NCL statement regarding efforts to ban menthol tobacco products

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) commends the Food and Drug Administration (FDA) for its efforts to ban menthol cigarettes and flavored cigars. The FDA states it will work to keep menthol flavored tobacco products off the market by enforcing a potential ban against manufacturers, distributors, wholesalers, importers, and retailers. The ban on menthol-flavored tobacco products is a historic measure to address health disparities present in vulnerable communities as a result of unfair marketing practices.

Menthol cigarettes continue to be heavily advertised, widely available, and priced cheaper in Black communities. Tobacco manufacturers have long deployed tactics that lure and entice young people with their menthol-flavored tobacco products, consequently contributing to a gateway for children to initiate cigarette smoking.

“For generations, tobacco companies have disproportionately targeted communities of color with advertisements of highly addictive menthol flavored tobacco products”, said NCL Executive Director, Sally Greenberg. The sales resulting from these predatory marketing practices have ravaged vulnerable communities, particularly African American youth. We applaud this Administration’s effort to protect consumers, particularly from the most marginalized areas of society, from the adverse effects of menthol-flavored tobacco products.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Consumer group urges FDA and CDC to remain vigilant in enforcing hand sanitizer standards

April 27, 2021

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

Washington, DC—This week, the National Consumers League (NCL) wrote a letter to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), urging them to remain vigilant on the enforcement of proper manufacturing and distribution of hand sanitizers as we continue to fight the COVID-19 pandemic.

During the initial surge in demand for hand sanitizers, the federal government relaxed certain regulations in order to get over-the-counter products into consumers’ hands. The combination of a need for an immediate ramp-up of hand sanitizer distribution and reduced oversight led to a concerning trend of what NCL believes is a case of mislabeling — and unfortunately misleading — information regarding hand hygiene products.

While local and small businesses stepping up to produce products for their communities is admirable, hastily manufactured hand sanitizer operations have resulted in lower efficacy rates, with even some reports of products being made with dangerous ingredients. As a result, the FDA has currently identified 230 hand sanitizer products marketed in 2020 as unsafe or ineffective.

NCL commends the FDA and the CDC for their ongoing efforts to keep the American people safe. But the fight against this virus is far from over, and under-regulated hand sanitizer production and distribution will only prolong this public health crisis.

The following statement is attributable to NCL Executive Director Sally Greenberg:

“For more than a century, the National Consumers League has fought for access to quality products, honest labeling, and safe, effective medicines for American consumers and workers. And leaving this growing issue alone would be a disservice to the many people NCL has worked so hard to protect.”

NCL urges the FDA and the CDC to enforce the law and hold accountable those businesses engaged in the production and distribution of poorly manufactured and dangerous hand sanitizer products.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL supports permanently lifting restrictions on access to mifepristone

April 26, 2021

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

Washington, DC—The National Consumers League (NCL) applauds the U.S. Food and Drug Administration (FDA) for moving to increase access to the abortion pill, mifepristone. As of April 12, the FDA will temporarily allow mifepristone to be dispensed by mail for the duration of the COVID-19 public health emergency. Patients are now able to obtain a safe and effective abortion pill through a telemedicine consult, without risking exposure to COVID-19 with an in-person visit.

Though mifepristone has been used in the United States for more than 20 years to safely and effectively end early pregnancies and treat early miscarriage, the FDA has placed particular restrictions on mifepristone when it’s used for pregnancy termination. Unlike other medications, patients can only obtain the abortion pill directly from a certified medical provider who has a prescriber agreement with the drug manufacturer.

In the early months of the pandemic, the American College of Obstetricians and Gynecologists (ACOG) and other provider groups filed a lawsuit that challenged these restrictions and subsequently won the suit to temporarily lift the restrictions to abortion care during the pandemic.

“This was a win for women’s health, but more importantly for women who live in rural and medically underserved communities who rely on telemedicine for their health care,” said NCL Executive Director Sally Greenberg.

The win, however, was short-lived. In January 2021, the Supreme Court ruled in favor of an appeal by the Trump Administration that put an end to the temporary lift, effectively restricting patient access to medication abortion care.

On April 11, Acting FDA Commissioner Janet Woodcock, sent a letter to ACOG and the Society for Maternal-Fetal Medicine (SMFM), stating that the FDA reviewed recent evidence and found that using telemedicine to provide abortion pills would not increase risks and would help patients avoid potential exposure to COVID-19.

