Bipartisan Pressure On PBMs
The Senate Finance Committee held a hearing on Thursday about the impact pharmacy benefit managers (PBMs) have on patients and taxpayers. “I believe this is an industry that is going in the wrong direction, and that’s having a big impact on the prices Americans are paying at the pharmacy counter,” Chairman Ron Wyden shared in his statement at the hearing. Senators on both sides of the aisle agree. Ranking Member Mike Crapo said, “Policymakers also need more line of sight into the black box of drug pricing relationships and transactions, especially as we look to pursue productive reforms in the future.” Cracking down on PBMs is gaining momentum to be “a major bipartisan effort,” that “the PBM industry is likely to challenge vigorously.” In 2022, the PBM trade group Pharmaceutical Care and Management Association spent $8.7 million on federal lobbying and then launched a seven-figure ad campaign earlier this year to try to counter arguments that the middlemen rake in profits while driving up costs. While the PBM industry throws money to try to maintain the status quo, bipartisan support for reform has never been stronger. “These are issues Democrats and Republicans all over the country and in Congress agree must be addressed,” Rep. Buddy Carter, a former pharmacist, explained. “The PBM lobby is powerful and influential, but it is not untouchable. We know how to fix this mess.” — (Senate Committee on Finance, Endpoints, Open Secrets, MM+M, The Hill)
2. “Saving Money Due To The Inflation Reduction Act”
Patients continue to see savings thanks to the drug price reforms in the Inflation Reduction Act. People on Medicare living with HIV will save tens of thousands of dollars when the $2,000 out-of-pocket cap provision takes effect in 2025 — a welcome change, considering people on Medicare living with HIV have disproportionately high prescription costs, spending 14 times as much on Part D drugs than other people on Medicare in 2020. Elected officials and leaders continued to spread the word about the historic new drug price law this week. Senator Joe Manchin explainedhow the $35 monthly insulin copay caps are delivering “tremendous savings” for people on Medicare and emphasized that the soon to be implemented out-of-pocket cost caps and Medicare negotiation will bring much needed relief. Department of Health and Human Services (HHS) Secretary Xavier Becerra discussed the law’s provision to insulate people on Medicare from drug company price hikes and detailed how free vaccines are providing relief to people on Medicare. “If you’re on Medicare – zero cost now out of your pocket to get [vaccines],” said Secretary Becerra. Martha in Wisconsin is relieved that seniors like her no longer have to worry about affording the shingles vaccine — shots that cost $200 out of pocket per dose. After meeting with Senator Tammy Baldwin, Martha wrote in an op-ed: “Mere months after making these vaccines free for those on Medicare, I know that seniors are already saving money due to the Inflation Reduction Act.” — (KFF, The Journal, TMJ4, Up North News)
3. Big Pharma Keeps Gaming The Patent System
In the latest Big Pharma patent shenanigan, Johnson & Johnson (J&J) is attempting to exploit our patent system to maintain its monopoly on its psoriasis and irritable bowel disease drug Stelara by delaying biosimilar competition from entering the market. J&J is trying to leverage patents it inherited from Momenta Pharmaceuticals when it purchased the company in 2020 to stall Amgen’s biosimilar version of the drug from coming to market. If successful, the move would allow J&J to continue to charge patients any price it wants for Stelara (which is worth almost $18 million per day in revenue for J&J). “It just goes to show the various different plays that are going on in order to delay Amgen coming in,” said Tahir Amin, co-founder of the Initiative for Medicines, Access, & Knowledge (I-MAK). Manufacturers of blockbuster drugs Keytruda and Humira have been manipulating the patent system in a similar fashion — blocking competition via patent thickets and forcing patients to pay unlimited, high prices. In light of these patent abuses and others, Reps. Jodey Arrington, Lloyd Doggett, Darrell Issa, Michael Burgess, and Ann Kuster sent a bipartisan letter to the U.S. Patent and Trade Office (USPTO) Director, Kathi Vidal, urging her to move forward with policies at the USPTO that would crack down on patent thickets and increase generic and biosimilar competition to lower drug prices. “Too often, Big Pharma’s masterful innovation is in creating new, manipulative ways to maintain monopoly power and charge monopoly prices,” shared Rep. Doggett. Rep. Arrington said: “I’m proud to lead this bipartisan effort to reform our patent system and increase competition so seniors and families have better access to affordable treatments.” We are grateful that members of Congress are advocating for patients — we must unrig our patent system and allow competition to lower drug prices. — (BioPharma Dive, Drug Discovery & Development, Representative Jodey Arrington)
BONUS: Another bill to hold Big Pharma accountable! Senators Catherine Cortez Masto and Amy Klobuchar introduced the Lower Drug Costs for Families Act, which would build on the Inflation Reduction Act by extending the inflationary rebate penalty to protect patients with private insurance as well as Medicare. ?
