Price gouging and usury and fraud, oh my!
Ben Wiseman, director of the Office of Consumer Protection at the Office….
Ben Wiseman, director of the Office of Consumer Protection at the Office….
June 19, 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—With a mission of protecting workers and consumers, the National Consumers League (NCL) applauds the Supreme Court’s landmark employment protection decision this week finding that employment discrimination on the basis of sexual orientation or gender identity is prohibited under federal civil rights law. This statement is attributable to Sally Greenberg, NCL’s executive director:
We are applauding this week’s landmark 6-3 Supreme Court decision finding that the law’s prohibition on sex discrimination in employment extends to those who identify as LGBT (lesbian, gay, bisexual, transgender). We commend and thank Justice Neil Gorsuch and his five fellow justices for concluding that ‘An employer who fires an individual for being homosexual or transgender fires that person for traits or actions it would not have questioned in members of a different sex. Sex plays a necessary and undisguisable role in the decision, exactly what Title VII forbids.’ NCL was founded to advocate for the rights of workers to receive decent pay, work in safe conditions and be free from discrimination in the workplace. This decision further extends these critical protections to the LGBT community.
Title VII of the 1964 Civil Rights Act prohibits discrimination in the workplace on the basis of race, religion, national origin and sex. We are pleased that the court found that “sex” is a distinct characteristic but inseparable from the concepts of sexual orientation and gender identity.
The decision is the most significant affirmation of LGBT rights in the United States since the 2015 Supreme Court decision that legalized same-sex marriage and the Court’s first decision addressing transgender civil rights.
Before the decision, LGBT job discrimination was still technically legal in much of the nation. Less than half the states have laws explicitly prohibiting workplace discrimination on the basis of sexual orientation or gender identity. An estimated 11 million Americans identify as LGBT, according to the Williams Institute.
###
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.
June 18, 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) applauds the Supreme Court’s decision today to block the Trump Administration’s attempt to end the DACA (Deferred Action for Childhood Arrivals) program for so-called “DREAMERS”—young people who came to the United States as children with parents who were not documented citizens at the time. Millions of these young people grew up in the United States, but their citizenship status is precarious. Thus, under this Obama-era program established in 2012, DACA is critically important to protect these young people and give them a path to citizenship.
This statement is attributable to NCL Executive Director Sally Greenberg:
NCL applauds the 5-4 decision of the U.S. Supreme Court today blocking the Trump Administration’s efforts to undo the protections of DACA. Thousands of aspiring and promising young people who arrived in the United States as children of undocumented immigrants will not, as a result of this decision, lose critical protections DACA provides. Today we join with them in celebrating the Supreme Court’s decision to block Mr. Trump from undermining these essential protections. NCL’s long history of fighting for the rights of workers and consumers includes the rights of immigrants, who remain among the most vulnerable targets of workplace and marketplace abuses. They deserve the same protections that flow to all American citizens. NCL’s policy position on this issue was adopted in 2013.
The Development, Relief, and Education for Alien Minors Act—the proposal to grant temporary conditional residency, with the right to work, to qualifying immigrants who entered the United States as minor—and, if they later satisfy further qualifications, they would attain permanent residency.
DACA was introduced by President Barack Obama in 2012 and allows young people who were brought to the U.S. illegally as children to stay in the country and work without being deported on a two-year, renewable term. As of March 31, 2020, 640,000 people have active DACA status, and since 2012, more than 825,000 people have utilized the program. The 5-4 Supreme Court majority, written by Chief Justice John Roberts, determined that President Trump and DHS did not adequately consider the impact on the DACA recipients themselves and the potential hardships for the some 700,000 young immigrants brought to the U.S. illegally as children by their parents.
###
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.
June 3, 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 deeply saddened by the recent unjustified killing of an African American man by police in Minneapolis—just the latest in a long, tragic chain of unwarranted deaths of African Americans by police around the nation. The following statement may be attributed to NCL Executive Director Sally Greenberg:
The callous murder of George Floyd, an African American devoted father, husband, brother, and friend is especially devastating to me personally because it occurred only a few miles from the Minneapolis home I grew up in. Like millions of Americans, I watched as a police officer choked to death a man who was accused by a local store owner of a minor charge of passing off a counterfeit $20 bill.
