NCL is excited to present the inaugural podcast episode of our new Health Podcast Series under the “We Can Do This!” podcast umbrella, hosted by our Senior Director of Health Policy Robin Strongin. This month we are celebrating National Hispanic Heritage Month with our esteemed guest Amy Hinojosa, National President & CEO of MANA.
By Sally Greenberg, Chief Executive Officer
In 1992, Congress created the 340B Drug Pricing Program to help ensure vulnerable patients would be able to access medications they need but may not be able to afford. This program provides steeply discounted drugs to health care providers – mostly hospitals – serving low-income patients with the intent that the providers would pass those discounts along to patients. Unfortunately, that is not what is happening. The National Consumers League (NCL) is increasingly concerned about this program, especially as it relates to hospitals’ abusive and aggressive debt collection practices, and how those practices lead to consumer medical debt. A recent letter from a bipartisan group of Senators underscores hospitals’ role in this growing problem.
We find it particularly troubling that many hospitals benefiting from 340B are not only nonprofit entities but are designated as charity hospitals – supposedly caring for low income and indigent patients. A 2022 report by the Alliance for Integrity and Reform of 340B found that charity care spending for nearly two-thirds of 340B hospitals was less than the national average for similar hospitals. Further, a December 2019 Government Accountability Office (GAO) report found that “some nongovernmental hospitals that do not appear to meet the statutory requirements for program eligibility are participating in the 340B program and receiving discounted prices for drugs for which they may not be eligible.” One report found that 82% of nonprofit hospitals spent less on community programs than the value of their tax exemptions.
Consumers are not benefiting from the 340B program in the way Congress intended. A patient whose income is above 200 percent of the Federal Poverty Level (FPL) is expected to pay full price for a drug they receive at the hospital, even though the care center from which they are “buying” the drug did not pay full price for it. Hospitals participating in the 340B program saved an average of $11.8 million per year, according to a 2019 report from Beckers Hospital Review, and multiple studies have found that a majority of hospitals markup medicines between 200-500 percent. Under the current program, an individual who makes $29,200 per year has to pay that price.
What is even more alarming is the fact that if a patient can’t pay, the hospitals that have benefited enormously from discounted drugs intended for vulnerable patients are aggressively suing these same patients. This illustrates a major disconnect between the intent of the 340B program and the way it is operating today.
While estimates differ, medical debt is believed to cause more than 60 percent of bankruptcies in America. Most consumers facing medical debt did not end up in that situation because of bad decisions or profligate spending. Most have had some kind of injury or unexpected illness and don’t have insurance – or don’t have sufficient insurance – to cover their medical and hospital costs. Patients who need financial assistance should be processed when entering the hospital for medical care. Many are not given the chance to do so and as a result, can be sued for debt after services are rendered. Medical debt collection practices are debilitating for low-income consumers and can destroy their credit ratings, subjecting them to subprime rates and a never-ending spiral of debt.
Even if patients don’t start out poor, because of excessive fees, penalties, and other costs added onto what may or may not be actual medical debt on the part of patients, aggressive debt-collection practices can leave them destitute. Many don’t have funds to hire a lawyer, and if summoned, they often don’t know they need to actually go to court; in fact, sometimes debt collectors advise them not to show up in court. As a result, default judgments are filed against them, leading to garnishments of wages, and liens on homes, cars, and other properties. In 2019, the Journal of the American Medical Association studied the garnishment of wages by hospitals in the state of Virginia and found that 71% of the hospitals were nonprofit and the gross mean annual revenue of hospitals engaged in garnishments was $806 million, with 8,399 patients having wages garnished.
Below are just a few stories illustrating hospitals’ medical debt collection practices playing out in communities throughout the nation.
We support the critical role hospitals play in communities across the country and understand many dutifully provide charity care to those who cannot pay. However, we believe that if hospitals are designated charity entities and are receiving 340B discounts, they should be required to prove that those discounts have been passed along to patients. The current situation is unacceptable and merits an in-depth investigation and tightening up of the 340B rules. Charity hospitals should not be able to both claim 340B status and drag the very populations they are pledged to serve into debt collection proceedings, taking their homes, their cars, and their possessions in the process. Changes need to be made to ensure that only eligible hospitals are allowed to participate in the 340B program and that the deep discounts for medicines are passed along to patients, as Congress intended.
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.
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.
June 7, 2023
Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831
Washington, D.C.— June 7, 2023 —The National Consumers League (NCL) today sent a letter signed by 37 leading advocacy organizations, including groups that represent patients with common and chronic conditions who depend on laboratory testing to manage their health, urging Senate and House leaders to protect access to clinical laboratory services by enacting the Saving Access to Laboratory Services Act (SALSA / H.R. 2377 / S. 1000) this year.
“Without congressional action this year, Medicare reimbursement cuts scheduled for January 2024 could limit access to essential tests that 65 million American seniors rely on to diagnose and manage disease,” said Sally Greenberg, NCL Chief Executive Officer. “The Saving Access to Laboratory Services Act would help ensure robust access to laboratory services that improve patient health.”
Highlights from the letter include:
Below is the list of signatories:
Click here to view the full letter.
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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.
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.
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:
Abortion-related statistics for each state include:
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
February 28, 2023
Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442
Washington, D.C. – Today, NCL Health Policy Director Robin Strongin testified at the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC). Robin’s full testimony can be found below.
Good afternoon, my name is Robin Strongin and I direct Health Policy for the National Consumers League (NCL).
Founded in 1899 by the renowned social reformer, Florence Kelley, the National Consumers League has long championed vaccines as lifesaving medical interventions.
