Who knows if the rumors are true about BTS breaking up? But what we do know is that we WILL break up Big Pharma’s monopoly pricing power.
Welcome to the Week in Review.
1. Reconciliation: It’s Alive!
The momentum to pass a reconciliation bill with drug pricing reforms is building as talks between Leader Schumer and Senator Manchin have progressed, with the majority leader’s staff reportedly taking the next steps to line up a vote for later this summer. President Biden said he believes the votes are there to pass drug pricing reform in an AP interview, and Speaker Pelosi also expressed optimism for the reconciliation bill, saying, “It’s alive.” Meanwhile, patients, advocates, and physicianswrote opinion pieces this week urging Congress to act quickly to lower drug prices. “It’s unfair that patients like me have to shell out thousands of dollars just to stay alive. We deserve better,” shares Bob Parant, a New York patient who lives with type 1 diabetes. “Policymakers face a choice: let prescription drug costs continue to rise unchecked, placing patients and families at continued risk, or pass sensible reforms that would make drugs more affordable for all Americans,” four doctors write. — (Politico, AP, New York Daily News, The Exponent-Telegram, The Hill, MedPage Today, The Philadelphia Inquirer)
2. Three Pinocchios For Pharma Front Group ? ? ?
A new fact check from The Washington Post debunks an ad from the pharma front group 60 Plus Association that dishonestly characterizes the drug pricing reforms before the Senate as a plan that would “strip $300 billion from Medicare” and leave patients with “fewer treatments and cures.” The truth? According to the nonpartisan Congressional Budget Office’s analysis, the reforms will save taxpayers and the federal government $300 billion while only reducing the number of new drugs coming to market by 0.8 percent over the next 30 years. In a desperate move to maintain the industry’s unfettered pricing power, pharma-allied groups are filling the airwaves with lies. Americans know better. — (The Washington Post)
3. Pulling Back The Curtain On Blood Thinners
In a letter to the Federal Trade Commission this week, Senator Klobuchar and Rep. Porter called on the agency to investigate the lockstep price hikes on the blood thinners Eliquis and Xarelto and whether they constitute a violation of antitrust laws. Eliquis and Xarelto, manufactured by BMS/Pfizer and Johnson & Johnson, respectively, were the subjects of a recent P4AD report examining how the systematic price increases and patent gaming on these drugs hurt patients and raise costs for taxpayers. We applaud the senator and representative for taking on the pharmaceutical industry and fighting on behalf of patients. — (FiercePharma)
4. More Wins For Patients!
On Tuesday, the Senate Committee on Health, Education, Labor, and Pensions passed an FDA bill that included three amendments to boost competition in the drug pricing system by easing the process for generic competition to come to market. One of the amendments, based on legislation P4ADNow has been advocating for since 2018, would close a loophole in the citizen petition process that brand-name drug makers have exploited to slow the approval of lower-priced generics to keep prices high. We thank Senators Murray, Baldwin, Hassan, and Paul for championing these amendments and urge the full Senate to pass this package with the citizen petition, orphan drug, and generic drug approval transparency reforms intact. — (P4ADNow)
5. Eyes On PBMs
The FTC is setting its sights on the byzantine practices of pharmacy benefit managers. On Thursday, the commission voted to study PBMs’ usage of rebates to determine if the system contributes to an anticompetitive prescription drug market that keeps prices high, and specifically pointed to insulin as a drug that has experienced soaring prices in part due to rebates paid to PBMs. This vote comes as a whistleblower suit alleges that CVS used its subsidiaries, including its PBM, Caremark, to push patients toward brand-name medications instead of cheaper generics in order to obtain higher rebates. The FTC’s decision to shine a light on these corporations and inject more transparency into the drug system is another welcome move for patients. — (Reuters, Endpoints News, FiercePharma)
One more thing: A new Gallup poll reveals that about 17 million Americans over 50 years old said they or a family member have not taken medication as prescribed to save money in the past year.
Have a great weekend, everyone!
