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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.
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC – This Thursday, October 22, the National Consumers League (NCL), America’s pioneering consumer and worker advocacy organization, will host a virtual fireside chat with Nevada Attorney General Aaron D. Ford and a panel of consumer protection experts on the growing threat of scams linked to the COVID-19 pandemic. The consumer watchdog organization aims to raise awareness in Nevada about the risk of COVID-19 related fraud and arm consumers with information they can use to spot and avoid these scams.
Since the pandemic began, NCL, which operates the website Fraud.org, has seen an uptick in complaints about a variety of scams preying on increasingly vulnerable, financially strapped, and fearful consumers. Scammers running phishing schemes, stimulus check fraud, unemployment benefits scams, and immigration scams have all been working overtime to use the COVID-19 pandemic as a way to defraud consumers. The experts at NCL have watched these scams emerge, forecast they will continue to increase, and are eager to work with AG Ford to get the word out about how Nevadans can protect themselves.
WHAT
Virtual “fireside chat” featuring Nevada AG Aaron D. Ford and NCL, followed by a panel discussion on resources and tips to avoid COVID-19 fraud and scams.
WHEN
Thursday, October 22, 2020
2:00 PM – 3:00 PM Pacific Daylight Time
WHO
Nevada Attorney General Aaron D. Ford
John Breyault, Vice President, National Consumers League
State Senator Dallas Harris, Consumer Rights Attorney, Legal Aid Center of Southern Nevada
Maria Moore, State Director, AARP Nevada
Assemblyman Edgar Flores, Immigration, Family, and Personal Injury, Gonzalez & Flores Law
HOW TO WATCH
YouTube Live link will be provided following registration via Eventbrite.
*** Members of the media are welcome to attend but must RSVP to Carol McKay, National Consumers League, carolm@nclnet.org. If you are unable to attend, a recording of the interview and panel can be provided upon request after the event concludes ***
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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.
Facebook is a terrific tool for staying in touch with old friends, former classmates, family, and community members. Unfortunately, like other popular social media platforms, it also attracts scammers looking to abuse the system for their own gain. We’ve recently heard from nearly a dozen consumers who have contacted Fraud.org about scammers using Facebook’s Messenger service to try to defraud them by posing as long lost friends.
The set-up for these scams is remarkably consistent. Consumers who sent us complaints report that these scams begin when they receive a message on Facebook Messenger from someone impersonating a former classmate or an old friend. When the recipient responds, the scammer strikes up a conversation to build trust. Once trust is established, the impersonator urges the consumer to send a text message to a number the scammer controls to get information on a grant, prize, or even government stimulus funds. When the victim texts the number, they are urged to pay an up-front fee and/or supply personal information (Social Security number, bank account/credit card information, etc.) to collect the non-existent money. Victims who do send the money are then urged to send even more money until they catch on. Unfortunately, the money is often sent via wire transfer or gift cards, which are extremely difficult or impossible to stop or reverse.
While this scam is not new, the request to take the conversation off Facebook Messenger and on to text message is a new twist. This is likely due to the scammers trying to evade anti-fraud technology employed by Facebook.
Here are tips to reduce your risk of falling victim to this scam:
Don’t immediately assume your Facebook friend is who they claim to be. Thanks to widespread data breaches, it is not difficult for scammers to get the information they need to compromise a Facebook account. If you receive a message from someone you have not spoken to in a long time, do not assume that the message is legitimate. The safest course of action is to simply ignore the message.
Test them. If you do engage in a conversation and become suspicious, you can try to verify the identity of the person messaging you by asking them a question only they would know (i.e., who was our 9th grade English teacher?).
Beware requests to take conversations off Facebook Messenger. Complaints we have received often describe requests to move conversation from Facebook (where they can be monitored) to text message. This is a big red flag for fraud.
Anyone who asks you to send money to get money is swindling you. If you are asked to pay money to collect a prize, grant, stimulus check, or any other type of reward, it is a scam.
Turn on two-factor authentication and encourage your friends to do the same. One of the reasons this scam occurs is that consumers tend to re-use passwords across multiple websites (your email and Facebook account, for example). That means that if your username and password are compromised at one website, scammers can use that information to try and compromise your account at other websites. An effective way to reduce the risk of this is to turn on two-factor authentication. This will require anyone trying to log in to your Facebook account to supply a special code (typically provided via text message or an authentication app) before they can log in.
If you suspect that you have become a victim, report it immediately. You can file a complaint at Fraud.org via our secure online complaint form. We’ll share your complaint with our network of law enforcement and consumer protection agency partners who can investigate and help put fraudsters behind bars.
Ben Wiseman, director of the Office of Consumer Protection at the Office….
