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It’s 2021, can we speak frankly about women’s s…
Watchdog group’s annual report tracking trends out today
For immediate release: February 1, 2021
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC—An analysis of the scams most frequently reported by consumers in 2020 tells the story of economic downturn, social isolation, pandemic fears, and opportunistic criminals, according to a new report released today by the National Consumers League’s (NCL) Fraud.org campaign. Through the Fraud.org website, NCL collects complaints from consumers about suspected and confirmed fraud incidents, tracks trends, and shares the data with law enforcement.
The report’s findings note the pandemic’s impact on fraud trends, including increases in “get rich quick” schemes and predatory scams of the heart. The number of complaints received at Fraud.org regarding bogus prizes, sweepstakes, and free gifts nearly doubled year-over-year. Another pandemic scam trend: a notable increase (30 percent) in romance scams, which experts at Fraud.org are linking to the social isolation brought on by the COVID pandemic and Americans turning to online communication for companionship.
“The COVID recession has fueled a rise in get-rich-quick schemes and romance scams,” said John Breyault, NCL Vice President of Public Policy, Telecommunications, and Fraud and the new report’s author. “The pandemic created a perfect storm for criminals: millions out of work and struggling with new financial hardship; people forced to isolate and seek companionship online; and incredible uncertainty about the future. Last year was a good year to be a con artist.”
With many of the conditions from 2020 still in place, the consumer watchdog is cautioning consumers against the most common scams that plagued Americans last year.
“While the exact pitch differs from scam to scam, there are red flags that consumers should consider,” said Breyault. “A request to send money to someone you’ve never met in person is almost always a scam. Another tried-and-true tactice scammers use is to create a false sense of urgency to get victims to send money before they stop and think. The best advice we can give to consumers is to stop, think, and talk to a friend or loved one before you send money.”
In 2020, consumers submitted more than 5,700 complaints to Fraud.org. Forty-three percent of complaints reported a monetary loss, with the median loss of $1,628.
Top Ten Scams of 2020
New fraud entered top ten: extortion scams.
“As the pandemic and the recession continue to grind on in 2021, we are paying special attention to so-called ‘Internet extortion’ scams, which entered the top ten scams for the first time last year,” said Breyault. Such scams fall in to two broad sub-categories. The first category are “sextortion” scams, where consumers receive a message where the scammer threatens to release embarrassing photos, videos, or other personal information to the victims’ friends and family. The second sub-category involves “psychic” services, where the scammer claims to had discovered that a “curse” or other tragic event is about to befall the victim. Only by paying a significant fee can the victim have the “curse” lifted.
Younger consumers and seniors are being targeted more frequently.
The percentage of complaints received from consumers aged 26-65 decreased by an average of 8.76% in 2020. By comparison, complaints from consumers aged 25 and below and those 65 and older increased by an average of 30.60% and 15.82%, respectively versus 2019. For consumers aged 25 and under, the top three most reported fraud categories were Internet merchandise scams, fake check scams, and romance scams. For those 65 and older, the top complaint categories were prize/sweepstakes scams, phishing/spoofing, and Internet merchandise scams.
The Web and the telephone remain scammers’ preferred contact methods.
With email spam filters growing increasingly successful at blocking out scam emails, fraudsters continued to turn to the Web and the telephone to find victims. Those two contact methods were mentioned in more than 81% of the complaints. “This highlights the need for consumers to be wary when responding to messages from unknown senders, particularly those encountered on social media,” said Breyault. “Consumers should also continue to be on guard for unknown callers seeking to offer them prizes or other inducements to send money.”
Read the full 2020 Top Scams report from NCL.
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneering 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.
For immediate release: January 29, 2021
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC—The National Consumers League (NCL), America’s pioneering consumer and worker advocacy organization, welcomes the appointment of Commissioner Jessica Rosenworcel to serve as acting chairwoman of the Federal Communications Commission (FCC). Rosenworcel is the second woman to lead the agency in its 86-year history.
