Advice to get rid of that debt monkey on your back
Michelle Singletary award-winning Washington Post columnist discusses how consumers can manage debt and…
Michelle Singletary award-winning Washington Post columnist discusses how consumers can manage debt and…
Sept. 21, 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) joins the nation in mourning the death of Supreme Court Justice Ruth Bader Ginsburg. Justice Ginsburg’s pioneering career as an attorney fighting gender discrimination in the 1960s and 70s, challenging norms about what women in the workplace “could or could not do,” and as a U.S. Supreme Court Justice serves as an example to Americans. In her 27 years on the Court, Justice Ginsburg championed the rights of women’s reproductive freedom, the right to form a union, and to be protected from marketplace abuses and promoted affirmative action, environmental regulations, and reasonable restrictions on guns.
Dubbed “the Notorious RBG,” the Justice became an icon for young women across America as a small-in-stature but a towering voice for rights and protections for women and People of Color. She worked out daily with a personal trainer, lifting weights and stretching; she fought off five bouts of cancer.
Though she was the mother of feminist jurisprudence, she was not a rigid ideologue. During a mock court case of the 1908 Muller vs. Oregon event at the Supreme Court, over which she presided, Ginsburg noted that the litigants in the 100-year-old case—including NCL’s Florence Kelley and Boston lawyer Louis Brandeis—who argued that laws saying women could not be forced to work more than 60 hours a week were not sexist. Having the law apply to only women was their “entering wedge” and the only opportunity to set maximum hours laws, Justice Ginsburg noted. Men went on to gain the same protections during the next decade.
Justice Ginsburg could be seen welcoming visitors to the Court and was especially gracious to those being sworn into the Supreme Court bar, an honor available to any lawyer in good standing who has a Supreme Court bar member to introduce them at special sessions held Court.
The National Consumers League is deeply saddened by the loss of such a powerful force on the Supreme Court of the United States. Her sense of justice and her influence on the Court won’t easily be replicated.
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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.
Sept. 17, 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 September 4, lawmakers introduced The Hemp and Hemp-derived CBD Consumer Protection and Market Stabilization Act of 2020 (HR 8179), which directs the U.S. Food and Drug Administration (FDA) to make hemp and hemp-derived CBD lawful as a dietary ingredient or dietary supplement. The National Consumers League (NCL) has long been concerned about the public health and safety risks posed by unapproved cannabis-derived products. NCL does not support legislation that seeks to bypass FDA’s authority and circumvent the scientific rigor of an FDA review.
Under current law, manufacturers and distributers of CBD products can already petition the FDA to review and approve a new ingredient for use as a dietary supplement (21 U.S.C. 350b). For FDA approval as a dietary supplement or new ingredient, manufacturers and distributors are required to submit scientific data, including any published studies, to provide a basis to conclude that a product is generally regarded as safe (GRAS). Unfortunately, there is a disconcerting lack of research and data about the safety of CBD products already in the market, whereby millions of consumers are using to self-treat serious and life-threatening ailments.
In response to the proliferation of unreviewed and untested CBD products in the market, NCL launched the Consumers for Safe CBD program to provide greater education to consumers about CBD. As demonstrated in a white paper published by NCL, cannabis companies tend to focus their research efforts on inexpensive, low-strength studies that are ultimately used for marketing purposes, not to enhance scientific knowledge or bring new proven therapies to patients. HR 1879 would further incentivize CBD manufacturers to forego the more rigorous and costly clinical trial process for developing an FDA-approved medicine.
NCL is concerned that CBD manufacturers and distributers making claims to treat certain medical issues will seek expedited approval of CBD products as a dietary supplement, instead of as a drug. Lawmakers should encourage the development of cannabis-based medicines that have undergone the rigor of randomized controlled clinical trials to learn more about how cannabis-derived therapies can both help and harm patients. This legislation seeks to fast-track the classification of CBD products as dietary supplements or ingredients without sufficient scientific data on their safety and efficacy, potentially placing consumers further at risk.
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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.
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) today applauded Delta Airlines and American Airlines for their decisions to end ticket changes fees. The decision, prompted by United Airlines’ decision on Sunday to end change fees, comes after nearly a decade of advocacy by NCL and other consumer organizations to put an end to such outrageous fees.
