NCL Health Policy Associate testifies on behalf of the Preterm Birth Alliance at the FDA hearing on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena

October 17, 2022

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

Washington D.C.— Today, NCL Health Policy Associate Milena Berhane representing the Preterm Birth Prevention Alliance testified at The Food and Drug Administration (FDA) hearing on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena or 17P. Milena’s full testimony can be found below.

Hello and thank you for the opportunity to speak today. My name is Milena Berhane, and I am a Health Policy Associate at the National Consumers League. I am here representing The Preterm Birth Prevention Alliance, a coalition of 15 maternal and women’s health advocacy organizations that came together in 2021 with a shared concern about the state of preterm birth in the U.S. and what the proposed withdrawal of Makena and its generics could mean for women at risk.

Collectively, the Alliance seeks to improve preterm birth outcomes in the U.S. by maintaining access to safe, FDA-approved treatments and advocating for more diverse medical research that adequately represents the experiences of newborns and women of color.

Since convening as an Alliance, our members have included the following pre-existing organizations with their own missions, leadership and voices coming together to speak with one voice on this issue. These groups include:

  1. 1,000 Days
  2. 2020Mom
  3. The American Association of Birth Centers
  4. Black Women’s Health Imperative
  5. Black Mama’s Matter Alliance
  6. Expecting Health
  7. Healthy Mothers, Healthy Babies
  8. Healthy Women
  9. Miracle Babies
  10. The National Birth Equity Collaborative
  11. The National Black Midwives Alliance
  12. The National Consumers League
  13. The National Partnership for Women and Families
  14. Sidelines and
  15. SisterReach

Over the next few minutes, I will speak to why we believe it is unnecessary and potentially detrimental to cut off access to this entire class of drugs. And I will address how removing 17P and its generics will not affect all women equally.

For full transparency, the panel should be aware that COVIS Pharma – the sponsors of Makena – are one of more than 100 funders who support the work of the National Consumers League. The company has provided some initial funding to support the Alliance but is not involved in the strategic direction of the Alliance or its activities. And—like all of NCL’s funders—does not hold sway over our positions or efforts.

As I’m sure you know and will hear from many others, women of color have substantially higher rates of preterm birth than their white counterparts. According to the March of Dimes 2021 Report Card, while the U.S. preterm birth rate declined a fraction of a percent in recent years—from 10.2 percent in 2019 to 10.1 percent in 2020—rates of preterm birth increased for Black and American Indian/Alaska Native women, who continue to be up to 60 percent MORE likely to give birth preterm compared to White women.

We at the Alliance believe that the removal of Makena and its generics would exacerbate these inequities and contribute to the already stark divide in maternal and infant health outcomes between Black, Indigenous, and other women of color and their white counterparts.

For more than a decade, maternal-fetal medicine specialists have safely used 17P and its generics to help women with recurrent preterm birth carry their babies closer to term, improving the chances of a healthy birth and reducing the risk of long-term health issues for the infant. Taking it off of the market would mean cutting off access to the only safe and effective drug for this indication, which would leave pregnant women and their providers without an affordable approved alternative.

The Alliance believes the FDA should allow for additional studies to learn which populations 17P is MOST effective in treating. And we believe this can and should happen while maintaining access to 17P for women at high risk of adverse outcomes. Based on available evidence, maternal healthcare providers and their patients should have the opportunity to decide together whether 17P would be beneficial to them in their pregnancy. 

I want to pause on this point of available evidence. All of the clinical trial and real-world evidence to date points to Makena and its generics being safe for women who have had a previous preterm birth. This makes keeping 17P on the market a question of efficacy, not safety. So why aren’t we doing everything possible to understand which populations 17P is most effective in treating before taking it off the market entirely?

Given the discrepancy in efficacy data between the original and confirmatory trials, it seems a logical next step would be to conduct additional efficacy studies in the population known to be at highest risk for recurrent preterm birth, which in the U.S., is Black and indigenous women.