The following statement is attributable to NCL Executive Director Sally Greenberg:
We welcome Commissioner Jessica Rosenworcel’s appointment as Acting Chairwoman of the FCC. Her years of service at the Commission and on Capitol Hill make her an ideal choice for this position. She brings an in-depth understanding of the Commission, its committed and talented staff, and the agency’s relationship with Congress.
Acting Chairwoman Rosenworcel is a strong proponent of consumer protections, net neutrality, and universal access to high speed broadband. Her appointment couldn’t come at a better time; the COVID-19 pandemic has exposed the chasm of access to high quality broadband in so many communities across America. Most critically, millions of students without affordable broadband access have suffered as schools have moved online during the past year. NCL is committed to working with Acting Chairwoman Rosenworcel and her team to address this critical problem.
We are honored that Acting Chairwoman Rosenworcel accepted NCL’s Trumpeter Award for consumer leadership in 2020. We welcome this strong consumer advocate who has always kept an open door for consumers from all backgrounds to discuss their concerns with the commission. We look forward to continuing to work with her and the talented FCC staff.
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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
For immediate release: January 29, 2021
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC—The National Consumers League welcomes President Biden’s nomination of Rohit Chopra, a current commissioner of the Federal Trade Commission (FTC), to chair the Consumer Financial Protection Bureau (CFPB).
This following statement is attributable to Executive Director Sally Greenberg:
We are very pleased by President Biden’s nomination of Rohit Chopra to serve as director of the CFPB. At the FTC, Commissioner Chopra has proven to be a fair, thoughtful, and even-handed regulator with a strong record of defending the interests of consumers and pressing the agency to uphold its mandate by doing more to fight fraud and combat unfair and deceptive practices.
Chopra was on the ground floor as the CFPB was built. He was one of the first hires by Sen. Elizabeth Warren (D-MA) when she took on the role as director of the—then—brand new agency. He brings a wealth of experience in the work of federal agencies, having also acted as special advisor at the U.S. Department of Education.
Despite his busy schedule, Commissioner Chopra always had an open door to hear from advocates and everyday consumers. When it comes to fighting abusive debt collection practices, crushing student loan debt, predatory payday loan companies, and auto lenders that discriminate against black, brown, and immigrant communities, consumers will have no greater champion than Rohit Chopra.
We urge the Senate to promptly confirm Commissioner Chopra so that he and his team can get started on the critically important mission of protecting the interests of the nation’s consumers.”
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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
In 2019, in response to the growing retail market of untested, unapproved cannabidiol (CBD) products, NCL identified the need for greater consumer education and increased regulation at the federal level. NCL and its partners — Consumer Federation of America and the Community Anti-Drug Coalitions of America — created Consumers for Safe CBD to help raise awareness of the unregulated CBD marketplace, champion the rights of consumers, and call on government and industry to do more to protect consumers. This year, we will continue to work with key stakeholders to encourage safe CBD food and beverage products and promote a pathway for new therapeutic products through clinically-tested scientific research.
We’ve come a long way since our launch, and FDA is making progress. Newly former FDA Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy recently called for better science, more data, and increased testing to determine the risks and benefits associated with CBD. We are encouraged by the commitments outlined in the FDA statement and look forward to continued collaboration with the Biden Administration and the new leadership at the agency to make the CBD marketplace fair, safe, and healthy for consumers.
Read more about the FDA’s comments on the Consumers for Safe CBD here and sign up for CBD updates from our Consumers for Safe CBD campaign here.
By Sally Greenberg, NCL Executive Director
As our nation celebrates Dr. Martin Luther King Day this week, let’s not forget the beautiful legacy of Dr. King at this difficult time in America.
Dr. King was a role model for all of us in how to bring about change peacefully. “True pacifism,” or “nonviolent resistance is a courageous confrontation of evil by the power of love,” Dr. King wrote. What America needs now—perhaps more than ever before—is Dr. King’s message and his devotion to nonviolent racial equality.