WASHINGTON, D.C. — The following statement was issued by David Mitchell, a cancer patient and founder of Patients For Affordable Drugs Now, in response to the Senate Health, Education, Labor, and Pensions Committee’s passage of a package that includes three amendments that would crack down on Big Pharma’s abuses of the drug pricing system:
“We applaud Chairwoman Murray, ranking member Burr, and members of the Senate HELP Committee for advancing S. 4348, which reauthorizes the FDA user fees and includes three key amendments to improve the U.S. drug pricing system to boost competition by easing the process for generic competition to come to market and drive down drug prices for patients. The bipartisan citizen petition provision, offered by Senator Baldwin (D-WI) and championed by Senators Shaheen (D-NH), Cassidy (R-LA), Bennet (D-CO), and Rubio (R-FL), will help restore integrity to the FDA citizen petition process by closing a loophole manipulated and abused by brand-name drug makers to slow the approval of lower-priced generics and keep prices high for patients.
“For years, the P4ADNow patient community has been calling on Congress to pass legislation to prevent Big Pharma from using the citizen petition process to delay or block more affordable generic drugs from coming to market. On behalf of patients across the country, we thank Senators Baldwin, Shaheen, Cassidy, Bennet, and Rubio for their work fighting for patients.
“We urge the Senate to quickly pass the FDA user fee package with the citizen petition, orphan drug, and generic drug approval transparency reforms intact.
“The committee’s approval of these provisions adds important momentum to the work being done in the Senate to pass a reconciliation package that includes the comprehensive drug price reforms, including Medicare negotiation, already passed by the House of Representatives. The Senate must advance the reconciliation package to deliver relief to all American patients.”
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Background:
P4ADNow has been advocating tirelessly since 2018,urging the federal government and Congress to address pharmaceutical companies’ abuse of the Food and Drug Administration’s citizen petition process.
The amendment, introduced by Senator Baldwin (D-WI) to crack down on abuse of the citizen petition process, has been previously introduced in the Senate as S. 562, the Ensuring Timely Access to Generics Act, which was sponsored by Senators Shaheen (D-NH), Cassidy (R-LA), Bennet (D-CO), and Rubio (R-FL).
The FDA’s 505(q) citizen petition process is intended to provide a forum for patients, consumer groups, and other entities to raise concerns about pending generic drug approvals under consideration by the FDA.
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.
Brand-name drug makers were behind 92 percent of all 505(q) citizen petitions filed between 2011 and 2015.
This bill 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 Senate HELP committee also included in S. 4348 the RARE Act (S. 4185), offered as an amendment by Senator Baldwin and sponsored by Senators Baldwin and Cassidy. The bill codifies FDA’s longstanding interpretation of the Orphan Drug Act and prevents drug makers from taking advantage of a 2021 circuit court decision that would enable them to block competitors. The House passed a similar provision in the chamber’s user fee package last week.
The Senate HELP committee also advanced a bipartisan amendment, led by Senators Hassan (D-NH) and Paul (R-KY), that would speed more affordable generic drugs to market by giving the FDA the authority to provide specific information on inactive ingredients and drug concentration levels to generic applicants working to come to market. The House passed a similar provision in the chamber’s user fee package last week.
