NCL statement on vaccine for COVID-19

For immediate release: November 12, 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) welcomes the very hopeful news that a coronavirus vaccine with a reported efficacy rate of 90 percent may be approved and rolled out in the next few months. NCL has historically advocated for vaccines because they have overwhelming effectiveness and safety profiles, preventing billions of often debilitating and deadly diseases across the globe—from small pox to measles to polio. The clinical evidence on the coronavirus vaccine—developed by Pfizer Inc. and partner BioNTech SE—though incomplete at the moment, is very promising.

“We applaud the unprecedented cooperation by public and private entities, along with concerted coordination among scientists, doctors, and researchers that has gone into developing a vaccine to combat this terrible pandemic, which has killed over 237,000 Americans, struck 10 million people, and only shows signs of worsening over the winter months,” said NCL Executive Director Sally Greenberg. “As this vaccine moves closer to being cleared for widespread use and the safety data verified, we are grateful to the companies and government officials who urgently prioritized the development of an effective and safe vaccine to combat the scourge of COVID-19. We are also encouraged that other companies are in the later stages of reviewing their own COVID-19 vaccines, which use different technologies to fight the virus but hopefully will be effective and safe as well.”

The FDA will be reviewing the safety data in the next few weeks on the Pfizer vaccine and will then determine to whom the first doses will be directed. Pfizer has said the vaccine could become available before the end of the year and that the company can produce 50 million doses globally—equivalent to reaching 25 million people because two doses are required for maximum protection from the virus. The most vulnerable populations are likely to receive the first batch of vaccines.

NCL cautioned consumers that during this period, people should maintain all the safety practices for preventing spread of the virus—wearing masks and practicing social distancing and keeping social gatherings to a minimum.

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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.

For patients’ safety, it’s time Congress updated rules governing the $10 billion contact lens industry

Contact lenses have come a long way since they were first introduced around 70 years ago.  Today, roughly 45 million Americans rely on them for safe, affordable vision correction each year.  But along the way, federal regulation of the contact lens market has not kept pace with the changing way Americans purchase and rely on these medical devices.  The result is that thousands of American consumers are at risk each year of adverse eye health outcomes including keratitis, corneal scarring, corneal ulcers, and infection.

Under federal law, online contact lens retailers do not require patients to provide their prescriptions before ordering contact lenses.  Patients can simply tell the retailer the lenses the doctor prescribed for them and the retailer then must verify the prescription with the prescribing doctor.  As required by the Federal Trade Commission’s Contact Lens Rule (“Rule”), contact lens-prescribing doctors have eight hours to respond to an online sellers’ verification communication before the contact lenses are sent to patients. If they don’t respond, the online contact lens seller can ship the products, regardless of the fact that prescription accuracy hasn’t yet been verified. Since the Rule was implemented in the mid-1990s, before the adoption of email, many sellers used automated telephone calls, or so-called “robocalls,” to fulfill the verification requirement of the Rule.

These automated robocalls use computer-generated voices.  They are often inaudible.  They frequently contain incomplete patient information, and, in practice, these robocalls are sent via computer at all hours of the day and night without noting any call back number to correct errors. This cumbersome process makes it nearly impossible for eye doctors to properly verify contact lens prescriptions.  In fact, this prescription verification system can lead to the shipment of incorrect contact lenses to patients with potentially dangerous consequences for patient vision health and safety.

As many consumers can attest from being bombarded with marketing robocalls, making sense of them is a nightmare. Using robocalls to verify important patient information, for the reasons previously outlined, is unsafe.

Current technology is capable of far better than this robocall system, especially due to the various forms of electronic communication we use today. These technologies can produce receipts, notify consumers of product shipments, and share product alerts and updates. Electronic communication is far more reliable and effective because it’s inexpensive, easy to understand, accessible.  It also creates a verifiable paper trail.  Therefore, we believe sellers of contact lenses should be required to use email or other forms of electronic communication, not automated robocalls, to keep consumers safe.