While the end of change fees at the Big Three airlines is a victory for consumers, the airlines continue to collect billions of dollars in add-on fees for services such as baggage, seat reservations, and early boarding. In addition, low-cost carriers like Spirit and Frontier and smaller airlines like JetBlue, Hawaiian, and Alaska continue to charge exorbitant change fees.
The following statement is attributable to National Consumers League Executive Director Sally Greenberg:
Following United’s lead, Delta and American have taken the right step for their customers by ending change fees. Consumers often need to change a ticket reservation due to circumstances beyond their control. We don’t think they should be penalized to the tune of hundreds of dollars when life’s uncertainties interfere with travel plans.
While Delta has committed to ending change fees permanently and American has agreed to also end change fees on some international flights, more needs to be done to ensure that change fees are consigned to the dustbin of aviation industry history. The commitment to not charge change fees should be included in all three airlines’ contracts of carriage, the legally binding document that underpins each ticket. Without this action, we fear that the airlines will simply slide back into their old ways when the economy rebounds from the COVID-19 crisis or when a new CEO takes over.
Congress should also continue to push for legislation like the FAIR Fees Act, which will promote transparency and fairness in the air travel marketplace for all consumers, not just customers of the biggest airlines. NCL will continue to advocate for such common-sense consumer protection legislation.
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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.
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, applauds United Airlines for its decision to permanently remove its $200 domestic change fee. The move comes after more than a decade of complaints by travelers and advocacy by consumer organizations like NCL who have urged the industry, the Department of Transportation, and Congress to rein in excessive, anti-competitive fees.
The following statement is attributable to National Consumers League Executive Director Sally Greenberg:
“We thank United Airlines for this bold policy change. United’s announcement is a victory for basic fairness in the air travel marketplace. The flying public has been beleaguered by hefty fees for everyday acts like changing an airline ticket, checking baggage, or reserving a particular seat on the plane. This comes at a critical time, as millions struggle financially due to the COVID-19 pandemic. United’s decision to end domestic change fees—and we take them at its word when it describes the change as permanent—is welcome news for airline passengers.
We also want to extend our thanks to fellow advocacy groups and pro-consumer Members of Congress like Sen. Ed Markey (D-MA), Sen. Richard Blumenthal (D-CT) and Rep. Steve Cohen who have fought for consumers in Congress by championing the FAIR Fees Act. This common-sense bill would require airlines’ add-on fees to be proportional to their actual cost.
United Airlines should be applauded for listening and responding to consumer advocates. NCL has long argued that change fees are an unnecessary and unfair money grab by the airlines, as it costs practically nothing to change a traveler’s reservation when the unexpected happens. We sincerely hope that other members of the airline industry, particularly the other two legacy carriers—American and Delta—will follow suit. Failing to do so will put them at risk of losing even more passengers to companies like United and Southwest that do right by their customers. NCL will continue to push for common-sense legislation that requires all airlines to resist using their considerable market power to gouge consumers on fees and penalties.”
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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.
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), the nation’s pioneering consumer advocacy organization, is today expressing concern about recent cuts to funding for the United States Postal Service (USPS) and the impact this has on consumers’ access to critical lifesaving medications.
The USPS has already suffered setbacks due to deteriorating financial conditions, and most recently the significant delays caused by the COVID-19 pandemic. The vulnerable agency is now caught in the middle of political strife as the President ponders withholding funding for the USPS in upcoming COVID-19 relief legislation, in order to impede mail-in voting. The USPS is an essential service, and consumers rely on these services daily to pay their rent, receive wages and Social Security checks, and most importantly, receive prescription medications via mail-order pharmacies.
These developments have grave ramifications for older Americans, and particularly veterans, of whom 80 percent receive their medications through mail-order pharmacies, 90 percent of which are delivered via the USPS. The Department of Veterans Affairs (VA) proprietary mail-order pharmacy system, the Consolidated Mail Outpatient Pharmacy (CMOP), consists of a group of seven automated hub pharmacies. The CMOP processes nearly 500,000 prescriptions daily, and ships packages to more than 330,000 veterans each working day.
