Consumer groups back FDA on NDI draft guidance

For immediate release: February 3, 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—While the Biden Administration reviews late-hour regulations enacted by the Trump Administration, one important FDA guidance related to CBD deserves further consideration. The U.S. Food and Drug Administration recently withdrew its pending CBD guidance, which the agency had submitted last summer. These highly anticipated guidelines were meant to elaborate on FDA’s CBD enforcement policy as unregulated, untested CBD products continue to infiltrate the consumer market. The FDA has not yet shared a timeline for re-submitting the CBD guidance.

NCL launched Consumers for Safe CBD in 2019 to encourage the FDA to use its existing authority to curtail the proliferation of potentially dangerous, unapproved CBD products and to incentivize CBD research, clinical trials, and the creation of science-based CBD medicines.

NCL Executive Director Sally Greenberg released the following statement in response to the FDA pulling its guidance:

The early weeks of 2021 have brought about many changes – with a new Administration, a new Congress, and continued progress in the fight against COVID-19,  there is hope for a safer, healthier future. NCL will continue to do its part to protect consumers and promote public health.

Unfortunately, CBD manufacturers continue to make unsubstantiated medical claims about their products, putting consumers at risk. We remain hopeful that the FDA and the Biden Administration will join us in our efforts to protect consumers from the potential dangers that exist in the current unregulated, wild west CBD marketplace.

NCL urges the FDA to re-circulate an updated proposal that encourages further research into CBD and the development of science-based CBD medicines and uses the FDA’s authority to regulate the CBD marketplace to protect consumers from CBD products that may put them at risk. Consumers deserve a safer, healthier future. We simply cannot abandon this work now.

To learn more about NCL’s Consumers for Safe CBD campaign, click here. To learn more about FDA’s recent efforts related to CBD, click here.

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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.

The Board and staff of the National Consumers League expresses condolences to Congressman Raskin on loss of his beloved son

For immediate release: January 7, 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 wishes to express our deepest condolences to our dear friend and colleague, Congressman Jamie Raskin (D-MD) and his wife, Sarah Bloom Raskin, on the tragic loss of their beloved son Tommy on New Year’s Eve.

Tommy was a wildly creative, energetic, passionate, brilliant young man with a wonderful sense of humor and so much promise. He was a treasured son, brother, grandson, cousin, and friend to so many. We mourn the loss of this outstanding young man. Tommy left this world far too soon, but we know that because of him, the world is a better place.

Once again, our hearts break for Tommy’s parents, sisters, and friends. Our thoughts are with the Raskin family during this terrible time.

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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.

National Consumers League applauds Congress for surprise billing protections for consumers

For immediate release: December 22, 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 welcomes the inclusion of long-needed surprise billing protections in the COVID Relief Omnibus Spending Bill.

Surprise billing happens when a patient’s insurance doesn’t cover a procedure provided by an out-of-network physician, something patients don’t know or realize when they get a procedure. An estimated one in five emergency visits and one in six inpatient admissions will trigger a surprise bill, which can run into the thousands of dollars.

Medical debt disproportionately drives people into bankruptcy. Bill collectors and hospitals often layer on fees, interest, and penalties, driving the original costs way up. A 2019 study published in the American Journal of Public Health found that 530,000 bankruptcies filed annually are because of debt accrued as a result of treatment for medical illness.

This statement is attributable to NCL Executive Director Sally Greenberg:

“We greatly appreciate the bipartisan leadership of Senators Maggie Hassan (D-NH) and Bill Cassidy (R-LA) in getting the surprise billing language over the finish line. We also thank House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR), Senate Health Committee Chairman Lamar Alexander (R-TN), and Ranking Member Patty Murray (D-WA) for their early leadership on this issue. This is a shining example of working across the aisle for the betterment of consumers.

Consumers can breathe a huge sigh of relief because under the bill—including the cost of an air ambulance—consumers will be ‘held harmless’ when exposed to out-of-network costs. Once this bill is law, consumers can expect that fees charged will be far more affordable and predictable at in-network rates. We are grateful to Congress for recognizing surprise billing as a predatory practice from which consumers need protection. The committee leadership not only helped to pass a bill but launched an investigation.

After two years of debate and discussion on how health care providers and health plans will negotiate these extra costs, it was agreed that patients should be taken out of the middle of dispute resolution processes. Now, we finally have a workable system for protecting consumers.”

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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.

