The boom in e-commerce has been a boon for fraudsters
The COVID-19 pandemic has greatly accelerated the growth of e-commerce…
The COVID-19 pandemic has greatly accelerated the growth of e-commerce…
By Sarah Robinson, Public Policy Manager
Earlier this month, NCL joined other consumer advocates and industry stakeholders in an event to highlight our consensus that Congress must act to create strong federal consumer privacy rights urgently. We joined colleagues at the 21st Century Privacy Coalition, the Business Software Alliance, and Common Sense Media in calling on Congress to commit to passing comprehensive privacy legislation by the end of the 117th Congress. In a virtual press conference, the groups, along with Rep. Jan Schakowsky (D-IL), Rep. Gus Bilirakis (R-FL), and Sen. Richard Blumenthal (D-CT) agreed that Congressional action to strengthen consumers’ privacy rights is long overdue.
The Washington Post Editorial Board highlighted our event stating, “the surprising degree of consensus around not only the general necessity of nationwide data protections but also the particulars” makes taking action a “no-brainer.” A *recent poll from Morning Consult revealed 80 percent of both Democrats and Republicans said Congress should make privacy a “top” or “important” priority in 2021.
There is bipartisan consensus and agreement from organizations across the spectrum that Congress must act. NCL’s message at the event is that it is now time to craft legislation that gives consumers back control over their personal data. At the event, Rep. Schakowsky, the chairwoman of the House Subcommittee on Consumer Protection and Commerce, announced her intention to hold a series of bipartisan roundtable discussions to examine ways to pass comprehensive privacy legislation. NCL is ready and eager to participate in those conversations to help ensure that a comprehensive bill gives all consumers strong, enforceable privacy rights.
While passing legislation this Congress is a priority, NCL made clear that we are not going to simply bargain away long held principles on data privacy. NCL believes that in order to protect the privacy and security of consumers’ personal data, the legislation must not preempt stronger state laws, must include strong enforcement provisions, including a private right of action and provide consumers with strong substantive privacy rights. The right legislation will include effective enforcement mechanisms that safeguard privacy rights for consumers and enshrine rules of the road for businesses.
We applaud Reps. Schakowsky and Bilirakis, and Sen. Blumenthal for their leadership and their commitment to continue fighting for comprehensive privacy legislation. We hope to continue to cooperate with this esteemed group as we work to achieve our shared goal.
*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings
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 Senate for voting to overturn the OCC’s “fake lender” rule, which allows predatory lenders to evade state interest rate laws by putting a bank’s name on the paperwork. In a 52 – 47 bipartisan vote this week, the U.S. Senate voted to approve S.J. Res. 15, a resolution under the Congressional Review Act (CRA), which was introduced by Senators Chris Van Hollen (D-MD) and Sherrod Brown (D-OH). Rep. “Chuy” García introduced a parallel resolution, H.J. Res. 35, in the U.S. House of Representatives. Now that the Senate has approved the resolution, the House needs to take swift action to stop the ongoing harm.
“We applaud this bipartisan rejection of rent-a-bank schemes,” said Sarah Robinson, NCL’s Public Policy Manager. “As consumers and small businesses look to rebuild from the devastation of the coronavirus pandemic, they must be protected from predatory lending. We now urge the House to move with urgency to prevent this rule from continuing to do harm.”
NCL was part of a broad coalition of more than 375 organizations representing all 50 states and the District of Columbia calling on Congress to overturn the “fake lender” rule, which threatens to harm consumers nationwide.
The rushed “fake lender” rule took effect in December and was issued by the Office of the Comptroller of the Currency (OCC). The rule protects “rent-a-bank” schemes whereby predatory lenders (the true lender) launder their loans through a few rogue banks (the fake lender), which are exempt from state interest rate caps. The rule overrides 200 years’ worth of case law allowing courts to see through usury law evasions to the truth and replaces it with *a pro-evasion rule that looks only at the fine print on the loan agreement. Predatory lenders charging 100 percent to 200 percent APR are already starting to push high-cost installment loans across the country that exceed the rates permitted under states’ laws.
