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

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.

###

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

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

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

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.

###

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

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.

###

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’s Greenberg joins panel to discuss the challenges and opportunities of the generic and biosimilar industries

February 15, 2023

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

Washington, D.C. – NCL’s CEO Sally Greenberg spoke at the Association of Accessible Medicines and International Generic and Biosimilar Medicines Association Annual Meeting in Orlando, FL on Wednesday, February 15, 2023.

Greenberg joined the panel “The Generic and Biosimilar Industries Global Reputation” moderated by former NY Times journalist Gardiner Harris.

In her statements, Greenberg made the following points:

  • The generic and biosimilar industry has saved the US health care system an estimated $2.4 trillion between 2011 and 2020 and the industry is incredibly important to a well-functioning health care system.
  • NCL reinforces the messages with consumers that generic drugs contain the same active ingredients in the same dosages as brand name drugs, are every bit as safe and effective, but cost far less.
  • Biosimilars, developed after patents expire on brand name biologics, are as safe and effective as the original biologic, both brand biologics and biosimilars are rigorously and thoroughly evaluated by the FDA before approval and biosimilars have no clinically meaningful differences from the original biologic.
  • Over 90% of drugs are available in a generic version today, compared to less than 19% less than 4 decades ago, saving consumers and patients many millions of dollars each year.
  • The role of consumer advocacy groups like NCL will continue to be as an independent voice disseminating accurate, evidence based, scientifically grounded information about medicines and their safety and efficacy.

For the first time since 2014, the 25th International Generic and Biosimilar Medicines Association (IGBA) Annual Conference will be held in the United States, in conjunction with AAM’s Access! 2023 Annual Meeting. This event offers an opportunity to hear from leading global stakeholders, industry leaders, and other experts offering their views and analysis of the most pressing policy questions influencing patient access to generic and Biosimilar medicines in countries around the world.

###

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 supports the bipartisan S 4918 (117th Congress) “Increasing Prescription Drug Competition Act”

February 7, 2023

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

Washington, D.C. – NCL is the nation’s oldest consumer and worker advocacy organization, formed in 1899 to work for a fair marketplace for all. NCL has long supported robust competition and affordable, accessible drugs for patients and consumers. We therefore appreciate the opportunity to provide our support for the bill introduced in the 117th Congress entitled “Increasing Prescription Drug Competition Act”, co-sponsored by Senator Maggie Hassan (D-NH) and Senator Mike Braun (R-IN). This legislation would bar the use of various loopholes in the law to block the introduction and sale of competitor drugs. One such familiar technique brand drug makers have used is claiming that a REMS programs (Risk Evaluation and Mitigation Strategies) required by the FDA for the brand version of the drug, prevents a competitor drug from entering the market. This argument goes against the prevailing view within the FDA and the FTC that a REMS requirement on the brand name drug must not be used as a way to block competition.

The Federal Trade Commission voted 4-0 to file an amicus brief  with the U.S. District Court for the District of Delaware on this topic.  The FTC brief takes no position on the scope or claim construction of the patent, but argues generally that there is significant harm to consumers when a brand lists a patent on a distribution system in the Food and Drug Administration’s “Orange Book” of approved drugs and thereby blocks the introduction of lower-cost generic medications or other follow-on competition. The FTC’s amicus brief explains how the Orange Book listing process can be abused, and emphasizes the harm to competition and consumers that can result from that abuse, including depriving consumers of potential competition from lower-cost alternatives and the ability to choose between products.

By way of background, we note these additional points:

  • REMS, or Risk Evaluation and Mitigation Strategies, are required by FDA for certain medications to ensure that the benefits of the drug outweigh its risks.  The sole purpose of a REMS is to protect patient safety
  • Despite policies that the former FDA Commissioner, Dr. Scott Gottlieb announced in 2018 to reduce the use of REMS programs as a way to block competition and access, followed by the CREATES act, which was signed into law in 2019, loopholes remain today
  • We look forward to the reintroduction of the bi-partisan bill proposed last fall by Senator Hassan (D-NH)and Senator Braun (R-IN), “Increasing Prescription Drug Competition Act”, which would no longer allow FDA approvals of medications to be delayed due to patents listed in the FDA “Orange Book” on REMS
  • We hope the legislation will address the problem of companies taking advantage of FDA-mandated safety programs at the expense of patients receiving innovative competitor medications, or generic medications. We believe that “Increasing Prescription Drug Competition Act”, bill will help to address that problem.

