NCL responds to Senators Crapo, Wyden announcement on needed PBM reforms

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March 14, 2024

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831

Washington, DC – The National Consumers League (NCL) today released a statement following Senators Ron Wyden (D-OR) and Mike Crapo (R-ID) recent press conference announcing their push to include bipartisan PBM reforms in the broader funding package.

The following statement is attributable to NCL Chief Executive Officer, Sally Greenberg:

“For far too long now, PBMs have been taking advantage of our drug pricing system, finding ways to increase their profits without delivering value to consumers. Now, after years of investigations, pharmacy closures and high out-of-pocket costs, our leaders are doing something about it. By disconnecting Medicare prescription drug costs from PBM profits, this legislation will address one of the many ways PBMs use the system to their financial advantage. Congress has a huge opportunity to help seniors better afford and access the medications they need. We urge Congress to get this done without delay.”

Learn more about NCL’s work to address the PBM problem here.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit nclnet.org.

NCL comments regarding Proposed Rule: Medication Guides: Patient Medication Information Docket No. FDA-2019-N-5959

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November 21, 2023

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831

The National Consumers League recently submitted comments regarding the Proposed Rule, Medication Guides: Patient Medication Information, that we believe will greatly improve the information patients receive with their prescription medicines.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit nclnet.org.

Financing the healthcare of tomorrow playlist: Tracks for consumers and policymakers

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By Robin Strongin, Health Policy Director

July 12, 2023

My husband has advanced Lewy Body Dementia and one of the few things we can still enjoy together is listening to music. We used to curate playlists for all kinds of music. We even put together playlists to mark special occasions (like our daughter’s wedding). Really, any topic became fair game for a playlist.

I was invited to speak at the Patients Rising Disrupting Healthcare Summit summer conference in Washington DC. My panel topic was Financing the Healthcare of Tomorrow. As I was preparing my presentation, I spoke with Michael Capaldi, Executive Director, the Institute for Gene Therapies. Mike is an expert on gene and cell therapies, and these therapies are definitely the healthcare of tomorrow, although thankfully, we are beginning to see the promise of these therapies today. When we talked about my presentation, he said, “you know, Robin, patients are really at a crossroads:  on the one hand, they are much more educated and empowered about their care, but some of the new therapies on the horizon are so complex, the cost and time commitments to innovate in these areas are so high, that groups like the National Consumers League [i]are in position to help patients and caregivers understand these complexities.”

And that’s when it hit me. A playlist. My colleague had me at Crossroads. If you’re a fan of delta blues, like my husband and me, then you know Robert Johnson and his classic, Crossroads.  The rest of my remarks rounded out my Financing the Healthcare of Tomorrow Playlist: Tracks for Consumers and Policymakers, which include:

Crossroads (Robert Johnson)—Robert Johnson’s haunting work reminds me of the difficult choices health policymakers have to make when it comes to healthcare financing—of course research and innovation are expensive—the diseases for which there are no cures, the conditions crying out for prevention, are complex and require decades of research, a deep understanding of basic science, and navigating an unpredictable regulatory path. Too many diseases and too few resources lead to heartbreaking trade-offs. Patients also have difficult choices to make when it comes to paying for their care. We shouldn’t have to be making deals with the devil—as Robert Johnson sings about in Crossroads. Instead, we need to reframe the questions we ask, review how we prioritize funding streams, and think creatively about financing mechanisms. Rather than question if society spends too much on healthcare, we should be asking how can we spend it more efficiently? How do we adequately incentivize all involved in funding transformational innovation? How do we make sure patients can afford and access the treatment they need?

I Am Woman (Helen Redding)—it gets really old but here we are, still talking about, and working on, closing the gender gap—in raising capital for venture funding for women-lead innovation teams; and in awarding grants to women lead research teams. Did you know, that according to the NIH Database monitoring NIH grants, grants awarded to women lead teams in 2022 numbered 19,028 and in the same year men won 31, 560 NIH grants? Progress yes, but not good enough. Not even close. Why is this important?  Because the teams with funding ask the research questions. The more diverse the research teams, the broader the array of diseases that are studied. More cures for more people.

Your Cheatin’ Heart (Hank Williams, Jr.)—I want to be careful and not paint all hospitals with the same brush but I would be remiss not to point out that too many hospitals are behaving badly: taking huge advantage of their nonprofit status, aggressively placing liens on patients who can’t afford their care, engaging in abusive debt collection activities, and worse, denying care; manipulating the 340B program designed 30 years ago to enable true safety-net providers to help low-income and other vulnerable patients access more affordable medicines and healthcare services. Some entities participating in the 340B program have taken advantage of the program’s current lack of clarity at the expense of the patients that the program is meant to serve.

