NCL urges FTC to use rulemaking to protect consumers’ data rights 

November 22, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

WASHINGTON, D.C. – The National Consumers League (NCL) this week filed comments in support of a Federal Trade Commission (FTC) regulation to protect Americans’ data privacy. In its comments, NCL urged the FTC to ensure that consumers have the rights to data confidentiality, access, deletion, portability, and ethical use. Such safeguards are critical for stemming the torrent of privacy abuses that Americans have suffered in the digital age—perpetrated by both corporate and governmental entities. 

“Given our dependency on the internet to conduct our daily lives, the fact that we have gone this long without federal privacy protections is profoundly disappointing. The FTC is doing critical work in initiating this rulemaking process,” said John Breyault, NCL Vice President of Public Policy, Telecommunications and Fraud. “Consumers should not be at risk of identity theft, financial loss, or other privacy intrusions simply by having an internet connection.” 

The League urged the Commission to give special consideration to sensitive data types, such as location and genetic information, as well as students’ data utilized by educational technology companies. 

“With the proliferation of ed-tech, classrooms have become another area of vulnerability regarding privacy. This follows students when they take their school-issued devices and software home with them,” said Eden Iscil, NCL Public Policy Associate. “Ed-tech is a particularly worrying sector as students typically have no choice but to use the technology mandated by their institution, regardless of its insecurity.”

NCL has made fighting for consumers’ privacy a priority. Earlier this year, the League released a slate of proposed genetic privacy rights for policymakers to implement. Additionally, the organization is in its seventh year of publishing the #DataInsecurity Digest, a semi-weekly newsletter containing policy analysis and news coverage related to digital privacy. 

NCL’s full comments to the FTC can be read 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.

Coalition of consumer organizations urge supermarket industry to address “digital discrimination”

November 17, 2022

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, (703) 298-2614

This week a coalition of national consumer organizations urged leading supermarket chains to offer alternatives to digital-only discounts. Currently, many senior citizens and lower-income shoppers cannot take advantage of digital-only discounts due to smartphone or internet inaccessibility.

In the past couple of years more and more weekly specials advertised by some supermarkets for meat, fish, poultry, produce, and store-brand items are digital-only deals. They typically require shoppers to first go online to electronically “clip” the offers to add them to their loyalty card account to be charged the sale price in the store.

Because 25 percent of seniors don’t use the internet and 39 percent don’t have smartphones, according to a 2021 study by the Pew Research Center, they are effectively shut out of these deals. Similarly, 43 percent of low-income households lack broadband internet access.

The consumer groups suggested multiple ways that supermarkets can offer an offline alternative to digital-only deals to accommodate both the digitally-disconnected and the digitally-challenged shoppers, which include: 

  •  Utilizing barcoded “clip or click” store coupons in store circulars so the customer can choose their preferred redemption method (e.g., Vons and The Giant Company).
  • Empowering cashiers to charge the digital price upon request.
  • Offering physical store coupons next to digital-only deals for those who did not/could not electronically “clip” the offer (e.g., H-E-B).

The letter to supermarket executives was sent on November 15 to the following chains: Kroger, Albertsons, Stop & Shop, Star Market/Shaw’s, Ralphs, QFC, Jewel Osco, Randalls, Fred Meyer, King Soopers, Smart & Final, and Safeway.

Consumer Action, Consumer Reports, Consumer World, National Consumers League, and U.S. PIRG are the consumer organizations pressing supermarkets to expand the way they offer digital-only deals.

The full letter can be viewed 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.

DC Attorney General files consumer protection lawsuit against football team and its owners

November 9, 2022

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

Washington D.C.— District of Columbia Attorney General Karl Racine announced today that he has filed a consumer protection lawsuit against the Washington Commanders, their owner Daniel Snyder, the National Football League (NFL), and NFL Commissioner Roger Goodell for allegedly colluding to deceive DC residents about an NFL investigation into the team’s toxic workplace culture, which includes sexual harassment.

