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.

Legislation is needed to close the environmental health gaps in the Polluters Pay Principle

By Eric Feigen, NCL Health Policy Intern

Today, more than 40% of Americans live in communities with unhealthy levels of air pollution and every year, millions of deaths and chronic illnesses have been found to be directly caused by various pollutant types. This represents the human cost inherent in environmental degradation. Despite this, policy-makers and regulatory agencies continue to ignore public health consequences when crafting legislation designed to address environmental issues nationwide.

The current approach towards addressing both climate change and environmental damage is rooted in the Polluters Pay Principle (PPP). This commonly accepted practice dictates that those who pollute are responsible for not only abatement costs, but also compensating those adversely affected by their actions. From the Clean Air Act to the more recent Inflation Reduction Act, PPP is the fundamental framework for the majority of environmental legislation in the U.S.

The core mechanism used in PPP is cost-benefit-analysis. Due to the fact that polluters receive a benefit from polluting, in the form of profits, they must correspondingly compensate individuals for the negative externality their pollution creates. For example, paying for a water treatment plant in order to ensure a safe water supply for a community.

One of the most significant externalities of pollution is long-term health conditions. High levels of particle air pollutants are linked to a variety of health issues including asthma, cancer, infant mortality, and premature death. However, as previously mentioned, while 40% of Americans live in places with failing grades in air quality, not all of these individuals have asthma. This illustrates the uncertainty inherent in including the costs to humans’ health in the PPP’s cost benefit analysis. Using this logic, Michigan v. EPA set the precedent for omitting the negative impact polluters have on health from PPP-based calculations.

The Public Health Air Quality Act is one solution to the uncertainty dilemma surrounding pollutants and chronic health conditions. This is because the Act sets thresholds for pollutant levels at the point where the pollutant becomes harmful to human health. In essence, while previous legislation has made polluters pay for the right to pollute, the standards in this legislation will prohibit contamination after the air quality reaches a dangerous level. Furthermore, the Act will also mandate new air pollution monitoring programs and allow the EPA to follow the “precautionary principle”, which errors on the side of safety when determining what levels of pollution may be harmful to humans.

Another arena where PPP must be supplemented is equity. While designed to reduce environmental damage nationwide, PPP fails to address how pollution disproportionately harms Black and Brown communities. An example of this is exposure to PM 2.5, an air pollutant responsible for upwards of 85,000 deaths a year. A recent study highlights that while the Clean Air Act has led to a nationwide decrease PM 2.5 related health conditions, the number of deaths this pollutant causes in communities of color has remained constant.

Climate change and environmental degradation are just as much a public health issue as they are an environmental one. Policy-makers have the obligation to create legislation to supplement PPP policies to mitigate the harm polluters inflict on public health and ensure an equitable approach to environmental regulation and cleanup.

 

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 strongly supports FDA’s proposal to ban menthol

August 3, 2022

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

Washington, DC – The National Consumers League filed comments today with the Food and Drug Administration (FDA) in support of the agency’s proposal to ban menthol products.

“We commend the FDA’s actions, though we believe the ban on menthol cigarettes in the United States should have been implemented years ago,” said Sally Greenberg, Executive Director of NCL. “Nevertheless, this ban on menthol will save hundreds of thousands of lives and will have especially important positive benefits for African Americans because tobacco companies have relentlessly marketed menthol cigarettes to African Americans for decades.”

NCL recently recorded a podcast with the African American Tobacco Control Leadership Council, the country’s leading public health education and advocacy organization taking on Big Tobacco to save Black lives. The podcast can be found here: https://nclnet.org/menthol-cigarettes-going-up-in-smoke/

NCL also noted that the United States is an outlier among nations of the world in its proposal to ban menthol just now. The EU implemented a ban for its 28 member countries in 2020.

“Menthol enhances the addictive effects of nicotine in the brain,” said Greenberg. “The tobacco industry knew this and yet continued to market the product to Americans, especially targeting African Americans. Menthol is associated with progression to regular cigarette smoking in youth and young adults.”

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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 the FDA for renewing its focus on infant formula

July 14, 2022

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

Washington, DC— The National Consumers League (NCL) applauds the Food and Drug Administration (FDA) for taking strong steps to assure consumers that infant formula coming from overseas has been properly inspected and is free from contaminants or adulterants and therefore safe for infants.

“Consumers should have confidence that the infant formula that is being imported to the U.S. … involved a thorough review of the information provided by the companies, including details about the product’s nutritional adequacy and safety, microbiological testing results, labeling information, and importantly, details about the manufacturing facility’s food safety production practices and inspection history,” according to a press statement posted on FDA.gov.

