Stop senior scams!
Happy Consumer Protection Week! While fraud can affect anyone, regardless of age and other demographic information, Fraud.org and NCL are putting the spotlight on scams targeting older Americans.
Happy Consumer Protection Week! While fraud can affect anyone, regardless of age and other demographic information, Fraud.org and NCL are putting the spotlight on scams targeting older Americans.
February 1, 2023
Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442
WASHINGTON, D.C. – The National Consumers League (NCL) today applauded the White House Competition Council’s announcement of a new slate of executive actions to protect consumers and rein in corporate power. NCL has long championed many of the solutions that the White House today supported, including prohibiting family seating fees on airlines, mandating all-in pricing and greater transparency in the live event marketplace, and getting rid of deceptive hotel resort fees.
The following statement is attributable to Sally Greenberg, Executive Director of the National Consumers League:
“More than 60 years ago, President Kennedy launched the modern consumer movement with a call to hold corporations accountable when they put profits over the public interest. We are thrilled today to see the Biden White House following in those footsteps. This Administration is taking the gloves off and putting corporate wrongdoers on notice that anti-consumer behavior will not go unchallenged. From airlines to banks to ticketing companies, businesses are leveraging their market dominance to squeeze every penny they can from hard-working families. We are thankful to have allies in the White House who are channeling consumers’ frustration into action.”
NCL has been pushing for reforms in the live-event ticketing industry for over a decade, including changes to the ticket purchasing process (some of which were adopted by the Competition Council) and the breakup of the Live Nation-Ticketmaster merger. In 2019, the League testified to Congress about the need for federal action to ensure that children are seated with their parents and caregivers without cost, something the Department of Transportation announced it would begin working towards today. Lastly, the Competition’s push to ban hotel resort fees and mandate all-in pricing echoes NCL’s previous calls on the matter.
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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.
January 25, 2023
Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442
WASHINGTON DC. – Yesterday, the National Consumers League (NCL) and a coalition of six consumer and passenger rights organizations filed comments with the Department of Transportation (DOT) in support of proposed regulations requiring the earlier disclosure of common airline ticket add-on fees. DOT’s proposed rules would require airlines and ticket agents to display fees associated with checked baggage, ticket changes and cancellations, and family seating on the first page of airfare search results.
“It is extremely difficult and time-consuming for consumers to do accurate apple-to-apples comparisons when shopping for airline tickets,” said John Breyault, NCL Vice President of Public Policy, Telecommunications, and Fraud. “DOT’s proposed rules would promote competition by making it harder for airlines and ticket agents to hide some of the most egregious add-on fees in the fine print at the end of the ticket-buying process.”
“The airlines love to nickel-and-dime passengers with junk fees, and in far too many cases travelers are hit with sticker shock when they finally realize the true cost of flying,” said William J. McGee, Senior Fellow for Aviation & Travel at American Economic Liberties Project. “We urge the DOT to address transparency of fees, and to eliminate certain fees altogether. This applies especially to fees for families with young kids to sit together, an issue Congress directed the DOT to address in 2016.”
“If airlines are going to continue to devise and impose all sorts of unreasonable fees, they must be required to reveal each fee when travelers first search for price and availability,” said Ruth Susswein, Consumer Action’s Director of Consumer Protection.
“Airlines have come up with all sorts of extra fees over the years: baggage fees, change fees, seat selection fees and more. We believe airlines should be required to disclose these fees before someone begins the actual booking process, not at the end. And these fees should be disclosed up front in real time to ticket agents that provide fare information. This would encourage price competition and ultimately give consumers more transparency in pricing,” said Teresa Murray, Consumer Watchdog for Public Interest Research Group.
To view the coalition’s full comments to DOT, 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.
January 24, 2023
Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442
WASHINGTON DC. – The National Consumers League (NCL) today applauded the Senate Judiciary Committee for holding a landmark hearing examining how Ticketmaster-Live Nation’s monopoly harms fans and competition in the live event industry.
“Just as we warned in 2009 when the Ticketmaster-Live Nation merger was proposed, the company has become a behemoth that controls many aspects of the live event industry and wields its market power ruthlessly,” said NCL Executive Director Sally Greenberg. “Ticketmaster sells tickets for 80 out of the top 100 arenas. Their presence in nearly every aspect of the industry—from event promotion to venue operations—makes it almost impossible for small, independent competitors to succeed. This is a monopoly.”