The National Consumers League is pleased that DC Attorney General Karl Racine can use the District of Columbia Consumer Protection Procedures Act (DC CPPA) to address broad ranging issues of public concern with respect to this lawsuit. NCL had a hand in the drafting and passage of this important consumer protection legislation, which was originally introduced by DC Councilmember Mary Cheh and adopted into law in 2012 and further strengthened with later amendments.

“We think that Attorney General Racine’s application of this consumer protection statute underscores the importance of broadly protective statutes that address fraud and deception,” says NCL Executive Director Sally Greenberg.

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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.

Nation’s leading advocacy groups express their concern over partnership between Major League Baseball and CBD maker

November 9, 2022

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

Washington D.C.— The National Consumers League, along with CADCA – a national nonprofit organization committed to creating safe, healthy, and drug-free communities globally – submitted today a joint letter to the commissioners of the Food and Drug Administration (FDA) and Major League Baseball (MLB) expressing concern over the recently announced partnership between MLB and cannabidol (CBD) maker Charlotte’s Web.

“The lack of the product is not well understood by the public and this type of agreement sends … a deceptive message to consumers, implying that CBD is regulated – or at the very least, tested, and proven safe,” according to the letter.

 

To view the letter to FDA, 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.

Consumer groups call for moratorium on smaller airplane seats pending FAA safety review

November 2, 2022

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

Advocates caution that out-of-date emergency evacuation testing standards could put flyers at risk 

Washington D.C.— A coalition of six consumer advocacy organizations yesterday filed comments in response to a Federal Aviation Administration’s (FAA) inquiry regarding minimum passenger seat dimensions. The groups called for the FAA to prohibit airlines from installing smaller seats in commercial jets while the agency reviews and updates its decades-old emergency evacuation testing standards.

“Airlines have a profit incentive to cram more people on their planes,” said Sally Greenberg, Executive Director of the National Consumers League, which organized the letter. “This trend has created a dangerous environment that could impede safe evacuation in the event of an emergency. The FAA has looked the other way for decades as the airlines have increasingly prioritized their bottom lines over passenger safety.”

U.S. law requires air carriers to ensure that they can evacuate their aircraft in 90 seconds or less. In an alarming number of real-world emergencies in recent years, evacuations took between two and five minutes, even though every airline has certified that their planes comply with federal standards. Despite this, the FAA continues to rely on emergency evacuation testing standards that reflect what flying was like in the 1990’s, not the environment that passengers encounter today.

To address the insecurity of current flying conditions, the consumer groups called on the FAA to take immediate action, including:

  • Instituting a moratorium on the further shrinking of passenger seats. Airlines have reduced the sizes of seats to record lows, having shaved off several inches from when the federal government last updated U.S. evacuation standards.
  • Updating federal evacuation standards to reflect the modern cabin environment, accounting for smaller seat sizes, increased baggage around the cabin, and the proliferation of personal electronic devices.
  • If necessary, provisionally requiring that airline seats be no smaller than 32 inches in pitch (commonly referred to as legroom) and 20 inches in width. These dimensions would ensure that seat sizes are not smaller than the typical minimum dimensions that airlines utilized in the early 1990s.

“In addition to hampering evacuation speeds, it’s important to consider how diminished seat sizes impact traveler health, even when there is not an emergency,” said John Breyault, Vice President of Public Policy, Telecommunications, and Fraud at NCL. “Cramped airline seating increases the risk that passengers will experience deep vein thrombosis and pressure sores. Current seat sizes make flying more dangerous and often embarrassing for many passengers, particularly those with disabilities or those who are too large to safely fit into the seats.”

In addition to NCL, the letter was signed by the American Economic Liberties Project, Consumer Action, Consumer Federation of America, Ed Perkins on Travel, and U.S. PIRG.

To read the coalition’s full comments to the FAA, 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.

The National Consumers League applauds Federal Housing Finance Agency’s (FHFA) recent decision to validate updated credit scores

October 31, 2022

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

Washington D.C.— The National Consumers League applauds Federal Housing Finance Agency (FHFA) Director Sandra Thompson’s recent decision to validate updated credit scores for the government-sponsored enterprises (GSEs). By allowing the use of updated innovative, more predictive scores like FICO10T which reduce the impact of unpaid medical debt and include alternative data sources like rental housing payment information, more consumers will be able to get scored and have access to the market.

