Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442
Washington, D.C. – The National Consumers League (NCL) welcomes the reintroduction of the Treat and Reduce Obesity Act (TROA) as a needed step to end outdated Medicare rules that leave millions of seniors with diagnosed obesity – particularly members of Black and Latino communities – vulnerable to disability, disease and premature death due to lack of access to the full range of treatment options.
Introduced by Senators Tom Carper (D-DE) and Bill Cassidy (R-LA) and Representatives Brad Wenstrup (R-OH), Raul Ruiz (D-CA), Mariannette Miller-Meeks (R-IA) and Gwen Moore (D-WI), TROA will end this regulatory logjam by expanding coverage under Medicare Part D to new FDA-approved anti-obesity medications, which are currently excluded under a policy dating back to 2003. TROA will also end Medicare Part B restrictions on intensive behavioral therapy (IBT) that limit the delivery of IBT to primary care providers and restrict the physical locations where this care can occur. Through TROA, clinical psychologists, registered dietitians and nutrition professionals will be able to provide IBT if an individual with obesity is referred by a physician.
At a time when the obesity rate among adult Americans exceeds 40 percent and is even higher among communities of color – virtually half of African Americans (49.6 percent) and 44.8 percent of Hispanics are living with obesity – passage of TROA could be a critical step in changing the trajectory of a disease that for too long has been overlooked and undertreated. The National Consumers League applauds TROA’s reintroduction in the 118th Congress and pledges our support to gain passage of this important legislation on an expedited basis.
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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.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-07-21 13:23:322023-07-21 13:23:32The National Consumers League applauds the reintroduction of bipartisan legislation to give millions of Medicare beneficiaries access to safe and effective obesity treatments
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.
https://nclnet.org/wp-content/uploads/2023/01/Screen-Shot-2023-01-10-at-12.16.19-PM.png387491Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-07-12 15:26:182023-07-13 03:53:01Financing the healthcare of tomorrow playlist: Tracks for consumers and policymakers
I have written before about being born into a family that experienced the agony of the polio epidemic. My uncle Roger Joseph’s battle with the disease—including his diagnosis in 1951 by my father, a practicing internist—devastated our entire family. My uncle, a golden boy, popular, handsome, brilliant, and kind, graduated from the University of Minnesota and Harvard Law School; he also won a silver star for his military service in WW2. Married with three daughters, he had a thriving law practice when he fell ill.
His case was severe and rendered him paralyzed. Confined to an Iron Lung for two years, the device was designed to stimulate breathing in patients whose lungs no longer functioned. With a great deal of therapy, my Uncle Roger, by then quadriplegic, moved to a motorized wheelchair that he ended up using for the rest of his life. He doted on his children, moved in with my grandmother, slept in a rocking bed to facilitate his breathing, and had an attendant on duty 24 hours a day. When we visited my grandmother, we visited our uncle too. He also came to our home for Sunday dinners, and I recall him taking breaths carefully before speaking, and when he did, he was wry and funny. He also had to learn to write again with his non-dominant hand. My mother, who had always idolized him, marveled at how his handwriting never changed.
My uncle lived 16 years with polio, thanks to a loving family, modern medicine, financial wherewithal, his wheelchair, and his attendant. Paralyzed from the neck down, he nonetheless spent these years productively, doting on his daughters, going to work every day, and attending baseball games, and even traveling abroad.
In 1954, U.S. physician Jonas Salk developed a vaccine to prevent the disease. The polio vaccine was first tested on 1.6 million children in Canada, Finland, and the United States before it was used more broadly. By 1957, annual cases had dropped from 58,000 to 5,600, and by 1961, only 161 cases remained. Had my uncle had access to the vaccine, he never would have gotten sick.
The powerful lessons about vaccines weren’t lost on anyone in my family. This explains why I feel obligated to confront head-on the dishonesty and lies of the anti-vaxxers. I have traveled to the CDC and the FDA numerous times to testify in support of childhood and adult vaccinations, and each time have been confronted by vaccine deniers.
Here’s the problem: Those of us with memories of family members with devastating diseases like polio are aging out. We are victims of our own success in wiping out childhood diseases. Younger generations have now been vaccinated for polio, measles, rubella, mumps, influenza, diphtheria, tetanus, and whooping cough so they do not know the trauma these illnesses caused to millions of families. Come to think of it, I’m in that category myself.
Florence Kelley, who in 1899 launched the National Consumers League, wrote in the 1880s about the dark days of “diphtheria”; she lost three young siblings to the disease, which sent her mother into lifelong depression. But I have never known anyone with diphtheria, thanks to vaccines.
My 27-year-old son never had measles—nor any of his friends. But my siblings and I all did, along with rubella, chicken pox, and the mumps. Measles alone is far more serious than often understood. In 2021 alone it killed nearly 128,000 unvaccinated children under age 5 around the world.
