Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442
Washington, D.C. – Today, the Supreme Court of the United States decided to deny relief to more than 40 million student borrowers. Despite the Supreme Court’s misguided ruling, the administration has a number of options still available to deliver relief to borrowers. The National Consumers League (NCL) urges President Biden and Education Secretary Cardona to implement debt cancellation without delay.
“A majority of justices have chosen to ignore the facts of the case, from the plaintiffs’ lack of standing to the administration’s plain legal authority to act, in favor of worsening the student debt crisis,” said NCL Public Policy Manager Eden Iscil. “Fortunately, today’s decision only applies to one statute, the HEROES Act. The administration has a responsibility to protect borrowers by utilizing its remaining options under the Higher Education Act.”
Data on student loan payments estimate that the average borrower will owe between $400 and $500 per month. With repayment set to begin in September, millions of student loan borrowers will default on their debts and face significant financial hardship without debt relief. Indeed, President Biden cited this as a primary reason for his cancellation program. These facts have not changed—9 million borrowers will likely be unable to make payments on their student debts should the Department of Education fail to act.
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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit nclnet.org.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-06-30 17:10:252023-07-04 14:38:24NCL urges Ed Secretary to deliver relief to student borrowers using all options available
Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442
Washington, D.C. – The National Consumers League (NCL) and nine other health and consumer organizations recently called on the Alcohol and Tobacco Tax and Trade Bureau (TTB) to increase its oversight over large global soft drink brands entering the alcohol marketplace.
The joint letter, which was submitted as part of the TTB’s public comment period regarding updates to Trade Practice Regulations, expressed concern that without sufficient oversight, the lines between soft drinks and alcohol beverages will continue to blur and lead to more underage drinking.
“Especially since alcoholic soft drinks, which may contain 5 percent alcohol by volume or more, tend to be inexpensive, are packaged in single-serving containers and tap into young people’s connection to brands they have grown up with,” the groups wrote in the letter.
In addition to the risks posed by the packaging and marketing of alcoholic soft-drinks, there are numerous documented instances where traditional soft drink brands and their alcohol-containing versions are being placed side-by-side in store aisles, as well as instances of alcoholic products being marketed next to children’s products.
In response to these instances and the corresponding risk for heightened underage drinking, the groups are calling on the TTB to expressly prohibit soft drink companies from paying slotting fees to procure more prominent shelf space for their alcohol sodas, hard seltzers, and ready to drink cocktails, as well as look into vertical integration by soft drink makers entering the alcohol space.
“The health and safety of the nation’s teens and adolescents require regulatory firewalls that continue to ensure alcohol products are not marketed to underage consumers,” the groups added.
In addition to NCL, signatories to the public comment letter include:
Alcohol Justice
Alliance for Better Children’s Diets
Consumer Reports
Families USA
Global Liver Institute
HealthyWomen
National Alliance for Hispanic Health
National Association of Pediatric Nurse Practitioners
About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit nclnet.org.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-06-29 14:11:122023-06-29 14:12:46National Consumers League, health and consumer organizations call for increased oversight of hard soda
Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442
Washington, D.C. – The National Consumers League (NCL) appeared at a June 28 hearing at the Consumer Product Safety Commission (CPSC) hearing to submit comments on a proposed rule to reduce injury and death associated with acute Carbon Monoxide (CO) poisoning[1].
“NCL strongly supports the CPSC rulemaking to address these preventable deaths and poisonings. Consumers rely on portable generators when the power goes out – they often don’t know that carbon monoxide (CO) emissions can reach dangerous levels, far higher than even from a car,” said Sally Greenberg, CEO of the NCL. “We applaud the CPSC for vastly improving the safety requirements for portable generators.”
Reducing CO emissions means employing CO detectors linked to alarms and shut-off mechanisms. Reliance on existing voluntary standards has proved insufficient and have not reduced the risk of injury.
1332 CO poisoning deaths were reported between 2004 and 2021. The CPSC proposal is particularly urgent because extreme weather conditions are becoming more common with climate change. Portable generator usage will only grow, and time is of the essence to make them far safer and reduce their CO emissions. Generators with safe designs are already available and on the market; the stronger safety standards should be required for all generators.