“While we welcome this temporary change, we urge the FDA to continue to review the evidence and scientific data and permanently lift unnecessary restrictions beyond the public health emergency. If it’s safe enough to prescribe through telemedicine during COVID, then it is clearly safe enough to use beyond COVID,” said Greenberg. “We hope the FDA will consider the vast health and socioeconomic benefits that increased access to medically safe abortion via telemedicine would pose for women who rely on this essential reproductive service.”

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Giving a voice to women facing preterm birth

By Sally Greenberg, NCL Executive Director

Born out of our historical focus on reducing health inequities in the United States, and a nearly year-long movement to preserve access to approved therapies that fight premature birth, NCL supported the launch of the Preterm Birth Prevention Alliance (PBPA), which brings together a coalition of 15 patient advocacy organizations who share concerns about the grave state of preterm birth in the United States and its disproportionate impact on Black, Indigenous, and women of color.

For the past decade, hydroxyprogesterone caproate, commonly called “17P,” has been the only available FDA-approved treatment option 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. However, in 2020, the FDA proposed withdrawing all forms of 17P, based on conflicting efficacy data from two studies composed of vastly different populations — one inclusive of women in the U.S. most vulnerable to preterm birth and one not. Both studies showed that this class of treatment is safe for both mother and baby.

Despite multiple formal requests to consider additional data and alternate ways to study the efficacy of this class of drugs before effectively depriving women of access, FDA made its recommendation without engaging the most important stakeholders—patients who are at the highest risk and their providers. And even after a recently published meta-analysis showed that 17P injections reduced the risk of preterm birth before 34 weeks in high-risk women with singleton pregnancies, FDA persisted in its recommendation.

The Alliance was formed to stand up for the needs of moms and babies of every race and ethnicity and urge regulators to hear directly from women facing prematurity and their providers about their real-world experiences — in a public hearing — before making a decision on withdrawal.

We believe that evidence of efficacy for Black, Indigenous, and women of color in the United States — who are at highest risk of adverse outcomes — should be more determinative than a lack of demonstrated treatment efficacy on primarily white women from other countries. And we believe that more inclusive studies and data are needed, across more racially and ethnically diverse patient populations, to better understand the causes and impact of disparate outcomes in preterm birth.

Alliance partners currently include:

  • 1,000 Days
  • 2020 Mom
  • American Association of Birth Centers
  • Black Mamas Matter Alliance
  • Black Women’s Health Imperative
  • Expecting Health
  • Healthy Mothers, Healthy Babies Montana
  • HealthyWomen
  • Miracle Babies
  • National Birth Equity Collaborative
  • National Black Midwives Alliance
  • National Consumers League
  • National Partnership for Women & Families
  • Sidelines High-Risk Pregnancy Support
  • SisterReach

Organizations or advocates concerned about the needs of women facing prematurity — whether you are a healthcare professional, maternal and infant health advocate or a health equity champion — are invited to join us and add your voice to this effort.

Learn more and join the Alliance: https://nclnet.org/pbp/

NCL testimony at CDC emergency meeting on J&J vaccine safety

April 23, 2021

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

Washington, DC—Today the National Consumers League (NCL) testified before the emergency meeting of the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) to discuss updates on the recommendations to pause the Janssen COVID-19 vaccine. The full testimony appears below:

José R. Romero, MD, FAAP, Chair
Advisory Committee on Immunization Practices
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mailstop A27
Atlanta, GA 30329-4027

RE: Docket No. CDC-2021-0044; Advisory Committee on Immunization Practices (ACIP)

For over 120 years, the National Consumers League (NCL) has championed vaccine education and access for consumers to these lifesaving medical interventions. We extend our gratitude to the Advisory Committee on Immunization Practices for the opportunity to serve as a voice for consumers.

NCL commends the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) for their concerted efforts to promptly address the recent adverse events observed by the Johnson & Johnson COVID-19 vaccine. The decision for a momentary pause in the distribution of the vaccine enacted out of “an abundance of caution” illustrates how swiftly the agencies acted on vaccine surveillance data.

Consumers should be comforted to know that the vaccine safety monitoring system in place to protect them is working effectively, and further encourages transparency, following the reports of severe cases of a rare form of blood clots observed in young women. The pause allowed the agencies to gather and review additional evidence to ensure the safety of the American people.