A broad, bipartisan cross-section of experts and officials have called on Congress to repeal the fake lender rule. They include a bipartisan group of 25 state attorneys general, concerned the rule would effectively gut their state usury laws. The Conference of State Bank Supervisors, National Association of Consumer Credit Administrators, National Association of Federally-Insured Credit Unions, and many other groups also support Congress overturning the rule.
According to national polling, two-thirds of voters (66 percent) are concerned about the ability of high-cost lenders to arrange loans through banks at rates higher than the state laws allowed.
*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings
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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.
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) supports Peloton Interactive Inc’s decision to recall its Tread+ treadmill.
“The company has finally come to its senses and agreed to recall its treadmill, which has been caused deadly injuries to children,” said NCL Executive Director Sally Greenberg. “Use of Peloton’s Tread+ exercise machines resulted in at least 72 reports of injuries, including the death of a 6-year-old boy.”
There were also 29 reports of children suffering broken bones, cuts, and abrasions. The agency that regulates these products, the Consumer Product Safety Commission (CPSC), took the unusual step of issuing an administrative subpoena in April when the company refused to provide information about the fatal injury to a child.
“It’s critically important that the company work with the CPSC to recall 125,000 treadmills, at no cost to customers, and safely replace or repair the treadmills so they no longer pose a threat to children or pets,” Greenberg said.
The recall agreement was accepted Wednesday morning in a vote by the Commission. The agreement requires Peloton to halt sales of the Tread+ machine and fully refund consumers who wish to return their equipment.
Greenberg also pointed out how problematic CPSC’s rules are for launching a recall like this one and called on Congress to amend its statute. “We agree with Acting Chair Robert Adler’s assessment that the CPSC faces nearly insurmountable hurdles in protecting the public because, under its statute, the Commission is required to negotiate at length with companies before it is allowed to issue any safety warnings. No other federal safety agency is under such restrictions. That needs to change for the safety of the public.”
To read our previous statement concerning the Peloton Tread+ recall controversy, click 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.
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, founded in 1899 to advance the needs of consumers and workers, is backing three important federal bills aiming to even the playing field between workers and employers. The three pieces of legislation—the Protecting the Right to Organize Act (PRO Act), the Farm Workforce Modernization Act (FWMA), and the Public Service Freedom to Negotiate Act—would strengthen labor laws and give workers greater opportunities to organize and form unions, protecting the most vulnerable in our labor force.
“Decades of industry lobbying have made it increasingly difficult for workers to organize,” said NCL Executive Director Sally Greenberg. “Employers enjoy unprecedented and unfair advantages during union organizing drives, which has led to far fewer opportunities for workers to make their voices heard in the workplace. NCL is pleased to support several legislative initiatives that would help right the course for America’s workers.”
According to a recent Gallup Poll, roughly two-thirds of Americans approve of unions—a number trending upwards up from about half in 2009.
“Consumers are recognizing that they are harmed when workers do not have a strong voice,” said Greenberg. “Industry abuses are more likely to go unchecked, resulting in unsafe and dangerous products making it to the marketplace. And when workers are fairly compensated on the job, they can afford to buy the products they create, stimulating further demand that benefits the economy.”
About the bills
The Protecting the Right to Organize Act (PRO Act) would enhance collective bargaining rights, impose penalties on employers if they retaliate against workers who are trying to organize, and update labor laws to protect workers. The bill passed in the House of Representatives with bipartisan support this spring on a 225-206 vote. The bill currently awaits action in the Senate. Of 50 Democratic and independent Senators, 45 are currently committed to supporting the bill. If the Senate passes the bill, President Biden has pledged to sign it.
NCL strongly supports the PRO ACT and urges the Senate to swiftly pass this important measure.
The Farm Workforce Modernization Act (FWMA) passed the House October 30, 2019, and was the product of bipartisan negotiations between leading Democrats and Republicans to modernize laws and treat with dignity and fairness our 2.4 million farmworkers, half of whom are undocumented immigrants. On March 18, 2021, the Farm Workforce Modernization Act, H.R. 1603, passed the House again by a bipartisan vote of 247-174, with 30 Republicans joining Democrats in support. H.R. 1603, like the earlier version of the legislation.
