NCL statement on nomination of Dr. Monica Bertagnolli as the Director of the National Institutes of Health

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May 15, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – The National Consumers League welcomes President Joe Biden nomination’s of Dr. Monica Bertagnolli as the Director of the National Institutes of Health (NIH).

NIH plays a critical role in advancing science to benefit patients. Dr. Bertagnolli’s deep understanding of biomedical research and proven leadership in directing the National Cancer Institute makes her an ideal nominee for the NIH Directorship.

“Dr. Bertagnolli brings so much experience to this post,” said Sally Greenberg, NCL’s CEO. “She is a physician, scientist, and a patient herself, so she has seen all sides of the issues facing patients and the NIH. We would be fortunate indeed to have someone of Dr. Bertagnolli stature and accomplishments leading the NIH.”

Dr. Bertagnolli is currently the Director of the National Cancer Institute (NCI). Prior to her role at the NCI, Dr. Bertagnolli was a professor of surgery at Harvard Medical School, and chief of the Division of Surgical Oncology at Brigham and Women’s Hospital and Dana-Farber Cancer Institute. In addition, she was the recent chair of the Alliance for Clinical Trials in Oncology, a national clinical trial network of the NCI.

“NCL believes that Dr. Bertagnolli is the right leader for this critical agency that advances public health. NCL supports her nomination and we urge the Senate to confirm her promptly,” Greenberg added.

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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 nclnet.org.

NCL statement on FDA review of the oral toxicity of cannabidiol (CBD)

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May 12, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – This week, researchers from the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration (FDA) published an analysis on the toxicity of cannabidiol (CBD). The National Consumers League (NCL), the nation’s oldest consumer advocacy organization, has been actively monitoring the growing threats to consumer safety as the market for untested, unapproved cannabidiol (CBD) products has exploded. NCL Chief Executive Officer, Sally Greenberg, released the following statement:

“We’re encouraged to see the experts at the FDA continue efforts to study CBD. These findings unfortunately further validate our concerns around the risks, including negative drug-drug interactions, disruption of critical metabolic pathways, liver injury, reproductive toxicity, and more. These concerns are of course heightened by the fact that many consumers are using products without physician oversight and often use products for long periods of time. The data highlights the need to ensure that FDA has sufficient regulatory tools and resources to mitigate public health risks in this wild west CBD marketplace.”

Learn more about the path to safe cannabis and CBD use here. And learn more about the cannabis consumer market at cannabiswatch.org.

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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 nclnet.org.

NCL applauds expansion of Medicaid in North Carolina

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March 28, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – North Carolina became the 40th state to expand Medicaid under the Affordable Care Act. “NCL applauds Governor Roy Cooper, the work of relentless advocates, and those in the state legislature -Republicans and Democrats- who worked to make this week’s legislation possible,” said Robin Strongin, director of NCL’s health policy work. House Bill 76, the Access to Healthcare Options, is expected to provide health coverage to over 600,000 people throughout North Carolina.

“The expansion of Medicaid is a lifeline for those in need, shoring up rural health care, strengthening mental health services, improving access to health care for working families. The other 10 states should follow North Carolina’s lead,” continued Strongin.

Governor Cooper proposed using a portion of the almost $1.8 billion Medicaid expansion signing bonus to create the Improving Health Outcomes for People Everywhere (IHOPE) Fund.  Medicaid expansion will take effect upon the signing into law of the FY 2023-25 appropriations act.

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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 nclnet.org.

NCL applauds the Biden Administration’s $11-billion budget proposal to eliminate Hepatitis C

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March 22, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – President Biden has proposed significant funding for a historic national Hepatitis C elimination program. “President Biden’s efforts to create a mandatory national program to expand testing, treatment, and prevention of Hepatitis C is a major step forward in eradicating a disease for which we have a cure.” said Robin Strongin, NCL’s Health Policy Director.  “We have the opportunity to use a proven oral medication to cure a lethal disease.  NCL stands ready to assist and is pleased to see initial bipartisan, bicameral support to relinquish a disease affecting 2.4 million Americans.”

Hepatitis C is a viral liver infection transmitted through blood. Roughly 40% of people do not know that they are infected.  Left untreated, Hep C can lead to chronic illness, including liver cancer and death.  The tragedy here is that a cure has existed since 2013.  The price of the once-daily, 8-12 week course of an oral therapy (pills) that cures the disease in 95% of patients is roughly $24,000, down from its original price, but still out of reach for many. Populations at increased risk of Hep C include people who use or inject drugs, people with HIV/AIDS, people experiencing homelessness, and the incarcerated.