The FTC’s revised Contact Lens Rule also adds a cumbersome paperwork requirement that consumers and eye doctors need to complete at the end of a contact lens exam and fitting. Under this rule, prescribers must collect and store a so-called signed acknowledgment form in which a patient verifies that they received a copy of their prescription, as is already required under federal law.

That’s all well and good, but we believe a far better system to inform contact lens patients of their rights would be to require prescribers to post a sign in their offices, which is clear and conspicuous, noting that patients have a right to a copy of their contact lens prescription at the completion of their contact lens fitting. This type of posted signage is already mandatory in California, seems to be working well there, and we think it should be emulated on the federal level.

That’s a better solution because like many other forms consumers and patients are asked to sign, consumers probably won’t take time to read the form and thus won’t understand what they are signing; this is an ineffective exercise, in our view, and will result in more paperwork without necessarily ensuring patients have access to their prescriptions as the law intends.

In short, it’s time for Congress to update the rules governing this important, $10 billion industry.  It should start by requiring the use of the latest technologies—not robocalls—to get consumers the information they need about their eye prescriptions and that those prescriptions are verified as accurate by their eye professionals.

Jeanette Contreras portrait

Low-income essential workers lack adequate COVID-19 testing

By NCL Director of Health Policy Jeanette Contreras

As the United States enters the third wave of COVID-19, low-income and minority communities hit hardest by the virus continue to disproportionately lack access to testing. The pandemic is shining a spotlight on the underlying health disparities that have long persisted within these medically underserved communities. Racial and ethnic minorities experience more severe COVID-related illness requiring hospitalization and are at higher risk for death from COVID-19. This is due largely to the prevalence of chronic conditions such as diabetes, asthma, heart disease, and chronic obstructive pulmonary disease (COPD).

In addition, racial and ethnic minorities make up a significant portion of the low-wage essential workers on farms, in grocery stores and warehouses, and in truck shipping. The essential workforce is composed of  64 percent women and 41.2 percent people of color. This translates to a higher risk of exposure to the virus among minorities because their employment involves interacting with the general public or co-workers in an unsafe environment. According to an August 2020 report from the U.S. Department of Health and Human Services (HHS), Hispanic/Latino persons were the largest demographic living in counties identified as coronavirus hotspots (3.5 million persons), followed by Black/African American persons (2 million).

HHS released a comprehensive strategy to address the lack of access to COVID-19 testing in vulnerable communities, which included expanded testing at federally qualified health centers (FQHCs) and partnerships with retail pharmacies. However, the very social determinants of health that these communities face, such as lack of transportation, child care, and paid sick leave, create significant barriers to getting to a community health clinic or a drive-through testing site. Despite higher demand in minority communities, there are fewer testing sites available to them when compared to access in predominantly white, more affluent areas. Researchers of the COVID Tracking Project found that zip codes with white populations of 75 percent had significantly more testing sites per capita than zip codes that were 75 percent minority.

Though adequate testing is only one of the prongs in confronting the pandemic, followed by contact tracing and isolation, it provides critical data needed to provide resources in the communities hardest hit by this pandemic. The World Health Organization (WHO) recommends conducting around 10–30 tests per confirmed case as a general benchmark–less than 5 percent positivity rate suggests the pandemic is under control. The U.S. currently has a positivity rate of 6 percent, and many states are not testing at a rate needed to contain the spread. Further adding to the disproportionate burden, there is no federal guidance for routine testing of essential workers. To provide adequate testing in low-income and minority communities, we need to address the underlying social determinants of health that place them at greater risk.

CMS Proposed Rule Ignores Data & Bipartisan Support for the Value of Copay Assistance Programs

By NCL Director of Health Policy Jeanette Contreras

Americans love getting a discount. As consumers, we like to shop to save without compromising the quality of the products we buy. But in healthcare, the stakes are higher at the checkout counter. Patients not only want a discount, they depend on it to afford necessary, sometimes lifesaving, medication to treat their health condition.