NCL supports the critical message that portable generators must never be operated inside. However, warning messages on generators need proper placement. They are used during complex emergency settings, in the aftermath of hurricanes, tornados or snowstorms. As NCL’s comments note, related factors, such as electrical cord length, rain and wind, lot size, or theft concerns lead consumers to place the generators too close to the home or even inside the home, which is poses serious risk of CO poisoning.
NCL’s made the following recommendations:
Add audible alarms to visual alarms when CO levels are high and have triggered a shutoff of the portable generator.
Replace wording on the generators to tell consumers to locate them “far away” from homes with existing CDC, FEMA, and CPSC guidance to say that they must be located at least 20 feet from homes.
Provide consumers with steps for safe operation in wet conditions.
NCL also noted in its comments that portable generators featuring lower CO emissions are currently on the market. The rule is not prescriptive, and there are no intellectual property obstacles to wider adoption of the safety technologies.
Matt Gillen, NCL consultant and expert, submitted oral comments to the CPSC on behalf of NCL; [2] NCL also submitted additional written comments.
Mr. Gillen noted that: “Portable generators help consumers when the power goes out. But they cause an average of 74 carbon monoxide fatalities each year. The CPSC’s proposed regulation will eliminate these preventable deaths. And with extreme weather events surging, there is a real urgency in adopting this proposed regulation.”
About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit nclnet.org.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-06-28 10:35:142023-06-28 13:58:33The National Consumers League supports Agency’s proposal to reduce CO hazards of portable generators
Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442
Washington, D.C. – Last week, the National Consumers League (NCL) filed comments urging the Federal Trade Commission (FTC) to strengthen its proposed rule that would provide consumers with greater transparency and control over their subscriptions. NCL weighed in alongside the National Consumer Law Center (NCLC) and other consumer advocacy organizations. While strongly in support of the Commission’s proposed updates, NCL urged the FTC to strengthen its rule even further with the following changes:
Stamp out free trial and subscription traps by requiring sellers to ask for consumers’ consent to automatic charges right before a subscription begins. Too many businesses depend on their customers forgetting to cancel a free trial before they get charged. Consumers should be able to utilize a free trial without committing to paying for the full service.
Keep consumers informed with notification prior to each recurring charge. Just like free trial traps, many individuals forget about an enrolled subscription until the money is taken from their bank account. Businesses should be required to give consumers a heads up before they charge them.
In updating its Negative Option Rule, the FTC is proposing numerous safeguards that would benefit consumers, such as requiring sellers to make subscription cancellation as easy as signing up. Additionally, the Commission’s proposal would require better disclosure of the terms of an automatically renewing subscription and compel businesses to send consumers annual reminders informing them of their ongoing subscription.
“No honest business should depend on their customers forgetting that they’re paying money to turn a profit. Unfortunately, Americans lose billions of dollars each year to unwanted and unnoticed subscriptions,” said NCL Public Policy Manager Eden Iscil. “The problem is even worse for younger individuals, with members of Gen Z and Millennials reporting higher subscription sign-ups compared to older consumers. The FTC’s proposed updates to its Negative Option Rule go a long way toward bringing transparency and control back to the consumer. If the Commission implements our suggested changes, this rule could vastly improve the consumer’s experience with subscription plans.”
The following organizations signed on to the comments:
Consumer Action
Consumer Federation of America
Demand Progress Education Fund
National Association of Consumer Advocates
National Consumer Law Center (on behalf of its low income clients)
National Consumers League
To read NCL’s full comments to the Commission, 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 nclnet.org.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-06-26 15:13:102023-06-27 18:37:15NCL urges FTC to strengthen consumer protections for subscriptions
Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442
Washington, D.C. – The National Consumers League (NCL), America’s pioneering consumer advocacy organization, today endorsed the Transparency in Charges for Key Events Ticketing Act (TICKET Act) introduced by Senator Maria Cantwell (D-WA) and Senator Ted Cruz (R-TX).
