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.

Consumer and industry groups call on agencies to crack down on user review fraud

October 11, 2022

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

Washington D.C.— A coalition of consumer advocacy and industry organizations is calling on the Federal Trade Commission (FTC) and the Department of Justice (DOJ) to do more to crack down on organized user review fraud. In a letter to FTC Chair Lina Khan and Attorney General Merrick Garland, the groups stressed that the trustworthiness of user reviews is a critical factor in consumers’ purchasing decisions and for businesses’ reputations.

While fraudulent reviews are not new, organized rings of review brokers coordinating the placement hundreds or even thousands of fraudulent reviews for products on popular marketplaces and e-commerce websites are a growing problem. These operations sell positive reviews to sellers of substandard products, resulting in consumers purchasing poor quality or even unsafe products and services. Honest sellers, including small businesses, are harmed when they lose sales to dishonest competitors who purchase reviews.

Fraudulent reviews cost consumers an estimated $152 billion globally in 2021, with $28 billion in losses from the U.S. economy alone. Additionally, researchers found that by deceiving buyers into purchasing lower quality and potentially unsafe products, fake reviews lead to $0.12 of consumer welfare lost for every $1 spent online.

Earlier this year, the Federal Trade Commission brought suit against Roomster, a rental listing platform that allegedly deceived consumers by buying fake reviews and charging for access to fraudulent listings. The FTC’s suit also targeted a review broker who organized the sale of tens of thousands of fake reviews to Roomster. The groups’ letter urged the FTC and DOJ to increase the resources devoted to fighting such scams to hold the purveyors of organized review fraud accountable.

“User reviews are a critical part of the purchasing process for millions of consumers every day,” said Sally Greenberg, Executive Director of the National Consumers League, which organized the coalition. “While the FTC and DOJ have taken some steps to crack down on brokers who profit off of fake reviews, more needs to be done if we are to safeguard the trustworthiness of reviews.”

“Online reviews provide great value to small brands as they are the great equalizer when customers are considering buying new products or patronizing new businesses,” said Rob Retzlaff, Executive Director of the Connected Commerce Council. “Fake reviews undermine trust in the entire e-commerce industry, and the FTC and DOJ should do everything in their power to crack down on those abusing the system.”

“Consumers have come to rely on online reviews to distinguish a valuable product or service from a waste of time and money. If fraudulent reviews become rampant online, they risk ruining a sizable portion of online purchases, “said Ruth Susswein, Consumer Action’s Director of Consumer Protection. “We need to rein in online fake review brokers.”

“It’s crucial that consumers have faith in brands,” said Maura Regan, president of Licensing International. “Counterfeiting and fraudulent reviews go straight to the heart of the global licensing industry because a lack of trust hurts all businesses across every category and on every platform.”

The letter to the FTC and DOJ was signed by the Center for Data Innovation, Chamber of Progress, Consumer Action, Connected Commerce Council, Licensing International, National Consumer Law Center (on behalf of its low-income clients), National Consumers League, National Restaurant Association, TechNet, and Women in Toys, Licensing & Entertainment/W I T Foundation.

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 https://nclnet.org.

NCL launches campaign to warn Americans about Chinese government’s collection of U.S. consumers’ genetic data 

September 7, 2022

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

WASHINGTON, D.C. – The National Consumers League (NCL) today announced it is launching a national campaign – www.protectmypatientdata.com – to warn Americans of the threat posed by the Chinese government’s collection of U.S. healthcare and genomic information. The campaign will target consumers, healthcare leaders, and lawmakers and will highlight the privacy and national security risks resulting from this bulk collection of data.

According to a February 2021 report from the U.S. National Counterintelligence and Security Center (NCSC), the Chinese government has made the collection of American healthcare information a top strategic priority and has gained access to large datasets in the U.S. and around the world through both illegal and legal means. This includes partnering with prominent research and healthcare entities in the U.S. to provide them with genomic sequencing services, allowing them to gain access to Americans’ health records.

On June 3, 2021 President Biden signed an Executive Order to further “address the threat of Chinese surveillance technology firms that contribute – both inside and outside China – to the surveillance of religious or ethnic minorities or otherwise facilitate repression and serious human rights abuses.”

“Genetic data remains one of the most sensitive and least protected types of personal information and yet the consequences of it falling into the wrong hands are profound,” said Sally Greenberg, executive director of NCL. “Authoritarian governments have already used genomic data to potentially surveil and control their own citizens and to conduct unsanctioned scientific research. That is why NCL is sounding the alarm and urging consumers and healthcare providers to be more diligent than ever when sharing personal healthcare information with third parties, particularly those funded or operated by the Chinese government.”