Over 560,000 Americans have already died from COVID-19. The risk Americans face for dying from COVID-19 is one in 600 persons. While the risk of dying from COVID clearly outweighs the risk of forming blood clots from the vaccine, we commend the efforts of public health officials to evaluate the specific effects of the vaccine on women, to help ensure further safety and efficacy.

Due to its ease of transport and one-shot delivery, the Johnson & Johnson COVID-19 vaccine is the most accessible and convenient vaccine presently available. The vaccine has been administered to over 7 million Americans, with overwhelming success. Further delay of administering this vaccine only delays our ability to end the pandemic that much sooner.

The reports of adverse events experienced by patients who received the Johnson & Johnson COVID-19 vaccine are concerning and we appreciate the transparency afforded to the public during this time to identify and resolve the situation. NCL has long advocated for vaccine safety and for consumers to feel confident that they are safe, especially in the midst of a mass vaccination campaign.

In closing, we encourage the CDC to maintain effective public messaging to instill vaccine confidence. Consumers should rest assured that vaccines are effective measures to protect public health and vital to national efforts in ending the pandemic.

Thank you for your consideration of our views on this important public health issue.

Sincerely,

Jeanette Contreras, MPP
Director of Health Policy
National Consumers League

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Leading patient advocates launch preterm birth prevention alliance to protect critical access to the sole fda-approved class of therapies to reduce recurrent preterm birth

April 20, 2021

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

Washington, DC—Today, the National Consumers League (NCL), along with a coalition of patient advocacy organizations dedicated to advancing the health of mothers and infants, announced the launch of the Preterm Birth Prevention Alliance.

Members of the Alliance are joining forces in an effort to preserve patient access to the only Food & Drug Administration-approved class of treatments for pregnant women who have previously had an unexpected, or spontaneous, preterm birth. Together, Alliance members seek to ensure that the Food & Drug Administration (FDA) hears concerns from the full range of stakeholders about the potential risks and impact of withdrawal for at-risk pregnant women and their providers.

For the fifth year in a row, the U.S. preterm birth rate has increased (to 10.2 percent of births), and preterm birth and its complications were the second largest contributor to infant death across the country. Preterm birth also represents a significant racial health disparity, with Black women in the U.S. experiencing premature delivery at a rate 50 percent higher than other racial groups throughout the country.

However, in 2020, the FDA proposed withdrawing hydroxyprogesterone caproate, commonly called “17P” or “17-OHPC”, the only FDA-approved class of branded and generic treatments to help prevent the risk of preterm birth in women with a history of spontaneous preterm birth. The FDA is currently determining whether to hold a hearing on the status of 17P, based on conflicting efficacy data from two studies composed of vastly different patient populations, one inclusive of women in the U.S. most vulnerable to preterm birth and one not.

“We’re fighting for a more inclusive healthcare system that gives everyone an equal chance to have the best outcomes possible,” said Sally Greenberg, executive director of the National Consumers League. “We don’t believe that removing 17P from the market without gaining a better understanding of who could benefit the most from its use is in the best interests of patients, nor their healthcare providers, particularly as there are no other approved treatment options available.”

To date, 14 organizations have joined NCL to advocate for the health interests of at-risk pregnant women and infants, including: 1,000 Days; 2020 Mom; American Association of Birth Centers; Black Mamas Matter Alliance; Black Women’s Health Imperative; Expecting Health; Healthy Mothers, Healthy Babies Montana; HealthyWomen; Miracle Babies; National Birth Equity Collaborative; National Black Midwives Alliance; National Partnership for Women & Families; Sidelines High-Risk National Support Network; and SisterReach.

“As a trained obstetrician and gynecologist, I know firsthand the impact of preterm birth on Black women and birthing people. I also know that racism – not race – is the driving factor leading the disproportionate impact of preterm birth on Black women and birthing people thereby exacerbating systemic inequities in maternal and infant health. To achieve birth equity, which is the assurance of the conditions of optimal births for all people with a willingness to address racial and social inequities in a sustained effort, we must work to protect and uphold a standard of care for spontaneous, recurrent preterm births and ensure it remains accessible and affordable for all who stand in need,” added Dr. Joia Crear Perry, founder and president of the National Birth Equity Collaborative.

The Preterm Birth Prevention Alliance is calling for the FDA to grant a public hearing to fully consider all of the data, additional research methods, and stakeholder perspectives before deciding whether to withdraw approval of this critical class of therapies. The health of America’s moms and babies warrants the utmost care and consideration.

