The first of the drug price reforms in the Inflation Reduction Act went into effect on January 1. For people on Medicare Part D, vaccines are now free and insulin copays are capped at $35 a month. For patients, these reforms are life-changing, “The new cost cap will make a big difference. I won’t have to watch what I use. I can buy groceries,” patient advocate and former nurse Justine Miner, who lives with type 2 diabetes, shared with the Wall Street Journal. Patient advocate Jackie Trapp knows firsthand how expensive essential vaccines can be, she paid more than $200 out of pocket for her shingles vaccine, “I’m so relieved that future patients like me won’t have to spend what I did just to protect themselves from diseases like shingles.” The reforms remain popular among the American people, with majorities across the political spectrum supporting the Inflation Reduction Act and, specifically, the insulin copay cap. This week, the Department of Health and Human Services (HHS) and Centers For Medicare and Medicaid Services (CMS) outlined their plan for implementing the Medicare drug price negotiation provision in the law. “Today’s announcement is a critical step towards unshackling Medicare and delivering on the promise of drug pricing fairness,” Senate Finance Chairman Ron Wyden said upon the release of the plan. We couldn’t agree more. — (P4ADNow, P4ADNow, The Wall Street Journal, Navigator Research, Fierce Healthcare, United States Senate Committee On Finance)
2. Perpetual Pandemic Profiteering
This week Moderna CEO Stéphane Bancel said the pharmaceutical company is considering quadrupling the price of its COVID mRNA vaccine as it moves to the commercial market. The huge jump in price to a range of $110 to $130 per dose from the current $26 per dose the company charges the U.S government, mirrors the increase Pfizer plans to make on its mRNA vaccine. This is just more pandemic profiteering on the backs of patients causing incoming Senate HELP Committee Chairman Bernie Sanders to pen a letter to Bancel calling the price increases “unacceptable corporate greed” and highlighting that the vaccine was funded by U.S. taxpayers: “You propose to make the vaccine unaffordable for the residents of this country who made the production of the vaccine possible. That is not acceptable.” — (Axios, Office of Senator Bernie Sanders)
3. Humira Hope For Patients
AbbVie has been gaming the U.S. patent system for years to maintain monopoly pricing power for its blockbuster drug Humira, which treats several debilitating diseases, including psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The company blocked any biosimilars from coming to market in the U.S. by building up a patent thicket of more than 130 patents, preventing competition and allowing AbbVie to increase the price time and time again to its current astronomical price tag of $81,590 a year. But change is coming — more than half a dozen biosimilar versions of Humira are expected to become available throughout 2023. Patients like Samantha Reid have been waiting for this moment for a long time. “Cost should never be a factor in whether or not people are in pain or suffering or not able to live their lives,” Reid, who has lived with Crohn’s disease since age 18, told the Chicago Tribune. But “it is, and the reason it is, is because companies like AbbVie charge so much for these medications.” P4AD’s David Mitchell added, “AbbVie, and how it has handled Humira, is the poster child for abuse of our patent system.” The next few years “will be a big test of how well can biosimilars perform to lower prices in this country,” Mitchell added. In Europe, where biosimilars for Humira have been on the market since 2018, the drug costs far less. It’s long past time for Humira to get some competition to drive down prices for patients who need this medication. — (Chicago Tribune)
Have a great weekend, everyone!
What. A. Year. Here’s a look back at this momentous moment in drug pricing.
Welcome To The Week In Review.
History Was Made: A New Era For Drug Prices Beginsrs Of Congress Call Out Big Pharma For Covid Vaccine Price Gouging
After the culmination of a decades-long fight, history was made when Congresspassed and President Bidensigned into law the Inflation Reduction Act, which will lower prescription drug prices and cap out-of-pocket costs for at least 50 million Americans on Medicare. “With this legislation, we have changed the trajectory of drug pricing policy in the United States,” saidP4ADNowfounderDavid Mitchell. “We have finally begun to break the power of multinational drug corporations to dictate prices of brand-name drugs to the American people.” This success was hard won by patients, consumers, seniors, unions, small businesses, employers, physicians, nurses, and disease advocacy and human rights organizations whosentletters, ranads, videos, pressconferences, webinars, and tele-town halls. As patients begin to realize savings from this new law in 2023, we will continue to work to lower drug prices for everyone in the U.S. who needs access to affordable medicines.