Bad to the Bone (George Thorogood) – When it comes to taking advantage of our healthcare system, one major player in the drug pricing process might be considered “bad to the bone” – pharmacy benefit managers, or PBMs. PBMs continue to find ways to increase their profits while consumers are forced to pay high out-of-pocket costs for the prescription medicines they need. Although they were intended to help negotiate savings on medicines (which would be good), they are not passing along discounts to patients and are actually incentivized to steer patients to higher cost medicines – b-b-b-b-bad to the bone if you ask me!

Party Like It’s 1999 (Prince)—Shakespeare asked, What’s in a name? Fair question. Reminds me to also ask, what’s in a definition and when is it time to update it? How we defined value, quality (as in value of care, quality of care) and other terms in 1999, needs to be reevaluated on an ongoing basis. New innovations, insights, and understandings necessitate we revisit how we define, measure, and update the terms and metrics used to make decisions that affect healthcare financing. A great example comes from another colleague[ii]  who has co-authored and published compelling work on a “paradigm shift in managing high blood pressure.” He and his colleagues make the case that “Abandoning the view that hypertension is a disease in favor of regarding it as a cause of a disease and hence, adopting a population-based preventive approach would encourage the development of simpler guidelines.” Refreshed decades old thinking that could yield the elusive results the status quo has not achieved seems worthy of a party, like its 2023.

I Will Survive (Gloria Gaynor) and Stayin’ Alive (The Bee Gees)—Really, isn’t this what we are all trying to do?

A Change Is Gonna Come (Sam Cooke)—for patients like my husband, for our family, and for all the other patients and caregivers, change cannot come soon enough.  I pledge to do everything possible to advocate for meaningful change and help Patients Rising.

[i] I direct health policy for National Consumers League

[ii] Wald, Nicholas J., Wald, David S., Kellermann, Arthur L., “When Guidelines Cause Hypertension,” Commentary, The American Journal of Medicine, 2018, pp. 1402-4.

The National Consumers League applauds Eli Lilly Decision to cap prices on insulin

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March 6, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – The National Consumers League commends the decision by drug company Eli Lilly to cut prices for insulin and cap costs insured patients pay to fill prescriptions.

“We applaud the Eli Lilly company for  taking steps to cap prices for insulin.  This action will provide much needed relief to patients suffering from diabetes who are currently facing steep annual costs for insulin, medicine that is life saving for those coping with their illness,” said NCL CEO Sally Greenberg.

The company said it will cut the list price for its most commonly prescribed insulin, Humalog, and for another insulin, Humulin, by 70% starting in October..

Lilly also said Wednesday that it will cut the price of its authorized generic version of Humalog to $25 a vial starting in May.

Lilly also is launching in April a biosimilar insulin to compete with Sanofi’s Lantus. NCL strongly supports the use of biosimilars as they introduce much needed competition and lower prices into the drug marketplace.

Lilly said people without insurance can find savings cards to receive insulin for the same amount at its InsulinAffordability.com website.

The federal government in January started applying that cap to patients with coverage through its Medicare program for people age 65 and older or those who have certain disabilities or illnesses.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit nclnet.org.

The National Consumers League sent a letter urging Senate Committee on Commerce, Science and Transportation to ensure that consumers get a fair deal at the pharmacy

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February 21, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – The National Consumers League (NCL) sent a letter urging Senate Committee on Commerce, Science and Transportation to ensure that consumers get a fair deal at the pharmacy. When it comes to the high out-of-pocket costs consumers face at the pharmacy counter — often for lifesaving medications — consumers today have an unfair disadvantage.

“With three PBMs controlling nearly 80 percent of all prescription drug claims, it is timely that lawmakers are looking at PBMs’ role in driving up the cost of drugs to consumers and patients,“ said Sally Greenberg NCL Chief Executive Officer. “We are encouraged to see the committee looking into the workings of PBMs and we are supportive of your efforts to hold these entities accountable.”

Beyond addressing the antitrust issues and increasing transparency of PBM revenue streams, we encouraged legislators to:

  • Remove medication barriers: PBMs should not be allowed to limit access to the medicines doctors prescribe.
  • Require PBMs to pass on savings directly to consumers: PBM rebates should be shared so that consumers can benefit from more affordable out-of-pocket costs. Additionally, patient cost-sharing should be based on the net cost of the drug, not the list price.
  • Ensure simple, single administrative PBM fees: PBMs too often tack on arbitrary fees to local pharmacies, with many independent and community pharmacies struggling to stay in business, this trickles down to the consumers, resulting in increased prices and pharmacy closures, leading to many communities facing pharmacy deserts.
  • Ensure PBM profits are not tied to the costs of medications: The system currently incentivizes PBMs to favor medicines with higher list prices so that they can negotiate larger rebates and/or steer patients to medicines with higher price tags to increase their own profits.