Yet, the proposal to withdraw approval was based not on the original trial – MEIS (“Mees”) – which included nearly 60% African American and other women of color in the United States and found that 17P substantially reduced the rate of recurrent preterm delivery among women at high risk for preterm birth. Instead, the proposal to withdraw seems to be based on the results of the confirmatory trial – PROLONG – which was conducted primarily outside of the U.S. among mostly white European women, and which found Makena to not have the same level of efficacy as in the MEIS trial.

These trials studied two vastly different patient populations, one inclusive of women in the U.S. most vulnerable to preterm birth and one not. So the fact that they had different outcomes is not surprising. What doesn’t make sense is why the outcomes among white European women should carry more weight in decision-making than the outcomes among women of color in the U.S.

The Preterm Birth Prevention Alliance believes that evidence of efficacy for women of color in the U.S should be more determinative than a lack of demonstrated efficacy on white women in Europe.

In 2021, a meta-analysis study called EPPPIC (“eh-pick”), published in the Lancet, pooled data from thirty-one randomized trials in asymptomatic women at risk of preterm birth.  It concluded that both 17P injections and vaginal progesterone reduced the risk of preterm birth before 34 weeks in high-risk women with singleton pregnancies. It also noted that shared decision making with women that have high-risk singleton pregnancies, should discuss an individual’s potential risks and benefits. However, despite this reinforcing conclusion about the efficacy of 17P, the agency made no change to its recommendation to remove.

To achieve birth equity and protect the physical, financial, and emotional wellbeing of mothers and infants, we cannot study pregnant women as a monolith.  Instead, we must gain a better understanding of who can benefit most from treatments like 17P, through more diverse studies that include adequate representation from the women in this country who we know are most affected and are at the highest risk.

We believe that this research must explore the causes of disparate outcomes and risk of eliminating approved treatment options before a decision is made. And we believe that while these additional studies are conducted, 17P should absolutely remain available to patients and providers.

This last point is truly critical from the Alliance’s perspective. Considering the proven, life-impacting outcomes from the first clinical trial, years of anecdotal clinical data, and follow-up studies like EPPPIC, we believe that maintaining patient access to 17P while additional studies are conducted is KEY. The Alliance is fighting for a more inclusive healthcare system that gives every pregnant person an equal chance at having the best birth outcomes possible.

We do not believe that removing 17P from the market without understanding who could benefit the most from its use is in the best interests of patients or healthcare providers, especially without any other approved treatment options available. 

Women of color need a seat at the table.

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 https://nclnet.org.

NCL testifies at The Food and Drug Administration (FDA) hearing on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena

October 17, 2022

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

Washington D.C.— Today, NCL Executive Director Sally Greenberg testified at The Food and Drug Administration (FDA) hearing on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena or 17P. Sally’s full testimony can be found below.

Hello and thank you for the opportunity to speak today. My name is Sally Greenberg, and I am the Executive Director of the National Consumers League, the nation’s oldest consumer advocacy organization. For 123 years, it has been our mission to protect and promote social and economic justice for consumers and to provide the consumer’s perspective on safe and effective medicines and patient-centered health care.

We are deeply concerned about CDER’s recommendation to withdraw all forms of 17P.

We have shared our concerns with the FDA many times over, dating back to our first letter in June of 2020, which urged the agency to protect patient access to this critical therapy for preterm birth. The sentiments outlined in that letter—which was co-signed by more than a dozen maternal and infant health advocates, many of whom you will hear from today—have been reiterated in a series of subsequent letters, statements, and requests for meetings.

And long before that, the National Consumers League spent years advocating for increased regulation and oversight of medication compounding – an issue central to the question of why pregnant women deserve to maintain access to approved 17P, the only class of FDA drugs indicated to prevent a recurrent spontaneous preterm birth.