May 8, 2020
Contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC –Washington, DC / Harrisburg, PA—Next Monday, May 11, the National Consumers League (NCL), America’s pioneering consumer and worker advocacy organization, will host a virtual fireside chat with Pennsylvania Attorney General Josh Shapiro and a panel of consumer protection experts on the growing threat of scams linked to the COVID-19 pandemic. The consumer watchdog organization aims to raise awareness in Pennsylvania about the risk of COVID-19 related fraud and arm consumers with information they can use to spot and avoid these scams.
Since the pandemic began, NCL, which operates the website Fraud.org, has seen an uptick in complaints about a variety of scams preying on increasingly vulnerable, financially strapped, and fearful consumers. Scammers running phishing schemes, stimulus check fraud, and even pet adoption scams have all been working overtime to use the COVID-19 pandemic as a way to defraud consumers. The experts at NCL forecast these scams will continue to increase and evolve and are eager to work with AG Shapiro to get the word out about how Pennsylvanians can protect themselves.
WHAT
Virtual “fireside chat” featuring Pennsylvania AG Josh Shapiro and NCL, followed by a panel discussion on resources and tips to avoid COVID-19 fraud and scams
WHEN
Monday, May 11, 2020
11:00 AM – 11:45 AM EDT
WHO
Pennsylvania Attorney General Josh Shapiro
John Breyault, Vice President, National Consumers League
Lorrie Cranor, Professor, Carnegie Mellon University
Mary Bach, Chair, AARP Pennsylvania Consumer Issues Task Force
Andrew Goode, Esq., Vice President, Metro Philadelphia Better Business Bureau
HOW TO WATCH
YouTube Live Link will be provided following registration via Eventbrite
*** Members of the media are welcome to attend but must RSVP to Carol McKay, National Consumers League, carolm@nclnet.org. If you are unable to attend, a recording of the interview and panel can be provided upon request after the event concludes ***
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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.
April 10, 2020
Contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC – April 10, 2020 – The National Consumers League (NCL), in partnership with 42 patient and provider advocacy, public health, industry, and research groups, has issued joint letters to Vice President Mike Pence, the U.S. Department of Justice (DOJ), U.S. Federal Trade Commission (FTC), U.S. Food and Drug Administration (FDA), and other state and federal leaders calling for swift action to protect consumers against COVID-19 misinformation, scams, and fraud online.
“NCL commends the White House Coronavirus Task Force and other officials for their dedication in responding to the coronavirus crisis,” said NCL Executive Director Sally Greenberg. “The COVID-19 pandemic makes your work against healthcare and financial fraud more important now than ever. However to further flatten the curve and save lives, we urge the Administration to quickly implement increased evidence-based actions and to help protect consumers from predatory attempts to take advantage of our new economy.”
Since the start of the pandemic, criminals launched thousands of COVID-specific global scams and phishing attacks, using the coronavirus crisis to profit at patients’ expense. “Criminals have exploited the fear and confusion caused by the coronavirus for their own personal profits. More must be done to mitigate the health and financial harms experienced by consumers nationwide,” said Greenberg. In the past few weeks alone, more than 100,000 website domain names have been registered containing terms like “covid,” and “corona,” most of which have been found to be outright dangerous. The Federal Trade Commission indicated receipt of nearly 14,000 coronavirus-related complaints totaling fraudulent losses nearly $10 million.
NCL has long called for increased regulation and enforcement against illegal online acts that result in public health and economic harm. The joint letter encourages the Administration to move swiftly to enact and enforce existing no-cost solutions to better protect consumers. Additionally, it calls on the Administration to ground their efforts in science, address systemic internet policy problems and prepare for an ongoing wave of COVID-19 related scams during the economic downturn.
Co-signers of the letters include Alliance for Safe Online Pharmacies, BIO, Coalition for a Safe and Transparent Internet, Consumer Brands Association, Kroll, Lilly, LegitScript, and USP. The full letter can be read here.
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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.
By Sally Greenberg, NCL Executive Director
There I was, searching for hand sanitizer to help keep reducing my risk of infection. I had scoured my local stores for hand sanitizer, to no avail. At last, desperate, I found a tiny bottle of sanitizer on the shelf at my local gas station. A bottle that usually retails for around a dollar was marked up to $3.99. What choice did I have? I paid the money and walked out of the store.
Like moths to the flame, profiteers cannot resist the allure of easy money. In this time of national emergency, it should perhaps come as little surprise that those who wish to make a quick buck off the desperation of consumers are finding few obstacles in their way.
In past natural and man-made disasters, whether in the aftermath of Hurricane Katrina or the 2008-09 financial crisis, there were always crooks who sought to deprive those in need of their last penny. Unfortunately, the COVID-19 crisis seems to be little different in this respect.