All of which leads me to the reason I have written this blog. Each year, Uncle Roger’s daughters proudly award the Roger E. Joseph Prize, (created by my Uncle Burton Joseph, in honor of his brother and their dad) and for this year’s prize, my cousin Linda produced a video; it tells a compelling story of her experience with her father’s illness. Hebrew Union College, which graduates reform rabbis, hosts the awards. Honorees have included Rosa Parks, Henry Louis Gates, Morris Dees, Sara Bloomfield, and the Center for Reproductive Rights. A complete list is at the link below.
Indeed, the Roger E. Joseph Prize is a point of immense pride for our family, but it also gives us the opportunity to talk about diseases like polio and, now Covid, and the critical importance of the vaccines developed to prevent them.
How truly fortunate we are to have a medical establishment that has helped to prevent families from suffering, the way ours did, when a loved one falls ill from an infectious disease.
As the anti-vaccine movement grows each year—a = movement that traffics in conspiracy theories and junk medicine—note Robert Kennedy Jr.’s anti-vaccine crusade, which his own family has denounced in this article published by Politico.
Now more than ever we need to have conversations about the critical importance of vaccines.
https://nclnet.org/wp-content/uploads/2020/08/Sally2017_92px.jpg968968Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-06-21 14:02:532023-06-21 14:10:26We must never forget the importance of vaccines
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.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-05-12 14:05:142023-05-12 14:15:22NCL statement on FDA review of the oral toxicity of cannabidiol (CBD)
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.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-03-28 21:32:592023-03-28 21:38:25NCL applauds expansion of Medicaid in North Carolina
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.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-03-22 20:07:382023-03-22 20:07:38NCL applauds the Biden Administration’s $11-billion budget proposal to eliminate Hepatitis C
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.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-03-06 15:22:342023-03-06 15:24:23The National Consumers League applauds Eli Lilly Decision to cap prices on insulin
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.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-02-28 21:11:592023-03-01 21:12:26NCL Health Policy Director testifies at FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC)
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.
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.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-02-21 15:00:082023-02-21 15:07:03The 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
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.
https://nclnet.org/wp-content/uploads/2023/02/access-2023-Social-share-3.jpg6751200Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-02-15 22:01:332023-02-15 22:14:34NCL’s Greenberg joins panel to discuss the challenges and opportunities of the generic and biosimilar industries
PBPA Commends HHS Funding to Support Maternal and Infant Health
The Preterm Birth Prevention Alliance (PBPA), a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, applauds the U.S. Department of Health and Human Services (HHS) for awarding nearly $350 million to states across the country to improve support for safe pregnancies and healthy babies.
“For far too long, U.S. maternal health care has lagged behind that of other developed countries, particularly for women of color,” noted Sally Greenberg, Executive Director of the National Consumers League. “This additional funding will enable local health departments and nonprofits to better address the health care needs of the most vulnerable mothers and their babies.”
The funding, awarded by HHS’ Health Resources and Services Administration (HRSA), will support home visiting services, increase access to doulas, address infant mortality and maternal illness, and improve data reporting on maternal mortality.
“Maternal health care in the U.S. has consistently failed women of color,” Greenberg continued. “We applaud HHS for this additional funding that will help to improve the maternal health for all mothers and babies, especially women of color and those most at-risk.”
The funding announcement follows the release of a report by the U.S. Commission on Civil Rights which found that Native American women are more than two times more likely to die from pregnancy-related complications than white women in the U.S. This disparity was further exacerbated for Black women in the U.S., who are three to four times more likely to die from pregnancy-related complications than white women.
“In addition to expanding programs to support maternal health, we must increase representation from racially and ethnically diverse groups in research and clinical trials, particularly those studying treatment options to prevent maternal morbidity and mortality,” said Greenberg. “The need for the additional HHS funding and the report from the Commission on Civil Rights clearly illustrate how critical representative research and real world evidence are to ensuring all mothers and their babies have the same opportunity for the best possible health outcomes.”
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.
PRETERM BIRTH PREVENTION ALLIANCE APPLAUDS FDA’S GRANTING OF HEARING FOR THE ONLY FDA-APPROVED THERAPIES TO REDUCE RECURRENT PRETERM BIRTH
WASHINGTON, DC, August 26, 2021 –
Preterm Birth Prevention Alliance a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, commends the U.S. Food and Drug Administration (FDA) for granting a public hearing to discuss 17P, the only FDA-approved class of branded and generic treatments to reduce preterm birth in indicated patients.
We appreciate the FDA’s willingness to hear directly from individuals facing prematurity and the providers who treat them about their experiences with 17P,” said National Consumer League’s Executive Director Sally Greenberg. “It is an important step towards better understanding variations in efficacy across diverse populations and ensuring all women have an equal chance at the best possible outcomes.”