Despite what we know about the value and impact of copay assistance programs, a new policy from the Centers for Medicare & Medicaid Services (CMS) could put a barrier between these critical programs and the patients who need them most.

Manufacturer copay assistance programs include discounts, coupon cards, and vouchers which many of our friends, family members, and neighbors use to afford their prescriptions. Studies have shown that without these financial support systems, many patients couldn’t afford their medicines.

The CMS proposal, which has yet to be finalized, would require manufacturers to guarantee that this assistance goes directly to patients—and if manufacturers do not, they would be required to include the value of the copay assistance in Medicaid Best Price and Average Manufacturer Price (AMP) calculations. That would be fine but there’s a  problem.

CMS has a separate policy that was already finalized earlier this year: the Notice of Benefit and Payment Parameters (NBPP) Rule for 2021. In part, the NBPP allows health insurance companies and pharmacy benefit managers (PBMs) to use policies that stop copay assistance from counting towards a patient’s out-of-pocket burden—sometimes called copay accumulator adjustment programs.

NCL criticized HHS for permitting health plans to use these so-called copay accumulator adjustment programs.

“Removing this cost-sharing assistance will force those patients to pay thousands of dollars more in unexpected costs at the pharmacy. These new costs could push some to forego those medications, leading to worsened health outcomes. This could compromise medication adherence and will lead to increased health care costs over time.” – NCL Executive Director Sally Greenberg

Separate studies conducted by the Centers for Disease Control and Prevention (CDC) and IQVIA show that out-of-pocket costs can contribute substantially to reduced adherence or to patients not taking their medication altogether. This is counterproductive because if patients do not take their meds as directed, it means higher costs in other parts of the healthcare system stemming from increased hospitalizations, ER visits, and long-term health issues.

If the data doesn’t convince CMS, voters should. Weeks before the presidential election, we can clearly see widespread support for the value of copay assistance regardless of political affiliation. According to a new National Hemophilia Foundation national survey, more than 80 percent of registered voters believe the government should require copay assistance to be applied to patients’ out-of-pocket costs. Even lawmakers agree that CMS should stop this policy before it launches. A bipartisan group of 36 members of the U.S. House of Representatives sent a letter to CMS urging the agency to not finalize the “contentious line extension section or the Medicaid best price change as currently defined in the notice of proposed rulemaking.”

Clearly, copay assistance is critical to Americans. We hope CMS reevaluates the potentially harmful consequences of this new rule on patients and pulls back this counterproductive proposal.

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.

NCL testified before FDA Vaccines and Related Biological Products Advisory Committee

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 Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration (FDA). For over 120 years, NCL has advocated on behalf of consumers who depend on vaccines as lifesaving medical interventions. NCL extended its gratitude to the Vaccines and Related Biological Products Advisory Committee for all they do to protect public health and for the opportunity to speak before the Committee.

In its testimony, NCL highlighted the following priorities: the deployment of Emergency Use Authorizations; the safety and effectiveness of the vaccine; and the inclusion of diversity in clinical trials. These three concerns align directly with NCL’s efforts to enhance vaccine confidence and uptake, especially in the context of COVID-19.

Safety and Effectiveness:

NCL trusts that the FDA will release a vaccine only upon careful consideration of its safety and effectiveness. Post-market surveillance of the vaccine is imperative to determining the ongoing efficacy of the vaccine. Implementing the release of a vaccine on such a magnificent scale will involve precise coordination that traverses all levels of government and consumers will rely on public health agencies to communicate and respond to any potential adverse events regarding the COVID-19 vaccine.

Emergency Use Authorization (EUA):

There has never been a more critical time for consumers to have confidence in the Food and Drug Administration. The FDA is entrusted with ensuring the safety, efficacy, and security of the treatments needed to treat and prevent the spread of the virus.

Throughout the pandemic, consumers have received conflicting information from the Administration on various COVID-19 treatments. NCL is aware that developing a vaccine for COVID-19 is a time-sensitive priority, however, we are concerned that consumers may believe that the FDA is hastily approving investigational tests and drugs.