NCL testified before CDC committee on COVID-19 vaccine recommendations

For immediate release: December 22, 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) testified before the Centers for Disease Control and Disease Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) this weekend on the equitable distribution of the Moderna vaccine and recommendations for consumer education on vaccine safety. In its testimony, NCL applauds the transparency and access afforded to the public throughout the COVID-19 vaccine approval process.

Equitable distribution:

NCL is encouraged that the Food and Drug Administration (FDA) has approved the Moderna vaccine and that the U.S. government will lead distribution efforts. Due to its ease of transport and storage, the Moderna vaccine stands to readily ship to rural and hard to reach communities. NCL calls on federal health officials at the helm of distribution to facilitate access to the Moderna vaccine to medically underserved areas.

Safety and efficacy:

NCL expressed its trust in the FDA and CDC’s robust inter-agency collaboration to continue ongoing, post-market surveillance of adverse events among recipients of the COVID-19 vaccine and to inform consumers of any additional safety recommendations. NCL urged the CDC to educate consumers about potential reactions and side effects, as this transparency will further encourage the compliance necessary to achieve herd immunity. The vaccine is expected to induce flu-like symptoms after the initial dose and this may deter some patients from getting their second dose if they aren’t warned about what to anticipate.

Vaccine adherence:

NCL encouraged the CDC to conduct culturally competent and inclusive public messaging about vaccine safety to ensure that communities of color and persons with limited English proficiency are informed and feel empowered in their decisions to vaccinate. Adding to the complexity of administering the vaccine, public health officials will need to ensure the completion of two doses in a series. This stands to create additional challenges because evidence has shown that when a vaccine involves multiple doses, nearly 50 percent of patients fail to return for a second dose.

Equitable allocation:

NCL applauds ACIP’s recommendations to prioritize vaccinations for health care workers and long-term care facility residents in Phase 1a. Now that there are two approved vaccines, NCL calls on ACIP to prioritize recommendations to vaccinate the approximately 87 million non-healthcare essential workers unable to work from home—such as bus drivers and grocery workers—who are at higher risk of exposure. Racial and ethnic minorities make up more than 40 percent of the essential workforce and are the backbone of many essential industries. The pandemic has illustrated that low-income minority communities experience more severe COVID-related illness requiring hospitalization and are at higher risk for death.

Persons who recovered from COVID-19:

Lastly, over 18 million individuals in the U.S. have been infected with the coronavirus. It is expected that individuals who recover will acquire some natural immunity to COVID-19. Individuals who recover from the coronavirus want to know if they are protected from reinfection and for how long. We call on the CDC to expedite developing vaccine recommendations for persons who’ve recovered from COVID-19.

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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.

NCL statement on White House pressure to approve COVID-19 vaccine

For immediate release: December 11, 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 – In just a matter of days, we could potentially have an FDA-approved COVID-19 vaccine ready for rollout. Now more than ever, the public needs to see the evidence of a transparent and deliberate process to ensure the safety of a vaccine. NCL has actively participated in the vaccine approval process, testifying before the Centers for Disease Control and Prevention and the Food and Drug Administration’s (FDA) vaccine advisory committees to ensure that the nation’s most vulnerable consumers are considered at each step of the approval process. The race to a vaccine is a critical one, consumers should not be discouraged by the careful deliberation of the States’ vaccine approval process, but should instead be encouraged that the U.S. is following deliberate, well-established protocol to vet and review the data. 

NCL is amongst the stakeholder groups advocating for increased scrutiny of the data, particularly citing reports from the U.K. about adverse reactions to the Pfizer vaccine among people with severe allergies. We expect that the FDA will be aware of these concerns and call on the agency to perform ongoing post-market surveillance to ensure public safety. Consumers should rely on continuous guidance regarding potential adverse events, as this will be critical to ensuring vaccine confidence. 

NCL has continually recognized the integrity of the career-scientists at the FDA who are entrusted with ensuring the safety of the U.S. drug supply and applaud their demonstrated commitment to fostering public trust throughout the COVID-19 vaccine development, evaluation, and approval processWe have great confidence in the FDA’s rigorous approval methods and trust that the agency will issue an Emergency Use Authorization only after careful consideration of the available safety and efficacy data.

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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.

NCL testified before FDA committee meeting on Pfizer-BioNTech COVID-19 vaccine

For immediate release: December 11, 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) testified before the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) this week regarding the Pfizer-BioNTech COVID-19 Vaccine.

“As the nation’s oldest consumer advocacy organization, NCL has been encouraged by the honesty, transparency, and access afforded to the public during this critical time.” NCL commended the Food and Drug Administration, Centers for Disease Control and Prevention, and other public health entities for their commitment to fostering public trust throughout the COVID-19 vaccine development and approval process and thanked the committee for the opportunity to speak.