“America’s farms and food systems depend on immigrants who pick our crops. But because so many don’t have legal status, they live in fear of deportation and cannot challenge illegal or unfair treatment in their jobs or in their communities,” said Greenberg. “FWMA provides a path to lawful permanent residency for these workers. Under the bill’s provisions, farmworkers would be able to improve their wages and working conditions and seek enforcement when their rights are violated. It also makes America more food-secure by ensuring that farmers have workers to harvest their perishable crops.”
The FMWA is a pro-consumer, pro-worker, and pro-agriculture bill that NCL strongly supports. NCL urges the Senate to pass this legislation and send it to President Biden’s desk for his signature.
The Public Service Freedom to Negotiate Act (PSFNA, HR 3463 and S 1970), would set a minimum nationwide standard of collective bargaining rights that all states would have to provide to state and local workers.
There are nearly 17.3 million public sector workers across the country. Unlike private-sector workers, there is no federal law protecting the freedom of public sector workers to join a union and collectively bargain for fair wages, benefits, and improved working conditions.
Currently, 20 states do not provide all state and local public sector workers the ability to collectively bargain for fair wages and benefits.
Among the bill’s provisions is a requirement that public sector employers recognize labor unions chosen by a majority of the employees voting, and that they bargain with the labor organization over wages, hours, and other terms and conditions of employment. If states fail to meet these standards, the bill gives the federal government the authority to intervene on behalf of public-service workers, ensuring their rights to form a union and negotiate with their employer.
NCL strongly supports the Public Service Freedom to Negotiate Act and urges swift Congressional action in both the House and the Senate so that President Biden can sign the bill into law.
“America would be unrecognizable without the gains made by working families and unions,” said Greenberg. “The movement needs an even playing field to do its job. These three bills are a good start, and NCL is proud to support each of them.”
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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 23, 2021
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC—The National Consumers League (NCL) is deeply disappointed with today’s Supreme Court ruling in AMG Capital Management, LLC v. Federal Trade Commission. For decades, the Federal Trade Commission (FTC) has relied on section 13(b) of the FTC Act to seek restitution for victims of fraud. The court’s decision in this case undermines that authority, making it significantly more difficult for the Commission to provide relief to consumers who are defrauded by scam artists and companies engaged in unfair or deceptive business practices.
The following statement is attributable to NCL Vice President of Public Policy, Telecommunications and Fraud John Breyault:
The Court today put the interests of a convicted scammer above the needs of fraud victims. We are incredibly disheartened at the decision to deprive the FTC of one of its most effective tools for clawing back criminals’ ill-gotten gains. This decision will embolden the criminals who annually defraud millions of consumers, costing them billions of dollars and untold emotional damage. We hear practically every day from victims of scams whose financial lives have been ruined by scammers. Consumer need and deserve a consumer protection agency empowered to make them whole. Congress should urgently pass legislation restoring the FTC’s 13(b) authority to obtain compensation on behalf of fraud victims.
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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.
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 is advising consumers to stop using Peloton treadmills and is calling on Peloton to immediately recall its Peloton Tread+ treadmill exercise machine. According to recent reports, the product poses a danger to children and pets — including a child death — in what has been described by the Consumer Product Safety Commission (CPSC) as a “different hazard pattern than is typically seen.” The CPSC learned that there were dozens of such incidents and issued a safety warning over this past weekend, saying it “found that the public health and safety requires this notice to warn the public quickly of the hazard.” The CPSC also took the unusual step of issuing an administrative subpoena to require Peloton to disclose the name of the child who died.
“This pattern of injury and death is not acceptable, and it is wrong for Peloton to blame user error,” said NCL Executive Director Sally Greenberg. “The CPSC shouldn’t have to subpoena a company for information about a child who died using its product. The company should be working closely with the federal safety agency with jurisdiction over these products. Dozens of children getting dragged under a Peloton Treadmill and sustaining grave injuries or death requires immediate action by the company. Peloton should recall these Treadmills at no cost to customers and either redesign them to prevent hazards or stop selling the product altogether.”