NCL appreciates that the FDA recognizes that EUA is not intended to replace randomized clinical trials and that clinical trials are critically important for the definitive demonstration of safety and efficacy of a treatment. Through our education and outreach of consumers, we support the FDA in its efforts to develop a safe, effective, and expedited pathway towards a COVID-19 vaccine.

Diversity in Clinical Trials:

Finally, to mitigate the disproportionate disease burden experienced by people of color during the pandemic, NCL requests that clinical trials for the COVID-19 vaccine are inclusive and consist of diverse subjects. People of color are significantly underrepresented in clinical trials and undertreated in medical settings. This phenomenon will prove to be a challenge when encouraging vaccine uptake. Ensuring adequate representation in clinical trials would foster vaccine confidence across all demographics.

In closing, to stem the tide of deaths from these vaccine-preventable diseases, NCL submits these comments for review by the Committee to ensure that consumers are afforded with safe and effective vaccines to combat the 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.

Equitable allocation of a COVID-19 vaccine

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

As the world waits with bated breath for the release of a safe and effective COVID-19 vaccine, one concern that is paramount is the proper distribution of the vaccine. According to leaders of Operation Warp Speed (OWS)—a coordinated partnership between the Department of Health and Human Services (HHS) and the Department of Defense (DoD)—detailed planning is ongoing to realize OWS’s lofty goal of delivering 300 million doses of a COVID-19 vaccine, with the initial doses available by January 2021.

Implementing a vaccine program of this magnitude is contingent upon precise coordination that traverses federal, state, local, tribal, and territorial governments. The prodigious task ahead is determining who would get the first initial doses of the vaccine upon release. The pandemic has further illustrated that communities most vulnerable to COVID-19 are often rife with systemic racism and socioeconomic factors conducive to higher infection rates. An initial limited supply of a vaccine will only intensify these inequities.

Multiple analyses conducted on the federal, state, and local levels confirm that people of color have experienced a disproportionate burden of COVID-19 cases and deaths. Hispanic or Latinx, and American Indian and Alaskan Native (AI/AN) communities have experienced three times the rate of infection, and Black communities two times the rate of infection, compared to White populations. The CDC warns that this imbalance in morbidity and mortality is begotten by deep-seated disparities that stem from generations of racism and unaddressed social determinants of health.

To mitigate these inequities, the National Academies of Science, Engineering, and Medicine (NASEM) have formed a committee to establish an overarching framework addressing key considerations for the equitable allocation of a COVID-19 vaccine, including at-risk communities, priority populations, geographic distribution, scalable measures, and vaccine hesitancy.

The framework proposes four phases of vaccine distribution and their corresponding priority populations, as follows:

[Source: NASEM]

The above proposal will inform CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendations in advance of a COVID-19 vaccine release; and it was developed through careful consideration of CDC’s Social Vulnerability Index (CDC SVI), and the apropos, COVID-19 Community Vulnerability Index (CCVI). To elucidate, these phases were designed with people of color in mind, as they experience heightened risk of exposure working in essential roles in society, and therefore succumb to higher rates of infection.

Another key component of the vaccine plan is addressing vaccine hesitancy. People of Color are significantly underrepresented in clinical trials and undertreated in medical settings. This phenomenon, compounded by a general mistrust of medical establishments by minorities, will prove to be a challenge when encouraging vaccine uptake. Community engagement will be essential in building trust among the vaccine hesitant and messaging should be delivered by community leaders, or healthcare providers that resemble the population they treat. Culturally competent care has proven to have favorable effects on health outcomes and it is critical in encouraging vaccine confidence.

Once a vaccine becomes available, health officials across the country will need to deploy resources and personnel to ensure access to the vaccine among our most vulnerable. As affirmed by U.S. Army Lt. Gen. Paul Ostrowski (OWS), “We have to be able to go beyond the pharmacies, the hospitals and so forth to get after nursing homes; to get after meatpacking facilities; to get after those that are sheltered [at home]. We have to get this out to all four corners of this nation.” Getting to a vaccine is a challenge in itself, but once its released, it’s all hands-on deck.

