NCL letter to Members of Congress opposing TPP – National Consumers League
September 7, 2016
Read the letter here.
September 7, 2016
Read the letter here.
August 26, 2016
Contact: NCL Communications, Cindy Hoang, cindyh@nclnet.org, (202) 207-2832
Washington, DC—The National Consumers League (NCL), the nation’s pioneering consumer and worker advocacy organization, founded in 1899, joins comments by other consumer groups in support of a rule proposed by the Consumer Financial Protection Bureau (CFPB) to limit the use of forced arbitration clauses by banks, credit card companies, lenders, and other financial services. Nearly 13,000 comments were filed with the CFPB on this important rule. NCL is a signatory to a letter signed by 281 consumer and labor groups praising the CFPB’s rule.
Sally Greenberg, NCL’s executive director, stated: “This rule will finally help to even the playing field and work to curb the worst abuses in the financial services marketplace. While we would like to see additional reforms to help restore consumer rights, promote transparency, and improve the market, we see this as a significant step forward in efforts to curb industry practices and make consumer financial markets fairer and safer.”
The Dodd-Frank Act required the CFPB to study the use of arbitration provisions, and the bureau produced a lengthy report in March 2015 to lay out the basis for its curbs. Based on the report, the CFPB unveiled its proposed rule to prohibit companies from putting forced arbitration clauses in new contracts that block consumer participation in class action lawsuits in May.
While the proposed rule does not bar all uses of forced arbitration, as NCL had hoped, the rule will make a meaningful difference in consumer transactions moving forward. NCL has long advocated against companies’ use of arbitration clauses, which are often found hidden deep in the fine print of consumer contracts and user agreements.
Forced arbitration clauses eliminate the rights of consumers to go to court over future disputes that they may have with the company. Instead of having the right to bring cases to a court of law before an impartial judge paid by taxpayers and have a case heard on a public record, consumers have to go before an arbitrator–who is often chosen from a list created by the company. The company can keep choosing that arbitrator for repeat business, so there’s an incentive for the arbitrator to favor the company. This arbitrator is not required to follow established law or procedure. The arbitrator’s decisions cannot be appealed, and are often kept secret.
“These clauses are found in nearly every conceivable consumer contract, including those for credit cards, bank accounts, mobile homes, nursing homes, wireless cell phone carriers, physicians’ offices, and many others,” said Greenberg.
The Federal Arbitration Act, a statute enacted in 1925, was designed so that businesses could elect to settle their own disputes out of court if they wished to do so. “It was never intended to be used to deprive consumers of their rights. Unfortunately, a conservative Supreme Court, often decided by a close 5-4 vote, has approved business’ use of these clauses in consumer contracts,” said Greenberg. “The law has been converted into a weapon against consumers to force them to ‘agree’ to give up their rights.”
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
August 15, 2016
Contact: Cindy Hoang, National Consumers League, cindyh@nclnet.org, (202) 207-2832
Washington, DC–Today the nation’s pioneering consumer advocacy organization, the National Consumers League (NCL), will submit comments to the U.S. Food and Drug Administration on the reauthorization of the Prescription Drug User Fee Act for fiscal years 2018 through 2022 (PDUFA VI). Founded in 1899, the National Consumers League has long been concerned with ensuring the safety of foods and drugs. Among NCL’s top priorities are ensuring the safety, effectiveness, and appropriate use of both prescription and over-the-counter (OTC) drugs, and medication adherence, which NCL has helped to advance through its Script Your Future Campaign.
“As PDUFA VI goes through the reauthorization process, NCL urges the FDA to remain mindful of the concerns expressed by some that because industry pays user fees, industry thereby controls the FDA’s agenda and process. It is critical for the agency to act independently of industry influence and to uphold its high standards for safety, efficacy, and quality of prescription drug products,” said Karin Bolte, NCL director of health policy, who will deliver a statement and submit comments on behalf of NCL today.
“NCL wants to be sure that in the quest to reduce barriers to new drug approvals, FDA does not lose sight of the importance of the agency’s mission of protecting and promoting the health of consumers and patients. The FDA must balance the needs of consumers who are concerned about serious side effects with the concerns of patients who may be facing a life-threatening illness where time is of the essence. However, even patients in great need may be harmed rather than helped by drugs that have been approved too quickly without adequate consideration of safety and effectiveness or toxic side effects.”