In its testimony, NCL noted that there has never been a more critical time for consumers to have confidence in the FDA.

Emergency Use Authorization (EUA):

The FDA has undergone scrutiny from the scientific community for prematurely issuing EUAs for COVID-19 therapeutics. NCL is aware that developing a vaccine for COVID-19 is a time-sensitive priority and appreciates that the FDA recognizes that an EUA is not intended to replace long-term randomized clinical trials data associated with full FDA approval. We are encouraged by data reporting a consistent vaccine efficacy rate of 95 percent across age, gender, race, and ethnicity demographics and look forward to seeing more guidance around the vaccine, as the trial continues to collect safety and efficacy data.

Safety and Effectiveness:

NCL noted the public’s growing trust in the FDA’s rigorous vaccine approval process and called on the agency to perform ongoing post-market surveillance. Such surveillance performed in the United Kingdom found that the vaccine may be unsafe for individuals with severe allergies. Consumers will rely on ongoing guidance from public health agencies regarding any potential adverse events from the vaccine and expect that the FDA will be aware of these concerns.

Innovative Vaccine Delivery Systems:

Additionally, ensuring innovative vaccine delivery methods, such as including oral or nasal options, could address geographical access issues, diverse health needs, and increase uptake overall.

Diversity in Clinical Trials:

We applaud Pfizer’s efforts to ensure diversity in their COVID-19 vaccine clinical trials. NCL requests that the FDA continue to prioritize vaccine clinical trial data that reflects diversity, as people of color will need to have confidence in the vaccine’s efficacy. This will affect the overall uptake of the vaccine.

The development of a COVID-19 vaccine in such a short time frame is a huge scientific feat, made possible through robust collaboration between private and public entities. NCL will continue to support the FDA and CDC in efforts to release a COVID-19 vaccine safely and expeditiously.

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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.

National Consumers League Expresses Concern Over Amy Coney Barrett Confirmation

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 next three weeks will be critical for the American people. Amid a global pandemic, a historic presidential election, and the attempt to fill an equally historic Supreme Court vacancy, there’s a lot at stake for health care. On October 26, the Senate will vote on Judge Amy Coney Barrett’s nomination to succeed the late Justice Ruth Bader Ginsburg on the US Supreme Court. On November 10, merely a week following the presidential election, the Supreme Court of the United States (SCOTUS) hear arguments in the case of California v. Texas, the latest challenge to Patient Protection and Affordable Care Act (ACA), more commonly called Obamacare.

The rush to fill Justice Ginsburg’s seat on the Court on the eve of this election has worried health advocates and consumers alike, as a conservative majority court could potentially overturn the ACA. Conservatives have been hostile to the law, and Coney Barrett, herself an arch-conservative, seems to share that very hostility toward the ACA. This is illustrated by her disapproval of Justice John Roberts Jr.’s support of the ACA in a 2017 essay. In it, Coney Barrett wrote that Justice Roberts had “pushed the Affordable Care Act beyond its plausible meaning to save the statute.”

In 2017, the strife between Democrats and conservatives worsened when the individual mandate provision of the ACA was found unconstitutional. Following that ruling, conservatives have tried to grasp at opportunities to repeal the entire law, including arguing for severability. Severability of the individual mandate provision, as explained by Justice Roberts, would allow the Court to excise the provision with “a scalpel rather than a bulldozer.” Severability would still maintain the ACA as the law of the land and would save access to healthcare for over 20 million Americans. But the plaintiffs, all Republican Attorneys General from across the country, have argued that the individual mandate cannot be severed and if it goes down, the whole law falls.

Although Coney Barrett was reticent during the Senate Judiciary Committee hearings, her record serves as a warning about how she will come down on a host of consumer health issues. These include reproductive decisions granting women agency over their bodies and the freedom to choose how they form families. Based on her prior endorsement of the anti-choice organization Right to Life and her public support of overturning Roe v Wade, there is cause for concern that medical interventions like contraception, abortion, and even in-vitro fertilization (IVF), could all be at risk following Judge Barrett’s appointment to the high court.

Aside from reproductive issues, there are countless health care protections on the chopping block pursuant to the ACA deliberation. Below are a few at risk if the ACA is overturned:

The stakes are high. If the ACA is overturned, COVID-19 could be considered to be a pre-existing condition. The pandemic has laid bare deep structural inequities; stripping away coverage during such dire times would be unconscionable.

There are a few ways the Supreme Court could rule on the case come November 10.

