NCL urges the public to heed warnings about unregulated versions of GLP-1 weight loss drugs

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Media Contact: Lisa McDonald, Vice President of Communications, 202-207-2829

Washington, DC — As an organization with a long history of helping the public avoid fakes and unregulated products, the National Consumers League (NCL) is urging consumers and health professionals to heed the warning from the Food and Drug Administration that compounded versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs now widely promoted on television and online are not FDA approved and may cause serious health problems.

Because studies show that FDA-approved anti-obesity medications (semaglutide and tirzepatide) can help individuals achieve significant weight loss, demand for GLP-1s has surged, prompting supply shortages and consumers to seek alternative ways to obtain these drugs because many health plans do not cover GLP-1s. This dynamic first opened the door for compounding pharmacies to sell non-identical versions of GLP-1 drugs under specific FDA regulations that apply when there is a shortage. Yet now, consumers are navigating a largely unregulated marketplace where numerous actors – telehealth companies, med-spas, illegal online pharmacies, and others – are marketing untested compounded GLP-1 drugs or actual counterfeits that, according to the FDA, may contain incorrect dosages, the wrong ingredients, too much, too little or none of the active ingredients, and possibly bacteria.

Underscoring the potential health consequences from dosing errors and exposure to the wrong ingredients, the FDA has received 607 adverse event reports related to compounded versions of semaglutide and tirzepatide as of November 24, 2024, many of which involve life-threatening and even deadly consequences. This includes approximately 10 deaths and over 100 hospitalizations from compounded semaglutide alone.

Besides the potential health risks, the National Association of Boards of Pharmacy (NABP) warns that illegal online pharmacies are selling substandard or falsified GLP-1 agonists without holding the required pharmacy licensure and without requiring a valid prescription. In fact, NABP has identified thousands of websites that promote the illegal sale of GLP-1 agonists, including sites that are connected to domain names that include GLP-1 drug’s brand names, including Ozempic and Wegovy. Additionally, NCL is aware of new research reported in the JAMA Health Forum, which finds that many websites for mass-produced compounded GLP-1 drugs do not include information about the drugs’ adverse effects, warnings, and contraindications, including hospitalizations, and use misleading language suggesting the compounded product is FDA-approved or equivalent to an FDA approved GLP-1 drug.

Recognizing that incorrect beliefs about obesity, misinformation about treatment options, and restrictive insurance policies keep Americans from getting quality obesity care, NCL and the National Council on Aging issued the first Obesity Bill of Rights for the nation, which establishes The Right to Accurate, Clear, Trusted, and Accessible Information as essential for informed decision-making. In furtherance of this right, NCL urges Americans to follow this advice from the FDA and obesity medicine specialists regarding compounded GLP-1 drugs:

  • Be aware that a compounded drug for obesity is not a copy of an FDA-approved GLP-1 drug. There are differences in how the different medicines are produced and often, the ingredients are different. Further, unapproved drugs have not gone through the FDA’s rigorous review process to ensure safety, effectiveness, and quality.
  • Before seeking treatment with an injectable GLP-1 drug, talk to your doctor or health provider to determine if you are a candidate for treatment with a GLP-1 based on your risk factors and degree of obesity. Also, ask questions about the differences between FDA-approved innovator drugs and off-brand compounded versions.
  • Because GLP-1 drugs are serious medicines that carry risks as well as benefits, it is best to obtain a prescription from your doctor or a health professional you know and fill the prescription at a state-licensed pharmacy.
  • In situations where you choose a telehealth option, beware of prescribing practitioners who do not take your personal history, do not diagnose the degree of obesity with appropriate evaluation measures, or prescribe a GLP-1 drug without ongoing monitoring.

Before ordering a compounded GLP-1 drug through an online pharmacy, follow the FDA’s tips to spot the warning signs that the website may be unsafe, such as the online pharmacy is not licensed in the US or by a state board of pharmacy and offers deep discounts that seem too good to be true.

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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. 