2. Patient Advocates: The Backbone Of The Win
There is no doubt that patient advocates across the country, especially those who shared their personal experiences of the burden of high drug prices, made passage of the Inflation Reduction Act a reality. Patients were front and center in articles, radioandTVinterviews, podcasts, op-eds, letters, ads, and much more – explaininghowthedrugpricereforms willchangetheirlives for the better andimploringlawmakerstoact. Notably, patients introduced President Biden at the White House and at events on the road, urging passage and celebrating the new drug law and the ways it will benefit patients. “Insulin cost is inhumane,” patient advocate Bob Parant, a Medicare beneficiary who lives with type 1 diabetes, shared ahead of introducing the president (see photo below). “But thanks to President Biden and Democrats in Congress, the reforms in the Inflation Reduction Act will save me, and millions others, hundreds, and in some cases, thousands of dollars a year…The Inflation Reduction Act will allow me to do things I cherish – be able to travel to see my grandkids and also worry less about depleting my retirement savings.” We’re so grateful to our ever-growing community of over 400,000 patients and allies – we could not have done this without you.
Democrats outperformed expectations in the 2022 midterm election – and a keypart of their successful campaigns for Congress was spotlighting the fulfilled promise of lower drug prices from the reforms passed into law in the Inflation Reduction Act. The drug price reforms are verypopularwithvoters – and backing this popular bill helped usher in wins for frontline candidates like Senators CortezMasto and Warnock and Reps. Wild, Pappas, Horsford, Craig, and Phillips. Constituents also took notice when members of Congress opposed the bill and worked to do the bidding of Big Pharma. When Senators Lee, Lankford, Lummis, and Rubiointroduced the so-called Protect Drug Innovation Act, which aims to reverse the life-changing drug price reforms, patientsspokeupanddenouncedthem. And Democrats who didn’t back the reforms had some serious setbacks as well. Reps. Peters, Schrader, Rice, and Murphy attempted to block and then weakened the drug price provisions in the House. The result? Rep. Schrader lost his primary to a Democrat who called out his pharma-friendly policies and Reps. Rice and Murphy chose not to seek re-election. Rep. Peters, the only one still in Congress, lost his bid to lead the New Democrat Coalition, in part due to his pharma friendly policies. The results of this year’s elections are clear: Americans support lower drug prices and those who stand in the way do so at their own political risk.
4. Big Pharma Continued Hiking Drug Prices In 2022
In a year when inflation reached historic heights and the pandemic lingered on, Big Pharma kept hiking drug prices to profit at the expense of patients. The industry started off the year by increasing prices on 554 drugs in early January, then hiked the price of 188 more drugs later that month, for a total of 742 hikes. The pharmaceutical industry raised prices again in July, bringing the total number of price hikes for the first seven months of the year to 1,186 — exceeding the number for the same periods of time in 2020 and 2021. P4AD released a report that details how the drug companies behind Eliquis and Xarelto, two blood thinners used by millions of patients, have raised their prices in lockstep over the past decade to avoid competition and extract increasing profits from patients and taxpayers. (And later in the year, Senator Klobuchar and Rep. Porter wrote a lettercalling on the FTC and DOJ to investigate the lockstep price hikes on the blood thinners Eliquis and Xarelto and whether they constitute a violation of antitrust laws). Big Pharma also brought new drugs to market at record-setting prices – Amylyx Pharmaceuticals set an annual price of new amyotrophic lateral sclerosis (ALS) drug Relyvrio (which lacks evidence it is effective for patients) at $158,000; Provention Bio set the price at nearly $200,000 for a 14 day course of a new treatment that may delay the onset of type 1 diabetes for an average of 2 years; and CSL Behring’s new breakthrough treatment, Hemgenix, for hemophilia is now the most expensive drug in the world with a whopping price tag of $3.5 million per dose. New innovation is worthless for those who can’t pay unjustifiably high prices – drugs don’t work if people can’t afford them!
5. Big Pharma Lost, Despite Spending Record Amounts On Lies
The drug industry spentrecord amounts of money to try to stop the Inflation Reduction Act from passing – yet the industry still suffered its biggest loss in decades. Pharmaceutical Research and Manufacturers of America (PhRMA) and closely allied groups spent at least $57 million on ads in the year leading up to the law’s passage. On lobbying, PhRMA spent over $29 million and allied industry association BIO spent over $13 million. These lobbyists and ads spread Big Pharma lies to scare patients and lawmakers about the drug price reforms in the Inflation Reduction Act. The Washington Post, KHN, and Kaiser Health News and Politifactdebunked these claims and set the record straight on Medicare negotiation and government spending. In August, P4ADNow sent a letterto Democrats in Congress countering the drug lobby PhRMA’s letter to Capitol Hill that was rife with drug industry lies meant to intimidate members of Congress as they sprinted toward a vote on the legislation. In the end, patients took on Big Pharma power and won. We’ve seen signs of turmoil within the industry ever since – BIO’s CEO resigned soon after the passage of the landmark legislation, one of PhRMA’s top lobbyists left the trade group the same month the new drug price law was passed, and in December, AbbVie left several industry trade groups including PhRMA and BIO. As STAT summarized: “PhRMA, once a titanic lobbying powerhouse, lost its edge.”
