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

What will happen to President Biden’s student debt forgiveness plan?

Sally Greenberg

By Sally Greenberg, Chief Executive Officer

Last week, I attended the oral argument in the Supreme Court challenging student debt forgiveness initiative launched by the Biden Administration. The states of Missouri, Nebraska and four others, along with two students, are challenging Biden’s proposal to forgive student loan debt for 40 million Americans.

During his campaign, President Biden promised to reduce the albatross of student debt burdening millions of young Americans through his Department of Education. His proposal only applies to federal loans and is narrowly tailored and means tested. The plaintiff states and students challenging the loan forgiveness plan are arguing that it exceeds federal law, and that “canceling hundreds of billions of dollars in student loans is a breathtaking assertion of power.” The administration countered that Education Secretary Miguel Cardona has the authority to forgive the debt under a 2003 law, the Higher Education Relief Opportunities for Students Act.

The debt forgiveness program would cancel up to $10,000 of debt for those who have federal student loans as long as they make under $125,000 or $250,000 for couples. Those getting Pell grants are eligible for an additional $10,000. Thus, 20 million students could see their debt totally wiped out; all told, it will cost taxpayers $430 billion.

Sitting in the courtroom, I was seeing the new members of the Supreme Court in action for the first time and that was fun. Each of the justices has their own distinct style. Some are far more engaged than others, like the newest member, Justice Katanji Brown Jackson, who fired away a series of questions to the AG from Missouri about whether the state had standing to challenge the law. Even conservative Justice Amy Coney Barrett questioned standing,  asking why those alleging injury weren’t plaintiffs in the case. Justices Sotomayer and Kagan also pressed the plaintiffs on both the broad language in the law and the standing problem.

Solicitor General Elizabeth B. Prelogar, whose argued the case for the Biden Department of Education, argued that the Department’s plan was exactly what Congress had in mind when it passed the 2003 law, giving the executive branch the power to … “waive or modify any statutory or regulatory provision.”  I Wiki’d Prelogar and learned some cool facts: she’s a Harvard Law grad who won Miss Idaho Teen USA of 1998!  She is fluent in Russian, and her father went to my alma mater, Antioch College in Yellow Springs, OH and oh yes, I was delighted to see that her dad served at one time as head of consumer protection for the North Carolina Attorney General.

I realize I’m not an unbiased observer, but I thought Prelogar had the better arguments, First, the law is broadly worded and gives a lot of latitude to the Executive Branch on student loan waivers. Second, the standing issue is a serious hurdle for the opponents. To challenge the loan forgiveness program, they need to show that they have suffered a specific, rather than generalized, injury that can be remedied by relief from the Court. Neither of the challengers can show direct harm.

The bottom line for the National Consumers League and the hundreds of groups that support this narrowly tailored loan forgiveness is that the $10,000- $20,000 debt for 40 million Americans can be crippling to families –the reality is that student debt prevents many young people from buying homes, starting families and getting on with their lives. We are therefore hoping against hope that the Supreme Court throws out this challenge and the student debt forgiveness proposal at last be implemented.

White House Competition Council announcement is a big deal

By John Breyault, Vice President of Public Policy, Telecommunications and Fraud 

Ask almost any consumer and they will tell you that junk fees are one of the banes of their existence. Not only do these fees add often unexpected costs to the price of goods and services, but they also inhibit competition; contributing to higher prices, worse service, and poorer product quality. Add to this the lost time and aggravation that comes with fighting companies that try to charge these fees and we have a recipe for constant consumer frustration. 

Fortunately, the Biden Administration seems to be hearing these concerns loud and clear. Last week, the White House Competition Council announced a range of executive actions and legislative proposals targeting junk fees and competition concerns that NCL have made a priority for years. These actions build on commitments the Administration made last fall to go after junk fees and other anti-consumer practices.  

So, what is in this announcement for consumers? The short answer is quite a bit. 