###

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 https://nclnet.org.

NCL statement on FDA decision regarding CBD regulatory framework

January 27, 2023

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

Washington, D.C. – The National Consumers League (NCL), the nation’s oldest consumer advocacy organization, applauds the FDA’s decision that “a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”

NCL has been actively monitoring the growing threats to consumer safety as the market for untested, unapproved cannabidiol (CBD) products has exploded.

“This announcement is a critical step in the right direction. NCL supports FDA’s assessment that the existing dietary supplement and conventional food pathways are not appropriate for CBD,” said NCL Executive Director Sally Greenberg. “We are encouraged to see regulators prioritizing science and consumer safety, and we are committed to working with Congress, the FDA and other stakeholders to explore potential regulatory pathways that prioritize management of health risks associated with CBD and acceleration of rigorous research into cannabinoids’ therapeutic potential.”

“To that end, NCL was pleased to see FDA highlight the need for risk management tools, including clear labels, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children.”

Along with our partners – the Consumer Federation of America and the Community Anti-Drug Coalitions of America – NCL created the Consumers for Safe CBD in 2019, now Cannabis Consumer Watch, to educate consumers about the potential dangers of CBD in an unregulated market.

“We will continue advocating for policies that preserve meaningful, scientific research incentives while protecting public health,” Greenberg said. “As Congress works to develop a new regulatory pathway for CBD, it is critical that we bear in mind there’s greater urgency to address the risks posed by intoxicating cannabinoid products in the hemp market. As we’ve seen, these products pose significant risks to consumers, and must be addressed. Science should continue to guide policy discussions to ensure a safe and effective regulatory pathway.”

To learn more, visit cannabiswatch.org.

###

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 https://nclnet.org.

It is time to give Medicare beneficiaries effective obesity care

Sally Greenberg

By Sally Greenberg, Chief Executive Officer

“What we’ve got here is a failure to communicate.”

As one of the most recognized quotes of all time, this line from the 1967 movie, Cool Hand Luke, originally addressed the struggle of a person’s will over government control.

Now the line is applicable to another and equally intractable struggle: ending outdated Medicare rules that leave millions of seniors with diagnosed obesity – particularly members of Black and Latino communities – vulnerable to disability, disease and premature death due to lack of access to the full range of treatment options.

The struggle is not new. As documented in a 2010 report from the US Surgeon General, the prevalence of obesity began to increase sharply in the 1980s and by the 1990s, public health leaders were calling obesity a national emergency. Now, the obesity rate among adult Americans exceeds 40 percent but is even higher among communities of color: virtually half of African Americans (49.6 percent) and 44.8 percent of Hispanics are living with obesity. Moreover, because obesity is directly linked to over 230 medical conditions, the disease is responsible for an estimated 400,000 deaths a year, costing the nation over $1.72 trillion annually in direct and indirect health costs.

Confronting this growing crisis, in 2012, the United States Preventive Services Task Force (USPSTF) issued guidelines recommending screening all U.S. adults aged 18 and above for overweight and obesity and encouraging clinicians to treat or refer adults with obesity for treatment. Then, in 2013, the American Medical Association officially recognized obesity as “a disease state” on a par with other serious chronic diseases, like type 2 diabetes and hypertension, so healthcare professionals (HCPs) would be motivated to diagnose, counsel and treat obesity. These actions were the impetus for most private insurers, state health plans and state Medicaid programs to cover obesity care to some degree. Moreover, the Office of Personnel Management, which oversees health coverage for federal employees, now requires that insurers cover the full range of obesity treatment options, including intensive behavioral therapy (IBT), prescription weight loss drugs, and bariatric surgery. Additionally. Tri-Care, which covers military personnel and their families, and the Veterans Administration cover AOMs for adults who do not achieve weight loss goals through diet and exercise alone.