One more thing: Here at P4AD, we were thrilled to welcome Merith Basey as our new executive director! Her arrival came at a key moment when sweeping reforms to the U.S. drug price system became law and advocates are turning to other key policies to ensure patients and all of us here in the United States can afford the drugs we need. Check out thesevideos to get to know her better!
Have a great weekend, everyone!
January 2023: Millions Of Patients Will Pay Less For Medication Thanks To Inflation Reduction Act
This Month, Insulin Copays Are Capped At $35 And All Adult Vaccines Are Free Under Medicare Part D
WASHINGTON, D.C. — January 1, 2023, marked a milestone for drug price reforms in the United States. Thanks to the Inflation Reduction Act, for the first time ever, all patients who receive their insulin through Medicare Part D (including most forms of insulin delivered via syringes and pens) now have their copays capped to $35 per month, and all beneficiaries now face $0 out of pocket for all vaccines covered by the drug program.
“2023 marks a momentous year for patients – millions of people in the U.S. will begin to feel the impacts of the historic drug price reforms in the Inflation Reduction Act, both on their health and well being as well as in their wallets,” said Merith Basey, executive director of Patients For Affordable Drugs Now. “While we’re delighted to begin the year knowing that millions of people on Medicare Part D will now have their insulin copays limited to $35 a month and will have access to free vaccines, we acknowledge that there is so much more to be done. This is just the beginning.”
The insulin copay cap includes most forms of insulin delivered via syringes and pens (insulin delivered via pumps will be capped in July 2023). About 2.7 million Medicare beneficiaries will experience savings from the January insulin copay cap, and savings are projected to average around $850 a year per beneficiary.
“I live with high blood pressure as well as insulin-dependent diabetes,” said Patricia McKenzie, a Medicare beneficiary who lives in Lithonia, GA, and receives her Humalog insulin through Part D. “I live on a fixed income, so I have to plan carefully in order to afford my prescriptions. The new $35 copay cap for my insulin will ensure I can afford my insulin for as long as I need it.”
Steven Hadfield lives with a rare blood cancer as well as type 2 diabetes and takes Lantus insulin. “My Lantus insulin carries a monthly list price of $283, which only adds to the large financial burden of my other drugs,” Steven of Charlotte, NC, who gets his insulin through the Part D drug program, shared. “Over the past year, I’ve gone without my Lantus at times because of its cost. Now, it will only cost me $35 which will bring me more consistency and, for the first time, lower my drug costs.”
For the millions of Medicare beneficiaries who receive vaccines each year, access to free vaccines will bring relief. Expensive vaccines such as Shingrix, which treats shingles, had cost about $200 out of pocket for Medicare beneficiaries, but are now free. And Medicare beneficiaries will continue to receive COVID-19 vaccines and boosters for free.
“When I got my two shingles vaccines, they cost over $200 out of pocket, even with Medicare,” said patient advocate Jackie Trapp of Muskego, WI, who lives with multiple myeloma, an incurable blood cancer. “Now that vaccines are free for Medicare beneficiaries, I’m so relieved that future patients like me won’t have to spend what I did just to protect themselves from diseases like shingles.”
All of the drug price reforms in the Inflation Reduction Act will continue to be implemented in the coming months and years. In addition to capping insulin copays and making vaccines free, drug companies will finally be penalized for raising prices above the rate of inflation in 2023. Over the next three years, Medicare will also begin to negotiate lower drug prices directly with drug companies; and starting in 2025, Medicare Part D beneficiaries will have their out-of-pocket prescription costs capped starting at $2,000 a year.
For more information on the implementation of the drug price reforms in the Inflation Reduction Act, visit medicarenegotiation.org.
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After patients scored a huge goal against Big Pharma with passage of drug price reforms in the Inflation Reduction Act, things are looking Messi within the industry ⚽??
Welcome To The Week In Review.