Like many consumers of color, Mr. Floyd was suspected of a crime by just walking in the door. White Americans must grapple with this reality: African Americans are often followed in stores for no reason, pulled over by police for no reason, and have police called on them for no reason. NCL champions consumer protection and especially for those who suffer from discrimination and predatory practices when they engage in the everyday activities we all take for granted: shopping, walking, driving, jogging, playing music in our cars, or pumping gas. We have also seen how COVID-19 has had the most devastating impact on communities of color. These oppressive disparities must stop.
NCL’s first leader Florence Kelley, raised in an abolitionist Quaker family, refused to stay in hotels that didn’t admit African Americans and appeared on the original charter of the NAACP. To this day NCL has carried forth her legacy and stood alongside African Americans fighting for equality and fair treatment under the law.
NCL supports the peaceful protesters advocating for systemic change. We pledge to be part of the solution as we try to move on from this devastating moment in American history and will seek out like-minded allies and friends to join us in this struggle.
We are all Americans, and we are all interconnected. It is time to listen and time for each of us to take responsibility to heal the nation. No more delays.
We can do this!
###
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 Nailah John, Linda Golodner Food Safety and Nutrition Fellow
It was a rainy Thursday afternoon when I decided to take a trip to Mom’s Organic Market (MOM’s) in College Park, Maryland. MOM’s CEO, Scott Nash, was the subject of NCL’s We Can Do This! podcast a few months ago because he is infamous for consuming food whose “sell by” date is expired and living to tell the tale.
As expected, the parking lot was partially empty due to many neighboring businesses being forced to close due to coronavirus. I exited my car, pulled my mask over my mouth and nose, and walked in. I was greeted by a store employee also wearing a mask. He politely asked me if I needed a cart, disinfected it, and handed it to me. As I entered the grocery store, there were two signs: one that highlighted measures “Helping Each Other” during COVID-19, and the other noted that it is mandatory by law to wear a mask. It was good to read that if you forgot your mask, Mom’s Organic Market may be able to provide you with a disposable version.
In the produce section, everyone was practicing social distancing and wearing masks. I continued my journey through the grocery store from aisle to aisle, picked up a few things that I needed for my pantry, and went to pay for my items. As my turn to check out was approaching, I decided to engage the staff member who was standing on the side guiding customers on social distancing. I introduced myself and asked if she was a manager, and she responded with enthusiasm that she was. I asked her a few questions regarding the safety measures MOM’s is taking during COVID-19 and whether any staff members at the College Park location had tested positive. She said no but that if any staff member does test positive for COVID-19 or presents a doctor’s note stating that they need to quarantine for 14 days because they have been exposed, they will be given 14 days of paid sick leave. Also if they want to stay home for longer, they could choose to do so without being paid, but would not be terminated. She also told me that if any staff member comes to work feeling sick, they would be sent home. All staff members are outfitted with masks and gloves and protective glass at check out counters. It was reassuring to know the safety measures that Mom’s Organic is taking during COVID-19 to protect workers and customers.
The experience I had at Mom’s Organic Market was one that I could relate to at other grocery stores across Maryland. But to understand what other stores are doing, across the country, I embarked on creating a survey, which we distributed to NCL Board Members who reside in different States. The grocery stores patronized were Safeway, Whole Foods Market, Trader Joe’s, Harris Teeter, Costco, and Gelson’s Market. According to our board, 80 percent of these grocery stores require that all customers are mandated by law to wear a mask while shopping. 13 percent of the grocery stores provide a mask if you do not have one. and 88 percent did not provide a mask. Among the stores, there is no mandated policy for customers to wear gloves while shopping. 89 percent of the grocery stores did not provide gloves to customers while 11 percent did. Regarding social distancing, 90 percent practice social distancing while 10 percent did not. 75 percent of grocery stores sanitized the carts and then handed a cart to the customer while 25 percent did not.
When asked the question: Does your preferred grocery store limit the number of customers that enter at each given time? 80 percent said yes while 20 percent said no. When asked if grocery store cashiers wear masks, 90 percent said yes and 10 percent said no. 70 percent of the grocery stores in this survey have a protective glass at the cashiers while 30 percent did not. 89 percent of the grocery stores have hand sanitizing stations for customer use while 11 percent did not. It is safe to conclude that most grocery stores are taking the necessary measure to protect customers and staff during COVID-19.
As luck would have it, the daughter of one of my NCL colleagues works at the Safeway bakery. I also talked to her about grocery store COVID-19 related safety precautions. She told me that each staff member at Safeway was provided with a mask, made of either medical or reusable cloth and that some staff who requested face shields were also provided with it. All cash registers were outfitted with protective glass and employees must practice social distancing—six feet apart. Each hour, the intercom prompts workers to stop working and wash their hands while cashier wash their hands more frequently because they interact more with customers.