The VA has stated that changes in the USPS have delayed medication deliveries by 25 percent in the last year, and has experienced an influx of mail-order prescriptions as entry to VA facilities have been limited to curb the spread of COVID-19. Veterans in rural or remote areas often rely exclusively on mail-order prescriptions, and as older Americans are cautioned to quarantine and social distance throughout the pandemic, ensuring timely access to medication is ever more imperative. The VA is currently rushing to mitigate potential delays by temporarily converting its deliveries from USPS to UPS 2nd Day Air or FedEx. Additionally, the VA will set up a specialized USPS code, to help prioritize veteran prescription deliveries.
The VA has advised patients to request refills for their medications at least 10 days before their treatment course ends, to ensure timely delivery of medications. Disruptions in medication deliveries caused by a lack of funding to the USPS could drastically impact overall health outcomes and medication adherence. As the country navigates the COVID-19 pandemic, it is crucial that our most vulnerable have timely and adequate access to the medications they need to maintain their health and avert potential progression of disease.
The National Consumers League stands with the United States Postal Service workers, as they tirelessly work to provide essential services during these challenging times. We call on Congress to hold the Administration accountable to ensure that consumers maintain access to the essential USPS services on which they depend.
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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.
As America’s premier consumer advocacy organization, with a rich history of fighting to make the marketplace fair, safe, and healthy for consumers, NCL is hard at work on the most important issues in food and drug safety and to collaborate on improving consumer education.
In recent years, NCL has been observing the CBD, or cannabidiol, marketplace exploding, with products lining shelves of grocery stores, specialty shops—even gas stations. Products were appearing to make many claims or hint at miracle cures, and most consumers had no idea how or whether the products were being regulated. Who is making sure these tinctures, oils, gummies, and lotions are safe, and do they do what they claim?
This is why last year, NCL joined forces with the Consumer Federation of America and the Community Anti-Drug Coalitions of America, to create a national campaign called Consumers for Safe CBD.
NCL had identified a serious need for greater education among consumers about CBD, and that’s why Consumers for Safe CBD was created. Consumers for Safe CBD aims to help educate the public about the risks related to untested, unapproved CBD products on the market, champion the rights of consumers, and call on the U.S. Food and Drug Administration (FDA) and industry to do better to ensure safety and promote a pathway for new products through clinically tested scientific research.
“Cannabidiol, commonly referred to as CBD, is being used in a growing number of consumer products and is illegally sold in stores and on the Internet,” said NCL Executive Director Sally Greenberg. “We’re working to educate consumers and ensure accurate labeling, clear guidelines, and further research to protect against unknown and known risks of CBD products.”
NCL and its partners continue to raise awareness among consumers, policymakers, and regulators about the health risks associated with the unregulated CBD marketplace, in particular with the unproven health claims and often inaccurate labeling of products on the market today. Beyond the known health risks associated with unregulated CBD, there are a number of unscrupulous marketing tactics that prey on unsuspecting consumers. This includes false and dangerous claims that CBD has medical benefits that can prevent and stop the spread of the COVID-19.
By warning consumers about these false claims, participating in media interviews and publishing op-eds across the country, highlighting important research and reports, and sending letters to several retailers, state Attorneys General and Members of Congress, the campaign is working to protect consumers across the country from unapproved and potentially dangerous CBD products.
“We need to better understand the potential health benefits of CBD, but this can only be accomplished through clinical testing and scientifically validated methodologies,” said Greenberg. “We need the FDA to step up for consumers and for the public health.”
The time for action is now. CLICK HERE for more information about the Consumers for Safe CBD effort.
By NCL Health Policy intern Talia Zitner
The past month has seen a serious surge in reported coronavirus cases in the United States. It seems the virus is going to be with us for a while. Of states where COVID is spiking, the majority are in the South, many of which had ambitious reopening plans that are now being reconsidered.
Three of these states—Texas, Florida, and Arizona—have current surges. All three pushed to reopen their economies early in an attempt to “return to normal.” The current deluge in cases that resulted was due to a lack of continuing stay-at-home order and a failure to require masks.
Texas officially started Phase 1 of its reopening plan on May 1, but—as of June 26—had to retract much of the opening that it had started. In total, Texas was only able to reopen the state for 55 days. As of July 27, Texas has seen an average of 8,089 new cases of the coronavirus over a seven-day period. Compared to cases in April, when there were 814, this is astounding. Texas Governor Greg Abbott (R) has since ordered everyone to start wearing face masks and has limited the size of public gatherings.