Members Of Congress Call Out Big Pharma For Covid Vaccine Price Gouging
Earlier this week, Sen. Elizabeth Warren and current Rep. and Senator-elect Peter Welch sent a letter to Pfizer CEO Albert Bourla condemning his plans to increase the price of its COVID vaccine by nearly four times. The U.S. government currently pays $30 per dose of the vaccine – this astronomical price increase will bring that number to up to $130 per dose. Sen. Warren and Rep. Welch pressed Bourla to respond by Jan. 9 to nine questions the members posed about the price hikes and the impact on Pfizer’s bottom line and patients alike. “Pfizer has made past assurances that market pricing for a COVID-19 vaccine would be ‘unethical’ and would amount to ‘taking advantage of a situation,'” Sen. Warren and Rep. Welch wrote. “But that is exactly what the company is doing, and the impact of this price increase will fall hardest on the uninsured and underinsured.” Taxpayer dollars funded research leading to the development of mRNA COVID vaccines, and now taxpayers will be forced to pay again through out-of-pocket costs and higher premiums. Meanwhile, Pfizer could walk away with an additional $2.5 – $3 billion in revenue if the company follows through with these vaccine price hikes. Thank you Senator Warren and Senator-elect Welch for calling out this pandemic profiteering and standing with Americans. — (Office of Senator Elizabeth Warren, The Hill)
2. Case Study: Death Sentence For Hepatitis C Patients In Prisons
STAT’s Nicholas Florko released an 8-part investigation that looks closely at state prisons’ failure to test or treat incarcerated people for hepatitis C (HCV). Florko explains that while once-daily HCV pills are highly effective (95 percent of those who take the treatment are in fact cured), the treatments are very expensive and thus out of reach for many. Given that the drugs are so unaffordable, prisons are left to choose between paying tens of thousands of dollars to cover the HCV treatment for incarcerated people in their care or deny patients access and instead only cover their ongoing medical needs due to the condition. The result of this inhumane choice? “1,013 people died of hepatitis C-related complications in states’ custody in the six years after the first cure, a Gilead antiviral drug called Sovaldi, hit the market in late 2013.” Dubbed the “1,000 dollar pill,” Gilead has raked in billions from the hepatitis C treatments which originated in an Emory University lab with taxpayer funds. The corporation shamelessly continues to defend its prices as “fair and responsible.” This investigation – which included 100 interviews, 225 public record requests, and thousands of pages of legal filings – spotlights the inhumanity of our drug pricing system and how it disproportionately impacts society’s most vulnerable. Hundreds of lives lost because patients in prison didn’t have access to lifesaving medication? Unacceptable. — (STAT)
3. Spotlight On AbbVie
AbbVie made headlines this week – one for its repeated abuse of the patent system to keep Humira prices high and another for a controversial move to leave major industry trade groups in D.C. As a reminder, the price of AbbVie’s blockbuster drug Humira has swelled over the years as the company has extended the drug’s monopoly status in the U.S. by building a thicket of patents to prevent cheaper biosimilars from coming to market — a truly unethical scheme. After two decades of Humira monopoly, biosimilars for Humira are slated to come to market next year, an outcome that should increase competition and drive down price. But in 2016, ahead of the upcoming competition, AbbVie whipped up a new formulation of Humira (a slight tweak from the original), and in 2018, completed a product hop, moving patients from the original formulation to a new one. At that point, many of the biosimilars for the original formulation had already been approved by the FDA. When those biosimilars come to market next year, they will not apply to the new formulation of Humira, allowing AbbVie to maintain a portion of the market share. AbbVie’s shenanigans are a prime example of why we so desperately need to reform our patent system and speed generics and biosimilars to market. AbbVie opposes federal legislative changes that impede on its ability to dominate the market and price its drugs as high as it wants. Perhaps that plays a part in the company’s recent decision to leave several industry trade groups, like PhRMA and Bio, which are responsible for lobbying for the interests of brand-name drug companies. We can’t help but notice that the decision follows PhRMA and BIO’s failure to stop the passage of the historic drug price reforms in the Inflation Reduction Act that, for the first time, allow Medicare to negotiate for lower drug prices and curb drug company price gouging. We see you, AbbVie. ? — (Quartz, Politico)
One more thing: A reminder that the next two drug price provisions of the Inflation Reduction Act will go into effect next month. Starting January 1, Medicare beneficiaries will get their vaccines for free and patients on Medicare Part D will have their insulin copays capped at $35 monthly. We couldn’t be more excited for all the Inflation Reduction Act drug price reforms to be implemented. Patients like Brenda and Meg need relief from high drug prices.
Have a great weekend, everyone!
Icon of the year? Tie between the new drug price reforms in the Inflation Reduction Act and Michelle Yeoh. That’s Wicked cool.
Welcome To The Week In Review.