NCL’s full comments are available here.
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
August 11, 2016
Contact: Cindy Hoang, National Consumers League, cindyh@nclnet.org, (202) 207-2832
Washington, DC—In light of this week’s system-wide failure at Delta Airlines and subsequent cancellations of thousands of flights, the National Consumers League (NCL) today calls on Congress to investigate the lack of consumer protections when airlines suffer from widespread outages. The following statement is attributable to Sally Greenberg, executive director of NCL:
“It is outrageous that while airlines are enjoying record profits, they remain unable to provide the most basic level of customer service. Delta’s system failure that resulted in flight cancellations was compounded by ineffective interlining agreements between carriers, which left consumers stranded and without alternative transportation options. This failure is yet another example of how the lack of competition is harming consumers. It is up to leaders in Congress to hold the airlines accountable and to demand stronger consumer protections from industry and the Department of Transportation to not only ensure that this never happens again, but to also ensure that consumers receive the refunds they deserve for their canceled flights.”
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
April 20, 2016
Contact: NCL’s Cindy Hoang, cindyh@nclnet.org, (202) 835-3323
Washington, DC–The National Consumers League (“NCL”) and BBUSA Bakeries USA (“BBUSA”) are pleased to announce that they have resolved consumer-related litigation pending in the Superior Court of the District of Columbia, NCL v. BBUSA Bakeries USA, Case No. 2013 CA 006548 B. NCL and BBUSA recognize the importance of a focus on nutritional content in bread product offerings and ensuring that customers have nutritious options. Without admitting liability, BBUSA has agreed to provide additional disclosures on the back of product packaging and on the Thomas’® and Sara Lee® websites and to make a donation to Feeding America.
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
July 15, 2016
Contact: NCL Communications, Cindy Hoang, cindyh@nclnet.org, (202) 207-2832
Washington, DC—The National Consumers League (NCL) today welcomed the Federal Trade Commission’s (FTC) action to require fundamental restructuring and significant consumer redress as part of its settlement with multi-level marketing company Herbalife. In March 2013, NCL was the first consumer group to call on the Commission to investigate allegations that Herbalife was engaging in a sophisticated pyramid scheme. In March 2014, the FTC responded to calls from NCL and others by opening an investigation into the company’s conduct.
The following statement is attributable to NCL Executive Director, Sally Greenberg:
“The FTC’s action today addresses many of the concerns that NCL and other experts on pyramid schemes raised about Herbalife’s business practices. Specifically, consumers will benefit greatly from the settlement’s requirement that Herbalife base its compensation structure on verifiable retail sales to end-users of the product, not recruitment of new distributors. This is the core distinction, as enumerated by more than 30 years of case law, between a legal direct-selling company and a fraudulent pyramid scheme. The settlement’s requirement that at least 80 percent of product sales, companywide, must be made to end-users will further address concerns about a lack of retail sales to buyers outside the business opportunity. The FTC’s settlement will also address many of the blatantly unsubstantiated earning claims made by Herbalife’s distributors to entice new recruits to join the business opportunity and keep existing distributors paying to remain in the business opportunity. We look forward to the FTC’s forthcoming guidance to the direct selling industry as an opportunity to address the persistent lack of clarity that has characterized many industry practices.”
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
July 14, 2016
Contact: NCL Communications, Cindy Hoang, cindyh@nclnet.org, (202) 207-2832
Washington, DC—The National Consumers League (NCL), America’s pioneering consumer and worker advocacy organization, today released statements regarding the passage of two consumer-focused bills in the Energy and Commerce Committee of the U.S. House of Representatives.
NCL applauds the House Energy and Commerce committee’s passage of H.R. 5104, the Better On-line Ticket Sales (BOTS) Act of 2016, an excellent first step forward toward the goal of promoting a fair live event ticketing marketplace.