NCL has a long history of calling for consumer protections in the genetic testing industry. In February 2019, NCL issued a statement calling for investigation of direct-to-consumer genetic testing services like FamilyTreeDNA in the wake of reports that these services were sharing genetic data with law enforcement agencies.

On August 29, 2022, MGI Americas, an affiliate of Chinese genome research giant BGI, re-entered the U.S. next-generation sequencing market, having been previously barred from selling its genome sequencing machines in America. BGI is closely affiliated with the Chinese Communist Party (CCP) and People’s Liberation Army (PLA) and the data it collects has no legal protection against disclosure to the Chinese government.

A recent Reuters investigation found that BGI had scraped the DNA data of pregnant women from its pre-natal test kits and added them to the China National GeneBank, which it manages for the Chinese government. BGI has also been implicated in the repression of the Uighur minority in Xinjiang, for which two of its entities were sanctioned by the U.S. Department of Commerce.

NCL is urging providers and researchers to be cognizant of the risks of partnering with BGI and other Chinese healthcare companies, whose collection of data could be used to advance the country’s precision medicine industry and for more nefarious purposes, including the potential surveillance, exploitation, and manipulation of American citizens. NCL recently published a Genetic Privacy Bill of Rights and released a Policy Framework detailing steps that Congress, the Biden Administration, and industry can take to protect these consumer rights.

In addition to the education campaign, NCL will also embark on a series of initiatives to protect consumers:

  • Working with Members of Congress to create and implement new protections for genetic data, such as the Protecting Americans’ Data from Foreign Surveillance Act, introduced by Sen. Wyden (D-OR), Sen. Whitehouse (D-RI), Sen. Rubio (R-FL), Sen. Lummis (R-WY), and Sen. Hagerty (R-TN).
  • Engaging with the Biden Administration as they develop a potential Executive Order aimed at increasing protections for sensitive personal information, like genetic data.
  • Participating in the Federal Trade Commission’s (FTC) rulemaking process regarding privacy and data protection, to ensure that genetic data is also protected.
  • Educating health care research institutions and major health care associations about the unique risks posed by a lack of safeguards for genetic testing, and what they can do to increase protections.

 

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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 mourns the death of NCL Awardee, labor champion and writer, Barbara Ehrenreich

September 6, 2022

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

WASHINGTON, D.C. – The National Consumers League is mourning the death of one of our Trumpeter Awardees, best-selling author of Nickel and Dimed, and hourly worker champion Barbara Ehrenreich.  Ehrenreich accepted NCL’s Trumpeter Award in 2008, which was presented because of her writing on behalf of the working poor.  In Nickel and Dimed,  Ehrenreich traveled around the country working minimum wage jobs and writing about how very difficult that was to do; she wrote a compelling narrative about impossibility of making ends meet, even as a single woman, living on jobs like restaurant server and hotel maid. She described in graphic detail the daily grind and many demeaning experiences she encountered.

NCL Executive Director Sally Greenberg speaks to her immense impact on the labor industry, “Barbara Ehrenreich talked the talk, and walked the walk with her long and admirable history of raising awareness about the plight of working Americans.  Nickel and Dimed showed the world just how difficult it is to live on subsistence wages, find housing, health care, buy food, own a car and then have to go to work. She pulled the veil off of the faulty notion that working people can comfortably live off minimum wage jobs. We owe her a debt of gratitude for putting her life on hold to work these jobs and write about the economic reality for working people.”

NCL was honored to have Ehrenreich at our annual Trumpeter Dinner in 2008, present her with the Trumpeter Award, and we mourn her passing this past Labor Day holiday.

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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.

Airline hotel and meal voucher commitments are a positive step forward

September 2, 2022

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

WASHINGTON, D.C. – The National Consumers League (NCL) welcomes the major U.S. airlines’ commitments to provide meals and hotel rooms for travelers stranded due to delays within air carriers’ control. This announcement comes as consumer and passenger rights organizations have advocated for greater protections for travelers within the aviation industry.

The following statement is attributable to NCL Executive Director Sally Greenberg:   

“In July 2021, NCL, alongside a coalition of other consumer and passenger rights groups, met with Transportation Secretary Pete Buttigieg. A key ask to him was to publicly and personally make the DOT’s airline consumer protection work a priority. As today’s announcement shows, he is taking our challenge to heart. Absent pressure from the Department of Transportation, driven by an unprecedented wave of consumer complaints, it is hard to imagine that the biggest U.S. airlines would have made a commitment to provide meal and hotel vouchers and reimbursement to stranded consumers. While there is much more work to be done achieving a range of consumer protection reforms in the airline industry, today’s news is a positive step forward.” 