First, the Consumer Financial Protection Bureau announced a new rulemaking to close a loophole in the law that allows banks to get away with charging outrageously high fees for late credit card payments. Thanks to this loophole, banks have been able to get away with charging late fees as high as $41. This is big money for the banks. In 2020, banks charged around $12 billion in such fees, representing more than 10% of all fees and interest revenue. Under the new rule, the maximum fee a consumer will be hit with will be $8. This change is expected to save American consumers as much as $9 billion annually. As far back as 2009, NCL was calling for legislation to protect consumers from these “gotcha” fees, so this announcement is great news.  

Second, the Department of Transportation (DOT) will soon propose a rule to prohibit airlines from charging passengers for the “right” to sit next to their young children. Separating children from their parents in the air not only creates safety risks in an evacuation scenario, but it puts kids at increased risk of sexual assault. Back in 2016, Congress directed DOT to review airline family seating policies and, “if appropriate” act. Under the regulation-averse Trump DOT, the agency did the minimum possible to comply with the law by creating a new consumer education web page that described airlines’ family seating policies. This week’s action, however, will ban family seating fees outright, fulfilling a demand that NCL and other advocates have worked towards for years. Thanks to this new rule, parents should soon be protected from having to choose between an affordable seat and their kids’ safety in the air. 

Finally, the Administration called on Congress to pass a Junk Fee Prevention Act to crack down on a range of anti-competitive junk fees. Fees targeted by the legislation would include: 

  • Cell phone and broadband early termination fees – These fees, which can exceed $200, lock consumers into service they may not want or no longer need for years. They also make it harder for new entrants in the marketplace to compete with the big wireless and broadband carriers. 
  • Live event tickets – For more than a decade, NCL has advocated for action to control the fees that can add 50% or more to the price of a concert or sporting event ticket. The Junk Fee Prevention Act would prohibit excessive fees, require that all fees be included in the advertised price, and mandate disclosure of ticket holdbacks that keep more than 50% of tickets for a typical event from ever making it to market. 
  • Hotel resort fees – Resort fees (also called “destination fees”) are increasingly used to hide the actual cost of a hotel room. Instead of being included in the advertised price of a room, sneaky hotel chains charge the fee when a consumer checks out. Not only does this cost consumers billions annually, but it also harms honest hotels that advertise the full price. Thanks to NCL’s advocacy, state and federal regulators have taken aim at these deceptive fees. Now it is time for Congress to step up. 

Taken together, this package of regulatory and legislative reforms show that the Biden Administration is putting companies on notice that their days of raking in billions in profits by nickel-and-diming consumers with unfair and deceptive fees are numbered. NCL, along with our allies in the consumer community, will continue to be on the front line to make sure the Administration and Congress follow through on these ambitious and long-overdue plans. 

Do children in America ever work in deplorable, dangerous, Dickensian conditions? The short answer is “yes.”

Reid Maki is the director of child labor advocacy at the National Consumers League and he coordinates the Child Labor Coalition.

Most Americans are unaware that the U.S. still has child labor, but 2022 made it abundantly clear that we do, and stories in the news made it clear that conditions can be downright shocking. Here are 10 child labor stories or developments that indicate child labor in the U.S. is not something in the past. Through the Child Labor Coalition, which the National Consumers League founded in 1989, we bring together 39 groups to work collectively to reduce international and domestic child labor and to protect working teens from occupational dangers. Our top 2022 U.S. developments:

  • Minors found working illegally in Brazilian-owned JBS meatpacking facilities in Nebraska and Minnesota. Several children suffered caustic chemical burns, including one 13-year-old. The children worked on the killing floor in cleaning crews, toiling long nights in the graveyard shift and used dangerous pressure-washing hoses while they stood in water mixed with animal parts. Initially, the number of children numbered 31 in Nebraska and Minnesota, but U.S. DOL has suggested the number of illegally employed teens in processing plant cleaning crews may be much larger. The CLC has expressed concerns about teens illegally working in meat processing plants since a large immigration raid in Iowa in 2003 found 50 minors working illegally in the plant.
  • Teens found working in an Alabama factory that supplied parts to Hyundai. In July, labor officials found three siblings, aged 12, 14, and 15, working in an Alabama stamping plant that supplied part to the car manufacturer Hyundai. According to reports, a larger number of minors worked in the factory in recent years. The story drew enormous publicity because factory-based child labor in the U.S. has become rare.
  • The Wisconsin legislature passed a bill to weaken child labor laws by expanding the hours of teen work, which endangers children’s educational development and presents certain health risks. The CLC amplified the work of labor unions on social media, we also wrote a letter to Gov. Tony Evers, urging him to veto the proposed legislation, which he did in February. According to research, high school age workers who toil more than 20 hours a week get lower grades and have an increased risk of dropping out.
  • An estimated 300,000 children still work for wages in agriculture, performing backbreaking labor in searing heat. Currently, federal law allows children who are only 12 to work unlimited hours as long as they are working when school is not in session. Federal legislation which would protect child farmworkers, the Children’s Act for Responsible Employment and Farm Safety (CARE), H.R. 7345, would raise the minimum age of farm work from 12 to at least 14 and lift the age of hazardous work from the current 16 to 18—the same as all other sectors. CARE saw some promising developments in 2022, including the holding of a congressional hearing on the bill—the first since 2009. We also secured over 200 organizational endorsements for CARE and we worked with CLC-members Human Rights Watch, Justice for Migrant Women, and First Focus Campaign for Children to obtain 47 CARE legislative cosponsors.
  • The Children Don’t Belong on Tobacco Farms Act, H.R. 3865 –and its companion bill S.2044—would ban child labor on U.S. tobacco farms where children toil long hours and routinely suffer symptoms of nicotine poisoning such as vomiting, fainting, dizziness, headaches and nausea. In a desperate attempt to keep nicotine off their skin, many teen tobacco workers toil while wearing black plastic garbage bags with holes punched out for their arms and head. Some teens work at great heights and great danger in tobacco drying barns. In the U.S., you have to be 21 to buy cigarettes but at age 12, you can work on tobacco farms and suffer poisoning from toxic nicotine. In this congressional session, we helped secure 32 cosponsors for H.R. 3865—more than double the amount of cosponsors in the 116th.
  • Enforcement of domestic child labor laws in 2022 through mid-November saw an almost 40 percent increase in the number of child workers involved in a violation of child labor rules—nearly 4,000 children, according to reporting by com, using Department of Labor data. Nearly 20 percent of the violations involved teens performing hazardous work.
  • USDOL and state labor agencies frequently found child labor violations among fast food restaurants. Massachusetts Attorney General Maura Healey fined Dunkin’, the donut franchises, $145,000 for over 1,200 child labor violations in 14 stores. U.S. DOL found violations in 13 Pittsburgh area McDonalds restaurants in which teens worked too many hours or too late, as well as a case of a teen doing prohibited hazardous work
  • In September, Human Rights Watch, a CLC member, issued a child rights report card for all U.S. states related to child marriage, child labor, juvenile justice, and corporal punishment, and how well they meet the standards set by the Convention on the Rights of the Child. Alarmingly, only four states earned passing grades: 20 received an “F”; 26 received a “D”; four received a “C” and none received a “B” or and “A.”
  • In July, Massachusetts became the seventh US state to ban entirely child marriage. Like child marriage globally, U.S. child marriage has substantial health, educational, and financial impacts on teens who marry. Most states have broad exemptions that allow teens to marry with the approval of parents or the courts. Massachusetts joins six other states that passed legislation to end child marriage: New York, Delaware, New Jersey, Rhode Island, Pennsylvania and Minnesota. The CLC is a member of the National Coalition to End Child Marriage, headed by the NGO Unchained at Last.
  • The CLC and HRW held a series of meetings with Wage and Hour in 2022 to secure the reopening of the occupational child safety rules for agriculture called “Hazardous Occupation Orders.” These rules have not been updated for agriculture in roughly four decades despite many lessons-learned about farm injuries during that time. We also helped Rep. Roybal-Allard and Rep. David Cicilline (D-RI) draft a letter to DOL Secretary Walsh urging enhanced safety precautions. The letter had 47 congressional signatories.