I appreciate having the time today to share thoughts on behalf of the National Consumers League to share our ongoing concerns and want to start by addressing some of the distortions and half-truths that have been floating around in the public dialogue about 17P over the past few years. I am not a scientist or a doctor, but I take our organization’s mission and ethos, which is rooted in safe products for consumers, and my responsibility as a consumer advocate very seriously. I have talked with numerous scientific, medical, and regulatory experts about this to separate fact from fiction. It is unfortunate that there has to be misinformation about such a serious subject, but that does appear to be the case.

I think you will hear from certain stakeholders that:

Makena should never have been approved. But the truth is that we aren’t here to debate the past. This class of products has been on the market for 10 years, and there is both safety and efficacy data to support that. To state it very simply: We are here today because of new, conflicting efficacy data – but that doesn’t render the original evidence null and void.

You may hear that there is no confirmed clinical benefit to 17P. This is not supported by the existing body of literature or the experiences of hundreds of thousands of American women. The primary basis for FDA approval of Makena was a randomized controlled trial conducted through an NIH network, in the highest risk preterm birth centers in the United States.  The one-third reduction in recurrent preterm birth was described in the New England Journal of Medicine in YEAR. Makena is one of the most well-studied medications given in pregnancy, with data from more than 2,000 women who participated in placebo-controlled trials, and more than 300,000 women treated to date. Every day doctors prescribe 17P for their patients because they have seen evidence of its effectiveness.

You may hear that the benefits of Makena don’t outweigh the risks. This implies that there are safety issues with the therapy. But the published evidence from both clinical trials and ongoing safety surveillance data does not bear this out. We know the FDA can act when there are safety issues. If such issues existed, I find it hard to believe that the FDA – which is one of most stringent and respected regulatory bodies in the world – would have waited three years to act.

You may hear that there are other options that could replace 17P as the standard of care. This is simply not true. With very few medications specifically approved to be given in pregnancy – and no others beyond Makena for recurrent, spontaneous preterm birth – the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine continue to support their members’ expertise in determining if Makena is appropriate for their patients. Yet, the regulatory uncertainty relating to 17P has created what must be an unprecedented situation where some providers are putting their patients on vaginal progesterone, which was previously denied approval for this indication, and is often prescribed in compounded form and would therefore likely not be covered by insurance. I cannot imagine the FDA intended to put healthcare providers and pregnant people in this kind of position when there continues to be a safe, approved standard of care for pregnant women at risk of having preterm birth when the issue at hand is inconclusive data on the effectiveness of two trials. But that is the situation before us.

You may also hear about the precautionary principle of public health as a reason to remove all forms of 17P from the market. Again, this is a diversion that seeks to focus this hearing on implied, non-existent safety issues, rather than on the effectiveness and how it can best be determined for which women this therapy is most effective. I would think the precautionary principle of public health could be much more logically applied to the use of vaginal progesterone for recurrent spontaneous preterm birth, since it was denied approval for this indication but is increasingly being used off-label, in compounded form and therefore not covered by insurance, yet because of the uncertainty being created about 17P because of the current regulatory situation, it is essentially being treated as an approved, equivalent therapy.

 You may hear that the company that manufacturers Makena put those who speak in support of continued access to 17P up to defending the product. No one asked me to do this. After the National Consumers League was chartered in 1899 one of our founders, Florence Kelley, who was a champion for equal rights and consumer protections, led the campaign for enactment of of the first federal health care bill, more commonly known as the Sheppard-Towner Act of 1921, which allocated federal funds to combat elevated mortality rates among mothers and newborns. The money went to state programs for mothers and babies, particularly prenatal and newborn care facilities in rural states. For decades, NCL has worked on our own and in collaboration with other advocates to ensure access to safe therapies. I believe that removing access to 17P – a safe therapy, which has been shown to be effective in its first clinical trial and for hundreds of thousands of women since coming to market – while it is determined for whom the therapy is most effective, would be a dramatic step along a path that seeks to limit access to women’s health care. Every step along that path can lead to negative consequences for the women and families who are affected.

