STATEMENT: P4ADNow Applauds Senate Judiciary Committee’s Bipartisan Passage Of Bills To Lower Drug Prices For Patients By Increasing Competition and Transparency

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:

• A recording of this morning’s Senate Judiciary Committee markup can be watched here. 
• The legislative package includes the following bills:  
  • S. 79, Interagency Patent Coordination and Improvement Act of 2023, establishes an interagency task force between the United States Patent and Trademark Office and the United States Food and Drug Administration to encourage collaboration on drug patents that will promote competition and lower drug prices.
  • S. 113, Prescription Pricing for the People Act of 2023, requires the FTC to examine the role of intermediaries within the pharmaceutical supply chain, including pharmacy benefit managers (PBMs), and develop policy recommendations to prevent anticompetitive behavior and ensure savings are passed on to patients. 
  • S. 142, Preserve Access to Affordable Generics and Biosimilars Act of 2023, cracks down on collusive pay-for-delay settlements by making them presumptively anticompetitive, a reform that would stop brand-name companies from artificially lengthening monopoly periods in an effort to keep more affordable generic competitors from reaching consumers in a timely fashion.
  • S. 148, Stop STALLING Act, eliminates drug company abuse of the Food and Drug Administration’s citizen petition program by defining sham petitions and deeming them anti-competitive under the Federal Trade Commission Act. 
  • S. 150, Affordable Prescriptions for Patients Act of 2023, defines product hopping as anti-competitive under the Federal Trade Commission Act and permits the FTC to undertake litigation against manufacturers engaged in this tactic; the bill also facilitates biosimilar market entry by limiting the number of patents a brand-name drug company can use to block competition from biosimilars. 
• The five bills can now receive votes on the Senate floor.

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

• As the Biden administration worked with lawmakers to craft the reconciliation package, patients across the country brought their stories to the highest office in the land. They offered the president their support as he pushes to deliver on his commitment to lower drug prices. Patient advocates Gail deVore, Iesha Meza, and Sa’Ra Skipper, who all live with type 1 diabetes, met with President Biden at the White House to share their experiences with high insulin prices and discuss the urgent need to include drug pricing reforms in the legislation. Iesha also introduced the president ahead of his December remarks on how the Build Back Better Act will lower drug prices, and Gail followed up with Vice President Harris to talk about getting the bill across the finish line.

2. Fighting Pharma’s Falsehoods

• The pharmaceutical industry and its front groups worked overtime in 2021 to spread misleading claims that drug pricing reforms will hurt patients, but the facts aren’t on their side. In response, P4AD released an innovation report and a video debunking pharma’s falsehoods that reforms would hinder innovation and explaining how we can have the innovation we need at prices we can afford. To refute unsubstantiated claims that drug price reforms will lead to reduced access to prescription drugs, P4ADNow launched a video and David Mitchell penned an op-ed emphasizing how lower drug prices will increase patient access to medications they need. Price hike reports show that pharma raises prices at will, resulting in outrageous costs for patients, enormous profits for drug companies, and huge paydays for their executives. To highlight Big Pharma’s web of influence, P4AD released a report detailing how the financial and organizational relationships between drug companies and major patient groups constrain these groups from advocating for meaningful legislation to lower drug prices. Over and over again, independent fact checkers rated pharma and its allies’ claims as false. The truth is that patients need Medicare negotiation now for real relief from high prices, and we must not fall for pharma’s fear-mongering. 

3. Congressional Priority: Drug Pricing

• This year, Congress is closer than it has been in nearly two decades to addressing high drug prices. Lawmakers wrapped up an investigation into pharmaceutical pricing practices and the House passed the Build Back Better Act including a hardfought compromise on drug pricing reforms. Patients shared their stories at all of the congressional hearings held on drug pricing and utilized an advocacy hub launched by P4ADNow to voice how they have been harmed by high prescription drug prices. P4AD founder David Mitchell spoke at hearings and press conferences about the urgent need for reforms. P4ADNow and influential organizations representing seniors, union workers, and patients ran ad campaigns urging Congress to seize the opportunity to help Americans by lowering drug prices. These groups, along with frontline Democrats, also sent letters to congressional leadership and penned op-eds pushing Congress and the White House to include drug pricing reform in the reconciliation package.  

4. Patients Fired Up

• In addition to sharing their stories with the White House and Congress, patients advocated for drug pricing reforms by writing to national and local publications, appearing in ad campaigns urging members of Congress to support Medicare negotiation, signing letters to Capitol Hill, and speaking to news media. Patients in Colorado, Maine, Massachusetts, Minnesota, New Jersey, New Mexico, and Oregon also delivered testimony and wrote op-eds in support of state legislation, including bills that would ban pay-for-delay deals and create prescription drug affordability boards. We are so thankful to all the patients who have dedicated their time to fighting for legislative reforms. The national conversation on drug pricing would not exist without your voices.

5. Thank You, Taxpayers

• In the second year of the pandemic, drug companies pointed to the development of the COVID-19 vaccines as a reason why prices must be kept high — failing to tell the full story involving billions of dollars in government investment in vaccine research and development. P4AD’s David Mitchell penned a New York Times op-ed, Wall Street Journal letter, and blog post that lays out how the government and taxpayers underwrote the risk while drug companies now stand to shatter sales records and collect billions of dollars from the vaccines. “To all those drug corporations and executives making billions from those of us paying the bills,” Mitchell writes, “You’re welcome.”

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.