Consumers often have no choice but to deal with Ticketmaster when seeing their favorite artist or sports team. This makes some of the corporation’s business practices inescapable, such as adding 78% to the ticket price in hidden fees.
“Today’s hearing showed that there is a strong support for free markets—regardless of party,” said NCL Vice President of Public Policy, Telecommunications, and Fraud John Breyault. “Senators from both sides of the aisle centered the experiences of fans, artists, independent promoters and venue owners, recognizing the harms caused by Live Nation’s market consolidation. Witnesses repeatedly described a pervasive fear of retaliation if they and other live event industry stakeholders speak up about Live Nation’s monopolistic practices. It is our hope that their testimony gives more actors in the live event industry confidence that Ticketmaster-Live Nation is not above the law.”
Since 2009, NCL has opposed the Ticketmaster-Live Nation merger. Most recently, NCL has been working as part of the Break Up Ticketmaster coalition to urge the Department of Justice to enforce existing federal antitrust laws and take action against Ticketmaster to increase competition in the marketplace.
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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.
January 10, 2023
Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442
WASHINGTON DC. – The National Consumers League (NCL) this week filed comments in support of a Federal Trade Commission (FTC) regulation to ensure the reliability of user reviews. In its comments, NCL urged the FTC to prohibit user reviews from individuals who did not purchase a product or service (or are misrepresenting their experiences with a product or service) and to prohibit sellers from manipulating consumer reviews. In addition, the League advocated for the Commission to require hosts of user reviews to implement measures to protect review integrity, such as requiring purchase verification.
“Consumers frequently cite user reviews as a key factor when deciding what to buy,” said John Breyault, NCL Vice President of Public Policy, Telecommunications and Fraud. “As a result, fake endorsements steer billions of dollars each year towards certain products and away from competitors. The impacts range from buyers receiving goods of poorer quality than expected to serious safety risks.”
NCL also encouraged the FTC to prohibit the commercial exploitation of social media engagement metrics, such as buying and selling likes, comments, or shares. Such practices can be used to boost fraudulent product reviews and endorsements, allowing bad actors to manipulate social media platforms to broaden their reach.
“Right now, it is extremely easy to spend a few dollars and receive hundreds of likes, followers, or other signals that a product or service is of high quality,” said Eden Iscil, NCL Public Policy Manager. “By jumpstarting a post with purchased engagement, the content has a greater chance of reaching a real audience—and being believed by them. Such practices not only affect consumers making purchasing decisions but can also be used to spread other types of misinformation.”
The FTC initiated this regulatory process following NCL’s request for greater federal enforcement against organized user review fraud, which can be found here.
NCL’s full comments to the FTC can be found 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.
December 27, 2022
Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442
WASHINGTON DC. – The poor performance of domestic airlines, namely Southwest Airlines, over the holiday season is yet another call to action for reform to the air travel industry. The National Consumers League (NCL) strongly urges Southwest Airlines to take all actions necessary to make both consumers and its employees whole, as well as to prevent similar incidents from reoccurring in the future. Additionally, the federal government should not delay in implementing the number of pending regulations that would strengthen consumer protections in air travel, including a proposed rule that would require refunds for stranded travelers.
Air carriers should function to alleviate consumer and employee issues, not exacerbate them. Reports of passengers unable to contact Southwest Airlines representatives to rebook cancelled flights or find lost baggage are distressing and emblematic of longstanding issues within the industry. Moreover, complaints from airline employees of outdated operations systems further disrupting service also highlight the lack of action taken to mitigate the issues faced by both consumers and workers over the holidays.
NCL urges Southwest Airlines to issue refunds to affected consumers without delay. Additionally, Southwest Airlines should invest significantly in improving customer service capacity and updating operations technology.
The travel meltdowns that are occurring this holiday season are another reminder that we must reform the governmental policies surrounding air travel. NCL is pleased that the U.S. Department of Transportation (DOT) is looking into Southwest Airlines’ performance, especially as it is the sole governmental agency with oversight of air carriers.