The TICKET Act would require primary and secondary ticket sellers to clearly and conspicuously disclose the all-in price for tickets, including fees, in all advertising, marketing, and price lists at the beginning of a transaction and prior to a buyer selecting the ticket for purchase. The bill would also require ticket resellers to disclose if they are listing a ticket for sale that they do not currently possess, an often-controversial practice known as speculative selling.
The following statement is attributable to NCL Vice President of Public Policy John Breyault:
“Hidden fees and speculative selling too often make buying tickets to see concerts, sporting events, and Broadway shows a frustrating experience for fans. The bipartisan TICKET Act is a long overdue solution to help fix some of the worst aspects of a ticket-buying process that is rigged against fans. We applaud the leadership of Senator Cruz and Senator Cantwell for championing this important consumer protection legislation.”
For more than a decade, the National Consumers League has worked in Washington and in the states to pass pro-fan ticketing legislation that bring much-needed reform to the ticketing industry. In the wake of last fall’s disastrous Taylor Swift ticket sale, leaders in Congress are taking notice and pushing for reforms. In addition to the TICKET Act, NCL has endorsed the BOSS And SWIFT Act in the House of Representatives and the Junk Fee Prevention Act in the Senate.
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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit nclnet.org.
I have written before about being born into a family that experienced the agony of the polio epidemic. My uncle Roger Joseph’s battle with the disease—including his diagnosis in 1951 by my father, a practicing internist—devastated our entire family. My uncle, a golden boy, popular, handsome, brilliant, and kind, graduated from the University of Minnesota and Harvard Law School; he also won a silver star for his military service in WW2. Married with three daughters, he had a thriving law practice when he fell ill.
His case was severe and rendered him paralyzed. Confined to an Iron Lung for two years, the device was designed to stimulate breathing in patients whose lungs no longer functioned. With a great deal of therapy, my Uncle Roger, by then quadriplegic, moved to a motorized wheelchair that he ended up using for the rest of his life. He doted on his children, moved in with my grandmother, slept in a rocking bed to facilitate his breathing, and had an attendant on duty 24 hours a day. When we visited my grandmother, we visited our uncle too. He also came to our home for Sunday dinners, and I recall him taking breaths carefully before speaking, and when he did, he was wry and funny. He also had to learn to write again with his non-dominant hand. My mother, who had always idolized him, marveled at how his handwriting never changed.
My uncle lived 16 years with polio, thanks to a loving family, modern medicine, financial wherewithal, his wheelchair, and his attendant. Paralyzed from the neck down, he nonetheless spent these years productively, doting on his daughters, going to work every day, and attending baseball games, and even traveling abroad.
In 1954, U.S. physician Jonas Salk developed a vaccine to prevent the disease. The polio vaccine was first tested on 1.6 million children in Canada, Finland, and the United States before it was used more broadly. By 1957, annual cases had dropped from 58,000 to 5,600, and by 1961, only 161 cases remained. Had my uncle had access to the vaccine, he never would have gotten sick.
The powerful lessons about vaccines weren’t lost on anyone in my family. This explains why I feel obligated to confront head-on the dishonesty and lies of the anti-vaxxers. I have traveled to the CDC and the FDA numerous times to testify in support of childhood and adult vaccinations, and each time have been confronted by vaccine deniers.
Here’s the problem: Those of us with memories of family members with devastating diseases like polio are aging out. We are victims of our own success in wiping out childhood diseases. Younger generations have now been vaccinated for polio, measles, rubella, mumps, influenza, diphtheria, tetanus, and whooping cough so they do not know the trauma these illnesses caused to millions of families. Come to think of it, I’m in that category myself.
Florence Kelley, who in 1899 launched the National Consumers League, wrote in the 1880s about the dark days of “diphtheria”; she lost three young siblings to the disease, which sent her mother into lifelong depression. But I have never known anyone with diphtheria, thanks to vaccines.
My 27-year-old son never had measles—nor any of his friends. But my siblings and I all did, along with rubella, chicken pox, and the mumps. Measles alone is far more serious than often understood. In 2021 alone it killed nearly 128,000 unvaccinated children under age 5 around the world.