 

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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 applauds President Biden’s plan to cancel $10,000 in federal student loan debt to millions of Americans

August 24, 2022

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

WASHINGTON, D.C. – The National Consumers League applauds President Biden’s decision to relieve student borrowers of billions of dollars in educational debt and to extend the federal loan repayment moratorium. By cancelling $10,000 in student debt for borrowers earning less than $125,000 and cancelling $20,000 for borrowers who received Pell Grants, this administration is providing direct aid to consumers suffering from the plight of educational debt.

The following statement is attributable to NCL Executive Director Sally Greenberg:

“President Biden is providing critical assistance to millions of borrowers across the country. Importantly, this executive order will work to negate the impact of student debt that disproportionately affects women and Black borrowers. As consumers face increased rents, grocery costs, fuel prices, and even student loan interest rates, educational debt cancellation will help provide relief on strained household budgets by reducing—and in many cases eliminating—student debt costs.”

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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 Director of Health Policy testifies at Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights on how consolidation in the marketplace harms consumers

June 16, 2022

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

Washington, D.C. – On Wednesday, June 15, 2022, the National Consumers League’s Director of Health Policy Jeanette Contreras provided oral testimony to the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights on how consolidation in the marketplace harms consumers.

In her testimony, Ms. Contreras discussed the importance of consumers having choices for safe goods and services at a fair price, a core principle of NCL’s advocacy work. Touching on several issues impacting consumers in the U.S. – such as the infant formula shortage, consolidation of the airline industry, primary ticketing market for live events, and the unfair business practices of pharmacy benefit managers (PBMs) – Ms. Contreras reiterated the need for competition in the marketplace and enacting stronger antitrust laws, all of which help protect U.S. consumers.

Her testimony appears below.

June 15, 2022

Good afternoon Chairwoman Klobuchar, Ranking Member Lee, and members of the Subcommittee. My name is Jeanette Contreras. I am the Director of Health Policy at the National Consumers League. I appreciate the opportunity to testify remotely today- due to COVID.

Founded in 1899, NCL is America’s oldest consumer advocacy organization. A core principle of our advocacy is that the marketplace should encourage competition to guarantee that consumers have choices for safe goods and services at a fair price. Monopolies harm competition, leaving consumers with fewer options at higher prices. Monopolistic practices are especially harmful when they occur in the health care arena, where they can exacerbate health disparities.

We share the concerns of new parents regarding the recent shortage of infant formula. Our hearts go out to those parents who have lost babies or whose infants suffered devastating health consequences from contaminated formula. At NCL, we believe all goods and services sold to consumers should be safe and meet all legal requirements- including regulatory guidelines set forth by the FDA.

NCL applauds the FDA and the Administration for adopting a multifaceted approach to increase the supply of infant formula, including temporarily allowing foreign manufacturers to sell their products in the U.S. Additionally, we believe invoking the Defense Production Act to prioritize getting needed inputs to infant formula manufacturers was sound policy. These measures are helping to solve the immediate logistical problem of getting formula onto store shelves across the country.

While addressing the immediate formula shortage is most urgent, we are also troubled that it took the FDA almost four months to act on a whistleblower complaint sent to the agency. This complaint should have received immediate attention given the gravity of the allegations against the Abbott facility. We support a full investigation and, if warranted, bringing criminal and civil charges against those who falsified data. NCL also recommends that the U.S. create a single food safety agency and dedicate an office to overseeing the safety and supply of infant formula.

It should concern every American that one manufacturer controls 40% of the U.S. infant formula market. Only three companies — Abbott, Mead Johnson, and Nestle — control 98% of the industry.

Consolidation in the infant formula industry is a major contributor to the current crisis, but it is only one of many cases where market concentration in recent decades has limited competition and harmed consumers.

For example, NCL continues to raise concerns about the consolidation of the airline industry. Due to weak enforcement of existing antitrust laws, from 2005 to 2015, the number of major U.S. airlines declined from nine to four. And today they control more than 80 percent of the domestic U.S. market.

Our antitrust laws have also failed to protect consumers who attend live events. After merging with Ticketmaster in 2010, Live Nation Entertainment controls roughly 80% of the primary ticketing market in the U.S. As anyone who has purchased tickets recently can attest, this has led to an increase in add-fees and the basic price of tickets.