With the many evolving ways PBMs too often put profit over consumer interests, it is crucial that federal consumer protection agencies like the FTC have the tools needed to address the PBM problem.

To view the full letter, click here.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit nclnet.org.

NCL’s Greenberg joins panel to discuss the challenges and opportunities of the generic and biosimilar industries

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February 15, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – NCL’s CEO Sally Greenberg spoke at the Association of Accessible Medicines and International Generic and Biosimilar Medicines Association Annual Meeting in Orlando, FL on Wednesday, February 15, 2023.

Greenberg joined the panel “The Generic and Biosimilar Industries Global Reputation” moderated by former NY Times journalist Gardiner Harris.

In her statements, Greenberg made the following points:

  • The generic and biosimilar industry has saved the US health care system an estimated $2.4 trillion between 2011 and 2020 and the industry is incredibly important to a well-functioning health care system.
  • NCL reinforces the messages with consumers that generic drugs contain the same active ingredients in the same dosages as brand name drugs, are every bit as safe and effective, but cost far less.
  • Biosimilars, developed after patents expire on brand name biologics, are as safe and effective as the original biologic, both brand biologics and biosimilars are rigorously and thoroughly evaluated by the FDA before approval and biosimilars have no clinically meaningful differences from the original biologic.
  • Over 90% of drugs are available in a generic version today, compared to less than 19% less than 4 decades ago, saving consumers and patients many millions of dollars each year.
  • The role of consumer advocacy groups like NCL will continue to be as an independent voice disseminating accurate, evidence based, scientifically grounded information about medicines and their safety and efficacy.

For the first time since 2014, the 25th International Generic and Biosimilar Medicines Association (IGBA) Annual Conference will be held in the United States, in conjunction with AAM’s Access! 2023 Annual Meeting. This event offers an opportunity to hear from leading global stakeholders, industry leaders, and other experts offering their views and analysis of the most pressing policy questions influencing patient access to generic and Biosimilar medicines in countries around the world.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit nclnet.org.

The National Consumers League supports the bipartisan S 4918 (117th Congress) “Increasing Prescription Drug Competition Act”

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February 7, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – NCL is the nation’s oldest consumer and worker advocacy organization, formed in 1899 to work for a fair marketplace for all. NCL has long supported robust competition and affordable, accessible drugs for patients and consumers. We therefore appreciate the opportunity to provide our support for the bill introduced in the 117th Congress entitled “Increasing Prescription Drug Competition Act”, co-sponsored by Senator Maggie Hassan (D-NH) and Senator Mike Braun (R-IN). This legislation would bar the use of various loopholes in the law to block the introduction and sale of competitor drugs. One such familiar technique brand drug makers have used is claiming that a REMS programs (Risk Evaluation and Mitigation Strategies) required by the FDA for the brand version of the drug, prevents a competitor drug from entering the market. This argument goes against the prevailing view within the FDA and the FTC that a REMS requirement on the brand name drug must not be used as a way to block competition.

The Federal Trade Commission voted 4-0 to file an amicus brief  with the U.S. District Court for the District of Delaware on this topic.  The FTC brief takes no position on the scope or claim construction of the patent, but argues generally that there is significant harm to consumers when a brand lists a patent on a distribution system in the Food and Drug Administration’s “Orange Book” of approved drugs and thereby blocks the introduction of lower-cost generic medications or other follow-on competition. The FTC’s amicus brief explains how the Orange Book listing process can be abused, and emphasizes the harm to competition and consumers that can result from that abuse, including depriving consumers of potential competition from lower-cost alternatives and the ability to choose between products.

By way of background, we note these additional points:

  • REMS, or Risk Evaluation and Mitigation Strategies, are required by FDA for certain medications to ensure that the benefits of the drug outweigh its risks.  The sole purpose of a REMS is to protect patient safety
  • Despite policies that the former FDA Commissioner, Dr. Scott Gottlieb announced in 2018 to reduce the use of REMS programs as a way to block competition and access, followed by the CREATES act, which was signed into law in 2019, loopholes remain today
  • We look forward to the reintroduction of the bi-partisan bill proposed last fall by Senator Hassan (D-NH)and Senator Braun (R-IN), “Increasing Prescription Drug Competition Act”, which would no longer allow FDA approvals of medications to be delayed due to patents listed in the FDA “Orange Book” on REMS
  • We hope the legislation will address the problem of companies taking advantage of FDA-mandated safety programs at the expense of patients receiving innovative competitor medications, or generic medications. We believe that “Increasing Prescription Drug Competition Act”, bill will help to address that problem.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit https://nclnet.org.