That is why I am here today.  As both a mother, and the leader of an organization that cares greatly about the safety and welfare of consumers and patients.

Personal and shared distress over a decision that could impact the long-term health of hundreds of thousands of women and babies led NCL to spearhead the Preterm Birth Prevention Alliance, a group of 15 advocacy organizations that share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P. My colleague Milena Berhane, who leads the Alliance, will talk on behalf of that coalition at another time during this hearing.

I want to state plainly and for the record that while this is an unprecedented situation, the National Consumers League believes the FDA can create a win-win path that leads to BOTH new data on 17P and protected access for pregnant people.

I also want to break down some specific concerns and thoughts that led to and guide the National Consumer’s League’s commitment to this issue:

Number 1: The risks of leaving women without a safe and affordable alternative. But there are real risks to removing the only approved, safe option for women for this indication and so talked with healthcare providers who care for at-risk pregnant women to understand the risks involved in removing access to 17P. If all versions of Makena were to be removed, all that would be available to pregnant women for recurrent spontaneous preterm birth would be unapproved therapy that is often provided in compounded form.

Compounding has a role in our healthcare system, but creating a situation where more pregnant women with a history of preterm birth are given compounding drugs is an unwise course of action. Even before this issue, NCL led an advocacy effort to promote passage of federal legislation to strengthen laws relating to compounding of medications. We know that if done improperly, the process of compounding can pose significant safety risks.

There has been progress since the 2012 series of medical errors that resulted in the contamination of compounded medicines, which in turn caused a deadly fungal meningitis outbreak in the U.S. — killing more than 70 people and causing more than 750 cases of infection in 20 states. And we know there have been recalls of compounded 17P since the Drug Quality and Security Act (DQSA) of 2013. However, the FDA does not interact with a vast majority of compounders and is often not aware of problems until after the report of an adverse event or contamination.

We strongly urge that all current options remain on the table while additional studies are conducted.

Number 2: The need for more diverse efficacy research on 17P At issue here is the fact that the original clinical trial and subsequent confirmatory trial – upon which the recommendation to remove was based – were essentially comparing apples to oranges. The majority of participants in the first clinical trial (Meis) were African American and other women of color in the United States. This trial demonstrated that 17P substantially reduced the rate of recurrent preterm delivery among women who were at particularly high risk for preterm birth.

The participants in a subsequent confirmatory trial (PROLONG), which was conducted primarily outside of the U.S. after 17P was approved, were predominantly white and Eastern European. While PROLONG reaffirmed the safety of 17P, it did not confirm the same benefit in white European women that it did for women of color in the U.S. But this is not the population at highest risk of preterm birth, either in the U.S. or abroad.

Even after a meta-analysis that pooled data from 31 trials concluded that both 17P injections and vaginal progesterone reduced the risk of preterm birth before 34 weeks in high-risk women with singleton pregnancies, CDER persisted in its recommendation to remove.

Given that there is conflicting efficacy data between the original approval trial and a second confirmatory trial, we are advocating to maintain patient access to a class of treatments while allowing for additional research that reflects the experiences of women in the U.S.

Women most affected by preterm birth are also historically underrepresented in clinical trials. We believe it is critical that more diverse efficacy research be gathered and combined with the extensive amount of real-world evidence on 17P that exists today.

Number 3: The state of preterm birth in the U.S. As other stakeholders have and undoubtedly will testify during this hearing, the state of maternal health and preterm birth in the U.S. is incredibly concerning and many unanswered questions remain relating to it, especially for women of color.

For far too long, U.S. maternal health care has lagged behind that of other developed countries, and maternal health care in the U.S. has consistently failed women of color.

Pregnancy should be one of the most special and exciting times in a woman’s life, with preparation and celebrations to welcome a new addition to the family. I know it was for me. Unfortunately, for about 1 in 10 women in America, their anticipation may be cut short because of an unexpected preterm delivery. Black families, as Black women have a 50% increased risk of delivery before 37 weeks of their pregnancy.