Hispanic Heritage Month: Focus on the importance of participating in research through clinical trials

Hispanic Heritage Month: Focus on the importance of participating in research through clinical trials
by Elena Rios, MD, MSPH, FACP
President & CEO, National Hispanic Medical Association

The COVID-19 pandemic has impacted the world and the United States with a double threat: decreasing health and function of many, especially older patients with underlying diseases (obesity, asthma, diabetes, hypertension, etc.) that decrease the body’s immune response to fight off the virus; and millions left jobless as businesses downsize or close. In the healthcare arena, scientists and physicians are learning about the disease and how to treat it: We now know to limit ventilators to avoid high air pressures that can hurt damaged lungs; to place infected patients on their stomachs to allow lungs to expand; to use dexamethasone to decrease inflammation; and to use new antiviral therapies like Remdesivir and monoclonal antibodies. While there is no vaccine to prevent COVID-19, vaccine developers, researchers, and manufacturers are expediting the development of one.

The National Institutes of Health (NIH) and several pharmaceutical companies are conducting research through clinical trials that have found potential vaccines to be safe. This summer they started to enroll people and closely follow them for any adverse effects. Historically, Hispanics, Blacks, and Native Americans have been underrepresented in clinical trial research for a variety of factors, chief among them, a distrust of research and the concept of fatalism (leaving life’s challenges in God’s hands). But it is crucially important to have diversity in clinical trials to have information on the vaccine impact for Hispanics, for example. I encourage all persons over the age of 18 to enroll in the important COVID-19 clinical trials — and recommend websites for two ongoing clinical trials: the CoronaVirusPreventionNetwork.org from the NIH and Moderna, and the CovidVaccineStudy1.com

from Pfizer Inc. Each site provides consumers with information on the locations and how to enroll.

The National Hispanic Medical Association (NHMA) was established in 1994 to represent trusted Hispanic physicians and to improve the health of Hispanics and underserved populations. Given that, by 2042, one out of four people living in our nation will be Latino, NHMA has joined as a partner to encourage the Latino community to join the NIH All of Us Research Program. In May 2018, the NIH opened national enrollment for the All of Us Research Program—a momentous effort to advance individualized prevention, treatment, and care for people of all backgrounds—in collaboration with NHMA and other national partners. People ages 18 and older who reside in the United States, regardless of health status, are eligible to enroll. The overall aim is to enroll 1 million or more volunteers and to oversample communities that have historically been underrepresented in research to make the program the largest, most diverse resource of its kind. Our participation will provide information on how to better develop health care prevention and treatment programs for generations to come.

Precision medicine is an emerging approach to disease treatment and prevention that considers differences in people’s lifestyles, environments and biological makeup, including genes. By partnering with 1 million diverse people who share information about themselves over a 10-year period, the All of Us Research Program will enable research to more precisely prevent and treat a variety of health conditions.

Participants can access their own health information, including genetics information, summary data about the entire participant community, and information about studies and findings, that come from All of Us. Participants are asked to share different types of health and lifestyle information, through online surveys and electronic health records (EHRs), which will continue to be collected over the course of the program. At different times over the coming months and years, some participants will be asked to visit a local partner site to provide blood and urine samples and to have basic physical measurements taken, such as height and weight, to ensure that the program gathers information fromall types of people. This program is especially focused on those who have been underrepresented in research, but not everyone will be asked to give physical measures and samples. In the future, participants may be invited to share data through wearable devices and to join follow-up research studies, including clinical trials.

In addition, data from the program will be broadly accessible for research purposes. Ultimately, the All of Us Research program will be a rich and open data resource for traditional academic researchers as well as citizen scientists—and everyone in between. To learn more about the program and how to join, please visit https://www.JoinAllofUs.org.