Stronger antitrust enforcement would be especially beneficial for curtailing anti-competitive conduct in the health care industry, where we’ve seen consolidation lead to higher costs for consumers without an increase in quality or access to care. We are pleased that the Biden administration is looking into how hospital prices increase after acquisitions. We are also hopeful that the ongoing review of DOJ & FTC merger enforcement guidelines will result in more action by those agencies.

NCL also applauds the recent FTC decision to open an investigation into the unfair business practices of pharmacy benefit managers or PBMs. NCL works tirelessly to raise awareness of the outsized role that PBMs play in driving up prescription drug prices for consumers. According to a recent report, the three biggest PBMs controlled roughly 77% of all U.S. prescription drug claims in 2020. And a recent Senate Finance Committee report found some PBMs are getting a 70% rebate on insulin, while out-of-pocket costs for this life-saving medication continue to rise.

These cases are just a few examples of how monopolies and anti-competitive practices have become a problem for consumers. To ensure crises like today’s formula shortage do not happen again, market consolidation must be addressed so that the temporary shutdown of a single factory does not result in the collapse of an entire supply chain.

Whether it is baby formula, airline travel, live event tickets, or pharmaceutical sales, the lack of competition is having increasingly negative impacts on consumer welfare and requires urgent action.

Chairwoman Klobuchar, Ranking Member Lee, thank you for holding today’s hearing and inviting NCL to speak about this important issue. I look forward to answering your questions.

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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.

 

New York ticketing legislation is a victory for fans

June 9, 2022

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

Washington, DC— The National Consumers League (NCL) applauded the New York State Assembly for approving S.B. S9461, landmark consumer protection legislation that makes New York the first state to require all-in pricing of live event tickets. The bill also requires ticket brokers to disclose how much was originally paid for a ticket when they resell a ticket, prohibits the resale of tickets that were originally offered for free, and prohibits “print-at-home” fees.

“Fans in New York are the real winners from this bill,” said John Breyault, Vice President of Public Policy, Telecommunications, and Fraud at the National Consumers League. “Hidden fees and outrageous markups are some of consumers’ biggest pain points when it comes to buying tickets. While this bill will not solve every problem within the ticketing industry, getting rid of hidden fees addresses one of fans’ biggest complaints.”

A 2018 Government Accountability Office (GAO) report found that on average, consumers paid an extra 27% of the ticket’s original cost in fees. Media reporting has found instances where hidden fees were 78% of the fare’s starting price.

“Ticketing companies have long known that all-in pricing was a better solution for consumers, but they hesitated to provide it for fear of losing market share to competitors who hid their fees,” said Breyault. “That is the definition of market failure, which the New York bill fixes. We urge other states and the U.S. Congress to follow New York’s example and enact similar legislation.”

NCL applauded, in particular, the leadership of New York Senator James Skoufis whose investigative report on the ticketing industry was an important catalyst for this legislation.

“Senator Skoufis championed this important bill in the face of intense industry opposition and made sure it didn’t get watered down,” said Breyault. “Fans in New York will benefit immensely from his leadership.”

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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.

 

2022 Script Your Future Medication Adherence Team Challenge Winners

The eleventh annual Script Your Future contest saw participation by 24 schools in 11 states and directly counseled nearly 7,000 patients nationwide

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

May 13, 2022

Washington, DC —Today, the National Consumers League (NCL) and its partners announced the winners of the eleventh annual Script Your Future Medication Adherence Team Challenge, a competition designed to engage pharmacy students and faculty across the nation by encouraging teams to develop creative initiatives to raise public awareness about the importance of medication adherence, vaccine confidence, and safe drug disposal.

This year’s winners are Wilkes University, Temple University, Western University, Northeast Ohio Medical University (NEOMED), University of Pittsburgh, and Touro University California.

The 2022 Script Your Future Team Challenge is an awareness campaign coordinated by NCL with support from its partners and the Challenge sponsors—Eli Lilly, Deterra, the American Association of Colleges of Pharmacy (AACP), the American Pharmacists Association (APhA), and the National Community Pharmacists Association (NCPA).

The Team Challenge was first established in 2011 to nurture adherence-minded values in future generations of professionals entering the workplace.

In 2022, our Team Challenge student health professionals spread messaging on the importance of medication adherence, vaccine confidence, and a new health topic: safe drug disposal. This year, over 1,000 future healthcare professionals and volunteers from across 11 states participated in the Team Challenge.

2021 Medication Adherence Team Challenge Winners

This year’s winners, selected from dozens of applications and 24 participating educational institutions, are listed below.