Here in Washington, DC, the 704+ thousand of us who call this city home (and still have no voting rights in Congress) are surrounded by tall fences, members of the National Guard carrying AK 47s, and barbed wire. This is sadly necessary to protect the President and Vice President at their January 20 Inauguration from violence by the likes of the white supremacist mobs who were wearing Trump hats, carrying Confederate flags, and who stormed the Capitol on January 6. Many chanted “Hang Mike Pence,” Mr. Trump’s own Vice President, and searched for Speaker Nancy Pelosi in hopes of assassinating her.
How ironic that as we celebrate the life of the remarkable American icon and civil rights leader, Dr. Martin Luther King, the Memorial in his honor on the National Mall must be closed due to threats of violence.
King taught us that violence is not inevitable nor necessary to effect social change. Over the past year, 93 percent of Black Lives Matter protests were peaceful. Dr. King would have been proud of that.
So here’s to Dr. Martin Luther King, who was and remains a role model to so many Americans and an inspiration to millions more.
For immediate release: January 7, 2020
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC–On behalf of the Board of Directors and staff of the National Consumers League, America’s pioneering consumer organization founded in 1899, we wish to extend warm congratulations to our next President of the United States, Joe Biden and incoming Vice President Kamala Harris. As consumer and worker advocates, we look forward to building a strong relationship with the Biden-Harris Administration to advance the issues of democracy, which go hand-in-hand with consumer and worker protections. Among the top priorities on NCL’s agenda: enacting a $15 federal minimum wage and comprehensive privacy and data security laws; strengthening consumer protections regulations throughout the federal agencies; fighting fraud by enhancing consumer protections in financial transactions; restoring consumer protections to the flying public and American travelers; combatting predatory financial practices; and reducing the barriers facing all consumers seeking to gain access to the civil justice system.
Congratulations once again to President-elect Biden and Vice President-elect Kamala Harris on their election to the two highest offices in the land.
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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
For immediate release: December 22, 2020
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC – The National Consumers League welcomes the inclusion of long-needed surprise billing protections in the COVID Relief Omnibus Spending Bill.
Surprise billing happens when a patient’s insurance doesn’t cover a procedure provided by an out-of-network physician, something patients don’t know or realize when they get a procedure. An estimated one in five emergency visits and one in six inpatient admissions will trigger a surprise bill, which can run into the thousands of dollars.
Medical debt disproportionately drives people into bankruptcy. Bill collectors and hospitals often layer on fees, interest, and penalties, driving the original costs way up. A 2019 study published in the American Journal of Public Health found that 530,000 bankruptcies filed annually are because of debt accrued as a result of treatment for medical illness.
This statement is attributable to NCL Executive Director Sally Greenberg:
“We greatly appreciate the bipartisan leadership of Senators Maggie Hassan (D-NH) and Bill Cassidy (R-LA) in getting the surprise billing language over the finish line. We also thank House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR), Senate Health Committee Chairman Lamar Alexander (R-TN), and Ranking Member Patty Murray (D-WA) for their early leadership on this issue. This is a shining example of working across the aisle for the betterment of consumers.
Consumers can breathe a huge sigh of relief because under the bill—including the cost of an air ambulance—consumers will be ‘held harmless’ when exposed to out-of-network costs. Once this bill is law, consumers can expect that fees charged will be far more affordable and predictable at in-network rates. We are grateful to Congress for recognizing surprise billing as a predatory practice from which consumers need protection. The committee leadership not only helped to pass a bill but launched an investigation.
After two years of debate and discussion on how health care providers and health plans will negotiate these extra costs, it was agreed that patients should be taken out of the middle of dispute resolution processes. Now, we finally have a workable system for protecting consumers.”
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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
By NCL Director of Health Policy Jeanette Contreras
Surprise medical bills occur when patients unknowingly receive care from a provider who is not in their health insurance plan’s network. As the first COVID-19 vaccinations are administered, Congress has passed landmark legislation to ensure consumers needn’t worry about surprise medical bills from emergency medical services.
The passage of this legislation couldn’t come soon enough, as more than 476,000 Americans hospitalized with the coronavirus have already incurred exorbitant medical debt from COVID-19 treatment. Now, thankfully, 2020 will come to a close with renewed optimism in the American health care system.