America’s preterm birth crisis led the NAACP to recently spearhead a letter to the FDA, that was also signed by the National Health Law Program, the Prevention Institute and the National Partnership for Women & Families, and stated, and I quote:

The undersigned organizations believe that the confirmed evidence of this treatment for Black women in this country is determinative, and that any disruption of access would be detrimental…As the FDA considers a path forward, we collectively urge the agency to carefully consider all available mechanisms to maintain equitable access to approved 17P while additional evidence can be developed that more accurately reflects underrepresented racial and ethnic patient populations in the U.S.

Preterm birth can have a lasting a physical, mental, emotional, and financial tolls on affected babies and families. Given the dire state of preterm birth in the U.S. and the often-devastating impact of preterm birth on pregnant people and their families, the National Consumers League believes that the decision to utilize 17P in all its forms, branded and generic, should be one left to women and their health care providers. The fact that leading medical societies continue to recognize the role of individual providers and their patients when making treatment decisions about 17P, despite the ongoing regulatory situation, is compelling.

In closing, the company that manufactures the branded version of 17P has publicly said they are willing to do more research – why would we leave that option off the table when clearly there is conflicting efficacy data that needs to be resolved? To remove the only approved and safe therapeutic option to help reduce the likelihood of another spontaneous preterm birth, with the knowledge that the population that most benefits from 17P are women of color –  is not in line with consumer interest.

There is a win-win path here that could lead to both new data and protected access. To the Committee, I urge you to keep this, and the consumer perspective, in mind when making your recommendation to the agency.

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 https://nclnet.org.

NCL and 36 leading patient organizations urge Congress to protect seniors’ access to critical laboratory tests

September 21, 2022

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

Washington, D.C.— 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 diagnose and 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 / S. 4449 / H.R. 8188) this year.

“Without urgent congressional action, ongoing Medicare reimbursement cuts could jeopardize access to many clinical laboratory tests used to diagnose, monitor, prevent, and manage diseases for more than 50 million Americans,” said Sally Greenberg, NCL Executive Director. “It is essential that Congress act this year to permanently fix this problem.”

Highlights from the letter are included below:

  • “Without congressional action, Medicare reimbursement cuts – a fourth round scheduled to begin January 1, 2023 – could jeopardize access to many clinical laboratory tests that are used to diagnose, monitor, prevent, and manage common diseases for more than 50 million seniors.”
  • “Clinical diagnostic tests play a critical role in health care and inform 70 percent of medical decisions. For example, in 2020 more than 17 million hemoglobin A1C tests to assess the risk of developing diabetes, 28 million tests to diagnose and monitor heart disease, and 90,000 tests to diagnose leukemia and hereditary breast and colon cancer were provided to Medicare beneficiaries to support their care.”
  • “Between 2017 and 2022, payment for common tests for diseases like diabetes, cancer, and heart disease were cut by 27 percent. The next round of Medicare cuts would slash reimbursement up to another 15 percent for more than 800 laboratory tests, resulting in a staggering 38 percent cut to tests that are widely used to screen and manage many serious diseases. It is essential that Congress protect patients by acting this year to fix the Medicare payment model for clinical diagnostic tests.”
  • “Because of the serious implications for patients who rely on routine as well as advanced diagnostic laboratory services, Congress has acted three times to delay these cuts in recent years, but permanent reform is needed now. Fortunately, the Saving Access to Laboratory Services Actwould update Medicare’s payment system, which would help protect access to clinical laboratory testing, support investment in innovation, and strengthen America’s clinical laboratory infrastructure.”

