NCL statement on PBMs and new GAO report

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September 18, 2023

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 a recently released U.S. Government Accountability Office (“GAO”) report on Medicare Part D rebates.

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

“Investigation after investigation, report after report, and study after study prove that pharmacy benefit managers (“PBMs’) do not provide benefits to consumers. To the contrary, we believe PBMs, who are middlemen, drain billions of dollars that should be going into the pockets of patients and consumers and help them defray their healthcare costs. The evidence mounts that PBMs, which once had a noble purpose, have lost their way and become profit centers unto themselves, adding costs to our drug supply system at the expense of patients. This latest report by GAO underscores that our nation’s seniors – often our most vulnerable patients who rely most on medications – pay the highest price for PBM practices.

“In just one year, GAO found that the PBMs collected almost $50 billion in rebates from prescription drug manufacturers under the Medicare Part D program alone. These savings should go directly to Medicare beneficiaries, but for the nearly 80 of the highest rebated drugs analyzed, GAO found that seniors paid more than $20 billion, while their plan sponsors — often vertically integrated with PBMs — paid only $5.3 billion. PBMs are able to enrich themselves because they control access to prescription drugs, block competition, conduct business in the shadows, and pocket discounts meant for patients. PBMs simply driving up out-of-pocket costs for Medicare beneficiaries to the tune of millions of dollars.

“Congress has an opportunity to enact meaningful PBM reforms to prevent such behavior. We urge our leaders in Congress to closely examine the findings of the GAO report, and put a stop to the practices of PBMs to profit off of vulnerable patients. In doing so, our elected representatives will put money back in the pockets of patients and help them to better afford the medications they need.”

Learn more about NCL’s work to address the PBM problem at nclnet.org/pbms.

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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.

National Consumers League response to the Request for Information regarding FDA regulation of CBD

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August 25, 2023

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

Washington, D.C. – On August 17, the National Consumers League responded to the Request for Information regarding FDA-Regulation of CBD.

“In 2019, in response to the proliferation of unreviewed and untested CBD products, NCL identified the need for greater education among consumers about CBD and better enforcement of regulations in the CBD marketplace. NCL created Consumers for Safe CBD to address the need, champion the rights of consumers, and call on government and industry to do better – to ensure safety and promote a pathway for new products through clinically tested scientific research. Since then, action has been taken on the state and federal levels to increase access to cannabinoids beyond CBD. In response, NCL expanded our educational campaign and established Cannabis Consumer Watch.” 

The full letter can be found 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.

Safety in question: The alarming disparities between cannabis product health claims and research, and the magnified risks for women

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By Health Policy Intern Grace Lassila

July 27, 2023

When I started my National Consumers League (NCL) internship in May 2023, I quickly dove into NCL’s health policy work. NCL is leading on several efforts to protect consumers –one area of focus that stood out to me is their work in the cannabis policy space. NCL is a founding member of Cannabis Consumer Watch (CCW), which educates consumers on cannabinoids, their effects, the risks related to the unregulated marketplace, and the ways policymakers and regulators can help protect consumers. NCL is also a part of the Collaborative for Cannabinoid Science and Safety (CCSS), which also works to educate people about cannabinoids and policy in the interest of public health.

CCW’s “test your cannabis knowledge” quiz was shocking for me. Going into the quiz, I was fairly confident about my knowledge, but as I started getting wrong answer after wrong answer, I realized I had no idea that not only are these products under-researched, but they may pose serious public health risks for consumers. Products can be sold, without having gained FDA approval, making false claims about their medicinal abilities.  And side effects are not adequately researched or revealed to consumers.

One particularly concerning aspect of the cannabis marketplace is that while CBD or Delta-8 or other cannabis products are often marketed to women, there is a concerning lack of research into the safety of these products for women. Historically, misogyny and sex discrimination have made women’s health severely under-researched and underfunded. More research on diseases, disorders, and medication is conducted on men, not women. Women are misdiagnosed far greater than men are, and experience dangerous health outcomes because of it (Greenhalgh). And without sufficient research and data on women’s health, it is incredibly difficult for legislators to write policy (Adams). Overall, for women’s health to improve, more resources need to be devoted to this issue.

