The Bills Aim To Curb Patent Abuses By Drug Companies, And Shine A Light On Secret Practices Of Pharmacy Benefit Managers
WASHINGTON, D.C. — The following statement was issued by Merith Basey, executive director of Patients For Affordable Drugs Now, in response to the Senate Judiciary Committee’s vote to advance a package of five bipartisan bills that would lower drug prices and promote both competition and innovation by curbing anticompetitive behavior committed by pharmaceutical corporations and pharmacy benefit managers (PBMs):
“On behalf of patients all across the country, thank you Chairman Durbin, Ranking Member Graham, and members of the Senate Judiciary Committee for passing legislation to help fix key elements of our rigged drug price system. We fully support the bills to crack down on patent abuse, increase coordination between the FDA and USPTO to ensure patents are used to reward innovation and not to unfairly block competition, as well as investigate the practices of pharmacy benefit managers (PBMs). Together these bills can help to restore balance to our drug price system and increase competition to lower drug prices for patients.
“We urge Senate Majority Leader Schumer to bring these bills to the floor for a vote as soon as possible, and we call on each senator to support the passage of this bipartisan package intact without any weakening amendments from Big Pharma.”
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Background:
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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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
CC: Leader Schumer, Speaker Pelosi, Minority Leader McConnell, and Minority Leader McCarthy
Click here for PDF of letter
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
CC: Leader Schumer, Speaker Pelosi, Minority Leader McConnell, and Minority Leader McCarthy
Click here for PDF of letter
Drug pricing was trending in 2021. Here’s a look back at patient advocacy wins and progress toward victories in the year to come.
Welcome to the Year in Review.
1. One-On-Ones With The White House
2. Fighting Pharma’s Falsehoods
3. Congressional Priority: Drug Pricing
4. Patients Fired Up
5. Thank You, Taxpayers
WASHINGTON, D.C. — Patients For Affordable Drugs Now today launched new ads that will run in six frontline House districts thanking Reps. Colin Allred(TX-32), Angie Craig (MN-02), Andy Kim (NJ-03), Chris Pappas (NH-01), Lauren Underwood (IL-14), and Susan Wild (PA-07) for being champions in the fight for lower drug prices for Americans and for their votes to pass the Build Back Better Act. The ads feature a cancer patient named Jackie, whose cancer medication, Revlimid, is priced at over $20,000 every month.
“Millions of people like me are struggling. It’s time for our leaders to lead,” Jackie says in the ads.
The ads respond to the six representatives’ votes in favor of the Build Back Better Act, which passed the House of Representatives on Nov. 19. These members of Congress have been leaders in pushing for meaningful drug price reforms, including Medicare negotiation to lower drug prices for their constituents. Following the release of the White House’s Build Back Better framework, which did not include drug price reform, these frontline Democrats signed a letter, led by Rep. Craig, calling for the inclusion of reforms as an essential element in the Build Back Better Act. Throughout the year, these representatives also pennedop-edshighlighting the importance of lowering drug prices for Americans, and some signed onto a letter, led by Rep. Wild, calling on President Biden to include drug pricing in the Build Back Better Act.
“On behalf of patients all across this country, we thank Reps. Allred, Craig, Kim, Pappas, Underwood, and Wild for fighting to ensure the inclusion of meaningful drug price reforms in the Build Back Better Act,” 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. “Their steadfast support for the drug price provisions in the Build Back Better Act was a key factor in House passage of the bill that finally allows Medicare to negotiate lower prices. Ninety percent of voters support Medicare negotiation, and the reforms in Build Back Better will help millions of Americans.”
The ads will run as the Senate moves to take up the Build Back Better Act in December. The Build Back Better Act will, for the first time, authorize Medicare to negotiate prices directly for some of the most expensive prescription medicines, including insulin; institute a hard cap on out-of-pocket drug costs for Medicare beneficiaries; and limit annual price increases to stop price gouging by drug corporations.