  • If Coney Barrett is not sworn in before the oral argument, the Court could vote on the case with an 8-member court, leading to a potential tie. If tied, the case would be returned to the original trial judge for further analysis – meaning that in the interim, the ACA would remain the law of the land, ensuring protections for millions.
  • The Court may still rule in favor of salvaging the ACA. Many scholars deem the plaintiffs’ arguments to be legally weak. This is where the argument of severability comes in.
  • Finally, if a new justice is appointed to the Court and there is a majority vote to overturn the ACA, it may be overturned. The ACA is an extraordinarily complex and comprehensive law, and this result would wreak havoc across virtually every area of health policy.

Over the next few weeks, the health and civil liberties of millions of Americans will hang in the balance. NCL does not support Judge Amy Coney Barrett’s nomination. Justice Ginsburg was a champion of rights and protections for consumers and women and a strong defender of the ACA. Confirming a justice for the Supreme Court with Coney Barrett’s record before the election has the potential to endanger lives already vulnerable during this pandemic. We simply cannot afford to throw consumers’ health care into such chaos and uncertainly during this COVID-19 pandemic.

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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.

New report: COVID-19 pandemic highlights need for White House Consumer Advocacy Office

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 protection of consumers during the COVID-19 pandemic and beyond will require the next Administration to reestablish the White House Office of Consumer Affairs (WHOCA). The National Consumers League is calling for the restoration of the WHOCA to elevate the interests of consumers to the highest levels of government, including access to the Oval Office. For decades, WHOCA gave consumers a voice within the Administration and coordinated consumer protection activities across the U.S. government. Such leadership will be sorely needed to rebuild consumers’ confidence in the government’s ability to protect them from industry abuses.

In a new report, COVID-19 and the Impact on Consumers, the National Consumers League examines how consumers have been harmed by price gouging, fraud targeting stimulus checks, anti-worker practices, and a sharp dip in confidence in testing and vaccines since the COVID-19 pandemic began. The report also highlights legislation from the 116th Congress that advanced consumers’ interest and should be at the top of policymakers’ agendas next year.

“The COVID-19 pandemic has thrown into stark relief the impact of years of hollowing-out of our nation’s consumer protection agencies,” said NCL Executive Director Sally Greenberg. “With this report, we hope to shine a light of consumer protection policies that should be embraced over the next four years, regardless of which party comes out ahead in November.”

Issues covered in the report include:

  • Price gouging and profiteering – Congress should act to rein in price gouging on personal protective equipment. Refunds for cancelled or postponed flights and live events should be required to be provided quickly to consumers.
  • Scams targeting stimulus funds – An estimated $8 billion in unemployment insurance funds have been lost to scammers since the beginning of the COVID crisis. Many millions more in stimulus checks and other COVID relief may have also been diverted. In any future stimulus legislation, Congress must act to ensure that a second wave of scams targeting such relief funds do not deprive consumers of desperately needed support.
  • Restoring confidence in COVID-related health care – NCL has strongly urged public health agencies to increase and enhance infrastructure regarding vaccine confidence and has called for effective public messaging and strong vaccine recommendations to ensure that the American public feels safe, informed, and empowered in their decisions to vaccinate once a COVID-19 vaccine becomes available.
  • Protecting essential workers – Workers on the front lines of the COVID-19 crisis must receive the personal protective equipment they need to do their jobs safely. They must also be given pandemic premium pay to compensate them for the increased risks they bear keeping our economy functioning during this challenging time. They should also not be barred from seeking justice by overly broad liability protections that some in Congress to seek to attach to future stimulus bills.
  • Accountability for taxpayer funds – Money intended to support struggling small business payrolls should not go to support the super-wealthy. Bailouts targeted at specific industries like the airlines should not be diverted to unrelated purposes, such as lobbying.

To read the full report, click here.

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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.
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Facebook’s banning of Holocaust denial content is a win for consumers

Facebook’s banning of Holocaust denial content is a win for consumers

October 13, 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 decision by Facebook to ban Holocaust denial content from the platform is a welcome, if belated, move by the social media giant, according to the National Consumers League. The action, which comes after significant criticism by civil and human rights organizations, will help make Facebook a safer platform for all users, said the League.

The following statement is attributable to National Consumers League Executive Director Sally Greenberg:

“For far too long, Holocaust denial content was allowed to flourish on Facebook, a platform which reaches billions of users. We appreciate the statements from the company and its leaders, including Mark Zuckerberg, that they personally find such content abhorrent. However, words can only do so much without action to address the problem. Banning Holocaust denial content from Facebook will help create a safer and more welcoming platform for all consumers.

