Guest blog: The impact of patient inputs on policymaking

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By Mekdes Agezew, NCL Health Policy Spring Intern

On February 28, 2025, HHS announced rescinding the Richardson Waiver, a decades-old policy requiring voluntary public notice-and-comment periods for regulations related to public benefits like Medicare and Medicaid. While the Administrative Procedure Act (APA) does not mandate such participation for these rules, HHS has followed the waiver since 1971 to promote transparency.  HHS Rescinds Richardson Waiver, Reducing Public Input in Rulemaking. While it may seem innocuous because it only applies to voluntary public notice regulations, the move could signal a general slide toward less transparency and openness at HHS. NCL opposes this action by HHS and Secretary Robert Kennedy Jr. (RFK Jr.)

Public Participation under the Administration Procedure Act (APA)

The Administrative Procedure Act (APA) requires federal agencies to consider a rule or regulation to ensure their timeline allows for notice and comment periods. Rulemaking requires every agency, with a few exceptions (Sec. 2a), to publish the agency’s plan of rulemaking or policy in the Federal Register. The statement must include (1) the locations of the agency’s main and field offices, the official in charge, and the means of communication for the public to get information or make requests, (2) the function of the agency and its requirements and standards for their work, including the steps, forms, and instructions needed for paperwork, reports, or examinations, and (3) a description of the agency’s rules and policies to help the public understand its operations (Sec 3a).

Under the law, government agencies, whether funded and operating under a federal department or independently, are mandated to consider and incorporate suggestions and comments from patients and consumers before finalizing any proposed policy.

However, on March 3rd, 2025, Health and Human Services (HHS) RFK Jr. published a policy statement directing the agency to no longer require standard federal regulatory rulemaking procedures for matters “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.” Notably, this allows the agency to forego issuing public comment opportunities for specific administrative actions. 1

NCL does not support this action.  Public comment gives the public a chance to express concerns and viewpoints that may not have been considered by agency staff, helping improve health outcomes and advance public health goals. By involving patients and consumers, federal staff can enhance their awareness and knowledge of the strengths, problems, needs, challenges, and barriers experienced by the community they serve and learn more about the impact of any regulation they are considering. A study by the Office of Assistant Secretary for Planning and Evaluation (ASPE) within the U.S. Department of Human Health Services (HHS) and Inner City Fund (ICF) found that by engaging people with lived experience, products, tools, and resources were strengthened by increasing accessibility, responsiveness, and tailoring to consumers’ specific needs.

Why does the “Richardson Waiver” still matter today?

A little more information about the Richardson Waiver is helpful. In 1971, HHS issued a policy statement titled “Public Participation in Rule Making.” This policy directed the agency to use standard notice of proposed rulemaking procedures in instances not required by law, including matters relating to “agency management” and “public property, loans, grants, benefits, or contracts.” These procedures are codified by the Administrative Procedure Act (APA), which sets the rules for how administrative agencies create regulations and allows exemptions for agency actions under the listed categories.

In issuing the waiver, HHS cited a 1969 recommendation from the Administrative Conference of the United States, and a desire to see “greater participation by the public in the formulation of this Department’s rules and regulations.” This waiver has since been referred to as the “Richardson Waiver,” named after then-HHS Secretary Elliot L. Richardson, appointed by President Richard Nixon.

The Richardson Waiver (and Secretary Kennedy’s subsequent repeal) covered agency activities often considered “ ’proprietary functions,’ i.e., government control over its own resources.” These are distinct from agencies acting as regulators of other entities’ activities. For instance:

Agency Management: This exception only applies to agency management decisions that only affect the agency in question. This includes documents like employee handbooks and training materials. 2

Public Property: This doesn’t apply to rulemaking about managing public lands – it only applies to rules about the “distribution of public property.” 3

Under the APA requirement, the Agency has discretion to continue allowing comment opportunities, rescinding the waiver of some rules and policies, including:

Matters related to HHS grantmaking and methodology, such as through the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Administration for Children & Families (ACF), Agency for Healthcare Research and Quality, and other programs. HHS is the largest grant-making agency in the US and provides grants to state, local, and tribal governments and community organizations.