About NHMA

NHMA is a nonprofit association representing the interests of 50,000 Hispanic physicians with the mission to improve the health of Hispanics in the U.S. For more information, please visit www.NHMAmd.org

The FDA must create a win-win path leading to new data on 17P and protect access for pregnant mothers

The FDA must create a win-win path leading to new data on 17P and protect access for pregnant mothers

You may never have heard of hydroxyprogesterone caproate or “17P”—it’s a mouthful, but the role it has played in the lives of thousands of pregnant mothers and babies is easy to understand. For nearly a decade, it has been the only FDA-approved therapy to reduce the risk of recurrent preterm birth. It is available to women and their healthcare providers in both branded and generic prescription versions.

I have personally spoken with healthcare providers whose patients have had longer pregnancies thanks to 17P and a longer pregnancy can be a very good thing. As we noted in a letter we signed, along with 15 leading women’s and children’s health advocates, and sent to the FDA a few months ago, premature birth is the leading cause of infant death in the U.S. and has devastating effects on families and is very costly to our health care system. Among those babies who do survive, short and long-term complications can accompany preterm birth.

Prematurity also has a very significantly disproportionate impact on women of color. It is not something to take lightly. In fact, the preterm birth rate among U.S. black women is 49 percent higher than the rate among all other women. Factors associated with being African American—including experiencing institutional racism, racial health inequities, and higher psychosocial stress—contribute to prematurity.

One would think that preserving access to the one branded and five generic forms of 17P would be a priority for the FDA. Yet shockingly, earlier this week, the FDA proposed that all versions of 17P (branded, generics, and compounded for this indication) be withdrawn from the market.

The Center for Drug Evaluation and Research (CDER) within the FDA made this recommendation despite the fact that 17P has a very strong safety profile (two trials and a decade of use by U.S. women and their providers bear that out). It also made its recommendation without meeting with affected women or providers who have personal experience with the benefits of 17P, without comprehensively considering alternative methods to assess which patients benefit most, and without, in our view, fully accounting for the unique needs of black women, who face a rate of preterm birth in the U.S. that is about 50 percent higher than the rate of preterm birth among white women.

To be fully transparent, 17P does have conflicting efficacy data from two clinical trials with markedly different patient populations: the first of which included a majority of U.S.-based African American women (59 percent). This was the trial that led the FDA to approve 17P for use in the U.S. in 2011, and another which included data of a population of women, most of whom lived in the Ukraine and Russia, and few of whom (7 percent) where African American.

There are questions on the table about who specifically benefits most from 17P and those questions do need to be answered. But access to 17P should not be compromised without substantial evidence that there is lack of benefit in the appropriate population and we don’t believe that evidence exists today. We strongly believe that the FDA should accept any request for a hearing in order to allow providers and patients an opportunity to discuss these concerns in more detail.

The FDA was provided with a proposal to keep 17P on the market and gather data to determine which populations of pregnant women benefit most from the therapy. The company that makes the branded version of 17P provided a detailed plan for generating additional data and predictors of benefit in women with a history of recurrent preterm birth.

Utilizing alternate ways to evaluate and define the patient populations that benefit most from 17P while allowing continued access to those in need seems like a win-win approach, especially considering the fact that the second, predominantly international based clinical trial was conducted outside of the U.S. because U.S. healthcare facilities refused to give their patients a placebo rather than 17P, and the same would undoubtedly happen if another clinical trial was attempted on American soil.

We’re talking about pregnant women and babies, not just ‘clinical trial participants.’

As our nation continues to grapple with the effects of the pandemic on our health and lives, evidence has shown that there may be an increased risk of preterm birth and pregnancy loss among pregnant women with COVID-19, particularly pregnant women of color. And while no single solution will improve maternal and infant health outcomes, only one proven intervention currently exists to help pregnant women prevent a recurrent preterm birth.

By factoring in the experiences of mothers and providers, the FDA can continue upholding its strong history of regulatory integrity while taking a necessary, comprehensive view of 17P’s real-world clinical implications on pregnant women and their newborn babies. We urge the FDA not to leave at-risk pregnant women and their healthcare teams without a path forward in the middle of a pandemic.

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.