Peloton is a $34 billion company predicted to double in value by 2024.
“The CPSC and the company must work together to expedite a recall and get these products out of people’s homes. These injuries are certainly foreseeable, and we thank Senator Richard Blumenthal (D-CT) and Congresswoman Jan Schakowsky (D-IL), both of whom chair consumer subcommittees in Congress,” said Greenberg. “We agree with Senator Blumenthal, who called on Peloton to ‘immediately cooperate with the CPSC to recall its dangerous and deadly treadmill. Amid dozens of incidents of hurt kids and pets — with broken limbs, brain injuries, and death after being pulled underneath the machine — it’s clear that the Peloton Tread+ must be recalled.’”
Earlier this month, Congresswoman Schakowsky asked the CPSC to investigate earlier in April, noting: “With families spending more time at home and together, home exercise equipment dangers are especially worrisome, and any potential risks to consumers and their families must be carefully scrutinized. The CPSC must be able to act nimbly in identifying and responding to emerging hazards. In addition to the absence of publicly available information about the child fatality, other publicly reported incidents involving the same treadmill model suggest potential obstacles preventing the Commission from taking swift action to protect the public.”
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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.
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 action by leaders of the House Commerce and Judiciary Committees calling on the Biden Administration to more actively enforce antitrust laws in the live events ticket marketplace. In a letter to Attorney General Merrick Garland and Acting Federal Trade Commission Chairwoman Rebecca Slaughter, Representatives Bill Pascrell, Jr. (D-NJ-09), Frank Pallone Jr. (D-NJ-06), Jerrold Nadler (D-NY-10), Jan Schakowsky (D-IL-09) and David Cicilline(D-RI-01) signed a letter urging the Administration to more aggressively police antitrust violations in the live event industry and, specifically, to revisit the Department of Justice’s 2010 consent order which allowed the Live Nation-Ticketmaster merger to move forward, and launch an investigation of Live Nation Entertainment’s potentially unfair, deceptive, and anticompetitive conduct. The following statement is attributable to John Breyault, NCL Vice President of Public Policy, Telecommunications and Fraud:
“As we emerge from the COVID-19 pandemic and live events begin again, we must use this moment to address longstanding competition and consumer protection issues in the live event industry. The Live Nation Entertainment conglomerate controls 80 percent of primary ticket sales while holding significant market share in other areas of the live event industry, including venue ownership, event promotion, artist management, and secondary ticket sales. We urge the Biden Administration to heed Congress’ demand for stronger antitrust scrutiny of the live event industry and Live Nation Entertainment, in particular. Reining in the abuses of a rigged ticketing marketplace is a critically necessary step to restore fairness for live event fans.”
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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.
By Sally Greenberg, NCL Executive Director
If the pandemic has taught us anything, it’s that threats to our health care system can change lives, both in our communities and around the world. We have learned the value of preparedness and that the ability to respond to massive, impactful events is not easy or without compromise. Thankfully, as summer nears, we see that gradually, countries around the world are in a much better place, thanks to access to vaccines and greater knowledge of how to diagnose and care for patients.
Certainly, we can hope that lessons learned from our recent experience with the COVID-19 pandemic will put us in a better position to identify and address a health issue before it develops to pandemic proportions. But I would urge us to remain vigilant. There are other threats to our health care system that exist and deserve attention…now. One major threat to world health delivery systems is about to have its moment: Antimicrobial Resistance (AMR).
Antimicrobials, which include antibiotics, are critical to maintaining our health. Chances are, in the course of the year, someone in your family will take an antibiotic for an ear infection, an abscessed tooth, a hip replacement, organ transplant, or cancer treatment. In recent years, we have learned that taking too many antibiotics can lead to resistance and therefore a loss of effectiveness. This is true, but it’s important to note that the antimicrobials used to treat resistant infections are much more intense and used in more extreme circumstances than the antibiotics most of us are familiar with.