Groups signing the letter include:

  • A Breath of Hope Lung Foundation
  • Alliance for Aging Research
  • Alpha-1 Foundation
  • American Sexual Health Association
  • AnCan Foundation
  • California Life Sciences
  • California Society of Pathologists
  • Cancer Support Community
  • CancerCare
  • Caregiver Action Network
  • Caregiver Voices United
  • Crohn’s & Colitis Foundation
  • Chronic Disease Coalition
  • Community Liver Alliance
  • Down Syndrome Association Of Orange County
  • FORCE: Facing Our Risk of Cancer Empowered
  • Global Liver Institute
  • GO2 Foundation for Lung Cancer
  • HealthCare Institute of New Jersey (HINJ)
  • Healthcare Leadership Council
  • Heart Valve Voice US
  • HIV + Hepatitis Policy Institute
  • International Foundation for AiArthritis
  • LUNGevity
  • Lupus and Allied Diseases Association, Inc.
  • Lupus Foundation of America
  • Men’s Health Network
  • Minority Health Institute
  • National Consumers League
  • New Jersey Association of Mental Health and Addiction Agencies
  • Ovarian Cancer Research Alliance
  • Patient Empowerment Network
  • RetireSafe
  • The Kidney Foundation of Central PA
  • The National Grange
  • Triage Cancer
  • ZERO – The End of Prostate Cancer

 

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 www.nclnet.org.

National Consumers League weighs in on FDA’s OTC Hearing Aid Rule, encourages consumers to consult with medical professionals

August 17, 2022

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

Washington, DC – Today, the U.S. Food and Drug Administration (FDA) issued its final rule enabling access to over-the-counter hearing aids for consumers with perceived mild to moderate hearing loss. National Consumers League (NCL) strongly supports expanding access to and affordability of hearing aids. NCL is encouraged by the positive impact these policy changes will have on increasing access to life-altering hearing aids. “We hope this means that more people will proactively assess their hearing loss and seek the help they need for their hearing health needs” said Sally Greenberg, Executive Director of NCL.

At the same time, while OTC hearing aids are a promising first step in achieving that goal, NCL remains concerned about potential consumer safety issues surrounding the use of OTC hearing aids without consultation of a trained, medical professional. NCL strongly encourages consumers to first consult with a medical professional before treating their perceived hearing loss with a hearing aid, including those that will be sold OTC.

Safety is the cornerstone of NCL’s mission. This is why NCL, along with 90 leading healthcare and consumer organizations, weighed in during the public comment period and via a group letter to FDA urging the agency to adopt lower the maximum outputs for OTC devices and establish a limit on gain. This limit has been recommended by leading hearing health professional organizations to ensure consumer safety. FDA ultimately lowered the maximum outputs in the final rule but decided against establishing a gain limitation. While we are pleased that the FDA recognized the need to lower the maximum outputs, we believe these devices could have been safer by limiting the amount of gain, as recommended by hearing care professionals. The lack of a gain limit, coupled with excessive amplification of sound for prolonged periods of time, may put some consumers at risk of experiencing increased hearing loss.

Because hearing loss is a medical condition that is unique to each individual, it should be addressed in consultation with a hearing care professional. With OTC hearing aids expected to be in stores as early as mid-October, NCL encourages consumers to purchase hearing aids in consultation with a professional who can help them fully understand the nature of their hearing loss, if any exists at all, and ensure that the treatment plan is appropriate for their needs, including the potential use of OTC hearing aids.

If consumers experience any adverse events or complications related to the use of OTC hearing aids, including worsening hearing after using such a device, NCL encourages consumers to report these events to the FDA. Instructions for reporting adverse events, are available at https://www.fda.gov/safety/medwatch, or by calling (800) FDA-1088.

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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.

The National Consumers League commends the enactment of the Inflation Reduction Act in increasing Medicare and Medicaid beneficiaries’ access to adult vaccines

August 17, 2022

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

Washington, DC – The National Consumers League (NCL) is tremendously encouraged by the enactment of the Inflation Reduction Act (H.R. 5376), which includes important provisions to increase access to adult vaccines. More specifically, the Act will provide all recommended adult vaccines to Medicare and Medicaid beneficiaries at no cost to patients.