In a unanimous decision, the Federal Trade Commission voted this week to investigate the role of pharmacy benefit managers in the drug pricing supply chain and how their practices may influence high drug costs and patient access to drugs. As P4ADNow laid out in comments to the FTC, PBMs’ secret dealings have allowed them to become some of the most profitable players in the health care sector, and their opaque rebates and formulary decisions have a real impact on patient choice and the accessibility of cheaper generic competitors. P4ADNow has called for increased transparency and accountability into PBM practices; the commission’s investigation is a win for patients across the country. — (AP)
2. Soaring Prices Underscore Senators’ Work On Reconciliation
Passing comprehensive drug pricing reforms through reconciliation remains top of mind this week. As Treasury Secretary Yellen and Senator Kinghighlighted the importance of lowering prescription drug prices, Leader Schumer and Senator Manchin continued to discuss a framework for the reconciliation bill. Their work proceeds as a new research letter published in JAMA reveals the shocking growth of drug launch prices — the median price for a year’s supply of a new drug was $2,115 in 2008 and climbed to over $180,000 in 2021. It’s clear we need to end pharma’s unilateral pricing power to rein in soaring prices for patients. — (Punchbowl News, The Washington Post, CNN, WGME, Axios, NBC)
3. Life Or Death
Patientsandconstituentssharedtheirdrugpricingstories and advocated for reforms this week in news media and in letters to their local publications. In a CNBC segment, cancer patient and retired nurse Lynn Scarfuto described the life-or-death consequences of being unable to afford her medication, Imbruvica. “Too many Americans are forced to choose between buying the medications they need and paying for food, rent, gas, or utilities,” explains New Yorker Marie Santangelo. “I have found my payments increasing at the same time Big Pharma is receiving record profits,” shares Florida retiree Laura Fries. “We need this Congress to urgently pass a reconciliation package with comprehensive drug-pricing reforms to lower drug prices now,” writes Delaware patient Al Liebeskind. — (CNBC, Staten Island Advance, St. Augustine Record, Delaware State News, Nevada Current, Las Vegas Sun, The Capital Times, San Mateo Daily Journal)
One more thing: On Wednesday, a bipartisan group of senators sent a letter to the director of the U.S. Patent and Trademark Office urging the agency to address drug companies’ usage of patent thickets to insulate their products from competition.
President Biden, senators, and constituents all called on Congress to pass Medicare negotiation legislation this week. “We can reduce the price of prescription drugs by giving Medicare the power to negotiate with pharmaceutical companies and capping the cost of insulin,” President Biden writes in an op-ed explaining his plan to lower costs for Americans. At separate events with AARP chapters across the nation, Senators Durbin, Ossoff, and Blumenthal committed to continue fighting for lower drug prices for patients. “We’re out of time — every morning another American wakes up with a chronic disease like I did,” shares Samantha Cooksey Strickland, a multiple sclerosis patient. “Outrageous drug costs shouldn’t make the difference in how their future looks.” — (The Wall Street Journal, AARP Illinois, AARP Georgia, Fox61, Tallahassee Democrat)
3. What Are We Paying For?
A new analysis found that U.S. cancer mortality rates are similar to those of other wealthy countries even though the United States spends twice as much on cancer care. The researchers partly attribute these high expenditures to Medicare’s inability to negotiate lower prices, the frequent price hikes on cancer drugs, and FDA approval of expensive drugs without clear evidence of clinical benefit. The exorbitant sums that patients and taxpayers pay for cancer care are lining the pockets of drug companies instead of contributing to better health outcomes for Americans. It’s time to fix our broken drug pricing system. — (EurekAlert!, GoozNews)
One more thing: Alongside Public Citizen and 19 other organizations, P4ADNow signed a letter to President Biden on Wednesday urging him to nominate a director of the National Institutes of Health who will prioritize fair prices for taxpayer-funded medications.
Have a great weekend, everyone!
First and foremost, thank you for all of your support and hard work these past few weeks helping us continue the push for drug pricing reforms. We have not slowed our roll here at Patients For Affordable Drugs Now, and neither have tireless advocates like you. We have called on you to send messages to Congress, submit letters to the editor of your local newspaper, and help us amplify what legislators in Washington need to hear: Americans need lower prescription drug prices now.
The good news is our work is paying off. Leader Schumer and Senator Manchin are reportedly negotiating a reconciliation package behind closed doors that will include the drug price reforms already passed by the House of Representatives last fall. All 50 Senate Democrats have indicated their support for that drug pricing package. For the first time in months, Senator Manchin is saying he believes they can reach a deal and get this done. That is progress, and it’s due in no small part to the hard work and outreach by patients like you.
The reality is that with the legislative calendar growing shorter and the midterm elections fast approaching, time is running out for members of Congress to deliver on their promise to lower drug prices. We need the Senate to move with dispatch. This week, senators are in their home states, where they will undoubtedly hear from constituents like you about unconscionably high drug costs. When they return to D.C., they must take up the legislation and pass it.