It does not appear that Texas will shut down again, however. As the governor said, “we need to refocus on slowing the spread, but this time we want to do it without closing down Texas again.” Although it is an issue of public health, the issuance of a statewide masking policy and the staggered re-opening of the economy has become a matter of contention across party lines. Some residents find the Governor’s actions to be inadequate, and others feel as if the newly implemented precautions impede their personal liberties.
Florida and Arizona are not faring much better. As of April, Florida had 1,027 cases reported. In July, it was 6,563. Florida started its reopening plan on May 4 and entered into Phase 2 on June 5. Clearly, cases have surged.
Earlier this week, Florida reported 8,892 new COVID-19 cases. Like Texas, there seems to be a mixed reaction among Florida representatives to slow the spread of the virus. Senator Rick Scott (R) has been vocal about his intentions for Florida, and it appears the state will not roll back any of its reopening course. As Senator Scott put it a couple of months ago, “wearing a mask is a choice you get to make.”
Like Texas and Florida, Arizona is hurting badly, with only 115 in April surging to 4,753 cases in July. Arizona’s stay-at-home order lasted until May 15, and was replaced by the new Stay Healthy, Return Smarter, Return Stronger Executive Order, on May 16. When Arizona first reopened, Governor Doug Ducey did not require residents to wear face masks, but as the case numbers increased, he allowed local governments to set their own masking policies. As of July 1, officials said that Arizona saw the highest rate of new cases in the entire country.
Many public officials are starting to realize opening too soon was foolhardy and has spread the virus. New revelations by scientists show the virus can actually be airborne, urging those to take indoor transmission more seriously. The virus is also proving to be more of a blood vessel disease than solely a respiratory one, which may lead to long-term impacts that doctors are still learning about.
There’s one takeaway here: following the example of states like Texas, Florida, and Arizona is not recommended. The more seriously states take this crisis the better, and the sooner the entire country will be able to move towards a newer, safer “normal”.
Talia is a Washington, DC native and a rising sophomore at Wesleyan University, where she is studying English. Beyond health policy, Talia’s interests are in journalism, law, and social justice.
Today’s economic news is grim. Nearly 40 million Americans have found themselves without employment due to the COVID-19 pandemic. For the newly jobless, state unemployment insurance benefits are a lifeline that helps them keep the lights on and provide food for their families. Unfortunately, the combination of billions of dollars in federal stimulus money flowing to state unemployment funds and the tens of millions of new claimants has created a once-in-a- lifetime opportunity for identity thieves: unemployment benefits scams.
According to the Secret Service and media reports, organized rings of criminals are working to siphon off unemployment insurance payments, potentially worth hundreds of millions of dollars, intended for workers who have been laid off due to the COVID-19 pandemic. In the state of Washington, for example, scammers reportedly made off with nearly $1.6 million in a single month. This scam is reportedly even affecting consumers who have not yet lost their jobs.
The recent spike in this type of scam is unfortunately not unique. 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. In today’s coronavirus environment, there is an unprecedented opportunity for criminals to use the public’s fears about the virus and the resulting economic downturn to defraud consumers.
Since the pandemic began, NCL’s Fraud.org project 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,” said John Breyault, director of NCL’s Fraud.org campaign. “We forecast these scams will continue to increase and evolve and are eager to get the word out about how Pennsylvanians can protect themselves.”
Over the last several months, NCL has devoted monthly Fraud Alerts to giving consumers the tools to spot and avoid some of the many types of scams related to COVID-19. Alerts have featured the most pernicious types of scams that are increasing due to coronavirus, ranging from job scams to increased reports of fraudulent robocall activity.
“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,” said Breyault. It’s estimated 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 Breyault. “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.”
In May, NCL hosted 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. NCL’s Breyault and AG Shapiro discussed what they are hearing from consumers, tactics for reaching the most vulnerable populations, and the importance of collaboration for getting key messages out to consumers.
“The work [NCL] is doing to get the word out is so important,” said General Shapiro. “There will be some people who hear my voice, and some people who hear your voice. But the key is that collectively we are warning people about scams and that we’re working together to share actual information—not myths—and not propaganda by one group or the other.”
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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