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

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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

Our work to preserve America’s treatment option to fight premature birth

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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.

Read more

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

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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.

NCL concerned Congress seeks to approve unreviewed CDB products

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Sept. 17, 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—On September 4, lawmakers introduced The Hemp and Hemp-derived CBD Consumer Protection and Market Stabilization Act of 2020 (HR 8179), which directs the U.S. Food and Drug Administration (FDA) to make hemp and hemp-derived CBD lawful as a dietary ingredient or dietary supplement. The National Consumers League (NCL) has long been concerned about the public health and safety risks posed by unapproved cannabis-derived products. NCL does not support legislation that seeks to bypass FDA’s authority and circumvent the scientific rigor of an FDA review.

Under current law, manufacturers and distributers of CBD products can already petition the FDA to review and approve a new ingredient for use as a dietary supplement (21 U.S.C. 350b). For FDA approval as a dietary supplement or new ingredient, manufacturers and distributors are required to submit scientific data, including any published studies, to provide a basis to conclude that a product is generally regarded as safe (GRAS). Unfortunately, there is a disconcerting lack of research and data about the safety of CBD products already in the market, whereby millions of consumers are using to self-treat serious and life-threatening ailments.

In response to the proliferation of unreviewed and untested CBD products in the market, NCL launched the Consumers for Safe CBD program to provide greater education to consumers about CBD. As demonstrated in a white paper published by NCL, cannabis companies tend to focus their research efforts on inexpensive, low-strength studies that are ultimately used for marketing purposes, not to enhance scientific knowledge or bring new proven therapies to patients. HR 1879 would further incentivize CBD manufacturers to forego the more rigorous and costly clinical trial process for developing an FDA-approved medicine.

NCL is concerned that CBD manufacturers and distributers making claims to treat certain medical issues will seek expedited approval of CBD products as a dietary supplement, instead of as a drug. Lawmakers should encourage the development of cannabis-based medicines that have undergone the rigor of randomized controlled clinical trials to learn more about how cannabis-derived therapies can both help and harm patients. This legislation seeks to fast-track the classification of CBD products as dietary supplements or ingredients without sufficient scientific data on their safety and efficacy, potentially placing consumers further at risk.

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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.

Mail-in and absentee voting during COVID-19

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By NCL Executive Assistant Adrienne Archer

The National Consumers League (NCL) wants consumers to know that voting by mail or absentee ballot during the COVID-19 pandemic is safe. Due to conflicting information being shared by the media, and federal, state and local governments, it can be difficult to determine how best to vote. During the COVID-19 pandemic, a voter should always focus on keeping themselves and their family safe and healthy. Whether voting by mail-in or absentee ballot, it’s important to have a plan. However, due to the variety of challenges posed by the pandemic, it might be difficult to keep up with the changes or updates to a state’s voting guidelines. Voters should contact their local elections office.

Many states and the District of Columbia have made it easier to vote early by mail or by absentee ballot. In the past, voters needed a reason why they couldn’t vote in person. National Conference of State Legislators (NCSL) has resources for on state laws governing voting across the U.S. To know exactly when to vote in your state, contact your local elections office. USA.gov also offers information on the time frames for early or absentee voting.

All states will offer a form of mail-in voting and some states will make it more accessible to vote than others. Some states are still crafting legislation to make it easier for people to vote by mail or absentee ballot. The New York state legislature passed three bills allowing voters to request an absentee ballot or mail-in ballot because of COVID-19 fears. One of the bills allows for absentee ballots to be postmarked as late as election day and still be counted.

Government officials have noted possible instances of voter fraud. Some states have voiced concerns that mail-in ballots can easily be stolen, altered, or forged. Voters worry that they will not receive their ballot in time to vote. Congress is worried that the increase in mail will overwhelm the United States Postal Service (USPS) and delay the delivery of ballots. To add to the problems, the U.S. Postmaster General has made budget cuts to the USPS, dismantled machines, collected mailboxes, and reduced mail services causing consumers to worry that the USPS will not be able to process the increase in mail. Disability advocates want to ensure that mail-in voting will not be more difficult for voters with disabilities to exercise their right to vote.