Have a great weekend, everyone!
What do the PrincetonTigers and patients fighting for lower drug prices have in common? They’re both underdogs that recently scored against powerful opponents. ?
Welcome To The Week In Review.
Much More Than A Ban On QALYS
On Friday, the House Committee on Energy and Commerce passedH.R. 485 out of committee on a party line vote with Republicans voting in favor of an amended version of the bill which aims to block the ability of government and the private sector to use comparative effectiveness research (CER) measures to assess the value of medications for patients. Ahead of the hearing, P4ADNow sent a letter to the committee, urging members to oppose the bill unless elements to preserve CER measures that value all lives equally were included in the final version. “At the end of the day, there is no single factor more important in arriving at an appropriate price for a new drug than the value of the drug to patients,” the letter, signed by P4ADNow’s David Mitchell, states. Ranking Member Frank Pallone said he couldn’t support the bill without “assurances that nothing in the legislation would go beyond banning the use of QALYs or could be used to delay or disrupt the implementation of the drug price negotiations in the Inflation Reduction Act.” We agree and urge members of the House to oppose the bill on the House floor unless changes to address Rep. Pallone’s concerns are made. As David states in the letter: “It is axiomatic that to stimulate and reward innovative new drug development, we should pay more for high value drugs and less for low value drugs.” We need comparative effectiveness research to do that. — (House Committee on Energy and Commerce, P4ADNow, Energy and Commerce Committee Democrats)
2. Pandemic Profiteering: Moderna CEO Fails To Justify Vaccine Price Hikes
The Senate Health, Education, Labor & Pensions (HELP) Committee asked Moderna CEO Stéphane Bancel to justify the company’s planned price hike of its COVID-19 mRNA vaccine at a hearing this week. Spoiler: He wasn’t able to. Senator Patty Murray laid it out clearly: Taxpayers invested $12 billion into the vaccine, which costs $3 to make, and now Moderna is planning to increase the price 400 percent to $130 per dose. Indiana Senator Mike Braun called the planned price increase “preposterous.” Let’s be clear: Taxpayers funded the majority of early-stage research and drug corporations like Moderna swooped in at the last minute when there was an opportunity to line CEO’s pockets with record profits. “As soon as Moderna started to receive billions of dollars from the federal government, Mr. Bancel literally became a billionaire overnight and is now worth over $4 billion,” Senate HELP Chairman Bernie Sanders highlighted at the hearing. “Pfizer-BioNTech and Moderna have received about $100 billion in revenue from COVID-19 vaccines in the first two years of sales — certainly a generous return on their own investments by any standards,” wrote Hussain S. Lalani, Sarosh Nagar, Jerry Avorn, and Aaron S. Kesselheim in the Boston Globe. Try as Bancel might, we won’t let Big Pharma take credit for life-saving vaccines developed on the back of taxpayers, nor will we stand for price gouging that hurts patients’ pockets. — (Senate HELP Committee, Senator Patty Murray, Roll Call, Washington Post, CNN, Boston Globe)
3. The Hill Fights For Future Reforms
Washington was busy this week working to shed light on the actions of members of the drug supply chain. Senators Tammy Baldwin and Mike Braun re-introduced the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act, bipartisan legislation to require transparency for drug companies that increase drug prices. “This bill takes a step in the right direction by bringing much needed transparency and accountability to our broken drug price system, especially the challenge of unjustified price hikes and high launch prices,” P4ADNow’s Sarah Kaminer Bourland remarked. While answering questions for the Senate Finance Committee hearing on Wednesday, Secretary of Health and Human Services Xavier Becerra emphasized the Biden administration’s commitment to addressing pharmacy benefit managers (PBMs): “The administration is working on PBMs because we know that more and more, there is a growing concern that the middlemen in the process of getting drugs from manufacturer to patient are skimming off a good deal of the money that’s being generated.” Chairman Ron Wyden announced that the committee will hold a hearing on PBMs next week. And the Senate Commerce Committee passed the PBM Transparency Act of 2023 — another example of Congress continuing to scrutinize and crack down on PBMs. Keep up the good work, Congress! — (Senator Tammy Baldwin, Axios, Senate Committee on Finance, Fierce Healthcare)