In fact, Kelley’s support of vaccinations played a key part in mitigating a critical smallpox outbreak towards the end of the 19th century, and her tireless advocacy for immunizations has informed NCL’s bedrock principles for increased access and vaccine confidence.
124 years later, we are honored to persist in our efforts to protect consumers from vaccine preventable illnesses and we extend our gratitude to this committee for the opportunity to present our public comments.
We know that despite decades of effort, no vaccine to protect against RSV disease, in any population, has been authorized, resulting in a very serious unmet need. The dramaticrise in cases this past Fall was a wake-up call for us as a nation.
As Americans faced the threat of contracting RSV–the flu, pneumonia, and COVID were circulating simultaneously. The difference, of course, is that vaccines for COVID influenza and pneumonia are widely available and many in the most vulnerable communities have embraced these tools to reduce their risk of serious illness and death.
However, the lack of any such tool to protect against RSV made for a frightening reality for Americans already facing serious threats to their respiratory health, especially among the very young and the elderly.
NCL is also concerned with the serious strain these viruses put on our health care system, and its ability to provide quality and timely care for patients. From hospitals running at capacity, to over taxed health care providers and family caregivers, the prolonged burden such an uptick in cases can inflict is not sustainable.
We are encouraged by the continued progress in the development of vaccines to help strengthen our ability to fight back against devastating diseases like RSV.
Ensuring broad and equitable access to these vaccines is an important next step to improving the health of all communities while reducing the high burden these viruses place on our health care system.
NCL cares deeply about the health and well-being of our nation. We will continue to do our part to educate people about the importance of vaccines and the value they offer consumers–and society as a whole.
Thank You.
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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.
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:
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.
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:
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 work of the National Consumers League is making a difference in people’s lives across the country. Meet some of the consumers touched by our programs.
Read about NCL’s impact
Paige, 55, a Nashville wife and mother of two, answered an employment ad for secret shoppers. Before sending payment to the scammers, she reached out to NCL.
Read about NCL’s impact
A grease fire flared up in Decklan’s kitchen. As his family scrambled and panicked, fearing that the whole house might erupt in flames, Decklan remained calm. He hurried over to the pantry, grabbed some baking soda, and dumped it on the fire quickly extinguishing the blaze.
Read about NCL’s impact
Cincinnati resident Charles, 45, lost his computer business — and health insurance— during a time of economic downturn. A diabetic, Charles was now unable to afford his medication. He stopped taking it which made him seriously ill and put his life at risk.
Read about NCL’s impact
Jeremy is a fast-food worker who has been employed at a number of Chipotle restaurants in New York City. When he was just 20 years old, he took part in an NCL research project that revealed that management practices within the fast food chain were putting workers—and food safety for customers—at risk.
Read about NCL’s impact
By Sally Greenberg, NCL Executive Director
While the COVID-19 pandemic has led to hardship for all Americans, it is clear that people of color have been disproportionately burdened. Across the health care continuum, addressing this disparity has become part of the broader conversation about the history of systemic racism and the underlying social determinants of health that negatively affect the mental, physical, and economic health of individuals and entire communities.
The pandemic has underscored persistent health disparities, and there is growing recognition that representation in research and clinical trials can have a profound impact on health outcomes. A lack of representation from racially and ethnically diverse groups in research and clinical trials have typically led to gaps in data, missing the opportunity to assess the full impact of various treatments and drugs across a range of populations. The collection and use of real-world research and data to inform the potential use, risks, and benefits of medical products and treatments can ultimately lead to better health outcomes, particularly for those who have been underrepresented in the past.
Existing efforts to improve inclusion
Efforts to expand diversity and representation in medical research are underway in Congress. Policymakers are encouraging the incorporation of Real World Evidence (RWE) in drug development through the recent Cures 2.0 draft legislation released by Reps. Diana Degette (D-CO-1) and Fred Upton (D-MI-6). While the status quo limits us from effectively reaching underserved populations, the proposed legislation would allow studies that include RWE for some drugs after they have been approved. At the heart of this issue is a growing appreciation that the same therapy can affect different populations in different ways, which is why Cures 2.0 supports collecting data that more accurately reflects the unique experiences and needs of patients across diverse populations.
Recognizing the potential for RWE in maternal health
The lack of representative research in the field of maternal health is undeniable, and its implications are staggering. The dismal state of maternal care in the United States reflects how our health care system has failed women of color, including by not adequately studying treatment options to prevent maternal morbidity and mortality. The need for RWE is clear when you consider the persistent disparities in health outcomes that plague minority communities.
Preterm birth and its disproportionate impact on women of color is a stark illustration of the need to make progress on representative research in maternal health. Preterm birth is the second-largest contributor to infant death in America today. Despite the tremendous physical, emotional, and financial toll that preterm birth continues to take on our country — disproportionately so on women and families of color — not enough therapeutic tools currently exist to prevent it.
Today, “17P,” the only FDA-approved treatment to help reduce the likelihood of spontaneous, recurrent preterm birth in the United States is at-risk of being withdrawn from the market in all its forms, including the branded product and five generic versions. Unfortunately there is conflicting evidence from two different clinical trials, one representative of a diverse U.S. population and another studied in a largely white population in Europe. It’s not a straightforward comparison. If 17P is withdrawn, the women most affected by preterm birth, predominantly women of color, would be left without an FDA-approved treatment option.
The FDA is considering the path forward, including additional data collection through leveraging RWE from past patient use. The success of the first (approval) trial for 17P in the impacted communities signals the importance of RWE. Continued access to 17P is, at its core, a matter of health equity. Black women must not yet again be left vulnerable to a system that historically has overlooked them.