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About the Preterm Birth Prevention Alliance

The Preterm Birth Prevention Alliance is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, we seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org.

Initial support for the Preterm Birth Prevention Alliance is provided by Covis Pharma.

Antimicrobial Resistance is a major looming threat to global health systems

By Sally Greenberg, NCL Executive Director

If the pandemic has taught us anything, it’s that threats to our health care system can change lives, both in our communities and around the world. We have learned the value of preparedness and that the ability to respond to massive, impactful events is not easy or without compromise. Thankfully, as summer nears, we see that gradually, countries around the world are in a much better place, thanks to access to vaccines and greater knowledge of how to diagnose and care for patients.

Certainly, we can hope that lessons learned from our recent experience with the COVID-19 pandemic will put us in a better position to identify and address a health issue before it develops to pandemic proportions. But I would urge us to remain vigilant. There are other threats to our health care system that exist and deserve attention…now. One major threat to world health delivery systems is about to have its moment: Antimicrobial Resistance (AMR).

Antimicrobials, which include antibiotics, are critical to maintaining our health. Chances are, in the course of the year, someone in your family will take an antibiotic for an ear infection, an abscessed tooth, a hip replacement, organ transplant, or cancer treatment. In recent years, we have learned that taking too many antibiotics can lead to resistance and therefore a loss of effectiveness. This is true, but it’s important to note that the antimicrobials used to treat resistant infections are much more intense and used in more extreme circumstances than the antibiotics most of us are familiar with.

Antimicrobials fight bacteria and other causes of serious infection and are often the last line of defense against fatal infection. Antimicrobial resistance needs to be taken seriously. The Centers for Disease Control and Prevention (CDC) estimates that approximately three million Americans suffer from AMR infections each year with close to 50,000 deaths annually. Other estimates have placed annual deaths from AMR at 162,000, which makes AMR the third leading cause of death in the U.S. today. Surprised?

Here’s what surprised me: there has only been one new class of antibiotics approved in OVER 30 YEARS. Think about that. We have seen game-changing progress in medicine and treatments for countless diseases and conditions, but not AMR. And then think about how many causes of infection have become resistant to the tools we have to fight them.

AMR is a complex problem that’s not going to be easily solved. It takes years and years and billions of dollars to develop a molecule to fight AMR. Today we are faced with a slim menu of therapeutic options now and we find ourselves years away from expanding those options. I fear that AMR may be our next worldwide health emergency and I am not alone: The World Health Organization (WHO) lists AMR as one of the top ten health threats today. Sadly, it’s not a matter of “if”…but rather “when”.

Medicines don’t work forever. With the limited number of effective antimicrobials, we are looking straight down the barrel of the next health emergency. It’s difficult to even contemplate pivoting from all that we have been through with COVID to a new focus on something else equally frightening, but history tells us that being unprepared comes at a heavy cost. And being prepared is exactly what we need to do.

NCL statement on pause on J&J vaccine distribution

April 14, 2021

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

Washington, DC—The National Consumers League (NCL) commends the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) for their concerted efforts to promptly address recent adverse events observed by the Johnson & Johnson COVID-19 vaccine.

The decision for a momentary pause in distribution for the vaccine was enacted out of “an abundance of caution” on part of the CDC and FDA, following reports of 6 severe cases of a rare form of blood clots observed in young women, ranging from ages 18 to 48, roughly one to three weeks after receiving the shot.

Due to its ease of transport and one-shot delivery, the Johnson & Johnson COVID-19 vaccine is the most accessible and convenient vaccine presently on the market. The vaccine has been administered to more than 7 million Americans, with tremendous success. The measure to pause distribution to gather additional evidence is demonstrative of proper coordination between our most essential public health agencies.

The reports of adverse events experienced by patients who received the Johnson & Johnson COVID-19 vaccine are concerning, and NCL appreciates the efforts by public and industry partnerships to identify and resolve the situation. NCL has long advocated for vaccine safety and consumers need to feel confident that they are safe, especially in the midst of a mass vaccination campaign.

All three COVID-19 vaccines on the market have been shown to be effective against preventing severe symptoms and hospitalization from COVID-19. The incidence of adverse outcomes is very rare and should be put into context with the overwhelming benefits of the vaccine to prevent very serious effects of COVID transmission. Consumers should rest assured that vaccines are effective measures to protect public health and are vital to national efforts in ending 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.