All of which leads me to the reason I have written this blog. Each year, Uncle Roger’s daughters proudly award the Roger E. Joseph Prize, (created by my Uncle Burton Joseph, in honor of his brother and their dad) and for this year’s prize, my cousin Linda produced a video; it tells a compelling story of her experience with her father’s illness. Hebrew Union College, which graduates reform rabbis, hosts the awards. Honorees have included Rosa Parks, Henry Louis Gates, Morris Dees, Sara Bloomfield, and the Center for Reproductive Rights. A complete list is at the link below.
Indeed, the Roger E. Joseph Prize is a point of immense pride for our family, but it also gives us the opportunity to talk about diseases like polio and, now Covid, and the critical importance of the vaccines developed to prevent them.
How truly fortunate we are to have a medical establishment that has helped to prevent families from suffering, the way ours did, when a loved one falls ill from an infectious disease.
As the anti-vaccine movement grows each year—a = movement that traffics in conspiracy theories and junk medicine—note Robert Kennedy Jr.’s anti-vaccine crusade, which his own family has denounced in this article published by Politico.
Now more than ever we need to have conversations about the critical importance of vaccines.
https://nclnet.org/wp-content/uploads/2020/08/Sally2017_92px.jpg968968Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-06-21 14:02:532023-06-21 14:10:26We must never forget the importance of vaccines
Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442
Washington, D.C. – The National Consumers League (NCL) today applauded the Biden Administration for securing commitments from several live event industry stakeholders to adopt more transparent ticket pricing. The consumer organization urged the White House and pro-fan leaders in Congress to pass legislations ensuring that consumers receive the benefits of all-in prices regardless of what event they wish to attend.
“We are grateful to President Joe Biden for his leadership in bringing to the table the main players in the ticketing industry,” said NCL CEO Sally Greenberg. “Consumers are fed up with deceptive junk fees are glad to have an ally in the White House.”
Since 2009, NCL has worked with independent venues, ticketing companies, ticket brokers, promoters, venue owners, artists, advocates, and state and federal legislators and regulators to reform a live event industry that is rigged against consumers. NCL’s advocacy has led to pro-fan legislation being adopted in several states and well as the federal BOTS Act, which outlawed the use of ticket-buying “bot” software.
“Anyone who wants to attend concerts, sporting events, and Broadway shows knows the frustration that comes with seeing tickets advertised for one price, only to see that cost skyrocket once hidden fees are added at the end of the buying process,” said John Breyault, Vice President of Public Policy, Telecommunications, and Fraud for the National Consumers League.
“The commitments made today by some of the biggest names in the live event industry are a positive step forward. However, enforceable laws to rein in junk fees in the live event marketplace are still needed. There are bills in Congress today that would create a consistent all-in pricing experience for fans regardless of who they buy tickets from. We urge the Administration to work with legislators to move these pro-consumer bills 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 nclnet.org.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Katie Brownhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngKatie Brown2023-06-15 13:47:262023-06-16 14:07:32National Consumers League statement on White House all-in pricing announcement
Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831
Washington, DC – In preparation for a June 8 hearing, NCL submitted a letter to the DC Council urging that the council reject Bill 25-0280, the “Workers and Restaurants are Priorities Act of 2023.” NCL believes this bill is both anti-consumer and anti-worker and it sets a dangerous precedent for carving out an exemption to our DC Consumer Protection Procedures Act (CPPA) for the sole protection of restaurants.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Melody Merinhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngMelody Merin2023-06-09 15:48:222023-06-09 15:48:22NCL urges DC Council to reject anti-consumer and anti-worker bill
Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831
Washington, D.C. – The National Consumers League (NCL) today applauded President Biden for vetoing Congress’s attempt to roll back critical programs and protections for student loan borrowers. If the bill had become law, President Biden’s one-time debt cancellation would have been nullified, denying over 25 million borrowers critical relief. Additionally, the ongoing payment pause would have been abruptly ended and beneficiaries would have received surprise bills for the past few months of loan interest—interest that has been waived by bipartisan administrations. Lastly, borrowers who saw their loans discharged under longstanding debt cancellation programs, such as Public Service Loan Forgiveness, would have had their debts reinstated.