Antimicrobials fight bacteria and other causes of serious infection and are often the last line of defense against fatal infection. Antimicrobial resistance needs to be taken seriously. The Centers for Disease Control and Prevention (CDC) estimates that approximately three million Americans suffer from AMR infections each year with close to 50,000 deaths annually. Other estimates have placed annual deaths from AMR at 162,000, which makes AMR the third leading cause of death in the U.S. today. Surprised?
Here’s what surprised me: there has only been one new class of antibiotics approved in OVER 30 YEARS. Think about that. We have seen game-changing progress in medicine and treatments for countless diseases and conditions, but not AMR. And then think about how many causes of infection have become resistant to the tools we have to fight them.
AMR is a complex problem that’s not going to be easily solved. It takes years and years and billions of dollars to develop a molecule to fight AMR. Today we are faced with a slim menu of therapeutic options now and we find ourselves years away from expanding those options. I fear that AMR may be our next worldwide health emergency and I am not alone: The World Health Organization (WHO) lists AMR as one of the top ten health threats today. Sadly, it’s not a matter of “if”…but rather “when”.
Medicines don’t work forever. With the limited number of effective antimicrobials, we are looking straight down the barrel of the next health emergency. It’s difficult to even contemplate pivoting from all that we have been through with COVID to a new focus on something else equally frightening, but history tells us that being unprepared comes at a heavy cost. And being prepared is exactly what we need to do.
By NCL Director of Health Policy Jeanette Contreras
As consumers, when we go to the pharmacy for our medications, we expect a fair price. However, there’s growing evidence that pharmacy benefit managers — or PBMs — have been impeding the savings that should be going to consumers. Consumers deserve to share in the cost savings, and we need policymakers to step in and help make that happen.
We previously wrote about our disappointment in how PBMs have evolved from once honest brokers to becoming profit driven and greedy, now taking savings away from consumers and patients.
One avenue PBMs use to pocket savings is through pharmaceutical rebates. PBMs negotiate with companies to lock in discounts for drugs in order to secure the drugs’ placement on a list (formulary). PBMs have notoriously leveraged formularies to give greatest access to the drugs that pay the PBMs the largest rebates, leaving less expensive drugs off-limits to consumers.
A recent Senate Finance Committee report found that rebates to PBMs have significantly increased since 2013 (some as high as 70 percent). But these discounts fail to lower the patients’ out-of-pocket costs for necessary treatments, such as insulin. For one product, the manufacturer offered the PBM a 56 percent rebate – which means more than half of the savings for insulin are going to a company that doesn’t even make the lifesaving medication.
Insulin is expensive. Forbes recently reported that newer versions cost patients between $175 and $300 a vial. The story points out diabetes patients need multiple vials, the cost of which add up quickly; the total annual value of rebates and discounts for PBMs is likely to be more than $5,000 per patient. As a result, consumers lose, paying more than many of them can afford for lifesaving drugs.
Another way PBMs profit is by avoiding competition, which would drive value and savings for consumers. Three main PBMs accounted for about 60 percent of all U.S. prescription claims in 2019. And when it comes to insulin, with so few industry players, it’s no surprise that consumers again find themselves on the losing end.
We’re pleased to see that some policymakers in the states are taking steps to address these issues. In New Jersey, the state is shaking things up by creating alternatives to how it contracts with PBMs — which is, in turn, increasing competition and benefitting consumers. New Jersey residents are saving a bundle (to the tune of $2.5 billion over five years).
In New Hampshire, a recent study shows that the state can expect to save an estimated $17.8-$22.2 million annually thanks to legislation that will utilize a similar competitive PBM contract process.
While this is encouraging news, there is still more work to be done to bring to light the role of PBMs. Policymakers need to step in to ensure PBMs deliver savings to patients as they were originally intended to do. We’re encouraging state and federal action to review the role PBMs play in driving up costs and to address the many loopholes they use to increase profits.
Consumers — not PBMs — should come first at the pharmacy counter. Reach out to your elected officials. Share this story on social media to help raise awareness. And stay tuned as we continue the conversation.
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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