Time To Crack Down On Sham Citizen Petitions
While Congress is finalizing an end-of-year budget package, P4ADNow and seven groups sent a letter urging the Senate Committee on Health, Education, Labor and Pensions and the U.S. House Committee on Energy and Commerce to boost generic competition and lower prescription drug prices by including the bipartisan legislation Ensuring Timely Access to Generics Act (S. 562) in the package. This bill seeks to reform the Food And Drug Administration’s (FDA) citizen petition process — a tactic wielded by Big Pharma to delay generic approval and market entry. Currently, brand name drug manufacturers misuse the citizen petition process and submit sham petitions to prevent affordable generics from joining the market. “Passing the bipartisan citizen petition bill would be a win-win for Congress – it boosts competition by decreasing barriers for cheaper generic drugs to come to market, driving down prices for patients and saving the government hundreds of millions of dollars,” P4ADNow’s David Mitchell said. “We are grateful for Sens. Shaheen, Cassidy, Bennet, Rubio, and Baldwin’s leadership in advocating for this important reform to ensure the system works as intended for patients and consumers.” P4AD was joined on the letter by Alliance of Community Health Plans (ACHP), American College of Physicians, American Society of Health-System Pharmacists (ASHP), Blue Cross Blue Shield Association, The Campaign for Sustainable Rx Pricing, Friends of Cancer Research, and Protect Our Care. — (Patients For Affordable Drugs Now, Common Dreams)
2. Questions Answered By P4AD’s Merith Basey
P4AD’s patient community embraced our new executive director, Merith Basey, on Thursday with a virtual Q&A forum moderated by New Jersey patient advocate Lisa Ann Wetzel-Trainor. Over the past few weeks, patient advocates in 34 states submitted over 150 questions to Merith about her experience in the drug price advocacy world, the implementation of the Inflation Reduction Act, and how P4AD plans to fight for lower drug prices, for all patients, moving forward. “This is a really big deal, it wouldn’t have happened without patients. Everyone in this community should be proud,” Merith said of the passing of the Inflation Reduction Act. “This is a crack in the wall of pharmaceutical power – the prescription drug price reforms are truly, truly historic and they represent a monumental victory.” Lisa and Merith discussed the drug price reforms in the Inflation Reduction Act in detail – acknowledging this momentous win, explaining what’s in the new law, when it will be implemented, and the impact it will have on patients. Merith detailed P4AD’s goals for the future, which include implementation of the drug price reforms in the Inflation Reduction Act, patent reform, ensuring PBMs actually benefit patients, fair launch prices for new drugs, and expanding and diversifying our patient community. — (Patients For Affordable Drugs)
3. What To Expect In 2023
2023 is around the corner and patients on Medicare are expecting to soon feel the impact of the drug price reforms in the Inflation Reduction Act. Starting January 1, Medicare beneficiaries who pay for insulin through Part D will have their insulin copays capped to $35 a month. Additionally, Medicare beneficiaries will get their vaccines for free starting in the new year – patients will really feel this relief on expensive shots such as the shingles vaccine. Right now, “Medicare-enrolled recipients may have to pay up to $324 [for a shingles vaccine]— a huge burden for those of us on a fixed income who don’t have a lot to spare,” wrote Sharon Mayer, a senior in Iowa. In 2023, the government will also begin penalizing drug companies for increasing prices above the rate of inflation. For Medicare beneficiaries, that will mean more stability for coinsurances throughout the year. “The Inflation Reduction Act takes significant concrete steps to lower drug costs in the near term – as soon as January 1 – and improves health care affordability in the long-run,” Medicare Director Meena Seshamani said in an interview with Forbes. “It expands Medicare benefits, stabilizes prescription drug premiums and improves the sustainability of the Medicare program.” — (emissourian.com, KAGS, The Gazette, Tennessee Lookout, Forbes)
4. Perpetual Pandemic Price Gouging
Soon people in the U.S. will face a new pandemic reality: out-of-pocket costs and higher insurance premiums for COVID-19 vaccines and treatments. Paxlovid, which has been taken by almost 6 million people in the United States to prevent severe disease from COVID infections, has been sold at a discounted, bulk price of $530 per treatment to the federal government. When it hits the private market, it is expected to increase in price; which public health experts believe will lead to a substantial decrease in use of the life-saving medication. And because people of color with a COVID diagnosis in the U.S. are already much less likely to receive Paxlovid and other treatments than white patients, an increase in price is likely to further grow this disparity. Unaffordable pricing and limited supply has already restricted the use of Paxlovid in low and middle-income regions of the world where there is great need for treatment. The taxpayer-funded COVID bivalent vaccines, meanwhile, are expected to increase in price by 3 to 4 times the government rate on the private market for a price of around $100 each dose. “These costs will be borne by both public and private vaccine payers,” explains Kaiser Family Foundation. For Big Pharma, the COVID treatments and vaccines are “a multibillion-dollars franchise,” but for patients, it’s a matter of life or death. It’s pandemic profiteering as usual. — (Kaiser Health News, Kaiser Family Foundation, CNN)
Cell and gene therapies are the most recent frontier of modern medicine. These remarkable therapies will transform patient lives and could result in long-sought cures for some of the world’s most challenging conditions. But with price tags like Hemgenix’s record-breaking $3.5 million, patients and experts share concerns about how patients and our health system will be able to afford these miraculous new treatments. Patient Jerry McMillian Jr. lives with severe hemophilia and worries about whether Hemgenix will be covered by public and private health insurance plans. “There’s going to be a lot of poor people [without coverage] who can’t afford this,” McMillian said. The issue of price could be even more challenging when there’s a treatment for a larger population of patients. Sickle cell disease impacts 100,000 people in the United States with a staggering 40 percent of those patients qualifying for Medicaid. A promising treatment may come to the market as soon as next year. But if it enters at even a third of the price of Hemgenix, Medicaid will be forced to grapple with whether it can afford to cover the treatment at all. The question came up at the Milken Institute’s Future of Health Summit this week where experts discussed whether “providing [patients] what could be a functional cure for the disease [is] worth the steep price.” Patients’ health and well-being should not be an economic calculation — we can’t let drug companies dictate prices for these public goods. — (WIRED, Business Insider, Politico)
Have a great weekend, everyone!