The following statement is attributable to NCL Public Policy Manager Eden Iscil:
“With today’s veto, President Biden averted disaster for student borrowers nationwide. While the president’s action was important to prevent harm, we must do more to protect individuals with student debt before repayment begins later this summer. Millions of borrowers are currently in limbo as the Supreme Court decides whether they will side with the people and allow debt cancellation to go into effect, or if they will protect loan servicers’ interests and block relief. Repayment should not happen until we address the educational debt crisis.”
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00sepidehkhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngsepidehk2023-06-08 21:23:072023-06-09 13:55:43NCL applauds President Biden for protecting student borrowers and vetoing attempt to end critical programs
Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831
WASHINGTON, DC – National Consumers League (NCL) CEO Sally Greenberg today urged Congress to do more to rein in predatory junk fees that plague millions of consumers and honest businesses. In testimony before the Senate Commerce Committee’s Consumer Protection Subcommittee on the need for federal action to rein in predatory junk fees, Greenberg urged Senators to support multiple pieces of consumer protection legislation, including President Biden’s Junk Fee Prevention Act.
“American companies are addicted to junk fees,” said NCL CEO Greenberg. “These fees cause significant economic harm, especially to historically marginalized and economically vulnerable communities. Junk fees harm honest businesses, too, as consumers’ patronage is unfairly directed away from companies with the best price, quality, convenience, and honest practices to those with pricing that is higher, less transparent, and more deceptive.”
Greenberg urged Congress to support bills like the Junk Fee Prevention Act, which would rein in some of the worst offenders when it comes to junk fees; the Consumer Protection Remedies Act, which would fully restore the Federal Trade Commission’s ability to obtain monetary and other relief for consumers; and Forced Arbitration Injustice Repeal Act (FAIR Act), which would prohibit a pre-dispute arbitration agreement from being valid or enforceable if it requires arbitration of an employment, consumer, antitrust, or civil rights dispute.
“The Biden Administration and agencies like the Consumer Financial Protection Bureau, Department of Transportation, and Federal Trade Commission have taken steps to address the scourge of junk fees,” said Greenberg. “Congress can and should do more to support these initiatives.”
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00sepidehkhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngsepidehk2023-06-08 14:17:072023-06-08 21:17:31NCL CEO urges Congress to end companies’ addiction to junk fees
PBPA Commends HHS Funding to Support Maternal and Infant Health
The Preterm Birth Prevention Alliance (PBPA), a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, applauds the U.S. Department of Health and Human Services (HHS) for awarding nearly $350 million to states across the country to improve support for safe pregnancies and healthy babies.
“For far too long, U.S. maternal health care has lagged behind that of other developed countries, particularly for women of color,” noted Sally Greenberg, Executive Director of the National Consumers League. “This additional funding will enable local health departments and nonprofits to better address the health care needs of the most vulnerable mothers and their babies.”
The funding, awarded by HHS’ Health Resources and Services Administration (HRSA), will support home visiting services, increase access to doulas, address infant mortality and maternal illness, and improve data reporting on maternal mortality.
“Maternal health care in the U.S. has consistently failed women of color,” Greenberg continued. “We applaud HHS for this additional funding that will help to improve the maternal health for all mothers and babies, especially women of color and those most at-risk.”
The funding announcement follows the release of a report by the U.S. Commission on Civil Rights which found that Native American women are more than two times more likely to die from pregnancy-related complications than white women in the U.S. This disparity was further exacerbated for Black women in the U.S., who are three to four times more likely to die from pregnancy-related complications than white women.
“In addition to expanding programs to support maternal health, we must increase representation from racially and ethnically diverse groups in research and clinical trials, particularly those studying treatment options to prevent maternal morbidity and mortality,” said Greenberg. “The need for the additional HHS funding and the report from the Commission on Civil Rights clearly illustrate how critical representative research and real world evidence are to ensuring all mothers and their babies have the same opportunity for the best possible health outcomes.”
While the COVID-19 pandemic has led to hardship for all Americans, it is clear that people of color have been disproportionately burdened. Across the health care continuum, addressing this disparity has become part of the broader conversation about the history of systemic racism and the underlying social determinants of health that negatively affect the mental, physical, and economic health of individuals and entire communities.