Despite cannabis companies’ marketing efforts that claim their products can help with anything from menstrual cycle-related pain to morning sickness, there is little insight into the effects of cannabis or cannabis derivatives on women, pregnant people, nursing parents, and newborns. What we do know is that the risks are very real – a recent study found that THC use during pregnancy was linked to changes in fetal development and several studies have shown that CBD can be transferred to a baby via breast milk. The FDA strongly advises against THC or CBD usage while pregnant or breastfeeding. And, given the evidence currently available, I would caution any women from using these products for medical benefit.

The lack of regulation, as well as research, is very concerning. Because the FDA currently does not regulate these products, consumers have no way of knowing whether the dosage, ingredients, or claims on the label are accurate and no way of knowing whether or not they are contaminated. Though some products may acknowledge they are ‘Not Approved by FDA,’ many consumers may not see this fine print – and assume that anything they can buy at their local grocery store must be safe for consumption. While the risks of an unregulated cannabis marketplace affects all consumers, women who need medical health and relief and turn to cannabis products may be more at risk.

The good news is that in January of this year, the FDA recognized this grey area for regulation – particularly for CBD – and stated that CBD would not be regulated as a food and dietary supplement anymore, because of the unknown safety risks, and requesting that Congress act quickly to protect public health and the consumers involved.

While cannabis products are often marketed as a miracle drug, they are not. While there may be some health benefits, without comprehensive research and regulation of these products, the risks outweigh the potential good. Consumers remain responsible for making their health decisions, and women in particular should be vigilant. The FDA is heading in the right direction but more must be done to protect consumers – and women in particular. I encourage you to learn more about a safe path forward here and help NCL raise awareness of this important issue.

Sources:

Adams, Katie. “Women’s Health Is Suffering Due to Lack of Research and Funding, Experts Say.” MedCity News, 9 Dec. 2022, medcitynews.com/2022/12/womens-health-is-suffering-due-to-lack-of-research-and-funding-experts-say/#:~:text=Women’s%20health%20has%20been%20historically,healthcare%20conference%20in%20Washington%2C%20D.C.

Eversheds Sutherland. “FDA Says ‘No’ to CBD: Now What?” FDA Says “No” to CBD: Now What? – Eversheds Sutherland, us.eversheds-sutherland.com/mobile/NewsCommentary/Legal-Alerts/256713/FDA-says-no-to-CBD-Now-what#:~:text=Since%202018%2C%20the%20FDA%20has,%2Dapproved%20drug%20(Epidiolex). Accessed 6 July 2023.

Greenhalgh, Ally. “Medicine and Misogyny: The Misdiagnosis of Women.” Confluence, 5 Dec. 2022, confluence.gallatin.nyu.edu/sections/research/medicine-and-misogyny-the-misdiagnosis-of-women.

Grinspoon, Peter. “Cannabidiol (CBD): What We Know and What We Don’t.” Harvard Health, 24 Sept. 2021, www.health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-2018082414476.

“What You Should Know about Using CBD When Pregnant or Breastfeeding.” U.S. Food and Drug Administration, www.fda.gov/consumers/consumer-updates/what-you-should-know-about-using-cannabis-including-cbd-when-pregnant-or-breastfeeding#:~:text=FDA%20strongly%20advises%20against%20the,during%20pregnancy%20or%20while%20breastfeeding.&text=Cannabis%20and%20Cannabis-derived%20products,products%20appearing%20all%20the%20time. Accessed 6 July 2023.

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.

2023 Script Your Future Medication Adherence Team Challenge winners

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May 16, 2023

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

Washington, DC —Today, the National Consumers League (NCL) announced the winners of its twelfth annual Script Your Future Medication Adherence Team Challenge, an eight-week intercollegiate competition among health profession student teams and faculty to combat poor medication adherence in the United States, where nearly three out of four patients do not take their medication as directed.