The following statement is attributable to John Breyault, the Vice President of Public Policy, Telecommunications and Fraud:
“The bipartisan BOTS Act represents an important first step in promoting a fair ticketing marketplace for all consumers. Prohibiting the use of ticket bots to electronically ‘jump the line,’ ahead of consumers patiently waiting to purchase tickets will help promote a fair live event ticketing marketplace for consumers. Although this bill’s passage is a significant win for consumers, this bill also represents a missed opportunity to protect consumers from unethical ticketing practices. Prohibiting bot usage alone as the BOTS Act proposes, only fixes part of the problem. To put more tickets in the hands of everyday fans at a fair price, the live event ticket market needs additional transparency to require disclosure of how many tickets actually go to general sale as well as greater consumer protections to help empower fans to make better purchasing decisions.”
NCL applauds the Commerce Committee’s bipartisan passage of H.R. 5111, the Consumer Review Fairness Act. H.R. 5111 will protect consumers’ First Amendment right to provide honest reviews of products and services without fear of legal retribution from merchants who hide behind non-disparagement clauses in their terms of service agreements.
The following statement is attributable to John Breyault, the Vice President of Public Policy, Telecommunications and Fraud:
“Consumers rely on honest product reviews to make many important purchasing decisions. Unfortunately, some merchants and vendors want to remove this quintessential American right of free expression by inserting so called “non-disparagement” clauses that threaten legal action against consumers who post negative reviews H.R. 5111 would nullify these ‘terms of service’ rules aimed at silencing honest feedback, allowing consumers to benefit from accurate reviews. NCL welcomes these protections.“
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
July 12, 2016
Contact: NCL Communications, Cindy Hoang, cindyh@nclnet.org, (202) 207-2832
Washington, DC–For decades, the National Consumers League (NCL) has been fighting to get nutritional information, specifically an “Alcohol Facts Label” on all alcoholic beverages sold in the US. Consumers very much want this information and have come to rely on nutritional facts labeling on foods they consume.
Consistent with this theme, NCL is pleased that a new initiative from the Beer Institute will mean that participating companies will display specific consumer information on products, packaging or websites. Entitled “Brewers’ Voluntary Disclosure Initiative,” the participants in the initiative make up 81 percent of the beer industry in the US. These companies will voluntarily include a serving facts statement on their products, and will disclose ingredients on either the label or secondary packaging via a list of ingredients, a reference to a website with the information or through a QR code.
“The Beer Institute initiative is a milestone; beer is the most popular alcohol beverage in the United States, and having nutritional information on beer labels is a game changer,” said Sally Greenberg, NCL’s Executive Director. “We applaud the Beer Institute’s leadership for rolling out the Brewers’ Voluntary Disclosure Initiative, which will list calories, carbohydrates, protein, fat and alcohol by volume on their beer products.”
The serving facts statement is consistent with the Alcohol and Tobacco Tax Trade Bureau (TTB) ruling 2013-2. In addition, participants in the voluntary agreement will provide freshness dating, and disclose ingredients via a list, a reference to a website with the information, or a QR code on the label or secondary packaging. Beer Institute member companies, including industry leaders such as Anheuser-Busch, MillerCoors, HeinekenUSA, Constellation Brands Beer Division, North American Breweries, and Craft Brew Alliance, have agreed to follow these standards. These companies together produce more than 81 percent of the volume of beer sold in the U.S.
While NCL applauds the Beer Institute’s initiative, Greenberg noted that there are some missed opportunities in the announcement: providing alcohol content information and acknowledging the validity of the standard drink definition, as defined in the US Dietary Guidelines issued by U.S. Department of Health and Human Services (HHS). Those guidelines provide consumers with equivalencies in comparing beer, wine and spirits. Namely, that the average 12 oz of beer, average 5 oz of wine, and average 1.5 oz of spirits all contain the equivalent amounts of alcohol. Given the many positive aspects of the Beer Institute’s initiative today, NCL is urging the industry to embrace this common-sense definition of a standard drink as well.
“Thanks to the leadership of the Beer Institute and its members, consumers can look forward to having much sought nutritional information available for the first time on the label of the beer they consume. This is an encouraging and welcome development,” said Greenberg.
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
July 1, 2016
Question 1: During the hearing, Commissioner Buerkle inquired whether the Active Injury Mitigation System (AIMS) technology could be used on all different sizes of table saws. You answered tentatively that you thought it could be used on all, but indicated that you would like to check and get back to CPSC on that.