National Award Winner: Wilkes University Nesbitt School of Pharmacy – PA

Wilkes University is a fourth-time participant of the Script Your Future Team Challenge, and a first-time winner of the National Award! During the 2022 Team Challenge, students on the Wilkes team successfully collaborated with Highmark Health pharmacists to create a medication adherence questionnaire that was circulated to patients. They also creatively used social media, including TikTok and YouTube, to spread messages about the importance of medication adherence, vaccine confidence, and safe drug disposal. These messages got over 58,000 views. Students were also able to vaccinate patients for COVID-19 (boosters), Shingles, and Influenza. The Wilkes team was able to directly counsel 1,184 patients, and reached 49,313 people through their outreach efforts.

 

National Award Winner: Temple University School of Pharmacy – PA

Temple University is also a first-time winner of the Script Your Future National Award! This year, Temple students of pharmacy collaborated with health and community organizations in Philadelphia, including Temple University Hospital, and its affiliated clinics as well as the places where people live their lives such as local community pharmacies, parks, churches, charitable organizations, and schools. For example, Temple’s team worked with Dispose Rx to spread messages about the importance of safe drug disposal in North Philadelphia. This team also worked with the Children’s Mission to serve people who have no or unstable housing, and counseled them on their medications along with conducting blood pressure checks. Temple students directly counseled 234 patients, and reached over 400 patients through their activities.

 

Health Disparities/Underserved Focus Award Winner: Northeast Ohio Medical University School of Pharmacy – OH

The Northeast Ohio Medical University School of Pharmacy (NEOMED) team is this year’s winner of the Script Your Future Health Disparities Award! NEOMED’s team focused on reaching low-income and homeless individuals, the elderly, and refugees. NEOMED students worked with the Center for Families and Children, IKON Health Foundation, and Rose Centers for Aging Well to reach these underserved populations. Through their efforts, the NEOMED team vaccinated 456 patients, directly counseled 1,323 patients, reached 1,923 patients, and distributed and donated 3,254 resources.

 

Media Outreach Award Winner: Western University School of Health Sciences, College of Pharmacy – CA

This year’s winner of the Media Outreach Award is Western University College of Pharmacy! This team implemented creative uses of traditional and social media to spread messaging related to medication adherence, vaccine confidence, cardiovascular disease, diabetes, interprofessional collaboration, antimicrobial resistance, and safe drug storage & disposal. They created a brand-new podcast series that aimed to provide information on these topics, and made them available on multiple media platforms including Spotify, Apple Podcasts, Google Podcasts, and their website. The podcast series can be found here. Across all of these platforms, Western University’s team was able to get 1,203 views.

 

Creative Interprofessional Team Event Award Winner: University of Pittsburgh School of Pharmacy – PA

University of Pittsburgh’s pharmacy students demonstrated great interprofessional collaborations with other health professional students at their university. Their team included students from the University of Pittsburgh’s School of Dental Medicine, School of Health and Rehabilitation Sciences, School of Medicine, School of Nursing, and School of Social Work. Their multi-disciplinary intervention with different health professional students helped to bring multiple perspectives and skills sets together to bridge gaps in expertise when counseling patients. Their interprofessional team documented over 1,800 unique patient encounters at community pharmacy sites, including patients with disease states like hypertension, diabetes, and dyslipidemia to transplant and neurologic disorders.

 

Technology Innovation Focused Award: Touro University California, College of Pharmacy – CA

Touro University’s pharmacy students implemented creative uses of technology to increase messaging for medication adherence. They created a digital medication adherence wallet card, to help patients keep track of their medications in a more convenient way. Given that technology is so widely used today, this was a great effort by the students. They did mention an important issue, that there are people who do not have internet access, so these digital cards were given in complement with the physical wallet cards.

2022 School

Congratulations to the winners of the 2022 Script Your Future Medication Adherence Team Challenge!

 

A word from NCL and one of our generous Script Your Future sponsors

“The Script Your Future program has been a great way to engage future health professionals and spread messages about the importance of medication adherence, vaccine confidence, and now, safe drug disposal. As we are still combatting the COVID-19 pandemic, it is important to keep patients on top of their health care needs, and participants of this program have been a part of these efforts. This year, we had over 1,000 participants conduct community outreach activities, and NCL continues to be impressed by the impact these students have on their respective communities across the country.”

  • NCL Executive Director, Sally Greenberg

 

Student pharmacists have been important contributors to the outreach to communities, especially throughout the pandemic. Medication adherence, vaccine access, and substance use prevention are critically important priorities and AACP appreciates NCL’s commitment to this recognition program.

  • American Association of Colleges of Pharmacy (AACP) Executive Vice President and CEO, Lucinda L. Maine, PhD, RPh

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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.