The Challenge, hosted by NCL, returns to university campuses across the country to encourage student competition and innovation. “The Team Challenge was first established in 2011 to nurture adherence-minded values in future generations of health professionals. Since its launch, the campaign has supported close to 2,000 community health events, engaged over 60,000 healthcare providers, and reached 27.5 million consumers and counting. We are very proud of the contribution this effort has made to the public health of all consumers,” said NCL Chief Executive Officer, Sally Greenberg.

This year’s winners are:

  • Lake Erie College of Osteopathic Medicine (LECOM) School of Pharmacy,
  • Temple University School of Pharmacy,
  • Western University School of Health Sciences,
  • University of Charleston School of Pharmacy, and
  • University of Pittsburgh School of Pharmacy.

2023 Medication Adherence Team Challenge Winners

National Award Winner: Lake Erie College of Osteopathic Medicine (LECOM)

Lake Erie College of Osteopathic Medicine’s (LECOM) 2023 Script Your Future efforts were centered around Wellness, Adherence, Lifestyle, and Knowledge (WALK). LECOM students and faculty designed community service events in collaboration with various healthcare professionals across pathways (Erie, Bradenton, Distance Education) and programs (pharmacy, medical, and masters). The unified message promoted the importance of medication adherence, chronic disease state management, reducing disease stigma, smoking cessation, safe drug disposal, and OTC medication safety. To kick off 2023 Script Your Future, a healthcare pledge affirming the importance of interdisciplinary teamwork in improving patient outcomes was distributed and 223 current and future healthcare professional signatures were received. Overall, 817 educational materials were distributed in-person to 260 individuals. Social media, print, and broadcasting efforts reached an estimated 279,360 individuals. Overall, LECOM’s Script Your Future was a successful and impactful campaign that consisted of 159 volunteers, correlating to 273 hours of community service contributed throughout 23 service events that reached 279,779 individuals.

Under-Represented Community Outreach Award Winner: Temple University

Temple University’s main initiative this year was a community baby shower. Students got together and sought donations for diapers, wipes, baby clothes, diaper bags, strollers, car seats, baby bottles, and pacifiers, and advertised the event throughout social media to expectant mothers in the North Philadelphia community. Students connected with larger Philadelphia organizations to get the word out and have expecting mothers register for the event. The event was a great success! There was a panel on general women’s health and gestational diabetes to educate the expecting mothers and students created pamphlets on gestational diabetes and pediatric vaccinations. During the event students displayed safe drug disposal posters and educated the mothers on the importance of keeping medications in places where children and pets cannot reach them. The team was able to help over 50 expectant mothers in the North Philadelphia community.

Media & Communications Award Winner: Western University

In addition to creating TikTok videos, Western’s 2023 team recreated its website with a new, cleaner interface that is easier to use among every age group. A new tinyurl link (www.tinyurl.com/amcphealthhelper) and QR codes to link to the website were created, along with infographics for a variety of chronic diseases. The infographics were visually appealing and easy to read. Additionally, the infographics about COVID-19, high blood pressure, diabetes, and more were available to view in English, Spanish, Vietnamese, Mandarin, and Korean. For this year, the team provided a new translation for its infographics in Tagalog because there is a significant number of Filipino patients within the community. Visitors were able to download these infographics in each language for personal use, all infographics were available in these languages. By informing patients about their disease states, the students were able to help them understand why it is important to continue adhering to their medications. In addition to efforts to promote the TikTok videos and website, the team also collaborated with local pharmacies including Owl Pharmacy, Holt Pharmacy, Ontario Pharmacy, ABC Pharmacy, and Costco Pharmacy in distributing Script Your Future wallet cards. A total of approximately 2,000 wallet cards were distributed, including 1290 in English, 347 in Spanish, 142 in Vietnamese, and 80 in Mandarin.