The DOT should act quickly to promulgate regulations that require refunds to consumers in the event of a significant delay or cancellation, alongside other pending rules. Additionally, the DOT should implement recommendations from consumer advocates and state attorneys general, including a proposal to require airlines to provide travelers accommodations for meals and overnight lodging when necessary.
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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.
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.
February 3, 2022
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242
Washington, DC –The National Consumers League (NCL), America’s pioneering consumer advocacy organization, welcomed the enforcement action undertaken by the Federal Trade Commission (FTC) and the Department of Justice (DOJ) to end the deceptive marketing of contact lenses by Vision Path, Inc.
Vision Path, a direct-to-consumer seller of Hubble contact lenses, will pay penalties and redress totaling $3.5 million to settle charges that it violated the FTC’s Contact Lens Rule and put consumers at risk by failing to obtain proper prescriptions, and neglecting to properly verify prescription information, and by substituting Hubble lenses for those actually prescribed to consumers.
“This action against Vision Path should serve as a warning to any company that disregards laws intended to protect consumers. NCL has been at the forefront of efforts to get Congress and federal regulators to crack down on companies that deceptively market to consumers and illegally substitute their contact lenses in place of those originally prescribed by a patient’s eye doctor,” said NCL Executive Director Sally Greenberg.
The FTC’s complaint alleges that Vision Path engaged in other deceptive practices, such as failing to disclose that “independent” consumer reviews were actually solicited by the company. The FTC also alleges that Vision Path engaged in a deceptive negative-option billing model that encouraged consumers to sign up for 15 pairs of daily-wear contact lenses and then automatically enrolled them in a subscription plan. NCL has long supported legislation, such as the District of Columbia’s landmark Structured Settlements and Automatic Renewal Protections Act of 2018, that would require a consumer’s explicit affirmative consent before such automatically-renewing contracts could kick in.
“Consumers are best served when they work with their health care providers to ensure the most appropriate and safest use of FDA-regulated medical devices, like contact lenses,” said Greenberg. “We are grateful to the DOJ and the Consumer Protection Bureau at the FTC, which led this effort, for their rigorous enforcement of consumer protection laws. While this is an important development, violations of the Contact Lens Rule continue. We will continue to press Congress and federal agencies to ensure that the CLR is being implemented and enforced as Congress intended.”
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About the National Consumers League
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.
By Eden Iscil, Public Policy Associate
This week, NCL partnered with H&R Block to provide a free webinar on recent changes and other items to be aware of as we enter tax filing season. The event included a short presentation by Manuel Dominguez (Tax Agency Analyst at H&R Block) outlining the biggest changes tax filers should know, followed by a Q&A session with the panel of tax experts. Moderater NCL’s Vice President of Public Policy, Telecommunications, and Fraud, John Breyault, was joined by panelists Joanna Ain (Associate Director at Prosperity Now), Dominguez, and Garrett Watson (Senior Policy Analyst at the Tax Foundation). If you missed it, you can watch the event on NCL’s YouTube channel here.
One of the biggest takeaways from the discussion is this: your tax return could look very different from what you may expect due to changes stemming from the 2021 American Rescue Plan (President Biden’s COVID relief bill). For example, parents who received advance Child Tax Credit (CTC) payments throughout 2021, could see a smaller refund than previous years since part of that credit was given in monthly payments throughout the year. Additionally, consumers who were eligible but did not receive an Economic Impact Payment (a.k.a stimulus checks) could see larger-than-expected refunds.
Other credits that have seen changes include the Child and Dependent Care Credit, with allowable expenses increased to $8,000 for one dependent and $16,000 for two or more dependents. In addition, the Earned Income Tax Credit (EITC) saw an increase in the credit amount and income thresholds for taxpayers with no qualifying children as well as a “loopback election” which allows filers to use either 2019 or 2021 income for the purposes of claiming the EITC (in order to get the highest credit value).
Another change that could affect filings involves charitable contributions. Normally, filers who choose the standard deduction cannot claim a deduction for charitable contributions. But this year, single filers can claim a deduction of up to $300 for cash contributions to qualifying charitable entities ($600 for joint filers).