NCL urges FDA and FTC to investigate potentially false advertising claims made by a recent-FDA approved anti-wrinkle drug

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October 26, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

Washington D.C.— The National Consumers League (NCL) recently submitted a letter to the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) urging the agencies to look into misleading advertising claims made by a recent FDA-approved anti-wrinkle drug called DAXXIFY™ (DaxibotulinumtoxinA-lanm).

Revance Therapeutics, Inc., the manufacturer of DAXXIFY™, is promoting the drug’s ability to reduce the appearance of facial lines and wrinkles in about half of its users for about six months. However, FDA-required labeling verifies that roughly one-third of users experience no or mild facial lines for six months after injection – a 20 percent discrepancy from the company’s claim.

NCL believes this discrepancy is concerning and warrants a closer investigation. Moreover, a study mentioned in the company’s press release appears to make inaccurate claims about its results, according to NCL.

We ask that if our concerns are warranted, the FDA and the FTC should hold Revance Therapeutics to accurate claims and insist that the company correct anything deceptive in their advertising, says NCL Executive Director Sally Greenberg.

To view the full letter, click here.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit https://nclnet.org.

The National Consumers League applauds the FTC’s decision to investigate PBMs

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June 14, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, DC— NCL is deeply concerned by the lack of transparency and accountability surrounding pharmacy benefit managers (PBMs). The pervasive power of PBMs in the pharmaceutical industry has raised out-of-pocket costs for consumers and made it more difficult for them to receive essential medical treatment. NCL believes that the FTC’s investigation into PBMs represents a significant first step to addressing these issues.

The PBM system was originally intended to work on behalf of employers, health plans, labor unions, and states, to negotiate with drug manufacturers and process prescription drug claims. However, as their power and influence in the market has grown, there are major concerns that PBMs have increasingly prioritized profits, with consumers paying the price.

With the highest profit rates of any corporations in the prescription drug supply chain, PBMs have pocketed more than $450 billion in revenue in 2020, a stark $150 billion increase from eight years ago.  More concerning is that now, just three PBMs account for approximately 77 percent of all equivalent prescription claims.

PBMs often demand that drug companies provide them “rebates” or discounts to offer medicines as part of a drug benefit plan. While implemented to lower consumers’ out-of-pocket costs, these theoretical consumer savings seem to be nonexistent. In addition, to increase profits, PBMs intentionally steer consumers to higher-priced drugs, regardless of patient and treatment considerations.

As the most prominent PBMs have vertically integrated with the largest health insurance companies, they are employing monopolistic-like practices to increase prescription prices, limit consumer choice, and stifle market competition. NCL is encouraged that the FTC is taking preliminary action to hold PBMs accountable. In addition to this investigation, policy-makers and the FTC must continue to address the lack of regulatory oversight with the utmost urgency.

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About the National Consumers League (NCL) 

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

 

National Consumers League supports the HELP Copays Act to make prescription drugs more affordable for consumers

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June 2, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, DC— The National Consumers League (NCL) is pleased to support the HELP Copays Act (H.R. 5801), introduced by Representatives Donald McEachin (VA-04) and Rodney Davis (IL-13). NCL stands with other aligned stakeholder groups, as part of the All Copays Count Coalition (ACCC), to protect patients from increased out-of-pocket medical costs and ensure that essential and life-saving drugs are readily accessible for all consumers.

NCL’s support of the Help Copays Act follows our organization’s long history of ensuring access to health care and a fair marketplace for consumers in the United States. Across the nation, the cost of drugs vital to patients’ health and wellbeing are unaffordable for many families. This has made co-pay assistance including discounts, coupon cards, vouchers, donations, and more, a key tool for enabling people to pay for their prescriptions. However, recent policies, mainly copay accumulator adjustment programs instituted by health insurance and pharmacy benefit managers (PBMs), block these contributions from patients’ deductibles and out-of-pocket maximums, resulting in more costs for consumers.

The pandemic has only exacerbated consumers’ struggles to afford the medical treatment they need. A recent report by HIV and HEP Policy Institute, discusses how the average family cannot afford to cover the deductibles of their employer-sponsored health plans. The Help Copays Act will require these health insurance plans to count all forms of co-pay assistance towards patients’ out-of-pocket maximums, making essential drugs and treatments more affordable.

NCL supports H.R. 5801 as a solution to reducing the barriers that prevent our nation’s most vulnerable from receiving the medicines they need to maintain and improve health outcomes. According to a survey conducted by the National Hemophilia Foundation, 80 percent of voters support this bipartisan effort to ensure that copay assistance counts towards patients’ deductibles. NCL strongly urges policy-makers to fulfill their obligation to their constituents and support The Help Copays Act as this legislation is an important step in improving access to health care and establishing a fair marketplace for all consumers.

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About the National Consumers League (NCL) 

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.