FTC’s win in lawsuit against the makers of dietary supplement Prevagen

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December 11, 2024

Media contact: National Consumers League – Lisa McDonald, lisam@nclnet.org, 202-207-2829

Washington, DC – The National Consumers League (NCL) commends the Federal Trade Commission for its successful action against Quincy Bioscience, the makers of Prevagen, a supplement marketed as improving memory. By holding companies accountable for deceptive health claims, the FTC continues to protect consumers—particularly older Americans—from misleading marketing. Quincy Bioscience is just one of many dietary supplement manufacturers with a long history of making false claims, and we are so grateful to the FTC for pursuing this case successfully.  It should serve as a cautionary tale to all companies who engage in false and deceptive marketing and advertising.  This victory reaffirms the importance of rigorous scientific evidence in health-related advertising and demonstrates the FTC’s unwavering commitment to consumer protection.

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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.

Trump’s nomination of Robert F. Kennedy Jr. for Secretary of Health and Human Services threatens public health

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November 15, 2024

Media contact: National Consumers League – Lisa McDonald, lisam@nclnet.org, 202-207-2829

WASHINGTON, DC– President-elect Trump’s decision to nominate Robert F. Kennedy Jr. as Secretary of Health and Human Services (HHS) is a grave error, prioritizing conspiracy theories over evidence based science and medical research that is a foundation of our public health system.

The nomination is a staggering blow to the integrity of our nation’s healthcare delivery system. Kennedy, one of the loudest anti-vaccine voices during the COVID-19 pandemic, has been vocal about his theory that vaccines cause autism, a theory unsubstantiated by medical research. Vaccines are one of the most significant achievements in modern medicine, virtually eradicating childhood diseases such as smallpox and polio, saving millions of lives, and ensuring that our children grow up healthy and safe. The World Health Organization has repeatedly affirmed that vaccines are a cornerstone of public health, drastically reducing child mortality and preventing devastating diseases.

Parents across the nation, regardless of their political affiliations, share the same goal: to see their children grow up healthy and strong. By advancing vaccine skepticism, Mr. Kennedy jeopardizes not only children’s health but also public confidence in science, medicine, and the agencies tasked with protecting public safety—a foundation that has taken over a century to build.

If he is confirmed for the position, Mr. Kennedy, an environmental lawyer by training with no experience in the health or medical community, would oversee critical agencies such as the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). His anti-science stance raises serious concerns about his ability to lead a department responsible for infectious disease control, food and drug safety, Medicare and Medicaid policy, and life-saving medical research.

In addition, Mr. Kennedy has proposed drastic changes to the FDA, including loosening regulations on raw milk and eliminating the user fees that fund the oversight of drugs and medical devices. These fees are essential for ensuring timely reviews and approvals for medical devices and drugs. Eliminating them delay the availability of new medical innovations and treatments that serve public health.

This is not the first time that Trump has recommended an unqualified individual for Secretary of Health and Human Services. In 2016, President Trump selected Tom Price, whose tenure ended after just three months due to ethical issues and misuse of taxpayer funds.

The Department of Health and Humans Services deserves a leader committed to advancing science, protecting public health, and upholding the integrity of the nation’s healthcare systems. With this nomination, President-elect Trump is proposing putting the fox in the henhouse, essentially putting our public health under an unsuitable leader who would dismantle the very programs that protect our health and the nation’s food supply.

The National Consumers League calls on the U.S. Senate to reject this nomination. Furthermore, we urge President-elect Trump to withdraw this appointment and select a candidate who will champion science, uphold public trust, and protect the health of the nation.

Nancy Glick

The Obesity Bill of Rights: Priorities for government action

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Nancy GlickBy Nancy Glick, Director of Food and Nutrition Policy

Americans need and now have an Obesity Bill of Rights for a reason: People with obesity do not receive the same concern, level of attention, and quality care as those with any other serious chronic disease.  

Put into real-life terms: Though the adult obesity rate now exceeds 42 percent – the highest level ever recorded – obesity is still viewed as a problem of lack of willpower; too many health professionals act in discriminatory ways based on people’s size; and those seeking obesity care often face exclusions in insurance plans, restrictive practices that delay or deny treatment, or are not factored into decisions regarding medicine use.   

The consequence is that only 10 percent of people with obesity get help from medical professionals and only 2 percent of those eligible for treatment with Food and Drug Administration (FDA)-approved anti-obesity medicines (AOMs) have been prescribed these drugs, meaning the disease remains undiagnosed and undertreated. Compounding the impact, untreated obesity worsens the outcomes of more than 230 other chronic diseases, which is why obesity is responsible for as many as 400,000 Americans dying from obesity annually and costs the nation $1.72 trillion a year  in direct and indirect health expenditures – more than what Social Security paid in retirement benefits in 2022. 