The pandemic has underscored persistent health disparities, and there is growing recognition that representation in research and clinical trials can have a profound impact on health outcomes. A lack of representation from racially and ethnically diverse groups in research and clinical trials have typically led to gaps in data, missing the opportunity to assess the full impact of various treatments and drugs across a range of populations. The collection and use of real-world research and data to inform the potential use, risks, and benefits of medical products and treatments can ultimately lead to better health outcomes, particularly for those who have been underrepresented in the past.
Existing efforts to improve inclusion
Efforts to expand diversity and representation in medical research are underway in Congress. Policymakers are encouraging the incorporation of Real World Evidence (RWE) in drug development through the recent Cures 2.0 draft legislation released by Reps. Diana Degette (D-CO-1) and Fred Upton (D-MI-6). While the status quo limits us from effectively reaching underserved populations, the proposed legislation would allow studies that include RWE for some drugs after they have been approved. At the heart of this issue is a growing appreciation that the same therapy can affect different populations in different ways, which is why Cures 2.0 supports collecting data that more accurately reflects the unique experiences and needs of patients across diverse populations.
Recognizing the potential for RWE in maternal health
The lack of representative research in the field of maternal health is undeniable, and its implications are staggering. The dismal state of maternal care in the United States reflects how our health care system has failed women of color, including by not adequately studying treatment options to prevent maternal morbidity and mortality. The need for RWE is clear when you consider the persistent disparities in health outcomes that plague minority communities.
Preterm birth and its disproportionate impact on women of color is a stark illustration of the need to make progress on representative research in maternal health. Preterm birth is the second-largest contributor to infant death in America today. Despite the tremendous physical, emotional, and financial toll that preterm birth continues to take on our country — disproportionately so on women and families of color — not enough therapeutic tools currently exist to prevent it.
Today, “17P,” the only FDA-approved treatment to help reduce the likelihood of spontaneous, recurrent preterm birth in the United States is at-risk of being withdrawn from the market in all its forms, including the branded product and five generic versions. Unfortunately there is conflicting evidence from two different clinical trials, one representative of a diverse U.S. population and another studied in a largely white population in Europe. It’s not a straightforward comparison. If 17P is withdrawn, the women most affected by preterm birth, predominantly women of color, would be left without an FDA-approved treatment option.
The FDA is considering the path forward, including additional data collection through leveraging RWE from past patient use. The success of the first (approval) trial for 17P in the impacted communities signals the importance of RWE. Continued access to 17P is, at its core, a matter of health equity. Black women must not yet again be left vulnerable to a system that historically has overlooked them.
PRETERM BIRTH PREVENTION ALLIANCE APPLAUDS FDA’S GRANTING OF HEARING FOR THE ONLY FDA-APPROVED THERAPIES TO REDUCE RECURRENT PRETERM BIRTH
WASHINGTON, DC, August 26, 2021 –
Preterm Birth Prevention Alliance a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, commends the U.S. Food and Drug Administration (FDA) for granting a public hearing to discuss 17P, the only FDA-approved class of branded and generic treatments to reduce preterm birth in indicated patients.
We appreciate the FDA’s willingness to hear directly from individuals facing prematurity and the providers who treat them about their experiences with 17P,” said National Consumer League’s Executive Director Sally Greenberg. “It is an important step towards better understanding variations in efficacy across diverse populations and ensuring all women have an equal chance at the best possible outcomes.”
Last week, the FDA agreed to grant Covis Pharma, the manufacturer of the branded 17P product Makena its request for a public hearing to discuss 17P. Hydroxyprogesterone caproate—or “17P”—has been approved since 2011 and is the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth in the United States. In 2020, the FDA proposed withdrawing 17P in all its forms, including the branded product and its five generic versions, based on conflicting efficacy data from two studies composed of vastly different populations, one predominantly inclusive of women in the U.S. most vulnerable to preterm birth and one not.