NCL Response: AIMS technology is currently being used on both larger and smaller table saws. Indeed, one manufacturer, SawStop, is currently selling larger cabinet saws and smaller benchtop style jobsite saws, both with an AIMS design. Another manufacturer, Bosch, is currently selling benchtop style jobsite saws with an AIMS design. Hence, it is technologically and economically feasible to produce table saws in any size with an AIMS design.
It is very important that any table saw safety standard that CPSC promulgates include an AIMS requirement for all table saws. There are significant injury patterns associated with the use of each size of table saw—they all present an unreasonable risk to users, regardless of size. It is important to stress that the smaller benchtop saws, which are less expensive, are often used by consumers and hobbyists. For the same reasons that every passenger vehicle sold in the U.S., regardless of size or cost, must provide its occupants with adequate crash protection, so, too, table saws should provide all users with adequate protection from the foreseeable and all-too-frequent injuries from hand-blade contact. Table saw safety is not a luxury and should not be reserved only for users who can afford to buy larger, better equipped machines. It is important for hobbyists and less-experienced table saw users to have the same protection as users with more experience who might purchase bigger and more expensive table saws.
We recognize that adding AIMS technology to table saws will increase the price at retail. However, as consumers, we believe that, given the frequency and severity of injuries endured by consumers and other users over the past many years, the presence of AIMS is a significant value added to the product and to the overall well-being of society—the benefits far outweigh the costs. Moreover, as we have seen with many other product categories that have undergone significant safety improvements, once an industry begins to focus its expertise and technological prowess on compliance, the cost of such compliance will fall significantly.
In short, AIMS technology can be applied to all table saws regardless of size—and AIMS technology should be required for all table saws regardless of size.
Question 2: During the hearing, you commented that the UL Technical Panel on table saws is “heavily dominated by industry members” who have voted against AIMS requirements. My understanding is that even one of the strongest proponents of a particular mitigation technology voted against including it in the voluntary standard, and that the technology was also omitted from the recently updated IEC standard. Do these events suggest that industry’s representation on the UL panel is not the key issue?
NCL Response: The industry’s dominant control of the UL committee that votes whether to allow implementation of UL’s safety proposals is very much a key issue. When CPSC published its ANPR for table saws in October 2011, UL came to the commission in February 2012 and presented a plan for reducing the predictable injuries associated with table saw use by developing and adopting an AIMS requirement for use in its own table saw standard, UL 987. In essence, working with a special outside Working Group of technical experts, UL would direct its technical staff and test laboratories to develop the performance criteria and test methods needed to upgrade its standard for table saws that would greatly reduce the enormous risks associated with most table saws sold in today’s market. The final step would put the proposal to a vote of one of UL’s standing Scientific Technical Panels (STP).
Today, more than four years after UL made that commitment, its effort has ended in failure. To be clear, UL completed the research and developed the requisite performance criteria and test methods for an AIMS that it believed would reduce or eliminate the types of tragic injuries that occur by the tens of thousands each year. UL proposed including the AIMS requirement in the next version of its table saw standard. The decision-making mechanism for final acceptance of the proposal for its own standard was handed over to STP 745 for a vote.
For table saws, STP 745 was comprised of 21 voting members. Fifteen members are either employees of the table saw industry, former senior employees of the table saw industry, or staff of the industry trade association, the Power Tool Institute (PTI). The other six voting members represent consumers, specialty users, etc. After more than four years of research and laboratory testing, UL developed the performance criteria and test methods for including an AIMS requirement in its own standard, UL 987, the STP voted 14 to 7 against adoption. With the exception of SawStop, all the industry members and their surrogates voted NO. SawStop voted YES, as did the other six voting members of the committee, including the three consumer members and the UL member on the committee.
UL then made adjustments to its first AIMS proposal and proposed adoption of the second version. Again the industry and its surrogates voted NO via the same overwhelming bloc of votes, thus blocking the adoption of AIMS a second time.
Clearly, the composition of this committee overwhelmingly favors the industry perspective, and their unified stance on issues controls and dominates the outcome of the committee’s decisions. The fact that UL’s proposal to upgrade its own table saw standard with an AIMS requirement to protect consumers was summarily blocked by the industry is a prime example of how the application of the consensus process in practice can impede progress in matters of public safety.