The program overall is expected to cost $5.2 billion over 10 years after accounting for the reduced health care costs, and that’s only the financial calculation. It doesn’t take into account the number of lives saved from the devastation of losing a loved one. Dr. Francis Collins, the White House official who has championed this initiative from the beginning, estimates it would save more than 100,000 lives by 2050.

NCL echoes the sentiments expressed by White House Hep C senior advisors Dr. Francis Collins and Dr. Rachael Fleurence in their recent op-ed:

“It is rare to have the opportunity, using a simple and safe oral medication, to eliminate a lethal disease. But that is the situation facing the United States with hepatitis C. Congressional support can make possible a historic public health initiative that can prevent suffering, save lives, and ultimately save money — to the benefit of all U.S. residents. How can we not do this?”

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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 nclnet.org.

Judge Kacsmaryk is poised to redefine the withdrawal method: FDA interuptus should alarm everyone

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By Robin Strongin, Health Policy Director

Bill Tompkins

Here we go, again.

Up until the Dobbs decision in 2022, Roe v Wade had been the law of the land since 1973.

Up until today, women didn’t have to worry that mifepristone, approved by FDA in 2000, would be available as a safe and effective and legal way to end an early pregnancy.

But, Texas Federal Judge Matthew Kacsmaryk, who has been vehemently anti-choice his entire life, is the judge who will decide whether to issue a preliminary injunction ordering FDA to withdraw its longstanding approval of mifepristone, the first pill in the two-drug medication abortion regimen.

Women, and their health providers, stand at a crossroads.  All women, not just those in Texas.

For some, it’s not enough that Roe was overturned in 2022.  Back in November 2022 the Alliance Defending Freedom, a conservative legal group, filed a lawsuit on behalf of antiabortion medical organizations and doctors.  At issue is the FDA’s approval of mifepristone, otherwise known as the medication abortion pill.  The plaintiffs, led by the Alliance for Hippocratic Medicine, have asked the judge to issue a preliminary injunction ordering the FDA to withdraw mifepristone.

Photo: Robyn Beck / AFP via Getty Images

This is unchartered territory.  The court is being asked, for the first time, to basically overturn the approval of a drug.  A drug that has been safely used for decades by over 5.6 million[i] women.  The drug regimen terminates pregnancies successfully 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%).[ii]

This case, and several others that have been brought forward on medication abortion, raise questions about the role of the courts in reviewing the FDA’s findings about a particular drug.  This is chilling. Not only for the women who rely on this medication, but this case has the potential to set up an extremely alarming precedent for other FDA approved drugs.

And it’s dangerous territory for women and their health providers.  According to a court filing, FDA stated that overturning its approval of mifepristone would “cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.”

Should Judge Kacsmaryk rule in favor of the plaintiffs, over half the abortions in the US could come to a halt—this includes abortions in states where abortion rights are (still) protected.  This case is expected to find its way to the Supreme Court—to the same justices who overturned Roe v Wade.

Through a coordinated strategy to take away women’s reproductive rights, advancing abortion bans—at the federal level, at the state level, and through the courts, results in confusion, fear, and poor health outcomes.

Fortunately, experts seem to agree that if the worst were to happen, and the preliminary injunction is granted (and remain in place following the inevitable appeals), there are several options that could allow for the continuing supply of the drug and for providers to continue prescribing.

For example, some abortion providers are planning to provide only the second abortion medication, misoprostol, which is used safely on its own in many countries, though it does have more side effects than mifepristone.

Earlier this week, Governor Gavin Newsom (D-Calif) announced that California state government would no long do business with Walgreens because of their decision that it won’t sell mifepristone in states where Republicans have threatened legal action, even in those states where abortion remians legal.

All of this is happening during Women’s History Month.  But, knowledge is power. According to the Guttmacher Institute, a leading research and policy organization committed to advancing sexual and reproductive health and rights worldwide,  “Since its approval, medication abortion has been used over four million times and has become so widely accepted by patients and providers that it now accounts for more than half of all US abortions—492,210 of the 930,160 abortions (53%) provided in 2020 were done with abortion pills.”

According to the Guttmacher researchers, the impact of eliminating access to medication abortion would differ greatly state to state, but could be especially promounced in rural counties and regions of any state….These 10 states could experience the most severe impact:

Colorado, Georgia, Indiana, Iowa, Maine, Montana, New Mexico, Pennsylvania,Vermontand Washington.