This leaves the Medicare program, which today represents the biggest obstacle impeding access to quality obesity care. Outdated Medicare Part B policy places undue restrictions on intensive behavioral therapy by allowing only primary care providers to deliver IBT and severely restricting the physical locations where this care can occur. Equally troubling, new FDA-approved anti-obesity medications (AOMs) are excluded from Medicare coverage based on a statutory prohibition tracing back to the start of the Part D program. This was in 2003 when fen-phen (the drug combination of fenfluramine and phentermine) controversy raised questions about the safety of weight loss drugs, leading the Centers for Medicare and Medicaid Services (CMS) to classify these medicines as “cosmetic” treatments not eligible for coverage, just like hair loss drugs and cold and flu treatments.

But obesity medicine has improved substantially since 2003. Due to the latest science on obesity as a serious chronic disease, there have been major advances in drug development, including new anti-obesity medications that achieve meaningful weight loss. Yet, while science has moved forward, CMS policy is stuck in the past.

To change this situation, advocates have gone to both Congress and CMS for help. In Congress, public health and aging organizations have been working to pass bipartisan legislation called the Treat and Reduce Obesity Act (TROA) that would end the exclusion under Medicare Part D prohibiting coverage for AOMs and change Medicare Part B rules to permit all qualified health practitioners to provide Intensive Behavioral Therapy (IBT) to Medicare beneficiaries. With CMS, advocates have written to and met with key staffers on several occasions, urging the agency to use its inherent authority to allow flexibility to include drugs under Part D that might otherwise be excluded. One key argument is that CMS has already done this on multiple occasions, ending exclusions for treatments for AIDS wasting and other medical conditions when it is urgent to do so.   And yet, ten years have passed since AMA classified obesity as a chronic disease with no action from either Congress or CMS. In Congress, TROA did not receive a floor vote in the House of Representatives in 2022 despite having 154 co-sponsors and widespread support from medical societies, public health organizations and the aging community. Similarly, CMS has kept the exclusion on coverage for anti-obesity medications, even though the Biden Administration has asked for ways to address systemic racial inequity and obesity is a throughline to better health outcomes.

To start a dialogue that could lead to meaningful action, the National Consumers League and the National Council on Aging decided to change the dynamic. In September 2022, our organizations sent an urgent letter to CMS Administrator Chiquita Brooks-LaSure requesting a meeting so we could speak to her directly on behalf of  about 18 million traditional Medicare beneficiaries whose diagnosis of obesity puts them at risk of other serious conditions. Our letter was well received and on January 17, this meeting took place.

Recognizing that there has been a “failure to communicate” the urgency of the moment, our purpose was to put a human face on seniors with obesity and to convey that bureaucracy and intransigence cannot be the reason that 18 million older adults are denied effective obesity care. As such, we asked Administrator Brooks-LaSure to end the impasse in Part D coverage of FDA-approved AOMs by making access to obesity treatment an agency priority. This action could be the catalyst empowering CMS staff to think differently about obesity and be more open to interpreting the statutory exclusion provision in a way that would permit coverage for anti-obesity medications.

It is too soon to know what the outcome of the meeting will be. We opened a door and pledged to maintain a frank and constructive dialogue with Administrator Brooks-LaSure and staff she designates on the needs of Medicare beneficiaries living with obesity. Our hope is to elevate obesity as a priority for CMS policy and to work with CMS and other stakeholders to remove the access barriers that keep too many Americans from seeking obesity care.