Recognizing 2021 Black Maternal Health Week

April 12, 2021

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

Washington, DC—The National Consumers League (NCL) applauds the resolution introduced by Representative Alma Adams, (NC-12), Representative Lauren Underwood (IL- 14), and Senator Cory Booker (D-NJ) designating April 11-17, 2021 as national Black Maternal Health Week.

The dismal state of maternal and infant health disparities in the United States continues to disproportionately impact black women and babies. In 2020, the rate of pre-term births—the second largest contributor to infant death in the United States—increased to 10.2 percent of births. Black women experience premature delivery at a rate 50 percent higher than all other American women. To address this disparity, in June 2020 NCL led a coalition of organizations in advocating for the FDA to protect patient access to a critical therapy for pregnant mothers at risk of recurrent preterm birth—lack of access to this therapy could disproportionately and negatively impact women of color.

NCL has long advocated for policies to improve maternal health outcomes and sought to address the persistent racial and ethnic health disparities that lead to adverse birth outcomes for black women. NCL is proud to support the Black Maternal Health Momnibus, a package of 12 bills intended to comprehensively address the maternal health crisis that disproportionately impacts Black, Indigenous, and women of color in this country. NCL also applauded a provision within the American Rescue Plan that allows states to extend Medicaid coverage to women for up to one year after childbirth. This provision to expand postpartum care is vital to improving maternal health outcomes for our most vulnerable moms.

“In order to address the maternal mortality crisis in this country, we need to recognize the link between structural racism and the social determinants of health that contribute to the disproportionately high rate of maternal mortality among Black women. This resolution designating Black Maternal Health Week is an important step in supporting policies to improve maternal health outcomes for Black Mamas,” said NCL Health Policy Director Jeanette Contreras.

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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.

Jeanette Contreras portrait

PBMs profit while consumers foot the bill. Policymakers must act

By NCL Director of Health Policy Jeanette Contreras

As consumers, when we go to the pharmacy for our medications, we expect a fair price. However, there’s growing evidence that pharmacy benefit managers — or PBMs — have been impeding the savings that should be going to consumers. Consumers deserve  to share in the cost savings, and we need policymakers to step in and help make that happen.

We previously wrote about our disappointment in how PBMs have evolved from once honest brokers to becoming profit driven and greedy, now taking savings away from consumers and patients.

One avenue PBMs use to pocket savings is through pharmaceutical rebates. PBMs negotiate with companies to lock in discounts for drugs in order to secure the drugs’ placement on a list (formulary). PBMs have notoriously leveraged formularies to give greatest access to the drugs that pay the PBMs the largest rebates, leaving less expensive drugs off-limits to consumers.

A recent Senate Finance Committee report found that rebates to PBMs have significantly increased since 2013 (some as high as 70 percent). But these discounts fail to lower the patients’ out-of-pocket costs for necessary treatments, such as insulin. For one product, the manufacturer offered the PBM a 56 percent rebate – which means more than half of the savings for insulin are going to a company that doesn’t even make the lifesaving medication.

Insulin is expensive. Forbes recently reported that newer versions cost patients between $175 and $300 a vial. The story points out diabetes patients need multiple vials, the cost of which add up quickly; the total annual value of rebates and discounts for PBMs is likely to be more than $5,000 per patient. As a result, consumers lose, paying more than many of them can afford for lifesaving drugs.

Another way PBMs profit is by avoiding competition, which would drive value and savings for consumers. Three main PBMs accounted for about 60 percent of all U.S. prescription claims in 2019. And when it comes to insulin, with so few industry players, it’s no surprise that consumers again find themselves on the losing end.

We’re pleased to see that some policymakers in the states are taking steps to address these issues. In New Jersey, the state is shaking things up by creating alternatives to how it contracts with PBMs — which is, in turn, increasing competition and benefitting consumers. New Jersey residents are saving  a bundle (to the tune of $2.5 billion over five years).

In New Hampshire, a recent study shows that the state can expect to save an estimated $17.8-$22.2 million annually thanks to legislation that will utilize a similar competitive PBM contract process.

While this is encouraging news, there is still more work to be done to bring to light the role of PBMs. Policymakers need to step in to ensure PBMs deliver savings to patients as they were originally intended to do. We’re encouraging state and federal action to review the role PBMs play in driving up costs and to address the many loopholes they use to increase profits.

Consumers — not PBMs — should come first at the pharmacy counter. Reach out to your elected officials. Share this story on social media to help raise awareness. And stay tuned as we continue the conversation.