Last week, the FDA agreed to grant Covis Pharma, the manufacturer of the branded 17P product Makena its request for a public hearing to discuss 17P. Hydroxyprogesterone caproate—or “17P”—has been approved since 2011 and is the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth in the United States. In 2020, the FDA proposed withdrawing 17P in all its forms, including the branded product and its five generic versions, based on conflicting efficacy data from two studies composed of vastly different populations, one predominantly inclusive of women in the U.S. most vulnerable to preterm birth and one not.
“Mothers and birthing people deserve access to the best possible treatments to prevent preterm birth. We cannot achieve birth equity if we study pregnant women as a monolith,” said Blythe Thomas, Initiative Director of 1,000 Days. “It is only by systematically researching the real-world, post-market impact of 17P on individuals from a variety of racial and ethnic backgrounds, while maintaining access for all affected, that we can reduce disparities in maternal and infant health.”
While the hearing date has not yet been set, the Alliance looks forward to sharing the perspectives of affected individuals and their physicians with the agency once the hearing is scheduled and will continue to advocate for at-risk moms and babies of all races and ethnicities.
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ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE
The Preterm Birth Prevention Alliance (PBPA) is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, the 15 partners in the PBPA seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org
LEADING PATIENT ADVOCATES LAUNCH PRETERM BIRTH PREVENTION ALLIANCE TO PROTECT CRITICAL ACCESS TO THE SOLE FDA-APPROVED CLASS OF THERAPIES TO REDUCE RECURRENT PRETERM BIRTH
WASHINGTON, DC, April 20, 2021 – Today, the National Consumers League (NCL), along with a coalition of patient advocacy organizations dedicated to advancing the health of mothers and infants, announced the launch of the >Preterm Birth Prevention Alliance.
Members of the Alliance are joining forces in an effort to preserve patient access to the only Food & Drug Administration-approved class of treatments for pregnant women who have previously had an unexpected, or spontaneous, preterm birth. Together, Alliance members seek to ensure that the Food & Drug Administration (FDA) hears concerns from the full range of stakeholders about the potential risks and impact of withdrawal for at-risk pregnant women and their providers.
For the fifth year in a row, the U.S. preterm birth rate has increased (to 10.2 percent of births), and preterm birth and its complications were the second largest contributor to infant death across the country. Preterm birth also represents a significant racial health disparity, with Black women in America experiencing premature delivery at a rate 50 percent higher than other racial groups throughout the country.
However, in 2020, the FDA >proposed withdrawing hydroxyprogesterone caproate, commonly called “17P” or “17-OHPC”, the only FDA-approved class of branded and generic treatments to help prevent the risk of preterm birth in women with a history of spontaneous preterm birth. The FDA is currently determining whether to hold a hearing on the status of 17P, based on conflicting efficacy data from two studies composed of vastly different patient populations, one inclusive of women in the U.S. most vulnerable to preterm birth and one not.
“We’re fighting for a more inclusive healthcare system that gives everyone an equal chance to have the best outcomes possible,” said Sally Greenberg, executive director of the National Consumers League. “We don’t believe that removing 17P from the market without gaining a better understanding of who could benefit the most from its use is in the best interests of patients, nor their healthcare providers, particularly as there are no other approved treatment options available.”
To date, 14 organizations have joined NCL to advocate for the health interests of at-risk pregnant women and infants, including: 1,000 Days; 2020 Mom; American Association of Birth Centers; Black Mamas Matter Alliance; Black Women’s Health Imperative; Expecting Health; Healthy Mothers, Healthy Babies Montana; HealthyWomen; Miracle Babies; National Birth Equity Collaborative; National Black Midwives Alliance; National Partnership for Women & Families; Sidelines High-Risk National Support Network; and SisterReach.
“As a trained obstetrician and gynecologist, I know firsthand the impact of preterm birth on Black women and birthing people. I also know that racism – not race – is the driving factor leading the disproportionate impact of preterm birth on Black women and birthing people thereby exacerbating systemic inequities in maternal and infant health. To achieve birth equity, which is the assurance of the conditions of optimal births for all people with a willingness to address racial and social inequities in a sustained effort, we must work to protect and uphold a standard of care for spontaneous, recurrent preterm births and ensure it remains accessible and affordable for all who stand in need,” added Dr. Joia Crear Perry, founder and president of the National Birth Equity Collaborative.
The Preterm Birth Prevention Alliance is calling for the FDA to grant a public hearing to fully consider all of the data, additional research methods, and stakeholder perspectives before deciding whether to withdraw approval of this critical class of therapies. The health of America’s moms and babies warrants the utmost care and consideration.
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ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE
The Preterm Birth Prevention Alliance is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, we seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org.
Initial support for the Preterm Birth Prevention Alliance is provided by Covis Pharma.