Voting by mail is a safe option: it increases the overall voter response in the election. Even with these challenges to voting, military members and older Americans have been always encouraged to vote absentee. The Centers for Disease Control and Prevention (CDC) has provided recommendations for people to handle mail-in ballots safely when they are received. In response to consumer requests, the USPS has created a website to help voters ensure that they can receive and return their ballot safely. Also, voters should remember that the main goal of voting during this pandemic is to safely cast their votes.

Americans voting from abroad, or in the military should be aware of the following: potential delays with sending and receiving mail, possible embassy closures due to COVID-19, and ensuring that their personal address is updated with his or her state. Americans abroad should request a ballot immediately from the Federal Voting Assistance Program’s website and check with their local U.S. polling place for instructions on receiving and returning the ballot. Most states permit Americans abroad to request a ballot via email with the caveat that a completed ballot should be returned by well before the November 3rd deadline via postal mail. Under Federal law, ballots should be requested by overseas military voters by September 19th (at least 45 days before the election). The Military Postal Agency has a list of recommended mailing dates. After individuals have returned their ballot, they should be sure to contact their local elections office to ensure that their ballot was received or if they have any questions.

Voting by mail has always been a good way to ensure access to those with disabilities. The American Civil Liberties Union has guidelines to improve accessibility to persons with disabilities. They suggest voters with a disability should receive ballots electronically so they can vote from the safety of their homes. Voters could indicate their candidate on the ballot by using accessibility features on his or her device. Then the ballot should be printed and mailed to his or her local polling place. Some states require witnesses or notarization on the ballot envelope. The American Civil Liberties Union (ACLU) wants to dispense with this requirement. Election poll workers should receive training on accessible voting options and how to respectfully interact with voters with a disability. Lastly, every state should raise awareness about accessible voting options.

In summary, to effectively vote by mail or absentee ballot during the COVID-19 pandemic, the National Consumers League suggests these steps:

  1. Create a plan for voting by mail or via absentee ballot.
  2. Check your local polling office to ensure that it has your correct mailing address and you are eligible to vote in the upcoming election.
  3. Request your absentee or mail-in ballot NOW, well before the deadline of October 3rd (45 days before the election) from your local polling office.
  4. If voting from abroad or in the military, allow for extra time to request and receive your ballot.
  5. If you have a disability, every state has in place accommodations so you may vote safely and effectively. If you have questions, please contact your local polling place early so they may be resolved.
  6. When you get your ballot, review the instructions for completing and returning it. If you have questions, contact your local polling office for guidance.
  7. Mail-in your ballot immediately, in advance of your state’s deadline, allowing for time for it to be reviewed and counted.

Above all, vote, vote, vote!

Jeanette Contreras portrait

FDA Emergency Use Authorizations and public trust for COVID-19 treatments

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By NCL Director of Health Policy Jeanette Contreras

There has never been a more critical time for consumers to have confidence in the Food and Drug Administration (FDA). The FDA is charged with ensuring the safety, efficacy, and security of the drugs, biologic products, and medical devices needed to treat and prevent the spread of COVID-19. The agency has undergone scrutiny from the scientific community for issuing Emergency Use Authorization (EUA) for COVID-19 treatments and diagnostics that appeared to be politically motivated.

On August 23, the FDA issued an EUA for the use of an investigational convalescent plasma to treat patients with COVID-19, touting it as yet another achievement in the Administration’s fight against the pandemic. After just two days of backlash from the scientific community, FDA Commissioner Dr. Stephen Hahn, took to Twitter to concede his mistake, admitting that the criticism was justified. Commissioner Hahn stated that the EUA is not the final FDA approval and that the agency would revoke authorization if needed. Criticism included former FDA Commissioners who stand by randomized clinical trial as the gold standard for evidence-based medicine.