Price gouging is perhaps the most immediate threat. Most of us are aware of being asked to pay $5.00 for a bottled water in an airport or amusement park. In a time of crisis, however, the consequences of hiking prices outrageously is more than just a matter of a parched throat. For consumers in desperate need, it can come down to a choice between avoiding infection or paying the rent.
At a time when health care workers and first responders are putting their lives on the line to care for coronavirus patients, it is outrageous to see stories of unscrupulous sellers marking up the price on masks, hand sanitizer, disinfectant and, yes, even toilet paper.
Price gouging in times of crisis is illegal in most states. For example, Maryland’s anti-gouging statute prohibits raising the price of many consumer goods and services that increase the seller’s profit by more than 10 percent while the COVID-19 emergency declared by Governor Larry Hogan is in effect. California has a similar statute, punishable by up to a year in jail and a $10,000 fine. Price gouging is also illegal where I live, in the District of Columbia.
While state laws are important, enforcement alone won’t solve this problem. Reputable businesses must also play their part to keep price gouging off their shelves. This is one reason I was especially encouraged to see that that the biggest seller of consumer items on the planet, Amazon.com, stepped out so decisively against price gouging.
Last month, the company issued a policy that clearly states: “Amazon has zero tolerance for price gouging and longstanding policies to prevent this harmful practice.” In practice, this means the company is working overtime to remove price gougers from its marketplace, forwarding reports of price gouging to law enforcement, and making it clear to their sellers that price gouging is not allowed.
Amazon has removed more than half a million products and suspended more than 3,900 seller accounts in the United States.
The overwhelming majority of sellers on sites like Amazon, eBay, and other online marketplaces are honest. But these e-commerce marketplaces are where millions of consumers are going to find much-needed products. Particularly for consumers who are at high risk, these online services can be a lifeline, enabling them to stay home, avoid going out into public, and decreasing their chances of contracting the virus.
We should be very happy that there are state laws prohibiting price gouging and very grateful that Amazon has taken such a strong stance in protecting consumers by monitoring and prohibiting its sellers from gouging consumers and others during this terrible pandemic.
April 1, 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) is warning consumers about an expected rise in attempts at fraud as the economy continues to tank and criminals pivot their pitches to take advantage of fearful consumers.
“When news captures the public’s attention – think major hurricanes, terrorist attacks, and economic slowdowns – scammers come out of the woodwork to take advantage of legitimate fears and concerns,” said NCL Executive Director Sally Greenberg. “With coronavirus dominating the news globally, there is an unprecedented opportunity for criminals to use the public’s fears about the virus and the resulting economic downturn to defraud consumers.”
NCL is working to educate consumers about two of the most pernicious types scams that are increasing due to coronavirus: robocalls and stimulus check scams.
Coronavirus-related robocalls
Robocalls are, at the very least, a major annoyance for most consumers. However, as the coronavirus has upended daily life, robocall operators have quickly shifted to blasting out spam phone calls offering all manner of coronavirus-related products and services. YouMail, a cloud-based telecommunications provider that tracks robocall volumes, estimates that at least one million robocalls per day are inundating Americans’ cell phones. Fraudulent robocallers are offering air duct sanitation services, work-from-home opportunities, cut-rate health insurance, and immune-system boosting nutritional supplements. Other robocalls have reportedly offered free insulin kits to diabetics, along with free coronavirus testing kits.
“At best, consumers who respond to these calls are setting themselves up to lose money for a non-existent product or service,” said John Breyault, director of NCL’s Fraud.org campaign. “At worst, delaying needed emergency treatments on the belief that a fake coronavirus treatment will save your life could be deadly to you and those you come into contact with.”
NCL’s advice to consumers is simple:
Stimulus check scams
Last week, President Trump signed the biggest stimulus bill in U.S. history into law. Most American adults will receive a stimulus of $1,200 or more in the coming weeks thanks to the legislation. Crooks are already using these promised payments as a way to defraud consumers. Scams that have been reported involve crooks promising to expedite payment in exchange for a fee, impersonating a government official, and requesting sensitive personal information in order to process a check. Inaccurate social media posts have also circulated suggesting that consumers need to fill out the 2020 Census before they can receive a stimulus check.
“Stimulus checks will help millions of American households weather the coming economic downturn,” said Breyault. “Unfortunately, the phrase ‘free money from the government’ is magic to scammers’ ears. Consumers should be on the lookout for fraudsters who will try to use the coming stimulus checks to steal their money.”
Consumers can protect themselves from these scams by learning to spot these red flags:
NCL asks consumers to share their stories by filing a complaint at Fraud.org via its secure online complaint form. Complaints are shared with NCL’s network of nearly 200 law enforcement and consumer protection agency partners who can and do put fraudsters behind bars.
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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.
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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