National Consumers League applauds FDA’s decision increasing access to Mifepristone (the “abortion pill”)

January 5, 2023

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

Washington, D.C. – The Food and Drug Administration (FDA)’s decision this week to lift a major barrier blocking access to medication abortion care marks an important step forward for women.  Mifepristone is a drug that blocks the hormone needed for a pregnancy to continue. Mifepristone, when used together with another medicine called misoprostol, is used to end a pregnancy through ten weeks gestation.  And it is safe.

The FDA posted the following on its website: “Mifepristone is safe when used as indicated and directed and consistent with the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. The FDA approved Mifeprex more than 20 years ago based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use.  As of 2016, it can be used for medical termination of pregnancy up to 70 days of gestation.  The FDA’s periodic reviews of the postmarketing data for Mifeprex and its approved generic have not identified any new safety concerns with the use of mifepristone for medical termination of pregnancy through 70 days gestation. As with all drugs, the FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of pregnancy.”

NCL urges continuous attention on this issue. While FDA moved things forward by expanding access, too many people remain without care options because they live in states that ban telehealth for medication abortion or have banned abortion outright.

FDA’s lifting of the in-person dispensing requirement and establishing a new program to certify both brick-and-mortar and mail-order pharmacies to dispense mifepristone is a turning point for so many, especially young women and women in abusive relationships who may not have the privacy to receive medication by mail.

###

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 https://nclnet.org.

NCL welcomes FDA heightened concerns related to CBD products

December 29, 2022 [Updated]

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 703-298-2614

Washington, D.C. – The National Consumers League (NCL), the nation’s oldest consumer advocacy organization, is welcoming of the FDA’s heightened concern and attention to consumer safety risks in the CBD or cannabidiol consumer product market.

“The FDA’s continued engagement and work in the CBD consumer product market is critical to protecting consumer safety – the agency’s increased attention to CBD products is welcome news,” said Sally Greenberg, NCL’s Chief Executive Officer.

In 2019, in response to the proliferation of unreviewed and untested CBD products, NCL identified the need for greater education among consumers about CBD and better enforcement of regulations in the CBD marketplace. NCL created Consumers for Safe CBD to address this need, champion the rights of consumers, and call on government and industry to do better – to ensure safety and promote a pathway for new products through clinically tested scientific research.

Since then, action has been taken on the state and federal levels to increase access to cannabinoids beyond CBD, which is why NCL is now shifting its focus to cannabis more broadly with the establishment of Cannabis Consumer Watch. Cannabidiol (CBD) is a chemical compound found in cannabis plants. It is one of the main ingredients in cannabis, but unlike THC, it does not cause a high or have psychoactive effects.

“NCL called on the FDA to develop regulations for the CBD marketplace. We also asked the CBD industry to ensure safety and promote a pathway for new products through clinically tested scientific research,” said Greenberg.

The 2018 Farm Bill legalized hemp cultivation in the U.S., which led to significant growth in the CBD marketplace.

“Since 2019, NCL and other groups like the Consumer Federation of America and Community Anti-Drug Coalitions of America have been asking the FDA to step in and address the CBD marketplace – which is currently a ‘Wild West,’ with myriad unsubstantiated claims made by many in the industry about the so-called benefits of CBD products for everything from sleep disorders to cancer to pain relief, without regard to safe dosages,” Greenberg noted. “We want the agency to establish a regulatory framework for the legal sale of appropriate cannabis and cannabis-derived products. Some industry members have been asking for rules of the road as well. Any regulatory framework FDA recommends for cannabis-derived products must prioritize consumer safety and address the safety risks the agency has identified.”

There is only one FDA-approved drug on the market that employs CBD as its active ingredient – Epidiolex – a medication to treat a rare form of childhood epilepsy. That drug has undergone the rigorous FDA approval process and thus has substantiated therapeutic benefits that outweigh the risks which can be managed by prescribing physicians.

Cannabis Consumer Watch will continue to work to educate consumers about the potential dangers of CBD in an unregulated market and encourage the FDA to take strong, effective, and prompt action to protect the public from the potential harms posed by unregulated, untested CBD.

###

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 https://nclnet.org.