P4ADNow Urges Congress To Prioritize Patients By Promoting Competition And Lowering Drug Prices By Including Bipartisan Reform To FDA’s Citizen Petition Process In End-Of-Year Budget Package
WASHINGTON, D.C. — As Congress works towards finalizing an end-of-year budget package, Patients For Affordable Drugs Now (P4ADNow) sent a letter today urging the Senate Committee on Health, Education, Labor and Pensions and the U.S. House Committee on Energy and Commerce to boost generic competition and lower prescription drug prices by including the bipartisan legislation Ensuring Timely Access to Generics Act (S.562) in the end-of-year budget package. This bill addresses abuse of the Food and Drug Administration’s (FDA) citizen petition process in order to speed approval of more affordable generic drugs to lower prices for patients and save the government hundreds of millions of dollars. P4ADNow was joined on the letter by the Alliance of Community Health Plans (ACHP), American College of Physicians, American Society of Health-System Pharmacists (ASHP), Blue Cross Blue Shield Association, The Campaign for Sustainable Rx Pricing, Friends of Cancer Research, and Protect Our Care.
“In order to restore the intended purpose of the citizen petition process and ensure timely market entry of competition, we urge you to include the bipartisan Ensuring Timely Access to Generics Act in the year-end fiscal package,” reads the letter. “CBO reports the reform will save the government $207 million over ten years.”
Currently, the citizen petition process is often misused by brand name drug manufacturers that submit sham petitions in an effort to delay or block generic approval and market entry. The Ensuring Timely Access to Generics Act (S.562), sponsored by Sens. Shaheen (D-NH), Cassidy (R-LA), Bennet (D-CO), and Rubio (R-FL), would strengthen the citizen petition process, more effectively weeding out petitions that are filed with the intent to delay the approval of generics or biosimilars. The bill restores the integrity of the process, decreases administrative burden on the FDA, and will improve speedy patient access to more affordable generics and biosimilars.
“Passing the bipartisan citizen petition bill would be a win-win for Congress – it boosts competition by decreasing barriers for cheaper generic drugs to come to market, driving down prices for patients and saving the government hundreds of millions of dollars,” 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. “We are grateful for Sens. Shaheen, Cassidy, Bennet, Rubio, and Baldwin’s leadership in advocating for this important reform to ensure the system works as intended for patients and consumers.”
In addition to the citizen petition bill, P4ADNow also supports inclusion of two other priority bills in Congress’ end-of-year budget – Retaining Access and Restoring Exclusivity (RARE) Act (S. 4185) and Increasing Transparency in Generic Drug Applications Act (H.R. 7032) – which will clarify orphan drug exclusivity to crack down on prolonged monopolies and enhance the FDA’s authority to communicate with generic competitors.
Read the full letter and list of signers here and below.
December 5, 2022
The Honorable Patty Murray Chairwoman U.S. Senate Committee on Health, Education, Labor and Pensions 428 Senate Dirksen Office Building Washington, DC 20510
The Honorable Richard Burr Ranking Member U.S. Senate Committee on Health, Education, Labor and Pensions 428 Senate Dirksen Office Building Washington, DC 20510
The Honorable Frank Pallone Chairman U.S. House Committee On Energy and Commerce 2152 Rayburn House Office Building Washington, DC 20515
The Honorable Cathy McMorris Rodgers Ranking Member U.S. House Committee on Energy and Commerce 2152 Rayburn House Office Building Washington, DC 20515
Dear Chairwoman Murray, Ranking Member Burr, Chairman Pallone, and Ranking Member McMorris Rodgers,
As Congress works toward finalizing an end-of-year budget package, we urge the chambers to include bipartisan legislation to address abuse of the Food and Drug Administration’s (FDA) citizen petition process in order to reduce drug prices and save the government hundreds of millions of dollars by speeding generics to market to increase competition. The Ensuring Timely Access to Generics Act (S.562), sponsored by Sens. Shaheen (D-NH), Cassidy (R-LA), Bennet (D-CO), and Rubio (R-FL), strengthens the FDA’s ability to reject citizen petitions if it believes the primary purpose of the petition is to delay approval of a generic competitor. CBO reports the reform will save the government $207 million over ten years. Sen. Baldwin (D-WI) offered the legislation as an amendment during the Senate HELP Committee’s mark-up of the FDA user fee reauthorization legislation; it passed with a strong, bipartisan 16-6 vote.