“Congresswoman Wild just voted to pass the Build Back Better Act, which for the first time lets Medicare negotiate lower drug prices for Pennsylvanians,” the ad running in Pennsylvania’s seventh district says. “She stood up to Big Pharma attacks and did the right thing for patients. Tell Representative Wild: Thank you for voting to lower drug prices for millions of Americans.”
Watch the TX-32 ad here.
Watch the MN-02 ad here.
Watch the NJ-03 ad here.
Watch the NH-01 ad here.
Watch the IL-14 ad here.
Watch the PA-07 ad here.
Last week, Patients For Affordable Drugs Now announced a campaign highlighting Senator Manchin’s support for Medicare negotiation to lower drug prices for West Virginians and calling on the senator to get the job done by voting for the Build Back Better Act. The organization is also running a campaign, including this ad, in Arizona urging Senator Sinema to support drug price provisions in the Build Back Better Act. View all ads here.
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“We Must Deliver On Our Promise To Lower The Amount Of Money Our Constituents Pay For Prescription Drugs” |
WASHINGTON, D.C. — As congressional Democrats work to add drug pricing provisions, including Medicare negotiation, into the Build Back Better Act, 15 frontline House Democrats sent a letter yesterday to Speaker Pelosi and Majority Leader Hoyer urging immediate action to address the high price of prescription drugs. Led by Rep. Angie Craig (MN-02), the letter is signed by Reps. Colin Allred (TX-32), Cindy Axne (IA-03), Sharice Davids (KS-03), Josh Harder (CA-10), Steven Horsford (NV-04), Andy Kim (NJ-03), Susie Lee (NV-03), Lucy McBath (GA-06), Tom Malinowski (NJ-07), Chris Pappas (NH-01), Elissa Slotkin (MI-08), Abigail Spanberger (VA-07), Lauren Underwood (IL-14), and Susan Wild (PA-07). “On behalf of patients all across this country, we want to thank Congresswoman Craig and these members of Congress who are going to the mat fighting to add Medicare negotiation to lower drug prices back into the Build Back Better plan,” David Mitchell, a cancer patient and founder of Patients For Affordable Drugs Now, said in Rep. Craig’s press release. “Medicare negotiation is supported by 90 percent of voters who are depending on Congress to deliver years of promises to provide relief to patients struggling to afford their prescription medications. These members know that the moment for action is now to enact meaningful reforms that will fix a rigged system and restore balance to ensure we get the innovation we need at prices we can afford. The fight is not over, and we are proud to stand with these members.” Momentum has been building over the weekend to ensure that the most popular provision — allowing Medicare to negotiate lower drug prices — is included in the Build Back Better Act. Congressional leaders have been working to agree on meaningful provisions for the package that would lower prices for patients. Democratic members on both sides of the Capitol have been clear that Medicare negotiation must be included in the final package. Last week, Patients For Affordable Drugs Now and AARP demanded Congress add drug pricing reform into the Build Back Better Act. Patients For Affordable Drugs Now called the lack of its inclusion in the president’s framework “a huge failure” and AARP said it is “outraged” by the exclusion. Read the full letter here and below. |
October 31, 2021 The Honorable Nancy Pelosi Speaker U.S. House of Representatives Washington, D.C., 20515 The Honorable Steny Hoyer Majority Leader U.S. House of Representatives Washington, D.C., 20515 Dear Speaker Pelosi and Majority Leader Hoyer: Thank you for your leadership and continued efforts to lower the cost of prescription drugs. As majority-makers in competitive districts, we promised our constituents that we would come to Washington to fight on their behalf for lower drug prices. We cannot turn back now on our promise to the American people. We urge you in the strongest terms possible to include legislative language in the Build Back Better Act that will be voted on by the full House to accomplish this. The pharmaceutical industry has gouged the American public for decades. As a country, we spend hundreds of billions of dollars a year on prescription drugs, and yet our constituents must often choose between purchasing prescribed medications or putting food on the table. It is unacceptable that anyone in the wealthiest country in the world cannot access the medications they need to stay alive. With two lobbyists per Member of Congress, we know that Big Pharma is deeply invested in the status quo. Our current system forbids