Interprofessional Award Winner: University of Charleston

The University of Charleston School of Pharmacy (UCSOP) took a broad approach to interprofessional collaboration and included students studying political science and public health. These students were onsite during the West Virginia Rural Health Day and WVA Pharmacy Day at the Capital events. Political Science students were able to give advice to pharmacy students on presenting material and information to legislators and state leaders. Students focused efforts on increasing community influence around the importance of healthy lifestyles, medication adherence, and the confidence in vaccines. To broaden the effort further, the University of Charleston Nursing Program, University of Charleston Athletic Trainers and Exercise Undergraduates, along with various undergraduate students who could share knowledge on health topics participated in various events. In addition to UC associates, the team collaborated with several community partners, such as the West Virginia Pharmacists Association, West Virginia Rural Health Association, West Virginia Collegiate Recovery Network, American Foundation for Suicide Awareness, The American Heart Association, Mt. Olivet Baptist Church, and West Virginia local and state representatives. In working with these organizations, the team was able to broaden the number of community members influenced by its campaign efforts.

Technology Innovation Award: University of Pittsburgh

The Pitt Pharmacy team created innovative technologies where students had the ability to learn about cardiovascular emergencies in real time. Students ran simulations with simman. This “patient” can have a range of health concerns, from a heart attack to atrial fibrillation. Students learned how cardiac disorders are treated and performed simulations as instructors for future pharmacy students. In addition, student organizations hosted events with virtual reality technology where students could “treat” patients for these cardiovascular events.

Owen Hott, a student involved in the University of Pittsburg technology committee, stated, “As the head of the technology and innovation committee, Script Your Future was a great experience that allowed me to work with new people, come up with awesome ideas, and to play a part in a national campaign to empower patients. Part of my future goals as a pharmacist is to make sure that patients are as knowledgeable about their own health as their health providers. It’s all too often that I see issues that could have been avoided if anyone had spent the time to teach patients about their conditions rather than just sending them off with their medications, and I’m glad I was able to contribute to the cause!”

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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 statement on nomination of Dr. Monica Bertagnolli as the Director of the National Institutes of Health

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May 15, 2023

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

Washington, D.C. – The National Consumers League welcomes President Joe Biden nomination’s of Dr. Monica Bertagnolli as the Director of the National Institutes of Health (NIH).

NIH plays a critical role in advancing science to benefit patients. Dr. Bertagnolli’s deep understanding of biomedical research and proven leadership in directing the National Cancer Institute makes her an ideal nominee for the NIH Directorship.

“Dr. Bertagnolli brings so much experience to this post,” said Sally Greenberg, NCL’s CEO. “She is a physician, scientist, and a patient herself, so she has seen all sides of the issues facing patients and the NIH. We would be fortunate indeed to have someone of Dr. Bertagnolli stature and accomplishments leading the NIH.”

Dr. Bertagnolli is currently the Director of the National Cancer Institute (NCI). Prior to her role at the NCI, Dr. Bertagnolli was a professor of surgery at Harvard Medical School, and chief of the Division of Surgical Oncology at Brigham and Women’s Hospital and Dana-Farber Cancer Institute. In addition, she was the recent chair of the Alliance for Clinical Trials in Oncology, a national clinical trial network of the NCI.

“NCL believes that Dr. Bertagnolli is the right leader for this critical agency that advances public health. NCL supports her nomination and we urge the Senate to confirm her promptly,” Greenberg added.

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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 statement on FDA review of the oral toxicity of cannabidiol (CBD)

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May 12, 2023

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

Washington, D.C. – This week, researchers from the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration (FDA) published an analysis on the toxicity of cannabidiol (CBD). The National Consumers League (NCL), the nation’s oldest consumer advocacy organization, has been actively monitoring the growing threats to consumer safety as the market for untested, unapproved cannabidiol (CBD) products has exploded. NCL Chief Executive Officer, Sally Greenberg, released the following statement:

“We’re encouraged to see the experts at the FDA continue efforts to study CBD. These findings unfortunately further validate our concerns around the risks, including negative drug-drug interactions, disruption of critical metabolic pathways, liver injury, reproductive toxicity, and more. These concerns are of course heightened by the fact that many consumers are using products without physician oversight and often use products for long periods of time. The data highlights the need to ensure that FDA has sufficient regulatory tools and resources to mitigate public health risks in this wild west CBD marketplace.”