“Mothers and birthing people deserve access to the best possible treatments to prevent preterm birth. We cannot achieve birth equity if we study pregnant women as a monolith,” said Blythe Thomas, Initiative Director of 1,000 Days. “It is only by systematically researching the real-world, post-market impact of 17P on individuals from a variety of racial and ethnic backgrounds, while maintaining access for all affected, that we can reduce disparities in maternal and infant health.”
While the hearing date has not yet been set, the Alliance looks forward to sharing the perspectives of affected individuals and their physicians with the agency once the hearing is scheduled and will continue to advocate for at-risk moms and babies of all races and ethnicities.
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ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE
The Preterm Birth Prevention Alliance (PBPA) is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, the 15 partners in the PBPA seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org
LEADING PATIENT ADVOCATES LAUNCH PRETERM BIRTH PREVENTION ALLIANCE TO PROTECT CRITICAL ACCESS TO THE SOLE FDA-APPROVED CLASS OF THERAPIES TO REDUCE RECURRENT PRETERM BIRTH
WASHINGTON, DC, April 20, 2021 – Today, the National Consumers League (NCL), along with a coalition of patient advocacy organizations dedicated to advancing the health of mothers and infants, announced the launch of the >Preterm Birth Prevention Alliance.
Members of the Alliance are joining forces in an effort to preserve patient access to the only Food & Drug Administration-approved class of treatments for pregnant women who have previously had an unexpected, or spontaneous, preterm birth. Together, Alliance members seek to ensure that the Food & Drug Administration (FDA) hears concerns from the full range of stakeholders about the potential risks and impact of withdrawal for at-risk pregnant women and their providers.
For the fifth year in a row, the U.S. preterm birth rate has increased (to 10.2 percent of births), and preterm birth and its complications were the second largest contributor to infant death across the country. Preterm birth also represents a significant racial health disparity, with Black women in America experiencing premature delivery at a rate 50 percent higher than other racial groups throughout the country.
However, in 2020, the FDA >proposed withdrawing hydroxyprogesterone caproate, commonly called “17P” or “17-OHPC”, the only FDA-approved class of branded and generic treatments to help prevent the risk of preterm birth in women with a history of spontaneous preterm birth. The FDA is currently determining whether to hold a hearing on the status of 17P, based on conflicting efficacy data from two studies composed of vastly different patient populations, one inclusive of women in the U.S. most vulnerable to preterm birth and one not.
“We’re fighting for a more inclusive healthcare system that gives everyone an equal chance to have the best outcomes possible,” said Sally Greenberg, executive director of the National Consumers League. “We don’t believe that removing 17P from the market without gaining a better understanding of who could benefit the most from its use is in the best interests of patients, nor their healthcare providers, particularly as there are no other approved treatment options available.”
To date, 14 organizations have joined NCL to advocate for the health interests of at-risk pregnant women and infants, including: 1,000 Days; 2020 Mom; American Association of Birth Centers; Black Mamas Matter Alliance; Black Women’s Health Imperative; Expecting Health; Healthy Mothers, Healthy Babies Montana; HealthyWomen; Miracle Babies; National Birth Equity Collaborative; National Black Midwives Alliance; National Partnership for Women & Families; Sidelines High-Risk National Support Network; and SisterReach.
“As a trained obstetrician and gynecologist, I know firsthand the impact of preterm birth on Black women and birthing people. I also know that racism – not race – is the driving factor leading the disproportionate impact of preterm birth on Black women and birthing people thereby exacerbating systemic inequities in maternal and infant health. To achieve birth equity, which is the assurance of the conditions of optimal births for all people with a willingness to address racial and social inequities in a sustained effort, we must work to protect and uphold a standard of care for spontaneous, recurrent preterm births and ensure it remains accessible and affordable for all who stand in need,” added Dr. Joia Crear Perry, founder and president of the National Birth Equity Collaborative.
The Preterm Birth Prevention Alliance is calling for the FDA to grant a public hearing to fully consider all of the data, additional research methods, and stakeholder perspectives before deciding whether to withdraw approval of this critical class of therapies. The health of America’s moms and babies warrants the utmost care and consideration.
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ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE
The Preterm Birth Prevention Alliance is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, we seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org.
Initial support for the Preterm Birth Prevention Alliance is provided by Covis Pharma.