NCL has been a longstanding advocate of expanding vaccine access to consumers, and recognizes the importance of vaccines as a life-saving, preventive public health measure. As a member of the Adult Vaccine Access Coalition (AVAC), NCL supports increasing access to all recommended adult vaccines by eliminating no cost sharing policies, which can place an immense financial burden on patients. As with any other health service, cost burden has kept both Medicare and Medicaid beneficiaries from receiving their recommended adult vaccines. Limiting vaccine access is harmful, and keeps adults from protecting themselves and their communities from preventable disease.

The crucial vaccine provisions within the Inflation Reduction Act include language from both the Protecting Seniors Through Immunization Act, and the Helping Adults Protect Immunity (HAPI) Act, both spearheaded by AVAC and advocated for by NCL. The Act will provide free recommended adult vaccines for both Medicare and Medicaid beneficiaries starting in 2023. It also mandates that under Medicare Part D, there will be no copays or any other out-of-pocket expenses for any adult vaccine that is recommended by the Advisory Committee on Immunization Practices (ACIP). In addition, Medicaid and CHIP will increase access to adult vaccines by improving federal reimbursement for providers that immunize those patients. Expanding access to vaccines through these mandates will promote vaccine uptake through the removal of cost burden for both Medicare and Medicaid beneficiaries.

The inclusion of these provisions in the Inflation Reduction Act is a critical step towards increasing vaccine access and coverage to Medicare and Medicaid beneficiaries nationwide. Its enactment will not only promote better health outcomes for consumers, but also represents a significant step towards expanding health equity. NCL appreciates President Biden’s swift action in signing this landmark piece of legislation yesterday.

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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.

NCL provided oral testimony to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices in support of new pneumococcal vaccine recommendations for adults 65 years of age and older

June 22, 2022

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

Washington, DC— On June 22, 2022, NCL’s Health Policy Associate Milena Berhane provided oral testimony to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices in support of new pneumococcal vaccine recommendations for adults 65 years of age and older. NCL comments appear below.

Thank you, Dr. Lee. My name is Milena Berhane, and today I am representing the National Consumers League. Since NCL’s founding in 1899 by social reformer Florence Kelley, we have advocated for the critical role immunizations play in the preservation and improvement of public health. We extend our gratitude to this Committee for the opportunity to present public comments.

According to the National Foundation for Infectious Diseases (NFID), pneumococcal disease is a leading cause of serious illness throughout the world. In the US, nearly 50,000 people die each year from pneumonia. The death rate is even higher in those age 65 years and older. Vaccination is a critical public health measure for preventing disease, hospitalizations, and death, so it is critical that access to the pneumococcal vaccine is expanded.

We are concerned about the lack of clarity surrounding the current ACIP recommendations regarding the pneumococcal vaccine, for adults ages 65 years of age and older. It is critical that the recommendations for this age groups are clear, so that patients and providers are better able to understand who should receive which vaccine, and when. The pneumococcal vaccine will continue to be a safe and effective measure in protecting Americans from disease, and it is imperative that older adults are able to receive them.

Having clear recommendations for adults 65 years of age and older is also critical in addressing health equity issues, especially among older Black and Latinx populations that already face issues in lacking access to health care. Pneumococcal vaccine uptake needs to increase in these populations so that currently existing health disparities are not further exacerbated. Therefore, in order to promote health equity among all older adults and increase vaccination rates, it is critical that clear recommendations are provided for this age group.

The National Consumers League recognizes the extreme importance of immunizations in protecting the health and safety of all Americans, and will continue its efforts to increase vaccine confidence and uptake across lifespan. We look forward to the upcoming recommendations by this committee regarding the pneumococcal vaccine for older adults.

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 www.nclnet.org.