Learn more about the path to safe cannabis and CBD use here. And learn more about the cannabis consumer market at cannabiswatch.org.

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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 applauds expansion of Medicaid in North Carolina

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March 28, 2023

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

Washington, D.C. – North Carolina became the 40th state to expand Medicaid under the Affordable Care Act. “NCL applauds Governor Roy Cooper, the work of relentless advocates, and those in the state legislature -Republicans and Democrats- who worked to make this week’s legislation possible,” said Robin Strongin, director of NCL’s health policy work. House Bill 76, the Access to Healthcare Options, is expected to provide health coverage to over 600,000 people throughout North Carolina.

“The expansion of Medicaid is a lifeline for those in need, shoring up rural health care, strengthening mental health services, improving access to health care for working families. The other 10 states should follow North Carolina’s lead,” continued Strongin.

Governor Cooper proposed using a portion of the almost $1.8 billion Medicaid expansion signing bonus to create the Improving Health Outcomes for People Everywhere (IHOPE) Fund.  Medicaid expansion will take effect upon the signing into law of the FY 2023-25 appropriations act.

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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 applauds the Biden Administration’s $11-billion budget proposal to eliminate Hepatitis C

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March 22, 2023

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

Washington, D.C. – President Biden has proposed significant funding for a historic national Hepatitis C elimination program. “President Biden’s efforts to create a mandatory national program to expand testing, treatment, and prevention of Hepatitis C is a major step forward in eradicating a disease for which we have a cure.” said Robin Strongin, NCL’s Health Policy Director.  “We have the opportunity to use a proven oral medication to cure a lethal disease.  NCL stands ready to assist and is pleased to see initial bipartisan, bicameral support to relinquish a disease affecting 2.4 million Americans.”

Hepatitis C is a viral liver infection transmitted through blood. Roughly 40% of people do not know that they are infected.  Left untreated, Hep C can lead to chronic illness, including liver cancer and death.  The tragedy here is that a cure has existed since 2013.  The price of the once-daily, 8-12 week course of an oral therapy (pills) that cures the disease in 95% of patients is roughly $24,000, down from its original price, but still out of reach for many. Populations at increased risk of Hep C include people who use or inject drugs, people with HIV/AIDS, people experiencing homelessness, and the incarcerated.

The program overall is expected to cost $5.2 billion over 10 years after accounting for the reduced health care costs, and that’s only the financial calculation. It doesn’t take into account the number of lives saved from the devastation of losing a loved one. Dr. Francis Collins, the White House official who has championed this initiative from the beginning, estimates it would save more than 100,000 lives by 2050.

NCL echoes the sentiments expressed by White House Hep C senior advisors Dr. Francis Collins and Dr. Rachael Fleurence in their recent op-ed:

“It is rare to have the opportunity, using a simple and safe oral medication, to eliminate a lethal disease. But that is the situation facing the United States with hepatitis C. Congressional support can make possible a historic public health initiative that can prevent suffering, save lives, and ultimately save money — to the benefit of all U.S. residents. How can we not do this?”

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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.

Judge Kacsmaryk is poised to redefine the withdrawal method: FDA interuptus should alarm everyone

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By Robin Strongin, Health Policy Director

Bill Tompkins

Here we go, again.

Up until the Dobbs decision in 2022, Roe v Wade had been the law of the land since 1973.

Up until today, women didn’t have to worry that mifepristone, approved by FDA in 2000, would be available as a safe and effective and legal way to end an early pregnancy.

But, Texas Federal Judge Matthew Kacsmaryk, who has been vehemently anti-choice his entire life, is the judge who will decide whether to issue a preliminary injunction ordering FDA to withdraw its longstanding approval of mifepristone, the first pill in the two-drug medication abortion regimen.

Women, and their health providers, stand at a crossroads.  All women, not just those in Texas.