Over the past few months NCL, the nation’s oldest consumer advocacy organization, has issued several statements on the infant formula shortage. The shortage was caused primarily by the unconscionable and unsanitary practices at Abbott’s Michigan infant formula facility when it failed to follow safety protocols, falsified documents to the FDA, and then shipped contaminated formula resulting in babies contracting foodborne illnesses and as many as nine infant deaths, according to FDA documents. Abbott’s reckless actions – coupled with the FDA’s slow response to the outbreak – finally lead to both parties issuing a recall of the faulty formula and ultimately triggered a nationwide shortage of powdered infant formula.

As FDA renews its focus on infant formula, NCL applauds the agency’s determined outreach to keep parents informed about how to read food labels from products made abroad. These labels use metric measurements that consumers in the United States may not easily comprehend. Most importantly, FDA has ramped up inspections of the products to ensure good and safe manufacturing processes.

Below are several statements on the infant formula crisis issued by NCL in the past few months, one of which includes our June 16 testimony before a Senate Judiciary Subcommittee.

https://nclnet.org/ncl-applauds-fda-response-formula-shortage/

https://nclnet.org/senate-testimony-consolidation-harms-consumers/

https://nclnet.org/baby-formula-shortage/

 

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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.

A New Patient-Centered Action Agenda calls for people with obesity to have the same rights and access to care as people with other chronic diseases

July 7, 2022

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

Washington, DC— The National Consumers League (NCL) today released A New Patient-Centered Obesity Action Agenda: Changing the Trajectory of Obesity Through Patient Empowerment, Health Professional Intervention and Supportive Government Policies, a new report with a blueprint to change how Americans think about obesity, empower people with obesity to get the best care, and afford those with obesity the same access to care as adults with other serious chronic diseases.

Issued as a call to action, the report was prepared in consultation with a panel of leading obesity specialists as a roadmap for overcoming one of the difficult challenges affecting US adults now living with obesity: despite significant advances in the understanding and treatment of obesity, only 10 percent of people with obesity get help from medical professionals,[1] meaning the disease remains largely undiagnosed and undertreated. Accordingly, only 30 million[2] of the estimated 108 million adults living with obesity[3] have been diagnosed with the disease and only around 2 percent of those eligible for anti-obesity medications have been prescribed these drugs.[4]

The consequences of undertreatment affect virtually every aspect of the healthcare system. Obesity not only has a negative impact on almost every aspect of health and well-being, but it worsens the outcomes of over 230 obesity-related chronic diseases, from type 2 diabetes and heart disease to some forms of cancer.[5] Accordingly, obesity is responsible for an approximately 300,000 premature deaths each year[6] deaths and costs the U.S. economy an estimated $1.72 trillion annually in direct and indirect costs.[7]

“Although obesity is one of today’s most visible public health problems, it is often ignored and discounted as a serious disease, resulting in a health crisis that has only worsened with time,” said
Sally Greenberg, NCL’s Executive Director. “This report focuses attention on the numerous public perception, provider and policy-related factors that preclude Americans with overweight and obesity from getting effective treatment and must be addressed if obesity outcomes are to improve in the US.”

To change the trajectory of the obesity epidemic, the report calls for a national mobilization to overcome the “human” factors– incorrect beliefs about the cause and treatment of obesity, prejudice towards people due to their size, lack of training for health providers, access barriers, and outdated government policies – that continue to prevent Americans from seeking and obtaining obesity care. Towards this end, NCL’s patient-centered action agenda identifies nine priorities for action:

  1. Redefine Obesity for the American Public as a Treatable Chronic Disease

Although the American Medical Association classifies obesity as a chronic disease requiring treatment, three-quarters of Americans believe obesity results from a lack of willpower. Thus, redefining obesity as a treatable chronic condition will provide a new context for health providers and patients to have a positive discussion about weight, leading to more people getting diagnosed and treated.

  1. Adopt Patient-First Language for Obesity

Unlike other chronic diseases where health professionals use people-first language that puts a person before a diagnosis, practitioners routinely use terms to describe obesity that can be off-putting and demoralizing. To change this situation, the National Consumers supports the agenda of the People-First Initiative launched by the Obesity Action Coalition, which advocates for widespread adoption of people-first language by practitioners in all healthcare settings.

  1. Make Combatting Weight Stigma a National Priority

Studies show that 40 percent of healthcare professionals –physicians, nurses, dietitians, psychologists and medical students – admit to having negative reactions based on a person’s size.[8]Addressing this pervasive problem requires a unified national initiative that makes the impact of weight stigma “real” for clinicians and the public and disseminates the latest information to health providers on strategies to reduce weight stigma.

  1. Elevate the Need for Physician Training in Obesity

A recent study of 40 US medical schools finds that 30 percent of these institutions provide little or no education in nutrition and obesity interventions while one third of schools reported no obesity education programs in place.[9] These findings underscore the urgency for US medical schools to change their priorities and develop curricula that comprehensively addresses the disease of obesity.