NCL backs the Pregnant Workers Fairness Act to curtail workplace discrimination

June 21, 2022

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

Washington, DC— The National Consumers League (NCL) believes it is imperative that the Pregnant Workers Fairness Act (H.R. 1065), introduced by Representative Jerrold Nadler (NY-10), is enacted by Congress. In the uphill battle for equity in the workplace, NCL views H.R. 1065 as essential to protecting pregnant workers against unjustly losing their jobs and ensuring they receive pregnancy and post-partum accommodations to stay healthy.

Despite the steady decline of births in the United States since 2016, the number of federal pregnancy discrimination cases filed has steadily risen 67% from 2016-2020; and lawsuits are projected to set a new annual record this year. Workers lose approximately two thirds of the cases filed due to gaps in the current legal framework. H.R. 1065 will close loopholes in the Pregnancy Discrimination Act which requires pregnant workers to demonstrate that other workers are benefiting from comparatively similar accommodations before gaining approval from their employe

Women of color are more likely to work in physically demanding jobs, which also places the baby at  increased risk for preterm birth, low-birth weight, preeclampsia, birth defects, and more. While these health problems can be severe, long-term, and even deadly, studies illustrate how low-cost and basic accommodations for pregnant and postpartum workers can significantly reduce their risk. These include providing access to a chair to decrease time spent standing and basic accommodations for breastfeeding parents, such as a private space and additional break time to pump.

NCL strongly supports H.R. 1065. It will ask employers to provide reasonable accommodations for workers affected by medical conditions relating to pregnancy and childbirth. This will not only reduce health-related risks, but also improve workers’ economic security by safeguarding their jobs, income, health insurance, their baby’s health and more. Furthermore, by directly targeting discriminatory employment practices, H.R. 1065 represents a strong step in addressing sexism and racism in the workplace.

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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.

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

June 14, 2022

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

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

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

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

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

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

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About the National Consumers League (NCL) 

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

 

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

June 2, 2022

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

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

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

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

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

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About the National Consumers League (NCL) 

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

 

NCL applauds federal funding for maternal health in 2022 appropriations

March 18, 2022

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

Washington, DC— The National Consumers League applauds the passage of the 2022 omnibus appropriations act. The appropriations bill, signed into law, includes over $1 billion in federal funding to support critical maternal health provisions needed to address the nation’s alarming maternal mortality rates.

We are pleased that many provisions of the Black Maternal Health Momnibus Act of 2021 were included in the FY 2022 appropriations bill. The new law provides a significant increase in funding for the CDC’s safe motherhood & infant health programs. This additional support will help to identify drivers of maternal death rates in the states and expand evidence-based programs and interventions at hospitals and birthing facilities across the nation. The bill also includes a significant funding increase to the Maternal and Child Health Block Grant, which will assist state and local health entities in providing the essential health and social services that our most vulnerable birthing people and babies need.

Provisions from the Maternal Health Quality Improvement Act were also included in the fiscal year 2022 omnibus appropriations bill. These provisions provide funding that supports health professional schools to train future health care professionals about perceptions and biases in maternal health, which currently contribute to inequities in maternal health outcomes. In addition to racial bias, it is critical to invest in diversifying and expanding the perinatal workforce to include nurses, doulas, behavioral health professionals, and other practitioners. In a recent blog post, NCL Health Policy Associate Milena Berhane discusses the importance of diversifying the workforce and the negative impacts of racial bias on the quality of care for racial and ethnic minorities.

We recognize that perinatal suicides, which occur during pregnancy or up to one year postpartum, are a leading cause of maternal mortality in the United States. We are pleased that this appropriations act provides increased federal funding for maternal mental health programs. The additional funding will be critical in expanding access to community-based treatment and recovery services for pregnant people and new mothers who struggle with mental health or behavioral health conditions. The spending bill also funds additional necessary mental health resources, by increasing funding for the 24/7 maternal mental health hotline that is available to pregnant people and new mothers.

NCL applauds Congress for providing funding for critical maternal health provisions within the FY22 Omnibus bill. We will continue to advocate for the passage of additional maternal health provisions in future legislation and spending bills until we end the maternal mortality crisis in our nation.

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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.