This new law will also protect consumers from surprise billing from out-of-network ambulance and air ambulance trips, which can amount to tens of thousands of dollars in medical bills. Most patients are conscientious consumers, careful to find a doctor that accepts their insurance before making an appointment. However, in the case of an emergency, a patient faces the possibility of receiving care from an out-of-network doctor in an out-of-network hospital.
As Congress debated legislative fixes to surprise billing, the Administration showed political will toward finding a solution with the issuance of Executive Order 13877, Improving Price and Quality Transparency in American Healthcare to Put Patients First, which includes principles on surprise billing. In a July 2020 report addressing surprise billing, the U.S. Department of Health and Human Services (HHS) further urged Congress to act, recognizing that 41 percent of insured adults nationwide were surprised by a medical bill in the past two years.
Following Executive Order 13877, HHS finalized a set of regulations to address price transparency for consumers. The first rule set to take effect on January 1, 2021, requires hospitals to publicly list standard charges for the items and services that they provide. The second rule, set to take effect in 2022, demands similar transparency from most health plans and issuers of health insurance coverage. These regulations offer consumers more control over their health care spending and better information as they shop and compare health coverage options for themselves and their families.
The new HHS regulations, coupled with the surprise billing legislation, amount to the greatest consumer protections in America’s health care system since the Affordable Care Act. Consumers with health insurance should not have to worry about surprise medical bills—especially during a pandemic. The health care system will be a little more consumer-friendly in 2021, which is good news for all of us.
For immediate release: December 22, 2020
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC – The National Consumers League (NCL) testified before the Centers for Disease Control and Disease Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) this weekend on the equitable distribution of the Moderna vaccine and recommendations for consumer education on vaccine safety. In its testimony, NCL applauds the transparency and access afforded to the public throughout the COVID-19 vaccine approval process.
Equitable distribution:
NCL is encouraged that the Food and Drug Administration (FDA) has approved the Moderna vaccine and that the U.S. government will lead distribution efforts. Due to its ease of transport and storage, the Moderna vaccine stands to readily ship to rural and hard to reach communities. NCL calls on federal health officials at the helm of distribution to facilitate access to the Moderna vaccine to medically underserved areas.
Safety and efficacy:
NCL expressed its trust in the FDA and CDC’s robust inter-agency collaboration to continue ongoing, post-market surveillance of adverse events among recipients of the COVID-19 vaccine and to inform consumers of any additional safety recommendations. NCL urged the CDC to educate consumers about potential reactions and side effects, as this transparency will further encourage the compliance necessary to achieve herd immunity. The vaccine is expected to induce flu-like symptoms after the initial dose and this may deter some patients from getting their second dose if they aren’t warned about what to anticipate.
Vaccine adherence:
NCL encouraged the CDC to conduct culturally competent and inclusive public messaging about vaccine safety to ensure that communities of color and persons with limited English proficiency are informed and feel empowered in their decisions to vaccinate. Adding to the complexity of administering the vaccine, public health officials will need to ensure the completion of two doses in a series. This stands to create additional challenges because evidence has shown that when a vaccine involves multiple doses, nearly 50 percent of patients fail to return for a second dose.
Equitable allocation:
NCL applauds ACIP’s recommendations to prioritize vaccinations for health care workers and long-term care facility residents in Phase 1a. Now that there are two approved vaccines, NCL calls on ACIP to prioritize recommendations to vaccinate the approximately 87 million non-healthcare essential workers unable to work from home—such as bus drivers and grocery workers—who are at higher risk of exposure. Racial and ethnic minorities make up more than 40 percent of the essential workforce and are the backbone of many essential industries. The pandemic has illustrated that low-income minority communities experience more severe COVID-related illness requiring hospitalization and are at higher risk for death.
Persons who recovered from COVID-19:
Lastly, over 18 million individuals in the U.S. have been infected with the coronavirus. It is expected that individuals who recover will acquire some natural immunity to COVID-19. Individuals who recover from the coronavirus want to know if they are protected from reinfection and for how long. We call on the CDC to expedite developing vaccine recommendations for persons who’ve recovered from COVID-19.
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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
The 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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