The 2025 Repeal: What to Expect

In the policy statement suggesting repeal of the Richardson Waiver, Secretary RFK Jr. claims that the Waiver “imposes costs on the Department and the public, is contrary to the efficient operation of the Department, and impedes the Department’s flexibility to adapt quickly to legal and policy mandates.” It is important to note that the statement still allows agencies to “have discretion to apply notice and comment procedures to these matters but are not required to do so, except as otherwise required by law” – it is not a blanket ban on comment opportunities. Additionally, the statement affirms that HHS “will continue to follow notice and comment rulemaking procedures in all instances in which it is required to do so by the statutory text of the APA.”  That is good news, but then again, we shall see. This could be a slippery slope where the Secretary begins to eat away at notice and comment opportunities that lie outside the Richardson Waiver parameters. NCL supports full opportunities for public comment. RFK Jr. uses the “good cause” exception and claims the waiver got in the way of. Now the question is, has the waiver genuinely hindered the agency’s efficiency, or is it a strategic move to divert attention?

 

Visiting Jane Addams Hull House Museum in Chicago in April 2025

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By Sally Greenberg, NCL CEO

How fortunate we were to be in Chicago for the 31st teen consumer education competition this April 2025. Fortunate for several reasons – Chicago is truly one of the world’s great cities: wonderful architecture, grand old buildings, and charming neighborhoods, each with its own restaurants and customs.

However, we were fortunate as well because the roots of our organization, the National Consumers League, are found at Chicago’s Hull House. Today, it’s called Jane Addam Hull House Museum and is a National Historic Landmark. 

This site was America’s most famous original settlement house, today on the campus of the University of Chicago. The House was founded in 1889 by Jane Addams and her partner, Ellen Gates Starr, to serve poor Greek, German, Irish, Italian, Bohemian, Russian, and Polish Jewish immigrants flooding to Chicago to work in the city’s burgeoning industries. Addams was a prolific author and social reform visionary (she won the Nobel Peace Prize in 1931), opening the doors of Hull House for residents and their children in surrounding tenements, offering cultural experiences like dance, theater, and music, classes in English, weaving, American customs, and public baths. Little children were welcomed to the nursery and older children attended kindergarten.

Hull House Museum, with its many bedrooms and function rooms, became home to social reformers like NCL’s Florence Kelley. Other residents of the Hull House included Dr. Alice Hamiliton, Julia Lathrop, Grace and Edith Abbott, and Sophonisba Breckenridge. Kelley had fled New York City and an abusive husband, taking her three children with her Hull House in Chicago and successfully filing for divorce in the Illinois courts. She lived and worked alongside Addams. NCL co-founder Francis Perkins accepted a teaching position in Lake Forest, Illinois, in 1904 and immediately began to spend her free time at Hull House. 

Kelley served in the 1890s as chief factory inspector for the State of Illinois and undertook a project to map tenements. Kelley documented the overcrowded, dilapidated rooms, tracking wages, working conditions, and ages of residents. She discovered children as young as 4 and 5 not attending school but working many hours a day inside dark, airless dwellings with their families for pennies a day. Infectious diseases spread rapidly in these conditions, and many children and adults died. Kelley’s mapping effort provided critical data to enable her to make the case for comprehensive reforms. Addams enlisted Kelley to serve as General Secretary when they decided to form the National Consumers League.

So, my colleague Karen Silberstein, also a history buff, ventured to the Near West Side to see Hull House Museum. We beamed with pride at the exhibit of Florence Kelley, showing the “White Label” that she created to give to factories that respected worker rights. The exhibit describes her as a “labor activist, consumer advocate, and attorney.” Kelley later received her degree after taking night classes at Northwestern Law School.

We walked through the first and second floors, seeing exhibits of the many reformers and residents of Hull House and marveling at the looms, yielding handiwork and extensive crafts of Hull House. We read romantic poems and letters – once kept from the public but now proudly displayed – from Addams to her life partner, Mary Rozet Smith.

Hull House actually had 13 buildings, and while most of them aren’t open to the public, this national treasure is a must-see for Americans who are fascinated by our nation’s history during the turn of the 20th Century and the Progressive Era. NCL is proud to be an essential part of this American heritage. 