Debunking the myth of prepared foods being cheaper and healthier

By Ryan Barhoush, Food and Nutrition Program Associate

As we finish the holiday season (maybe a few pounds heavier) and get ready to put in place our New Year’s Resolutions, we recommend making one of them NOT buying prepared foods. and Instead, commit to cooking up healthier, cheaper, and quicker meals from scratch. With minimal shopping and prep time, we can all feed ourselves and our families with healthier options. Let’s debunk a few of these prepared food myths.

Myth 1. It takes too much time to shop for healthy food 

Grocery stores in the U.S. can be overwhelming, and we all feel the stress of walking into these sometimes exceptionally large stores, but do not be intimidated!  You can easily tackle the task of shopping quickly and efficiently with some practice and shopping discipline. In fact, if you do it right, you can be in and out of the store in 20-30 minutes with a healthy grocery basket full of food for you and your family. Here is how:

  • Make a shopping list and stick to it
  • Shop online and get your groceries delivered, or
  • Identify your favorite grocery store, get to know where products are and get in and out efficiently.

Myth 2. Prepared and frozen foods have the same nutritional value as a home cooked meal.

Prepared frozen meals are loaded with sodium and sugar; home cooked meals typically have much lower levels of both, thus are healthier and more nutritional.

Let’s compare some labels to prove it.  Start with one of most popular frozen food items, pizza. We looked at the Red Baron brand and compared its nutritional content to a standard meal of baked chicken, broccoli, and potatoes.

The results are staggering. One slice of the pizza contains 810 mg of sodium. The Dietary Guidelines for Americansrecommends adults limit sodium intake to less than 2,300 mg per day—that’s equal to about 1 teaspoon of table salt!  For children under age 14, recommended limits are even lower.

So, one slice of pizza is one-third of the total recommended daily intake. High sodium in prepared foods contributes to the hypertension epidemic in the U.S. Nearly half of adults in the United States (47%, or 116 million) have hypertension, defined as a systolic blood pressure greater than 130 mmHg or a diastolic blood pressure greater than 80 mmHg according to the CDC. Hypertension can lead to stroke, heart attack and other serious illnesses.

Red Baron’s Frozen Pizza Roasted Chicken with Potatoes and Broccoli
One serving of Red Baron’s is 380 calories per slice!

 

Amount per serving 353 calories
39g of carbohydrates

 

29g of carbohydrates
18g of Total fat

 

 8g of Total fat

 

45mg of cholesterol

 

 89mg of cholesterol

 

810mg of sodium per slice* 106mg of sodium

 

* That’s 3240 mg of sodium per pizza! Almost 1000 mg over the daily recommended limit!

 

Myth 3. It takes too much time to cook healthy meals for myself or my family. 

Meal prep can be amazingly fast, efficient, and fun! There are many websites with healthy meals that can be prepared in 5-10 minutes, with cooking times of 30 minutes or less. For example, this one: The best meal of the day doesn’t have to take your whole day!  I have compiled a list of 25 easy weeknight dinners to get you in and out of the kitchen in a flash.”  

Myth 4. Prepared frozen foods are cheaper than shopping and cooking my own food.  

Wegmans and other grocery stores have suggestions for affordable nutritious meals, as low as $2.75 a serving. Each 20.6 oz. Baron Frozen Pizza costs from $4.99-6.25 plus tax and includes four servings. But if you look at the label closely, each serving is one piece of pizza and that is an unrealistic serving size for an adult’s meal. Let’s say one pizza feeds two people, that doesn’t include anything else besides the pizza, such as salad or other side dishes. That is at least $2.50 – $5 a person. Already the frozen prepared food option is more expensive than a tofu dinner with vegetables or a chicken dinner with potatoes and broccoli.