It will be a challenge for Facebook to enforce this ban at scale. We expect that the purveyors of hate will continually look for ways to get around the ban. That is why we will continue to work with the company to ensure that this ban has real teeth, so that consumers can be confident that they and their families will not be subjected to such hateful content.”

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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.

National Consumers League statement urging FDA to make patient-centered decision on only available treatment option for pregnant mothers at risk for recurrent preterm birth

Oct. 7, 2020

Removing FDA-approved 17P could put countless pregnancies at risk even as COVID-19 adds new barriers for mothers with a history of spontaneous preterm birth

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 urging the U.S. Food and Drug Administration (FDA) to protect patient access to the only approved treatment to reduce the risk of preterm birth in women with a history of spontaneous preterm birth, following this week’s proposal that all approved treatment options be withdrawn. We maintain that it is not in the best interests of patients, nor their healthcare providers, to deprive pregnant women of access—especially as there are no other approved treatment options—without considering alternative methods to better understand which patients benefit the most from 17P.

Hydroxyprogesterone caproate or “17P” has been the only available FDA-approved treatment option for nearly a decade to reduce the risk of recurrent preterm birth. Patients and the healthcare providers who serve them currently have access to one branded and five generic versions of the prescription product.

Since last year, the FDA has considered whether to remove FDA-approved formulations of 17P due to conflicting data from two clinical trials with notably different patient populations: one of which included a majority of African American women (59 percent) from the United States, and another where African American women represented 7 percent of a predominantly international patient population.

Despite the strengths of the original clinical trial and experiences of thousands of women to whom 17P was administered over the past decade, the strong safety profile of 17P, and the fact that 15 leading patient advocates and providers urged them to carefully consider all of the data and recognize the needs of women of color, the Center for Drug Evaluation and Research (CDER) within the FDA recently proposed that approval for all versions of 17P (branded, generics, and compounded for this indication) be withdrawn from the market.

CDER made this recommendation without meeting with advocates or providers who have personal experience of the positive impact 17P can have on the lives of mothers and babies at risk of being born prematurely.

We strongly urge CDER and the FDA to commit to a transparent and patient-centered process before making a decision about the fate of this vital treatment. Removal of 17P from the market would leave at-risk pregnant women and their providers without a recommended standard of care, and in the interim, extends a period of uncertainty that has already lasted too long.

Appreciating the importance of continued access to FDA-approved treatment options for at-risk pregnant women, including those that reduce their risk of early delivery, several months ago, we led a joint effort to urge the FDA to maintain and protect patient access to 17P. An array of leading consumer, women’s health, and maternal health organizations and thought-leading healthcare providers joined our efforts, together expressing serious concerns that a regulatory decision could be based on a single study that was largely conducted outside of the U.S., in a predominantly white population of women.

In our outreach to the FDA, we urged the agency to consider alternative ways to further evaluate and define the patient populations that most benefit from 17P, without depriving women of access. We regret to state that the agency did not respond to our letter, nor two separate requests to meet with stakeholders who have stood ready to discuss these concerns for months.

Moreover, the company that makes the branded version of 17P reported that it submitted a proposal to the FDA earlier this year with a plan to generate additional data and predictors of benefit in women with a history of recurrent preterm birth. Despite the company’s effort to proactively initiate the first part of a retrospective study, it has indicated that it was not provided an opportunity to discuss this research with the agency before its recent response.

While we recognize there is no single solution that will improve maternal and infant health outcomes, only one proven intervention exists to help pregnant women prevent recurrent preterm birth. Especially during this pandemic, pregnant women and their unborn babies are under extreme stress, yet providers have few therapeutic options to help at-risk mothers. There may be an increased risk of preterm birth and pregnancy loss among pregnant women with COVID-19, and even under normal circumstances, preterm birth places mothers and babies at significant risk—particularly among pregnant women of color.

Access to FDA-approved treatment options should not be compromised without substantial evidence that there is a lack of benefit in the appropriate population—which we don’t believe we have today. Instead, it is our belief that findings from a study where the majority of participants resided outside the U.S. in countries with different health systems and different rates of preterm birth shouldn’t be generalized and that it is reasonable to pursue real-world data sources to help us better understand the overall benefits in a patient population where there are no other options.

We believe it is possible for the FDA to continue to uphold its strong history of regulatory integrity while listening to perspectives from patient advocates and providers that are rooted in years of clinical use. What we can’t believe is the alternative, which leaves providers and pregnant women without a path forward in the middle of a pandemic.

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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.