The citizen petition process at the FDA is intended to provide a forum for patients, consumer groups, and other entities to raise safety concerns about FDA decision making, including drug approvals. Too often, however, this process is co-opted by brand-name drug companies to delay competition. Currently, the FDA must delay authorization of any drug in order to process all citizen petitions. Brand drug companies often game the system by raising invalid, outdated, or extraneous issues in order to block or slow competition from generic products that are poised to enter the market. To that point, research has revealed that brand-name drug makers were behind 92% of all 505(q) citizen petitions filed between 2011 and 2015. Overwhelmingly, these petitions were “shams,” not raising legitimate safety concerns, which is why the FDA threw out nine of every 10 of these petitions.
Both the Trump and Biden administrations have identified submission of sham citizen petitions as a threat to timely approval of generics and competition. In 2018, Former FDA Commissioner Scott Gottlieb noted that manipulation of the process “can add to resource burdens on the generic drug review process and the FDA’s regulatory decision making” and decrease the speed of the approval process. In its 2021 drug pricing competition plan, the Biden administration also said that legislative changes were needed to “make it harder for brand manufacturers to abuse the regulatory process to prevent the introduction of biosimilar and generic products” such as through manipulation of the citizen petition process.
In order to restore the intended purpose of the citizen petition process and ensure timely market entry of competition, we urge you to include the bipartisan Ensuring Timely Access to Generics Act in the year-end fiscal package.
Sincerely,
Patients For Affordable Drugs Now Alliance of Community Health Plans American College of Physicians American Society of Health-System Pharmacists Blue Cross Blue Shield Association The Campaign for Sustainable Rx Pricing Friends of Cancer Research Protect Our Care
The Honorable Patty Murray Chairwoman U.S. Senate Committee on Health, Education, Labor and Pensions 428 Senate Dirksen Office Building Washington, DC 20510
The Honorable Richard Burr Ranking Member U.S. Senate Committee on Health, Education, Labor and Pensions 428 Senate Dirksen Office Building Washington, DC 20510
The Honorable Frank Pallone Chairman U.S. House Committee On Energy and Commerce 2152 Rayburn House Office Building Washington, DC 20515
The Honorable Cathy McMorris Rodgers Ranking Member U.S. House Committee on Energy and Commerce 2152 Rayburn House Office Building Washington, DC 20515
Dear Chairwoman Murray, Ranking Member Burr, Chairman Pallone, and Ranking Member McMorris Rodgers,
As Congress works toward finalizing an end-of-year budget package, we urge the chambers to include bipartisan legislation to address abuse of the Food and Drug Administration’s (FDA) citizen petition process in order to reduce drug prices and save the government hundreds of millions of dollars by speeding generics to market to increase competition. The Ensuring Timely Access to Generics Act (S.562), sponsored by Sens. Shaheen (D-NH), Cassidy (R-LA), Bennet (D-CO), and Rubio (R-FL), strengthens the FDA’s ability to reject citizen petitions if it believes the primary purpose of the petition is to delay approval of a generic competitor. CBO reports the reform will save the government $207 million over ten years. Sen. Baldwin (D-WI) offered the legislation as an amendment during the Senate HELP Committee’s mark-up of the FDA user fee reauthorization legislation; it passed with a strong, bipartisan 16-6 vote.
The citizen petition process at the FDA is intended to provide a forum for patients, consumer groups, and other entities to raise safety concerns about FDA decision making, including drug approvals. Too often, however, this process is co-opted by brand-name drug companies to delay competition. Currently, the FDA must delay authorization of any drug in order to process all citizen petitions. Brand drug companies often game the system by raising invalid, outdated, or extraneous issues in order to block or slow competition from generic products that are poised to enter the market. To that point, research has revealed that brand-name drug makers were behind 92% of all 505(q) citizen petitions filed between 2011 and 2015. Overwhelmingly, these petitions were “shams,” not raising legitimate safety concerns, which is why the FDA threw out nine of every 10 of these petitions.
Both the Trump and Biden administrations have identified submission of sham citizen petitions as a threat to timely approval of generics and competition. In 2018, Former FDA Commissioner Scott Gottlieb noted that manipulation of the process “can add to resource burdens on the generic drug review process and the FDA’s regulatory decision making” and decrease the speed of the approval process. In its 2021 drug pricing competition plan, the Biden administration also said that legislative changes were needed to “make it harder for brand manufacturers to abuse the regulatory process to prevent the introduction of biosimilar and generic products” such as through manipulation of the citizen petition process.