 

NCL applauds Senator Cassidy’s effort to shine light on 340B program oversight and accountability

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

Washington, DC – The National Consumers League (NCL) applauds Senator Bill Cassidy, M.D. (R-LA), Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, for releasing a new report exposing significant accountability gaps in the federal 340B drug discount program.    

“The 340B program was designed to help vulnerable patients afford life-saving medications—not to boost the bottom lines of large health systems or third-party contractors,” said Sally Greenberg, CEO of the National Consumers League. “Senator Cassidy’s report rightly calls for greater accountability, transparency, and reform. We urge Congress to act quickly so this critical program delivers on its promise to help the patients who need it most.”  

The report raises serious concerns about how hospitals, clinics, and pharmacies use 340B revenue—often with little transparency or direct benefit to low-income and uninsured patients. Key findings include:  

  • Large hospital systems report hundreds of millions in 340B revenue used for vague purposes like “capital improvements,” with no clear patient benefit.  
  • Federally Qualified Health Centers show inconsistent practices in delivering discounts to patients, despite a significant 340B income.  
  • Pharmacy chains like CVS and Walgreens impose rising fees on providers, making it harder to serve vulnerable patients.  
  • Drug manufacturers report misuse of discounts, including diversion to ineligible patients and duplicate discounts.  

Senator Cassidy proposes reforms to increase oversight, require annual reporting on 340B revenue use, and ensure patients—not intermediaries—benefit from the program.  

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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.   

Annual Spring Soirée 2025

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NCL decries the passage of resolutions weakening tailpipe emission standards

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

Washington, DC – This week, the House of Representatives passed three Congressional Review Act (CRA) resolutions that restricts states’ rights to establish robust tailpipe emission standards.  

“These resolutions ignore a simple truth: costs are low when clean car standards are high,” said Daniel Greene, Senior Director of Consumer Protection & Product Safety Policy. “Slamming the brakes on robust emission standards will inflict pain at the pump, hamper American competitiveness, exacerbate the climate crisis, and harm public health.  We implore the Senate to stop this assault on American manufacturing, affordability, health, and the environment.”   

Under the Clean Air Act, the Environmental Protection Agency (EPA) may issue the State of California a waiver to exceed federal emission standards for motor vehicles.  Other states are permitted to adopt California’s standards.  In 2024, the EPA provided California waivers for the State’s Advanced Clean Cars II (ACC II), Advanced Clean Trucks, and Omnibus NOx rules.  These standards, which have been adopted in full or in part by 17 states, have nationwide benefits: conserving energy, combating the climate crisis, improving health, and reducing pain at the pump. 

Please see this fact sheet detailing the CRAs and their effect on American competitiveness, affordability, health, and the environment. 

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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. 

America’s second obesity crisis is an infodemic of disinformation about GLP-1 weight loss drugs

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

The National Consumers League Launches a New Mobilization, “The Weight Truth,” to Combat the Infodemic of Disinformation Surrounding GLP-1 Drugs; New White Paper Identifies Nine Priorities for Action

Washington, DC – With mounting evidence that an infodemic of disinformation about GLP-1 weight loss medicines has become America’s second obesity crisis, the National Consumers League (NCL) – a leading non-profit fighting fraud in the marketplace – today released a white paper as a blueprint for policy changes to combat the flood of false information circulating online about GLP-1 products and launched an ambitious national anti-disinformation effort called the Weight Truth with the online hub, www.weight-truth.org, to drive action.

“Despite the promise of GLP-1 drugs to help Americans with obesity achieve a significant weight loss and improve their health status, an escalating ‘infodemic’ of disinformation online is causing consumers to opt for ‘cheap, easy and doctor approved’ products that may cause harm or could be fakes, “said Sally Greenberg, NCL’s CEO. “Infodemics are dangerous, which is why NCL is raising awareness of this serious health hazard and calling for a national mobilization to arm people with the facts about GLP-1s and to protect the public through legal and regulatory efforts.”