Safeway staff go through a checklist daily prior to their shift, with these questions asked:
Do you have any symptoms pertaining to COVID-19 or is there anyone in your family who has tested positive for COVID-19? If any staff member answers yes to any of the questions they are immediately sent home for 2 weeks of paid sick leave. Again, social distancing markers appear on floors at Safeway, and wipes are provided to sanitize shopping carts. Many of us visit grocery stores once or twice a week. It’s great to know that most of the grocery stores we visited or learned about are taking the necessary safety measures to protect workers and customers during COVID-19 and providing generous sick leave protections to ensure workers can afford to stay home if they are experiencing symptoms of the COVID-19 virus.
May 12, 2020
Contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC–Leaders in the U.S. House of Representatives today unveiled a new COVID-19 stimulus bill, the HEROES Act, that includes a new $50 per month subsidy ($75 per month for Tribal lands) to support access for low-income Americans to broadband. At time when the effects of the Digital Divide have never been more apparent, NCL is proud to support this effort.
The following statement is attributable to National Consumers League Executive Director Sally Greenberg:
“We have long known that affordability is a significant barrier to millions of American families who lack access to broadband. The COVID-19 pandemic, has highlighted as never before the societal costs of cutting off millions of families from the Internet. The inability to connect to distance learning, support networks and online government resources will make recovering from this pandemic even tougher for consumers who lack affordable access to broadband. It is for this reason that NCL strongly supports the proposed Emergency Broadband Connectivity Fund subsidy.”
###
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.
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 ***
###
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.
Fraidy Reiss, activist and founder/director of Unchained At Last,…
By Nailah John, Linda Golodner Food Safety and Nutrition Fellow
We all depend on running water to maintain good hygiene. Yet, as America grapples with the worst pandemic in several generations, unemployment is causing people to fall behind on essential utilities, like their water bill.
Consumer Reports notes that millions of Americans are at risk of losing running water. Two-fifths of the country relies on water utilities that have not put in place a policy of suspending shutoff for nonpayment during COVID-19. This is due to a confluence of related factors—institutional racism, environmental injustice, and poverty—which means communities that are most vulnerable to COVID-19 are also being the most adversely impacted by water shutoffs. *The Center for Disease Control and Prevention (CDC) recommends washing your hands often with soap and water for at least 20 seconds and to avoid touching your eyes, nose, and mouth with unwashed hands. How can you do so without running water?
According to NBC News, more than 26 million Americans have filed for unemployment benefits in the past five weeks due to COVID-19. And in Michigan, 23.8 percent of residents have filed for unemployment since March 14, the third-highest number in the country. To add to their woes, Detroit residents that fall behind on waters by as little as $150 are being faced with water shut off. At the start of the pandemic, 2,800 homes were estimated to be without water. Those numbers will soar if action isn’t taken to protect those who can’t pay their water bills. Michigan Gov. Gretchen Whitmer signed an executive order that reconnected shut off water service and started a $2 million grant program to help communities comply with the order, according to ECO Watch.
On the national level, no similar grant program has yet been introduced. The third rescue package included $1.5 billion to assist low-income households with water bills during the crisis, with a condition that required localities and utilities to suspend shutoffs to quality for financial aid. But the clauses were left out of the final bill approved by the Senate. There is some sign of political will with congressional Democrats wanting $12 billion for water subsidies in the fourth rescue package, with grants for utilities conditional on shutoff moratoriums, according to Consumer Reports.
Michigan also has one of the highest water rates in the country. Natural Resources Defense Council’s (NRDC) Erik Olson points out that Coca Cola and Pepsi get months to pay their water bills and then turn around and sell bottled water at 100 times the cost of tap water. Consumer Reports found that most bottled water sold in the United States comes from the same source and just goes through a purification process before being sold to the consumer.
For those not facing utility shutoffs, Consumers Reports confirms that there is no shortage of safe drinking water and health officials–assuring us that the public water supplies are not contaminated by the Coronavirus–are prohibiting hoarding of bottled water. The bottom line is that running water is part of the solution to beating this pandemic. No one should lose access to water if we truly want to flatten the curve and move beyond COVID-19.
*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings.
May 5, 2020
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) last week sent a letter to the CEOs of Cigna, Aetna, and UnitedHealth Group, urging them to enter into productive negotiations with air medical service providers to ensure coverage of emergency air medical transportation. The ask comes as the COVID-19 pandemic spreads across the country, making air medical services even more essential, particularly in rural America.