That’s why we are continuing to push as hard as we can. The fight for Medicare negotiation has been going on for nearly two decades, and now we are so close to getting it done. Thousands of you stood up and shared your stories and called for action. Without you, we would not be on the threshold of historic reform. I am so grateful.
We will keep you updated on what is happening and how you can help in the coming weeks. Patient voices have been the most important factor in this fight. Now, let’s keep working to win.
David Mitchell
Cancer Patient And Founder Of Patients For Affordable Drugs Now
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WASHINGTON, D.C. — The following statement was issued by David Mitchell, a cancer patient and founder of Patients For Affordable Drugs Now:
“We are encouraged by signs of progress in the Senate — Leader Schumer and Senator Manchin are reportedly in quiet negotiations on a reconciliation package that will include the drug price reforms already passed by the House of Representatives. Lowering drug prices is a top priority for voters, the reforms have overwhelming bipartisan support, and President Biden yesterday again called on Congress to send drug price legislation to his desk. All 50 Senate Democrats have indicated their support for the drug pricing package under consideration.
“With the legislative calendar growing shorter and the midterm elections fast approaching, time is running out for members of Congress to deliver on their promise to the American people to lower drug prices. We need action. After spending time in their home states — where they will undoubtedly hear from constituents about unconscionably high drug costs — the Senate must return and advance these reforms. Patients across the country are depending on it.”
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Welcome to the Week in Review.
1. Voters Are Watching
Rep. Kurt Schrader’s loss in his primary election sends a clear message to Congress: Voters want effective action to lower drug prices. “It is a wake-up call across the country on the importance of taking steps to hold down the cost of medicine,” said Senate Finance Committee Chairman Ron Wyden. Senator Manchin confirmed that he and Leader Schumer are in conversation about moving forward a reconciliation package centering around drug pricing reforms. Americans are clear: Congress must pass drug pricing legislation now to lower costs for patients and taxpayers. Voters are watching. — (The Washington Post, Axios)
Big Pharma continued to make headlines this week for its unethical practices to extract maximum profits from patients and taxpayers. Drug giant AbbVie is facing a lawsuit for violating anti-kickback laws by providing doctors who prescribed its blockbuster drug Humira with registered nurses acting in the best interest of the company, and a class-action suit alleges that GSK blocked generics from entering the market for decades by shifting patients onto reformulations of inhalers with the same active ingredients. A new Oxfam report also describes how taxpayer-funded COVID-19 vaccines have brought in massive profits for drug companies and minted new billionaires in the process. Over and over again, the drug industry has shown it can’t be trusted to do the right thing — and why government reforms are necessary to protect patients from the abuses of Big Pharma. — (FiercePharma, FiercePharma, United Press International)
One more thing: As the Senate works on a reconciliation bill with drug pricing reforms, states are moving ahead to protect their residents from high prices. Maryland’s prescription drug affordability board — the first of its kind in the nation — began its work to establish upper payment limits this week, and a New Jersey bill to establish a drug affordability board passed a critical committee vote in the state Assembly. Thank you to all state lawmakers fighting for patients!
Have a great weekend, everyone!
WASHINGTON, D.C. — The following statement was issued by David Mitchell, a cancer patient and founder of Patients For Affordable Drugs Now, following Jamie McLeod-Skinner’s primary victory in Oregon’s 5th Congressional District:
“Drug price reform figured prominently in Oregon’s 5th Congressional District primary, where Rep. Kurt Schrader tried to reinvent himself as pro-patient and anti-Big Pharma when he in fact led the effort to weaken legislation allowing Medicare negotiation. Voters saw through his lies, and for the first time in 42 years, an incumbent member of Congress lost his job in an Oregon primary. The result sends a clear message to Democrats and Republicans alike: Americans want Congress to pass legislation to lower drug prices, and those who stand in the way or fail to deliver on their promises will be held accountable by voters at the ballot box. More talk won’t do. Fake solutions won’t do. No more excuses. Right now, the Senate can deliver on its promises; the votes are there. The Senate must use its power under reconciliation now to enact the comprehensive reforms to lower drug prices already passed by the House of Representatives.”