It does not have to be this way. 

And this is where the Obesity Bill of Rights enters the picture. Developed by the National Consumers League (NCL) and the National Council on Aging, in consultation with leading obesity specialists, the bill of rights establishes eight essential rights with the core requirements so adults will receive the same person-centered, quality care for obesity as those with other chronic conditions. As such, the bill of rights serves as a blueprint for necessary changes in medical practice and government policy, starting with actions that can happen now. 

One immediate action item is pressing Congress to pass the Treat and Reduce Obesity Act (TROA), an important legislation that will allow more seniors to be treated with FDA-approved anti-obesity medications under the Medicare program. This matter is a high priority because obesity rates have nearly doubled among older adults to include two in every five Americans ages 65 and older. 

Another priority is ensuring that health professionals have the prescribing information to effectively treat people with obesity when they are taking drugs for other conditions, such as depression, schizophrenia, infections, and cancer. The simple fact is that certain drugs work differently in people with obesity and the consequences can be underdosing, a delay in response time, or the drug remaining in the body too long, potentially causing side effects. For example, studies show the drug brexpiprazole (Rexulti®), which treats depression and schizophrenia, takes significantly longer to reach effective levels in people with obesity – and some patients never reach these levels. Fortunately, the same research provides an improved dosing regimen so all patients with obesity can achieve efficacy. 

A different challenge involves drugs like posaconazole (Noxafil®), an antifungal often prescribed by oncologists to prevent infections. Two separate clinical trials show that obesity significantly increases posaconazole’s “half-life” – a term reflecting the amount of time it takes to rid the drug from the body. Half-life is an issue with posaconazole because many oncology medications must be delayed until the drug is out of the body’s system. Thus, if the package insert does not flag this matter when patients have obesity, doctors prescribing posaconazole may not know about the increase in half-life and start using oncology medicines too soon.  

These problems are not rare, but drug labels to guide safe and effective prescribing are dismissing people with obesity. For this reason, the Obesity Bill of Rights includes language to make accurate prescribing a requirement for receiving person-centered obesity care. Moreover, because increasing research validates the consequences of “flying blind” when drugs behave differently in the bodies of people with obesity, the obesity community is raising alarm bells, supported by a position statement from the American College of Clinical Pharmacology (ACCP), which urges FDA to close gaps in the testing and approval process for new drugs intended for use by people with obesity.  

However, because more immediate action is needed, five leading obesity organizations – American Society for Metabolic and Bariatric Surgery, the Obesity Action Coalition, the Obesity Medicine Association, the STOP Obesity Alliance, and The Obesity Society – issued a joint statement calling on drug manufacturers to update their labeling immediately to provide correct usage instructions for people with obesity when there should be a difference in dosing.  

NCL stands with the obesity community in calling for this sensible action and urges FDA to be a catalyst in ensuring that health professionals have the prescribing information needed for their patients with obesity to take important therapeutics safely and achieve the maximum benefit. For more information, visit right2obesitycare.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 www.nclnet.org.

NCL comments on Proposed Rule – Fish and Shellfish; Canned Tuna Standard of Identity and Standard of Fill of Container

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November 21, 2023

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831

The National Consumers League recently submitted comments regarding the Proposed Rule, “Fish and Shellfish; Canned Tuna Standard of Identity and Standard of Fill of Container.” We believe that the Proposed Rule, when implemented, will modernize the standard of identity for “canned tuna,” 21 C.F.R. § 161.190 (“canned tuna SOI”), to require an accurate measure and declaration of weight, and to allow for “safe and suitable” ingredients to provide manufacturers with the flexibility to keep up with changing consumer tastes.

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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 comments regarding Proposed Rule: Medication Guides: Patient Medication Information Docket No. FDA-2019-N-5959

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November 21, 2023

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831

The National Consumers League recently submitted comments regarding the Proposed Rule, Medication Guides: Patient Medication Information, that we believe will greatly improve the information patients receive with their prescription medicines.

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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

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.

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

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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.

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

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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.

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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 https://nclnet.org.