  1. Establish Excess Weight as a Vital Sign

Besides body temperature, blood pressure, heart rate and respiration, health providers routinely measure height and weight at each visit. Thus, if healthcare professionals were to calculate and provide patients with their Body Mass Index (BMI) at the time of the office visit, practitioners could have a tool to discuss excess weight when patients are most receptive to discussing their health status.  It is recognized that BMI is a crude measure and not the sole predictor of obesity but when combined with patient-friendly information that explains the level of weight and options for treatment, this interaction could initiate a positive, respectful conversation about obesity care.

  1. Provide the Tools for a Doctor-Patient Dialogue on Excess Weight

A major reason primary care providers (PCPs) are reluctant to provide obesity counseling is the lack of informational tools to have conversations with patients about their weight status and care options. Therefore, a unified effort to make available to PCPs evidence-based, patient-friendly content on obesity will facilitate a better dialogue between clinicians and patients and promote shared decision-making.

  1. Establish Coverage of Obesity as a Standard Benefit Across Insurers and Health Plans

Although employers and insurers are starting to cover treatment options for obesity in employee benefit packages, too many people continue to be denied coverage or face access barriers, such as step therapy and prior authorization, that delay treatment. Improving obesity outcomes therefore requires supporting legislative efforts, like the “Safe Step Act” that would require group health plans to provide an exception process for step-therapy protocols. It also necessitates collaboration among payers, providers, policymakers, and advocates to establish a standard, affordable benefit for the prevention and treatment of obesity that applies across plan types and payers.

  1. End Outdated Medicare Rules That Exclude Coverage for Necessary Obesity Care

Today, the many millions of Americans enrolled in the Medicare program are denied safe and effective obesity treatment due to outdated Medicare Part D rules that exclude coverage for FDA-approved obesity drugs and Medicare Part B policies that places undue restrictions on intensive behavioral therapy by allowing only primary care providers to deliver IBT and severely restricting the physical locations where this care can occur. Congress has the power to change this situation, which is why NCL has joined with the obesity, public health and nutrition communities is pressing for swift passage of the Treat and Reduce Obesity Act (TROA). The proposed legislation would expand Medicare coverage to allow access to IBT from a diverse range of healthcare providers while ending the exclusion for new anti-obesity medications that are improving the standard of care for adult Americans with obesity.

  1. Create a Patients’ Bill of Rights for People with Obesity

For too long, people with obesity have been stigmatized, discriminated against, and have faced significant hurdles and burdensome requirements to receive care. Changing this situation will require giving people with obesity the knowledge, skills and confidence to be advocates for their best obesity care. Therefore, NCL’s patient-centered obesity action agenda calls for the creation of a Patients’ Bill of Rights for People with Obesity based on the recognition that obesity is a treatable disease and everyone with obesity deserves the same level of attention and care as those with other chronic conditions.

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About the Report

To prepare the report, NCL partnered with the Obesity Care Advocacy Network (OCAN) to host a roundtable discussion in December 2021where public health specialists, leading professional societies, the minority health field and the obesity policy community assessed the state of the science on obesity today, the scope and cost of the disease in the US and the major barriers impeding quality obesity care with special attention to the “human” obstacles that keep people with obesity from seeking or obtaining treatment. Additionally, NCL conducted a literature review to gather additional insights, especially regarding how to change how people with obesity see themselves, so they become empowered to advocate for their care as patients with a chronic disease. Based on this assessment, NCL drafted the report, which was vetted by experts participating in the roundtable, and developed the policy recommendations included in the Patient-Centered Obesity Action Agenda.

 

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.

 

[1] Stokes A, et al. Prevalence and Determinants of Engagement with Obesity Care in the United States. Obesity. Vol. 26, Issue 5; May 2018, 814-818

[2] PharMetrics-Ambulatory EMR database, 2018. Novo Nordisk Inc.

[3] Hales CM,, et al. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. Centers for Disease Control and Prevention. NCHS Data Brief. No. 360. February 2020.

[4] PharMetrics-Ambulatory EMR database, 2018. Novo Nordisk Inc.

[5] Obesity Care Advocacy Network. Fact Sheet: Obesity Care Beyond Weight Loss

[6] Allison DB, et al. Annual deaths attributable to obesity in the United States JAMA 1999Oct 27 282(16)1530–8.

[7] Milken Institute (October 2018), “America’s Obesity Crisis: The Health and Economic Costs of Excess Weight.”

[8] Fruh SM, et al. Obesity Stigma and Bias. J Nurse Pract. 2016 Jul-Aug; 12(7): 425–432.

[9] Butch WS, et al. Low priority of obesity education leads to lack of medical student’ preparedness to effectively treat patients with obesity; results from the U.S. medical school obesity education benchmark study. BMC Med Educ 20, 23 (2020)

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