Given the new assistance provided by the federal government, the IRS will be sending new tax documents that filers need to have available when filing. Letter 6419 relates to any advance CTC payments received in 2021. Letter 6475 relates to the third Economic Impact Payment (stimulus check) which went out under President Biden. These documents are important to keep as they will ensure the information you input when filing taxes matches IRS data; if there are discrepancies, your tax return may be delayed.
For consumers who do not receive a Letter 6419 regarding advance CTC payments, the CTC Update Portal can help. Filers who do not receive a Letter 6475 regarding the third stimulus check should check their eligibility for the Economic Impact Payment and its correlated tax credit here.
Confused? You’re not alone!
Fortunately, there are government-sponsored tax preparation services available for free. The Volunteer Income Tax Assistance (VITA) program offers help to people who make less than $57,000, filers with disabilities, and individuals with limited English language knowledge. Additionally, the Tax Counseling for the Elderly (TCE) program is aimed at people 60 and older, with specialization in pensions and other retirement-related issues.
Lastly, taking the following steps can ensure that you receive your tax return as quickly as possible. First, filing your taxes online is much quicker than filing your taxes by physical mail. Because of backlogs in processing returns from 2021, returns mailed to the IRS will almost certainly result in slower-than-normal refunds being issued. Filing as early in tax season as possible is a great way to reduce the risk of tax identity fraud. Second, keeping those CTC and stimulus check letters (Letter 6419 and Letter 6475, respectively) as well as any previous notices given by the IRS will help avoid any errors and discrepancies which would otherwise cause a lag. Third, using direct deposit to receive refunds can save time by not relying on physical checks sent through the U.S. Mail.
If you would like to hear our panelists cover what you should know before filing your taxes in their own words, video of the full webinar can be found here.
November 15, 2021
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242
Washington, DC—Today, on America Recycles Day, National Consumers League (NCL) launched FactsAboutRecycling.org, an information hub where consumers can learn more about what actually happens to the food and beverage packaging they toss in the recycling bin. The new site houses an animated video to help explain the recycling system, correct misinformation proliferated through marketing, and educate and empower consumers to make environmentally sustainable purchases.
“Just because something can be put in the recycling bin doesn’t mean it will truly end up being recycled,” said Sally Greenberg, NCL’s executive director. “Consumers deserve to know the truth about the sustainability of their purchases, so they can make the most informed decisions possible.”
Building upon NCL’s sustainability and honesty-in-marketing work over the past year, including infographics, podcasts, and a white paper entitled Examining Sustainability, Consumer Choice, and Confusion in Food and Beverage Packaging, FactsAboutRecycling.org gives consumers and environmental advocates fresh insight into the true sustainability of plastic, glass, metal, and cartons.
“Misleading marketing claims don’t just harm consumers; they can harm the environment and exacerbate the ongoing plastic pollution crisis. Better information will support smarter purchasing,” said Greenberg.
For more information, visit www.FactsAboutRecycling.org.
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About the National Consumers League
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 work of the National Consumers League is making a difference in people’s lives across the country. Meet some of the consumers touched by our programs.
Read about NCL’s impact
Paige, 55, a Nashville wife and mother of two, answered an employment ad for secret shoppers. Before sending payment to the scammers, she reached out to NCL.
Read about NCL’s impact
A grease fire flared up in Decklan’s kitchen. As his family scrambled and panicked, fearing that the whole house might erupt in flames, Decklan remained calm. He hurried over to the pantry, grabbed some baking soda, and dumped it on the fire quickly extinguishing the blaze.
Read about NCL’s impact
Cincinnati resident Charles, 45, lost his computer business — and health insurance— during a time of economic downturn. A diabetic, Charles was now unable to afford his medication. He stopped taking it which made him seriously ill and put his life at risk.
Read about NCL’s impact
Jeremy is a fast-food worker who has been employed at a number of Chipotle restaurants in New York City. When he was just 20 years old, he took part in an NCL research project that revealed that management practices within the fast food chain were putting workers—and food safety for customers—at risk.
Read about NCL’s impact
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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.”
/in Blog, Health, Prevention Blog Post
By Sally Greenberg, NCL Executive Director
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.
MEDIA CONTACT:
Carol McKay, carolm@nclnet.org
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