For some, it’s not enough that Roe was overturned in 2022.  Back in November 2022 the Alliance Defending Freedom, a conservative legal group, filed a lawsuit on behalf of antiabortion medical organizations and doctors.  At issue is the FDA’s approval of mifepristone, otherwise known as the medication abortion pill.  The plaintiffs, led by the Alliance for Hippocratic Medicine, have asked the judge to issue a preliminary injunction ordering the FDA to withdraw mifepristone.

Photo: Robyn Beck / AFP via Getty Images

This is unchartered territory.  The court is being asked, for the first time, to basically overturn the approval of a drug.  A drug that has been safely used for decades by over 5.6 million[i] women.  The drug regimen terminates pregnancies successfully 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%).[ii]

This case, and several others that have been brought forward on medication abortion, raise questions about the role of the courts in reviewing the FDA’s findings about a particular drug.  This is chilling. Not only for the women who rely on this medication, but this case has the potential to set up an extremely alarming precedent for other FDA approved drugs.

And it’s dangerous territory for women and their health providers.  According to a court filing, FDA stated that overturning its approval of mifepristone would “cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.”

Should Judge Kacsmaryk rule in favor of the plaintiffs, over half the abortions in the US could come to a halt—this includes abortions in states where abortion rights are (still) protected.  This case is expected to find its way to the Supreme Court—to the same justices who overturned Roe v Wade.

Through a coordinated strategy to take away women’s reproductive rights, advancing abortion bans—at the federal level, at the state level, and through the courts, results in confusion, fear, and poor health outcomes.

Fortunately, experts seem to agree that if the worst were to happen, and the preliminary injunction is granted (and remain in place following the inevitable appeals), there are several options that could allow for the continuing supply of the drug and for providers to continue prescribing.

For example, some abortion providers are planning to provide only the second abortion medication, misoprostol, which is used safely on its own in many countries, though it does have more side effects than mifepristone.

Earlier this week, Governor Gavin Newsom (D-Calif) announced that California state government would no long do business with Walgreens because of their decision that it won’t sell mifepristone in states where Republicans have threatened legal action, even in those states where abortion remians legal.

All of this is happening during Women’s History Month.  But, knowledge is power. According to the Guttmacher Institute, a leading research and policy organization committed to advancing sexual and reproductive health and rights worldwide,  “Since its approval, medication abortion has been used over four million times and has become so widely accepted by patients and providers that it now accounts for more than half of all US abortions—492,210 of the 930,160 abortions (53%) provided in 2020 were done with abortion pills.”

According to the Guttmacher researchers, the impact of eliminating access to medication abortion would differ greatly state to state, but could be especially promounced in rural counties and regions of any state….These 10 states could experience the most severe impact:

Colorado, Georgia, Indiana, Iowa, Maine, Montana, New Mexico, Pennsylvania,Vermontand Washington.

Guttmacher created an interactive map, capturing abortion-related policies and data, categorizing states from the most restrictive to the most protective.

On the map, viewers can also see demographic information and key abortion statistics. The data for women of reproductive age* in each state include:

  • Age-groups and race/ethnicity
  • Proportion living below 200% of the federal poverty level
  • Types of health insurance used
  • Proportion born outside the United State

Abortion-related statistics for each state include:

  • Number and rate of abortions provided
  • Number of clinics that provide abortions
  • Average driving distance to the nearest abortion clinic

The new interactive map is available here.

*The use of “women” to refer to the population of people potentially impacted by abortion policies reflects the terminology in the US census, from which many of our data points are drawn. We recognize that gender identities are diverse and not everyone who needs an abortion may identify as a woman. We reflect that reality in our language where we can, while also accurately describing the underlying data.

[i] Mifepristone US Post-Marketing Adverse Events Summary through 6/30/2022; TTT #2022-2468.  NDA 020687.  ANDA 091178. www.fda.gov

[ii] Mifepristone US Post-Marketing Adverse Events Summary through 12/31/2018; RCM #2007-525.  NDA 20-687.  www.fda.gov