In order to restore the intended purpose of the citizen petition process and ensure timely market entry of competition, we urge you to include the bipartisan Ensuring Timely Access to Generics Act in the year-end fiscal package.
Sincerely,
Patients For Affordable Drugs Now Alliance of Community Health Plans American College of Physicians American Society of Health-System Pharmacists Blue Cross Blue Shield Association The Campaign for Sustainable Rx Pricing Friends of Cancer Research Protect Our Care
In just one month, the next two drug price provisions of the Inflation Reduction Act will go into effect — capping Medicare Part D insulin copays at $35 a month and making vaccines, for the first time, free for all Medicare beneficiaries. Patients and elected officials are continuing to tout the historic drug price reforms’ significance. Arizona patient Carol Brown is relieved that Congress finally listened to patients’ needs and passed legislation that would help her save thousands of dollars annually on prescription drugs that she needs as a lifelong asthma sufferer. “As I get older, I become more vulnerable to other medical conditions. I am relieved that no matter what happens, I can plan my budget to afford the $2,000 co-pay cap,” she shared on the Part D out-of-pocket cap that will go into effect in 2025. This week, Rep. Paul Tonko joined an AARP tele-town hall in New York and shared that passing the Inflation Reduction Act was one of the biggest milestones in his career. Next year, over ten thousand Medicare beneficiaries who need insulin in Rep. Tonko’s district will start to feel the relief from the new law’s $35-per-month insulin copay caps. Truly a victory for patients. — (Arizona Capitol Times, WAMC Northeast Public Radio)
2. Big Pharma Watchdog Alerts
Big Pharma is continuing to put profits over patients – here’s a roundup of the industry’s latest. Drug company Provention Bio set the price of a new treatment that delays the onset of type 1 diabetes for an average of 2 years at nearly $200,000 for a 14-day course. This new innovation could really help many Americans, but at an almost $200,000 price tag is price gouging plain and simple, putting it out of reach for so many patients. Similarly, a new breakthrough treatment, Hemgenix, for hemophilia is now the most expensive drug in the world with a price of $3.5 million set by its manufacturer CSL Behring. Gene therapy Hemgenix represents life-changing innovation for patients who can afford it, but that new innovation is worthless for those who can’t. Lastly, Merck appears to be eying a product hop for its blockbuster cancer drug Keytruda. The company is developing an injectable version of the medication, which Merck claims would warrant a new patent. The move could extend Merck’s monopoly on the drug by more than a decade, keeping prices high and limiting access for patients. Just another case of Big Pharma gaming the system to extend its pricing power. — (New York Times, CNN, Reuters)
3. Spotlight on Congress: Drug Prices Matter
This week, Rep. Annie Kuster defeated pharma-friendly Rep. Scott Peters in the bid to lead the New Democrat Coalition. A quick recap of Rep. Peters’ drug pricing history: After receiving hundreds of thousands of dollars from the pharmaceutical industry, Rep. Peters and three colleagues attempted to first block and then successfully weakened the drug price provisions in the Inflation Reduction Act. “Our goal was to get the strongest possible bill out of the House and in fact, it was Scott Peters who led the effort to water it down,” said P4AD’s David Mitchell. “Scott Peters has been and continues to be a handmaiden of the industry.” Rep. Peters is the only one of the four members who will serve in the 118th Congress – Rep. Kurt Schrader lost his primary to a Democrat who called out his pharma-friendly policies, and Reps. Kathleen Rice and Stephanie Murphy did not seek re-election. Rep. Peters’ defeat this week “means that one of the pharmaceutical industry’s biggest allies in Congress will not be leading a key bloc of House Democrats,” HuffPost said. Meanwhile, Rep. Kuster and many of her colleagues in the New Democrat Coalition fought for inclusion of strong drug price provisions. This year’s historic drug price law in the Inflation Reduction Act is a huge win for patients – no thanks to Rep. Peters – and marks a shift in power in Big Pharma lobbying. “PhRMA, once a titanic lobbying powerhouse, lost its edge,” STAT reported. The message is clear: drug price policy matters. — (HuffPost, HuffPost, STAT)
BONUS: This #WorldAIDSDay, we recognized that people living with HIV/AIDS face exorbitant prices for essential drugs because of price gouging from Big Pharma. Gilead Sciences, which has a monopoly on many essential HIV and AIDS medications, price gouges patients taking its HIV antiviral treatment Biktarvy, charging more than $3,500 a month for a drug that is keeping people alive. We must continue to fight for equitable access to life-saving drugs.