Guttmacher created an interactive map, capturing abortion-related policies and data, categorizing states from the most restrictive to the most protective.

On the map, viewers can also see demographic information and key abortion statistics. The data for women of reproductive age* in each state include:

  • Age-groups and race/ethnicity
  • Proportion living below 200% of the federal poverty level
  • Types of health insurance used
  • Proportion born outside the United State

Abortion-related statistics for each state include:

  • Number and rate of abortions provided
  • Number of clinics that provide abortions
  • Average driving distance to the nearest abortion clinic

The new interactive map is available here.

*The use of “women” to refer to the population of people potentially impacted by abortion policies reflects the terminology in the US census, from which many of our data points are drawn. We recognize that gender identities are diverse and not everyone who needs an abortion may identify as a woman. We reflect that reality in our language where we can, while also accurately describing the underlying data.

[i] Mifepristone US Post-Marketing Adverse Events Summary through 6/30/2022; TTT #2022-2468.  NDA 020687.  ANDA 091178. www.fda.gov

[ii] Mifepristone US Post-Marketing Adverse Events Summary through 12/31/2018; RCM #2007-525.  NDA 20-687.  www.fda.gov

New research reiterates the need for consumer caution, federal protection related to marijuana companies misleading claims

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March 13, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – Data Science Solutions, LLC, in partnership with NCL, today released new research that dives into false or misleading medical claims made by several leading marijuana companies on their social media platforms. The analysis qualitatively observes how these claims are framed to appeal to consumers, determines the reach of their messaging, and identifies policy solutions to help increase state and federal regulatory and enforcement action to end false – potentially harmful – marketing.

“Consumers should understand what they’re up against when perusing social media,” said Sally Greenberg, Executive Director of the National Consumers League. “Twitter in particular may be viewed as a more trustworthy platform and licensed marijuana companies will often site reliable academic institutions or studies in a misleading way. These companies use Twitter to target consumers and declare that their products can help address, even treat, health issues from ‘pain’ to neurological diseases, even cancer. However, these claims are not backed by sound, clinical research – though the data is lacking at best, companies don’t let that stop them from trying to profit.”

The FDA, FTC, and Congress can do more to protect consumers and hold these companies accountable. The paper urges Congress to “encourage FDA and FTC to expand their enforcement against therapeutic claims made by cannabis companies and provide the necessary resources for the FDA to conduct effective oversight of marijuana-related health claims on social media platforms,” And recommends FDA begin using automated tools to monitor cannabis companies’ social media posts efficiently and effectively.

“Consumers deserve better,” said Greenberg. “These companies can and should market their products in an honest way and put consumer health over profits. Investing in thorough research so that we may better understand the true therapeutic potential of marijuana would be a win-win for all.”

To learn more about the risks of unregulated cannabis products, visit cannabiswatch.org.

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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 nclnet.org.

The National Consumers League mourns death of Judith (Judy) Heumann, disability rights activist

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March 6, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

WASHINGTON, D.C. — The National Consumers League is deeply saddened by the death of disability rights activist, Judy Heumann.  Known as “the mother” of the disability rights movement, Judy Heumann was at the vanguard of major disability rights demonstrations, helped spearhead the passage of disability rights legislation, founded national and international disability advocacy organizations, held senior federal government positions, co-authored a memoir, and was featured in the Oscar-nominated documentary film, Crip Camp: A Disability Revolution.

National Consumer League Director of Health Policy, Robin Strongin, provided the following statement. “Judy’s fierce determination, tireless advocacy, and refusal to be defined by others, was instrumental in the development and implementation of national disability rights legislation, including Section 504, the individuals with Disabilities Education Act, the Americans with Disabilities Act (ADA), the Rehabilitation Act, and the UN Convention on the Rights of Persons with Disabilities.  Judy’s legacy will live on but we are saddened by the loss of this legendary champion.”

 

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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 nclnet.org.

The National Consumers League applauds Eli Lilly Decision to cap prices on insulin

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March 6, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – The National Consumers League commends the decision by drug company Eli Lilly to cut prices for insulin and cap costs insured patients pay to fill prescriptions.

“We applaud the Eli Lilly company for  taking steps to cap prices for insulin.  This action will provide much needed relief to patients suffering from diabetes who are currently facing steep annual costs for insulin, medicine that is life saving for those coping with their illness,” said NCL CEO Sally Greenberg.

The company said it will cut the list price for its most commonly prescribed insulin, Humalog, and for another insulin, Humulin, by 70% starting in October..