Disinformation Is Rampant
Coinciding with the end of a national shortage of branded GLP-1 medicines and the withdrawal of compounded versions from the market, the Weight Truth will help the public decode misinformation about these weight loss medicines at a time when researchers warn of an “alarming” amount of disinformation online that is sowing distrust in health institutions and encouraging consumers to opt for products promoted as “doctor approved” that FDA warns “can be risky for patients.” Consumers are also subjected to a flood of false claims about supposed new forms of GLP-1s, such as patches, shakes, gummies, drops, and versions with untested additives, without evidence that these products even work. Documenting the reach of this false information, one recent study estimated a 1200 percent increase in “violative or problematic” GLP-1-related ads between 2022 and 2024 (the time when FDA-approved GLP-1 drugs were in shortage).

New Poll Reveals the Consequences of Disinformation
Yet, the most persuasive data comes from a new NCL-commissioned survey of 1,500 women ages 18-55 fielded by Dynata, LLC in March 2025, which finds that 85 percent of women with obesity believe the false claims made in online ads. When respondents were shown a fictional ad for a compounded GLP-1 drug and were asked what the term “doctor approved” meant to them, 55 percent said the drug was “endorsed by medical professionals,” and 31 percent said the drug was “safe to use.” Reinforcing these viewpoints, 71 percent of the women polled said they believe compounded GLP-1s are only on the market if they were tested and proven safe, and more than half (53 percent) think these medications received FDA approval. Additionally, 49 percent think compounded versions have the same active ingredients, and 41 percent say the doses are the same as the branded drug. None of these perceptions are accurate.

“The Weight Truth is an essential tool that will help thousands of consumers navigate a weight loss market rife with bad actors promoting non-FDA-approved GLP-1s. People living with obesity deserve accurate information and access to safe, affordable, and effective care that allows them to succeed during their treatment journey,” said Dr. Angela Fitch, past president of the Obesity Medicine Association and Chief Medical Officer of knownwell.

Disinformation Is Dangerous and Leads to Serious Health Consequences
Underscoring why these findings of the new survey matter, NCL’s white paper – Compounding, Counterfeits, and Confusion: Confronting the Infodemic of Disinformation on Obesity Treatments – documents what happens when disinformation causes consumers to opt for medicines that the FDA does not review for safety, effectiveness, or quality before they are marketed. Regarding compounded GLP-1 drugs, patient safety advocates point to exemptions from standard product labeling requirements, which leave consumers without information on side effects, contraindications, and possible adverse effects and opens the door for marketers to tout the benefits of compounded GLP-1s without disclosing the risks. Moreover, the FDA warns that not undergoing a pre-market review increases the potential that drugs will have quality issues, such as contamination, sub- or super-potency, or incorrect dosing. Beyond compounded GLP-1s, patient safety advocates and state attorneys general point to drug counterfeiters and bad actors who put consumers at risk for harm from exposure to contaminated ingredients, undisclosed chemical agents, and dosing errors by illegally selling the active pharmaceutical ingredient (API) in GLP-1s directly to consumers online with dosing instructions.

“Disinformation about GLP-1 medications puts patient safety at risk, and The Weight Truth initiative is urgently needed to fight back. Every person affected by obesity deserves access to trustworthy, evidence-based information about their care options,” says Joe Nadglowski, President and CEO of the Obesity Action Coalition (OAC). “No one should be forced to navigate a sea of confusing or misleading claims that jeopardize their health and well-being.”

Documenting the potential health consequences from dosing errors and exposure to the wrong ingredients,
 FDA has received over 775 adverse event reports as of February 28, 2025, which includes reports of 17 deaths and over 100 hospitalizations. Moreover, poison control centers report nearly a 1,500 percent increase in calls since 2019 related to overdosing or side effects of injectable GLP-1 usage. Importantly, because most compounding pharmacies are not required to report adverse events from compounding drugs, the FDA indicates it is “likely that adverse events from compounded versions of GLP-1 drugs are underreported.