In its letter, NCL notes that it is increasingly concerned about emergency air medical access during this crisis, and that it believes this life-saving care should be covered by every insurance plan. NCL asks that insurers review the robustness of their coverage policies and immediately to enter into network negotiations with air medical providers so that this critical service is covered, and patients are never left with a bill they cannot pay.
Text of the letter, signed by NCL Executive Director Sally Green is below:
Dear Mr. Wichmann, Mr. Cordani, and Ms. Lynch:
The National Consumers League has long advocated for health care as a right and argued for fair treatment for all stakeholders across the health care spectrum – patients, physicians, hospitals, health plans, and health care providers. Our mission is particularly acute during the global COVID-19 pandemic, when medical professionals are on the frontlines fighting for our health and safety, stricken patients need life-saving care, and nearly everyone is focused on their health and that of their loved ones.
In this vein, we are increasingly concerned about access to emergency medical care, especially in rural America, as the virus indiscriminately makes its way across the country. When minutes count, Americans who fall victim to COVID-19 must be assured that they can get to the nearest, most appropriate medical facility as quickly as possible. As COVID-19 strains hospital capacity and critical medical equipment like ventilators become attenuated, emergency air medical transports between facilities are often the only way for patients to get the care they need.
According to the Centers for Disease Control and Prevention (CDC), 85 million Americans can only reach a Level 1 or Level 2 trauma center within one hour if they are flown by an air medical helicopter. The effects of this access problem are staggering, and even more pronounced as we wrestle with the COVID-19 crisis. For many Americans, air medical ambulances are a vital link to timely, life-saving care.
We believe that such life-saving care should be covered by insurance. Patients pay their monthly premiums – and copays and deductibles – so they are not bankrupted should the worst befall them or their loved ones. Unfortunately, there have been far too many stories of people who were transported by air ambulance because it was ordered by a first responder or doctor, only to be told later by their insurance company that they would have to shoulder the bulk of the cost. This should not be the case anytime, but especially now as our nation wrestles with a pandemic.
This explains why we at the National Consumers League are writing to you for your input and thoughts. We believe that emergency air medical transportation should be included in every health coverage plan. We think that insurance companies and air medical providers must work together to bring these services in-network, so patients are not left footing a bill they can never hope to pay. Adequate network agreements are imperative so that patients are not told – after the fact – that they were transported by an air ambulance that was not in-network. When an emergency happens, or worse yet, a pandemic strikes, patients are not choosing whether to take an air ambulance, let alone choosing a particular provider. Similarly, coverage denials based on “medical necessity” should be the exception, not the rule, in light of the fact that patients are not a part of the decision-making process.
We ask that your companies immediately take a comprehensive look at your coverage policies for air medical services and the robustness of your provider networks. We urge you and the air ambulance community to enter into network negotiations, take patients out of the middle, find a middle ground on reimbursement that fairly compensates both sides, and ensure rural communities have access to air ambulance transports. Refusing to fairly negotiate is simply not an option in light of the current crisis. Entering into productive negotiations immediately will ensure that patients across the country have access to the medical care they need and that they are simultaneously protected from balance bills.
Thank you for your attention to our concerns.
Sincerely,
Sally Greenberg
Executive Director
National Consumers League
###
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
[gravityform id=”11″ title=”true” description=”false”]
[gravityform id=”9″ title=”true” description=”false” ajax=”true”]
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.
###
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.
###
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
<embed src=”https://art19.com/shows/ce489618-5918-423a-9b5f-35ce4c28ca09/episodes/2f8fa6fc-6aad-4f1f-bf13-3bdb0aa41732/embed?theme=light-custom&primary_color=%231850a3″ width=”100%” height=”300″></embed>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/c7b22520-c0aa-4718-9b59-4ee67e494547/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/ab80228e-48d9-4a45-a894-a1bfc4e41c64/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/ea08cbc0-f9f2-4082-9222-4e33f68b6826/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/5039453f-6008-413a-9f6b-c9be649fd26e/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/fafb46f8-6d90-4cd8-91be-616366d1b8ca/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/25f0485d-bbce-46c8-bb90-139dcf1a2e7b/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/ffbcae35-84c5-4c8b-9686-6e2c79679dd0/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/520bdd73-d142-4508-9706-d81b5c042dff/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/12354e8b-bf15-4eba-b34f-20e435df3bb7/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/e2091efc-d66d-49f4-aa8e-8e6249858310/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>