This renowned round of criticism has come not long after the FDA provided EUA for hydroxychloroquine in March which it revoked in July after further review proved that it lacked efficacy.

The Federal Food, Drug, and Cosmetic Act provides the FDA Commissioner with the authority to issue EUAs for unapproved medical products or unapproved uses of medical products in response to a public health emergency, such as the current pandemic. An EUA can be revoked when new evidence emerges and the risk no longer outweighs the benefit of the unapproved use of a drug or product, yet the Trump Administration claimed that it was revoked due to political reasons.

Since February, when the Department of Health and Human Services (HHS) declared the pandemic a public health emergency, the FDA has exercised its authority to issue hundreds of EUAs for diagnostic tests, personal protective equipment, ventilators, and other medical devices to combat COVID-19. In August alone, the FDA revoked EUAs for over 100 diagnostic tests, including antibody and rapid tests. 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 drug, treatment, or product.

Throughout the pandemic, consumers have received conflicting information from the Administration on various COVID-19 treatments, testing products, and safety recommendations. After witnessing the media controversy over EUAs for hydroxychloroquine and convalescent plasma, we are concerned that consumers may believe that the FDA is hastily approving investigational tests and drugs for political gain. The FDA, now more than ever, needs to reestablish public trust as it proceeds to fast track the approval of a COVID-19 vaccine.

Compromised access to the USPS could result in worsened health outcomes

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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), the nation’s pioneering consumer advocacy organization, is today expressing concern about recent cuts to funding for the United States Postal Service (USPS) and the impact this has on consumers’ access to critical lifesaving medications.

The USPS has already suffered setbacks due to deteriorating financial conditions, and most recently the significant delays caused by the COVID-19 pandemic. The vulnerable agency is now caught in the middle of political strife as the President ponders withholding funding for the USPS in upcoming COVID-19 relief legislation, in order to impede mail-in voting. The USPS is an essential service, and consumers rely on these services daily to pay their rent, receive wages and Social Security checks, and most importantly, receive prescription medications via mail-order pharmacies.

These developments have grave ramifications for older Americans, and particularly veterans, of whom 80 percent receive their medications through mail-order pharmacies, 90 percent of which are delivered via the USPS. The Department of Veterans Affairs (VA) proprietary mail-order pharmacy system, the Consolidated Mail Outpatient Pharmacy (CMOP), consists of a group of seven automated hub pharmacies. The CMOP processes nearly 500,000 prescriptions daily, and ships packages to more than 330,000 veterans each working day.

The VA has stated that changes in the USPS have delayed medication deliveries by 25 percent in the last year, and has experienced an influx of mail-order prescriptions as entry to VA facilities have been limited to curb the spread of COVID-19. Veterans in rural or remote areas often rely exclusively on mail-order prescriptions, and as older Americans are cautioned to quarantine and social distance throughout the pandemic, ensuring timely access to medication is ever more imperative. The VA is currently rushing to mitigate potential delays by temporarily converting its deliveries from USPS to UPS 2nd Day Air or FedEx. Additionally, the VA will set up a specialized USPS code, to help prioritize veteran prescription deliveries.

The VA has advised patients to request refills for their medications at least 10 days before their treatment course ends, to ensure timely delivery of medications. Disruptions in medication deliveries caused by a lack of funding to the USPS could drastically impact overall health outcomes and medication adherence. As the country navigates the COVID-19 pandemic, it is crucial that our most vulnerable have timely and adequate access to the medications they need to maintain their health and avert potential progression of disease.

The National Consumers League stands with the United States Postal Service workers, as they tirelessly work to provide essential services during these challenging times. We call on Congress to hold the Administration accountable to ensure that consumers maintain access to the essential USPS services on which they depend.

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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.