Lilly also said Wednesday that it will cut the price of its authorized generic version of Humalog to $25 a vial starting in May.

Lilly also is launching in April a biosimilar insulin to compete with Sanofi’s Lantus. NCL strongly supports the use of biosimilars as they introduce much needed competition and lower prices into the drug marketplace.

Lilly said people without insurance can find savings cards to receive insulin for the same amount at its InsulinAffordability.com website.

The federal government in January started applying that cap to patients with coverage through its Medicare program for people age 65 and older or those who have certain disabilities or illnesses.

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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 nclnet.org.

NCL Health Policy Director testifies at FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC)

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February 28, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – Today, NCL Health Policy Director Robin Strongin testified at the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC). Robin’s full testimony can be found below.

Good afternoon, my name is Robin Strongin and I direct Health Policy for the National Consumers League (NCL).

Founded in 1899 by the renowned social reformer, Florence Kelley, the National Consumers League has long championed vaccines as lifesaving medical interventions.

In fact, Kelley’s support of vaccinations played a key part in mitigating a critical smallpox outbreak towards the end of the 19th century, and her tireless advocacy for immunizations has informed NCL’s bedrock principles for increased access and vaccine confidence.

124 years later, we are honored to persist in our efforts to protect consumers from vaccine preventable illnesses and we extend our gratitude to this committee for the opportunity to present our public comments.

We know that despite decades of effort, no vaccine to protect against RSV disease, in any population, has been authorized, resulting in a very serious unmet need.  The dramaticrise in cases this past Fall was a wake-up call for us as a nation.

As Americans faced the threat of contracting RSV–the flu, pneumonia, and COVID were circulating simultaneously. The difference, of course, is that vaccines for COVID influenza and pneumonia are widely available and many in the most vulnerable communities have embraced these tools to reduce their risk of serious illness and death.

However, the lack of any such tool to protect against RSV made for a frightening reality for Americans already facing serious threats to their respiratory health, especially among the very young and the elderly.

NCL is also concerned with the serious strain these viruses put on our health care system, and its ability to provide quality and timely care for patients. From hospitals running at capacity, to over taxed health care providers and family caregivers, the prolonged burden such an uptick in cases can inflict is not sustainable.

We are encouraged by the continued progress in the development of vaccines to help strengthen our ability to fight back against devastating diseases like RSV.

Ensuring broad and equitable access to these vaccines is an important next step to improving the health of all communities while reducing the high burden these viruses place on our health care system.

NCL cares deeply about the health and well-being of our nation.  We will continue to do our part to educate people about the importance of vaccines and the value they offer consumers–and society as a whole.

Thank You.

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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 nclnet.org.

The National Consumers League sent a letter urging Senate Committee on Commerce, Science and Transportation to ensure that consumers get a fair deal at the pharmacy

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February 21, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – The National Consumers League (NCL) sent a letter urging Senate Committee on Commerce, Science and Transportation to ensure that consumers get a fair deal at the pharmacy. When it comes to the high out-of-pocket costs consumers face at the pharmacy counter — often for lifesaving medications — consumers today have an unfair disadvantage.

“With three PBMs controlling nearly 80 percent of all prescription drug claims, it is timely that lawmakers are looking at PBMs’ role in driving up the cost of drugs to consumers and patients,“ said Sally Greenberg NCL Chief Executive Officer. “We are encouraged to see the committee looking into the workings of PBMs and we are supportive of your efforts to hold these entities accountable.”

Beyond addressing the antitrust issues and increasing transparency of PBM revenue streams, we encouraged legislators to:

  • Remove medication barriers: PBMs should not be allowed to limit access to the medicines doctors prescribe.
  • Require PBMs to pass on savings directly to consumers: PBM rebates should be shared so that consumers can benefit from more affordable out-of-pocket costs. Additionally, patient cost-sharing should be based on the net cost of the drug, not the list price.
  • Ensure simple, single administrative PBM fees: PBMs too often tack on arbitrary fees to local pharmacies, with many independent and community pharmacies struggling to stay in business, this trickles down to the consumers, resulting in increased prices and pharmacy closures, leading to many communities facing pharmacy deserts.
  • Ensure PBM profits are not tied to the costs of medications: The system currently incentivizes PBMs to favor medicines with higher list prices so that they can negotiate larger rebates and/or steer patients to medicines with higher price tags to increase their own profits.

With the many evolving ways PBMs too often put profit over consumer interests, it is crucial that federal consumer protection agencies like the FTC have the tools needed to address the PBM problem.

To view the full letter, click here.

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