However, we are disappointed that FHFA will require the use of VantageScore 4.0  Our concern is prompted by the fact that VantageScore, the company that created VantageScore 4.0, is owned by the credit bureaus, who  have proven themselves to be careless with consumer credit data and consumer protection laws over the years.

In fact, over the past few months, congressional leaders like Housing Banking Chair Maxine Waters and House Majority Leader James Clyburn have raised significant concerns about the anti-consumer activities of the credit bureaus. In August, Chair Waters called on the CFPB to put a moratorium on Equifax after it reported faulty credit scores for millions of consumers. On October 14,  Leader Clyburn requested that the CFPB investigate and review the nation’s largest credit bureaus for possible violations of the Fair Credit Reporting Act.

In July of 2021, NCL joined with other consumer groups in sending a letter to the CFPB and the Federal Trade Commission (FTC) asking them to update a 2012 study about the accuracy of financial data at the credit bureaus.

In addition to our concerns about data accuracy and anti-consumer anti-competitive behavior by the credit bureaus and the score that they own, NCL is also concerned about the potential cost burdens for consumers that will result from transitioning to this two-score system. Back in our 2018 comments, we asked FHFA to consider what the impact would be for the FHFA, the GSEs, mortgage companies, banks, and most importantly for taxpayers and consumers.

As FHFA works to implement this decision over the next year, we hope they keep the concerns of consumers first and foremost. The housing economy is struggling and we need to ensure consumers aren’t left paying the cost of this transition in increased fees and hidden payments.  We also need to make sure FHFA listens to the concerns of Congress and the consumer community when it comes to the credit bureaus. There is much work to be done and we stand ready to help in any way that we can.

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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 urges FDA and FTC to investigate potentially false advertising claims made by a recent-FDA approved anti-wrinkle drug

October 26, 2022

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

Washington D.C.— The National Consumers League (NCL) recently submitted a letter to the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) urging the agencies to look into misleading advertising claims made by a recent FDA-approved anti-wrinkle drug called DAXXIFY™ (DaxibotulinumtoxinA-lanm).

Revance Therapeutics, Inc., the manufacturer of DAXXIFY™, is promoting the drug’s ability to reduce the appearance of facial lines and wrinkles in about half of its users for about six months. However, FDA-required labeling verifies that roughly one-third of users experience no or mild facial lines for six months after injection – a 20 percent discrepancy from the company’s claim.

NCL believes this discrepancy is concerning and warrants a closer investigation. Moreover, a study mentioned in the company’s press release appears to make inaccurate claims about its results, according to NCL.

We ask that if our concerns are warranted, the FDA and the FTC should hold Revance Therapeutics to accurate claims and insist that the company correct anything deceptive in their advertising, says NCL Executive Director Sally Greenberg.

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.

Court decision jeopardizes CFPB and threatens critical government programs, says NCL

October 24, 2022

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

Washington D.C.— Last week, the Fifth Circuit Court of Appeals ruled that the Consumer Financial Protection Bureau’s (CFPB) funding structure is unconstitutional due to its non-reliance on annual Congressional appropriations. This ruling sets a dangerous precedent that could cause irreparable harm to consumers by undoing critical regulations against predatory fees and practices among financial servicers. Additionally, the Fifth Circuit’s logic, if extended across the federal government, would upend numerous federal entities that are also self-funded or otherwise receive revenue without regular Congressional appropriation, including Social Security and Medicare. 

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

“For more than 11 years, the CFPB has served as a dedicated champion for consumers in the federal government, preventing abusive, discriminatory, and predatory practices in the finance sector. The Fifth Circuit’s decision against the CFPB’s funding structure not only jeopardizes the CFPB’s invaluable work but also puts other key regulators at structural risk, such as the Federal Reserve System, the Federal Deposit Insurance Corporation (FDIC), and the Office of the Comptroller of the Currency (OCC). The Fifth Circuit’s ahistorical logic threatens other critical government programs as well, such as Social Security and Medicare. I hope upon further appeal, the American judicial system will not choose to side with payday lenders again.” 

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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 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.