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

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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

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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.

What you should know about the Healthcare.gov Open Enrollment

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

From November 1, 2020 to December 15, 2020, consumers will be able to enroll in health coverage through the health insurance marketplace, Healthcare.gov. Choosing the right health plan involves thoughtful decision-making, with careful consideration of your needs and your budget. COVID-19 testing and treatment, telehealth, and mental health services have been vital pandemic necessities, and consumers are advised to pay attention to any changes in their current health plans to account for any adjustments in health needs.

It is estimated that annually consumers typically spend 17 minutes when selecting plan options during open enrollment, most simply sticking with their plans from the previous year. If you need assistance navigating the health insurance marketplace, you can consult a healthcare navigator to help in comparing the coverage options that make sense for you. Healthcare navigators provide free, unbiased advice and offer services in a number of languages. To find a navigator in your area, please click here.

Even with the election and looming challenge to the ACA coming before the Supreme Court, California v. Texas, consumers should know that the federal health insurance marketplace, also known as Obamacare, is still available. The Supreme Court will hear oral arguments on November 10, but the ultimate decision can come as late as June 2021. We’ve written more about the implications of California v. Texas here. Despite multiple attempts by opponents to repeal the ACA, over 20 million people have gained coverage through the marketplace in the past decade.

The Centers for Medicare & Medicaid Services (CMS) recently announced that marketplace premiums have dropped by 2 percent nationally. Additionally, as a result of the pandemic, the marketplace has seen greater insurer participation – in turn, offering consumers with more robust options for coverage. Plans offered via Healthcare.gov are required to cover a set of essential health benefits mandated by the ACA, ensuring that you have access to comprehensive care – a provision that is of chief importance during this time. The ACA has afforded consumers with a host of health protections and prohibits insurance plans from discriminating against enrollees based on health status, including pre-existing conditions. To learn more about the marketplace, click here.

The National Consumers League encourages consumers to seek coverage via ACA compliant plans offered on the marketplace. If you miss the deadline to apply for coverage within the open enrollment period, you may be able to qualify for a Special Enrollment Period (SEP). Applying during a SEP is contingent upon meeting certain criteria, such as life events like having a child or losing health coverage. If you qualify for Medicaid or the Children’s Health Insurance Program (CHIP), you can apply at any time. Most importantly, in order to have coverage that is effective by January 1, 2021, you must sign up by December 15, 2020.

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

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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

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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

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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

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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.

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings

Protecting Nevadans from COVID-19 Scams: A Virtual Panel Event with NV Attorney General Aaron D. Ford and Fraud Experts

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Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC – This Thursday, October 22, the National Consumers League (NCL), America’s pioneering consumer and worker advocacy organization, will host a virtual fireside chat with Nevada Attorney General Aaron D. Ford and a panel of consumer protection experts on the growing threat of scams linked to the COVID-19 pandemic. The consumer watchdog organization aims to raise awareness in Nevada about the risk of COVID-19 related fraud and arm consumers with information they can use to spot and avoid these scams.

Since the pandemic began, NCL, which operates the website Fraud.org, has seen an uptick in complaints about a variety of scams preying on increasingly vulnerable, financially strapped, and fearful consumers. Scammers running phishing schemes, stimulus check fraud, unemployment benefits scams, and immigration scams have all been working overtime to use the COVID-19 pandemic as a way to defraud consumers. The experts at NCL have watched these scams emerge, forecast they will continue to increase, and are eager to work with AG Ford to get the word out about how Nevadans can protect themselves.

WHAT

Virtual “fireside chat” featuring Nevada AG Aaron D. Ford and NCL, followed by a panel discussion on resources and tips to avoid COVID-19 fraud and scams.

WHEN

Thursday, October 22, 2020
2:00 PM – 3:00 PM Pacific Daylight Time

WHO

Nevada Attorney General Aaron D. Ford
John Breyault, Vice President, National Consumers League

State Senator Dallas Harris, Consumer Rights Attorney, Legal Aid Center of Southern Nevada
Maria Moore, State Director, AARP Nevada
Assemblyman Edgar Flores, Immigration, Family, and Personal Injury, Gonzalez & Flores Law

HOW TO WATCH

YouTube Live link will be provided following registration via Eventbrite.

*** Members of the media are welcome to attend but must RSVP to Carol McKay, National Consumers League, carolm@nclnet.org. If you are unable to attend, a recording of the interview and panel can be provided upon request after the event concludes ***

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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.

COVID-19 increasing health concerns about obesity

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COVID-19 increasing health concerns about obesity
By Nailah John, Program Associate

The pandemic has brought many countries to a standstill, restricting movement, necessitating social distancing, and impeding economic activities across a broad spectrum of nonessential occupations. It’s also resulted in many people changing their habits, including changes in food consumption, physical activity, and an increase in people working from home, which may exacerbate current levels of obesity.

Obesity is a major concern here in the United States and worldwide. The World Health Organization defines obesity as “abnormal or excessive fat accumulation that may impair health.” In 2016, the World Health Organization released data that showed 650 million adults were obese, and in 2019, an estimated 38.2 million children under the age of 5 were overweight and obese. In the United States, the Center for Disease Control and Prevention indicates that, in 2019, the obesity rate surpassed the 40 percent mark and reached 42.4 percent.

Since the pandemic began, there have been dozens of studies reported that many patients who become sick with COVID-19 are obese. In an article in the journal Obesity Reviews, an international team of researchers compiled data from scores of peer-reviewed papers capturing 399,000 patients. The findings indicated that individuals with obesity suffer from metabolic dysfunction and low-grade inflammation, which are considerable factors in the manifestation of severe lung diseases. The primary cause of COVID-19 mortality is susceptibility to acute respiratory distress syndrome (ARDS) which is more likely in obese individuals. The review goes on further to state that “being an individual with obesity independently increases the risk of influenza morbidity and mortality, most likely through impairments in innate and adaptive immune responses. Potentially the vaccines developed to address COVID-19 will be less effective for individuals with obesity due to a weakened immune response.”

The Wiley Public Health Emergency Collection found that obesity increases vulnerability to infections and is a risk factor to COVID-19-related mortality. Body mass index (BMI) was significantly higher in patients with a severe form of Covid-19 infections. Being obese increases the odds of COVID-19 patients being hospitalized. The Wiley Public Health Emergency Collection highlighted that COVID-19 patients with obesity were hospitalized more than those without obesity. According to a report that looked at 5,700 COVID-19 patients with obesity in New York City, whereas 22 percent of the population is obese, they make up 41.7 percent of hospitalized patients.

Prevalence of obesity in the United States is increasing yearly, and there is a dire need for this health issue to be curbed. It will take efforts at the federal, state, and local level. Therefore, it is paramount that each individual engages in healthy eating habits, eats the right portion sizes, engages in physical activity, and encourages others.

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

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By Sally Greenberg, NCL Executive Director

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.
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