A Blueprint for National Actions
Because infodemics are dangerous, NCL’s white paper calls for collective action to combat the epidemic of false and misleading claims about GLP-1 weight loss drugs and policy changes to protect consumers during national drug shortages where there is a large mass market for these drugs. Toward this end, NCL’s blueprint identifies nine
priorities for action:

  1. Make Combating Infodemics a National Priority
    The growing threat of misinformation requires a unified national response, and NCL’s anti-disinformation initiative, the Weight Truth, can be the model for educating consumers and being a platform for clinicians, advocates, and policymakers to advance policy changes to protect consumers.
  2. Increase Coverage and Affordability of FDA-Approved GLP-1 Weight Loss Drugs
    Because increasing coverage of FDA-approved GLP-1 drugs is the best way to put a damper on an exploitative market for these products, the National Consumers League and many advocates are working to secure coverage through Medicare and state Medicaid programs and private insurers in order to help reduce patients’ out-of-pocket costs.
  3. Enforce Existing Drug Advertising Rules
    During the national shortage of GLP-1 drugs, online advertising proved effective in convincing consumers that compounded versions were essentially generic versions of branded drugs. Thus, the FDA can help stem the infodemic by monitoring content online and enforcing existing prescription drug advertising regulations.
  4. Explore a New Role for the Federal Trade Commission
    The Federal Trade Commission (FTC) has a strong regulatory framework to address deceptive marketing and ensure that advertising claims are truthful and substantiated, including health claims. Since FTC is taking aim at food companies that are developing “GLP-1 friendly” products, there is an opening for the FTC to take enforcement actions against companies that make false or misleading claims about GLP-1 drugs and to assert that supplements, gummies, patches, and related products are not forms of GLP-1s.
  5. Increase Pharmacovigilance of Online Pharmacy Websites
    During the national shortage of GLP-1 drugs, illegal online pharmacies were actively selling semaglutide without
    a prescription and shipping unregistered and falsified products. These pharmacies pose a major threat and should be a focus for enforcement efforts by the FDA and state boards of pharmacy.
  6. Intensify Federal and State Efforts to Protect Consumers from Counterfeiters

Counterfeit products are entering the U.S. supply chain. As identified by the FDA, the Federal Bureau of Investigation, and many state Attorneys General, key areas for enforcement are sellers using online app-based platforms to supply consumers with GLP-1 products containing insulin or “animal grade” ingredients and illegally selling the active pharmaceutical ingredient (API) in GLP-1s directly to consumers.

  1. Implement Labeling Rules for Compounders
    Not having labeling information on side effects, contraindications, and possible adverse events leads patients to underestimate the risks of compounded drugs and potential dosing errors. Given the millions of consumers who may take compounded drugs if/when there is another large and prolonged national drug shortage, the same labeling rules should apply to both branded and compounded copycat drugs during a shortage.
  2. Require Compounders to Submit Adverse Reactions Reports to FDA

Adverse event reports are often the way the FDA learns of safety issues with compounded drugs, which is why the agency should have accurate information on safety issues during a national drug shortage.

  1. Require Compounders to Disclose Information on the Composition and Distribution of Compounded Drugs

Currently, compounders are not required to disclose the source of their Active Product Ingredient (API), the main ingredient in making compounded GLP-1s, nor report the number of doses sold. Having access to this information during a national shortage will improve surveillance efforts and build trust in the integrity of compounded products.

“Everyone requires accurate information to make health care decisions that are best for ourselves and our families, and we rely on regulators to protect us from misleading claims about medical products,” said Michael C. Barnes, Counsel to Aimed Alliance. “The FDA, state boards of pharmacy, and state attorneys general can and should take enforcement action against suppliers of unapproved drugs and deceptive advertisers. Aimed Alliance supports NCL and federal and state health and safety officials’ efforts to protect consumers in the health care marketplace.”

About the Weight Truth Initiative

To combat false information circulating online about GLP-1 products, NCL commissioned new opinion research and consulted with leading obesity specialists, disinformation authorities, law enforcement officials, and regulatory experts to assess the infodemic, understand how the unregulated marketplace for GLP-1s operates, and determine what can be done to protect the public through education and policy change. Based on this assessment, NCL developed the Weigh Truth initiative, including an online hub – www.weight-truth.org – to arm people with the facts about GLP-1s and advance policies to prevent exploitative markets from operating during national drug shortages when there is a large mass market for compounded drugs.

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About 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.