As talks between the White House and Senate Democrats progress, major drug pricing provisions, including Medicare negotiation, continue to be a top priority for inclusion in a reconciliation package. President Biden again told reporters this week that he believes Congress can pass reforms to lower drug prices. Secretary Yellen said, “We can bring down other costs that are burdening households like prescription drugs,” and National Economic Council Director Brian Deese said the White House is working closely with the Senate to move the reconciliation bill forward and is hopeful they can get the job done. But lawmakers must act quickly as the midterm elections draw nearer — time is running out to pass this legislation that will both lower prices for patients and save money for taxpayers. Senators, Americans are counting on you to deliver on your promises and get these reforms across the finish line. — (Bloomberg, The Hill, The Hill,The Post-Standard)
2. INSULIN Act: A Gift To Big Pharma
This week, Senators Shaheen and Collins unveiled a bill to lower insulin costs — an issue that has special poignancy for Americans, as 4 out of 5 adults who live with diabetes or are caregivers for someone with diabetes have gone into debt to pay for insulin. However, the legislation only addresses insulin copays without guaranteeing lower list prices, which will result in cost-shifting and lead to higher premiums and taxes. Make no mistake: This bill is a capitulation to Big Pharma that allows drug makers to continue hiking insulin prices while leaving patients with less money in our pockets. If senators are serious about helping patients, they must pass the package of comprehensive drug pricing reforms, including capping insulin copays to $35 and historic provisions such as Medicare negotiation, through reconciliation. — (Roll Call, P4ADNow)
3. Pharma’s Up To No Good
Pharma’s shady behavior has been in the spotlight this month. Throughout June, P4AD has been highlightingsomeofthedrug companies with the highest 2021 revenues and how they repeatedly price gouge patients to maximize their profits. A new OpenSecrets report also details the deluge of recent pharma lobbying spending. Just last year, the drug industry groups spent over $350 million lobbying at the federal level and tens of millions more in state capitols — all to keep prices high and continue filling their coffers at the expense of patients. — (P4AD, OpenSecrets)
“The bipartisan effort by Senators Shaheen and Collins is further evidence of the power of the drug pricing issue for voters of all political persuasions — Democrats, Republicans, and independents alike. Members of Congress understand that Americans want action to lower drug prices — and insulin has special poignancy.
“People with diabetes are at the mercy of unjustly high insulin prices, and a $35 copay cap would deliver relief to those with insurance. Four out of five adults who live with diabetes or are caregivers for someone with diabetes have gone into debt to pay for insulin.
“But this legislative text does not guarantee lower list prices for insulin, without which copay caps will result in cost-shifting for insulin and lead to higher premiums and taxes. Without lowering list prices, the insulin copay caps are estimated to cost more than $20 billion over 10 years, according to a Congressional Budget Office score of the insulin copay cap bill passed by the House of Representatives. It is difficult to imagine insulin makers will voluntarily reduce their net prices. History tells us we cannot rely on pharma to do the right thing, and this bill does not offer any enforcement.
“Conversely, Senate Democrats have a unique opportunity right now to pass comprehensive legislation that would both cap insulin copays and lower the list price of insulin and other critical drugs. The drug price provisions passed by the House and under consideration by the Senate will cap insulin copays to $35, prevent drug corporations from price gouging patients with year-over-year increases, and finally allow Medicare to negotiate directly with drug companies for lower prices on prescription drugs, including insulin.
“There are millions of patients who rely on expensive medications who urgently need the reforms in the drug pricing package, including, most importantly, Medicare negotiation. There is a path forward in the Senate to pass the legislation through reconciliation. President Biden believes the votes are there to pass drug pricing reform, Speaker Pelosi expressed optimism for the reconciliation bill, Senator Manchin and Majority Leader Schumer’s negotiations on reconciliation have resumed, and Senator Manchin remains committed to passing comprehensive drug pricing reforms.
“In order to deliver on their promises to all patients — including those who depend on insulin — the Senate’s number one priority on drug pricing must be to pass the broad drug price provisions through reconciliation.”
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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.”