In fact, many of the voluntary standards committees that deal with consumer product safety are severely imbalanced by a dearth of consumer and non-industry representatives, the predictable effect of which is that committee decisions are controlled by the interests of the industry. While the application of a balance of interests is the theoretical goal for consensus-based decision making, the reality is that far too often there is a tiny number—often zero—of consumers and non-industry members to balance, challenge, and negotiate with the industry members when the critical decisions are being made. Such circumstances leave the industry free to write standards that suit its specific needs, and then masquerade behind the banner of using a consensus process that offers the opportunity for balanced inputs.
The same structural flaw exists with international product safety standards. In this case, for example, the committee that controls the U.S. national position, and therefore its vote, on the IEC standard for table saws is comprised of most of the same industry organizations and surrogates as the industry bloc that controls UL’s STP, with virtually no consumer participation or input. Indeed, the U.S. committee is managed by the staff of the Power Tool Institute. Hence, the absence of an AIMS requirement in the “updated” IEC standard is entirely predictable.
In summary, the lack of committee balance to articulate the needs of consumers and other key safety-focused stakeholders cannot help but result in weak voluntary safety standards, especially where the industry chooses for whatever reason to resist making the changes needed to address serious injury patterns. The practical effect of relying on the voluntary consensus standards process is that it is virtually impossible to make progress to protect consumers from unreasonable risks unless the industry agrees to negotiate the issue in good faith.
Fortunately, in the long painful journey for table saw users where meaningful voluntary corrective action has been stalled for years, CPSC has the statutory mandate and the authority to intervene on behalf of consumers.
Sally Greenberg
NCL Executive Director
Karin Bolte
NCL Health Policy Director
June 21, 2016
The Honorable Paul D. Ryan
Speaker of the House
United States House of Representatives
H-232, The Capitol
Washington, D.C. 20515
The Honorable Nancy Pelosi
Democratic Leader
United States House of Representatives
H-204, The Capitol
Washington, D.C. 20515
RE: National Consumers League opposition to H.R. 5525, the “End Taxpayer Funded Cell Phones Act of 2016
Dear Speaker Ryan and Leader Pelosi:
On behalf of the National Consumers League,[1] I am writing today to share our concerns regarding H.R. 5525, the End Taxpayer Funded Cell Phones Act of 2016,” which is scheduled for a vote in the House of Representatives today. The bill, sponsored by Representative Austin Scott, would undermine the ability of the Federal Communications Commission’s Lifeline low-income subsidy program to meet the needs of millions of low-income consumers to access affordable broadband service. We know that the Internet has dramatically enhanced our society, but has also widened the opportunity gap between those who have broadband and those who do not in key areas such as employment, education and healthcare access. At a time when the Lifeline program is undergoing significant modernization, now is not the time to arbitrarily constrain its budget and prevent it from supporting mobile voice and broadband service. We therefore urge you and your colleagues in the U.S. House of Representatives to oppose this bill.
Organizations from across the consumer, public interest and civil rights communities support the transition of Lifeline to supporting broadband. NCL agrees; we recognize that supporting access to the Internet for low-income consumers is critical to addressing the persistent wage, education and opportunity gaps that exist in our society. As we noted in our filing to the FCC, employers and government agencies are increasingly shifting their application processes for essential benefits programs online to an effort to efficiency. Lack of access to broadband makes it harder for low-income consumers and their families to stay in touch with job opportunities, family support networks and educational institutions.
Government at all levels has historically supported programs that help low-income consumers access to critical infrastructure like water, electricity and telephone service. Broadband Internet access should be no different.
We urge you to oppose any effort to constrain the FCC’s goal of providing affordable broadband service to millions of low-income consumers. We welcome the opportunity to discuss this issue with you in more detail. Thank you for your time and consideration.
Respectfully,
John Breyault
Vice President, Public Policy, Telecommunications and Fraud National Consumers League
Phone: (202) 207-2819
Email: johnb@nclnet.org
cc: Members of the U.S. House of Representatives
[1] The National Consumers League, founded in 1899, is the nation’s pioneering consumer organization. Our non-profit mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit https://nclnet.org.
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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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