Medicare from negotiating the prices it pays for prescription drugs. As a result, millions of Americans are forced to spend thousands of dollars a year on their medications – or go without. In many cases, as with insulin, these medications have been on the market for decades. In 1991, a bottle of Humalog insulin cost $21. Today the average list price is over $300. That is inexcusable. In these instances, we are not paying for research and development. By allowing the cost of drugs like insulin to rise year after year, we are financing soaring executive salaries, stock buybacks and outrageous profit margins on the backs of our seniors. With the Build Back Better agenda, we have a perhaps once in a generation opportunity to change the status quo and make good on our promise that no one should have to choose between affording their prescription drugs or food or housing. The public is on our side. Big Pharma is not. Soon, we must go back to our districts and explain what we’ve done in Washington to make our constituents’ lives better. We ran on upsetting the status quo and lowering out-of-pocket costs for healthcare and prescription drugs. If we fail, we’ll need to explain to them why we let Big Pharma win, why we let entrenched special interests take precedence over the American people. You have dedicated your careers to lowering the cost of healthcare. We stand with you in your continued efforts. The moment is now. We must deliver on our promise to lower the amount of money our constituents pay for prescription drugs. We must demonstrate that we work for the American people and not the pharmaceutical industry. Our constituents are counting on us. |
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Ad Responds To Reps. Peters, Rice, And Schrader And Senator Sinema’s Attempt To Gut Medicare Negotiation Legislation |
WASHINGTON, D.C. — In response to recent attempts by a small group of Democrats to gut Medicare negotiation provisions in the Build Back Better reconciliation package, Patients For Affordable Drugs Now released a new ad today urging Democrats to keep their promise and pass real Medicare negotiation that will reduce prices on costly, monopoly brand-name drugs. The ad features Therese Ball, a registered nurse and multiple sclerosis patient, and will run on national networks and digital platforms, as well as in Southern California, New York, Oregon, and Arizona starting this week. “Instead of standing with their constituents and supporting legislation that would let Medicare negotiate lower drug prices, pharma henchmen Reps. Scott Peters, Kathleen Rice, and Kurt Schrader — aided and abetted by Senator Kyrsten Sinema — are serving their Big Pharma campaign contributors by pushing an alternate bill that would exempt the most expensive drugs from negotiation and leave drug companies with the power to continue dictating prices for brand-name drugs,” said David Mitchell, a patient with incurable blood cancer and founder of Patients For Affordable Drugs Now. “Medicare negotiation is the most popular priority of the Build Back Better plan. Patients need relief now with real negotiation to lower the prices of brand-name drugs that are crushing us — not a bill that excludes those drugs and sells us out to Big Pharma.” Watch the ad here. Masquerading as Medicare negotiation, the alternate proposal that Reps. Peters, Rice, and Schrader and Senator Sinema are pushing would not allow for negotiation on the most costly drugs in both Parts B and D nor drugs still in their period of monopoly exclusivity. It would maintain the status quo, leaving drug corporations with the power to continue dictating prices of brand-name drugs and American patients paying four times what people in other nations pay for their prescription medicines. “The medications I need to live are priced at over $7,000 every month. I can’t afford these prices — I don’t know how anyone can,” multiple sclerosis patient Therese Ball of Ogden Dunes, Indiana, says in the ads. “It makes me so angry that members of Congress are choosing Big Pharma over patients — it’s unforgivable.” This new ad launches as President Biden has been pushing Democrats to settle outstanding issues in the Build Back Better reconciliation bill and pass a bipartisan infrastructure plan by the end of October. “Some in Congress are siding with Big Pharma to gut the plan to let Medicare negotiate lower drug prices,” the ad says while showing images of Rep. Peters, Senator Sinema, Rep. Schrader, and Rep. Rice. “Tell Democrats and President Biden to keep their promise. Don’t let Big Pharma dictate prices.” |
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