Another great place to find affordable, filling, healthy and easy recipes is the Delish website. The internet is full of great suggestions but stay away from sites that suggest using canned soups or packaged or frozen prepared foods, because they are often filled with elevated levels of sodium, sugar, and fat.

Myth 5. I only have a microwave, I do not have a kitchen, or the right kind of cooking utensils.

Do not be discouraged. With the unbelievable amount of cooking videos on social media you would think you would need a commercial kitchen just to have a normal healthy meal. Today with just a microwave you can still make many healthy meals. Check this out: 20 Easy to Cook Microwave recipes.

Also, electric stove tops are a terrific addition to any household. Even without a kitchen, just a few pots and pans and some YouTube videos; you could be well on your way to being a kitchen-less chef! Dried fruits and nuts are easy and healthy snacks that you do not have to store in the fridge. Apples and pears are great fresh fruit that do not need to be refrigerated.

As you can see, there are many ways to avoid processed foods and create healthy meals at a reasonable price. Here are a few links we include to create healthy, fast home-cooked meals that are reasonably priced. Plus, cooking for your family is fun and an effective way to get everyone together around the table. Good luck, eat healthy and enjoy!

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.

Celebrating the life of the brilliant Rev. Dr. Martin Luther King, Jr.

Sally Greenberg

By Sally Greenberg, Chief Executive Officer

Each year, I savor the MLK Jr. weekend and holiday because it gives me time to reflect on the impact that Dr. King had. And here in Washington, DC, there’s an annual march along the boulevard named for King that snakes through Ward 8, a largely African American community, with lots of inspiring speeches, marching bands, Double Dutch jump rope jumping, and health fairs along the route. I try never to miss it and today’s march did not disappoint!

King was a towering figure who spoke to all of us as Americans about injustice, racial and otherwise. I loved that he refused to be discouraged by poverty and discrimination, telling his followers “out of the mountain of despair, a stone of hope.”

My “shot in the arm” when I start to get down about my work is King’s famous command “We shall overcome because the arc of the moral universe is long, but it bends toward justice.”

MLK weekend is also a time for reckoning about how racial injustice took root in America—beginning with the enslavement of 12 million Africans in 1619 and continued over hundreds of years, and its debilitating effects throughout generations.

Personally, I’m constantly learning new facts about the many forms racial discrimination has been embedded in our culture. I recently attended a program held in the affluent Friendship Heights section of Washington, DC. A series of posters were displayed in the window of a PEPCO substation describing how the city fathers in the 1920s decided to tear down an entire black neighborhood, uprooting blocks of homes that made up a thriving middle class community in Tenleytown right off Wisconsin Avenue.

These elected officials and members of the business community made plans to build a junior high school and a high school next door for white students. They bulldozed black homes whose children had long attended their neighborhood school, albeit a segregated school. So up went Alice Deal Junior High and Wilson High School. The school for black students closed and the black families, now without homes, moved out. Where they went is a mystery but probably to another part of town. Students at Wilson High, now called Jackson Reed, did the research for this project.

I was so surprised to be learning this history for the first time because 20 years ago, my son attended both schools, and I served as co-President of Alice Deal Middle School. No one had ever discussed this history until now.

Which tells us that we need to have these discussions.

The exhibit showed me that redlining was—and no doubt is—alive and well, and that white leaders, either through malice or indifference, thought nothing of destroying cohesive, vibrant African American communities in hundreds of cities throughout the United States. In doing so, they destroyed the fabric of these communities, their family ties, their civic life, and their children’s futures. These histories must not be forgotten.

What can we do to right the wrongs?

There is no way to compensate the African American community for slavery, for Jim Crow, or pervasive redlining and discrimination. But the bill HR 40, introduced in the House of Representatives for decades, would set up a commission to study the issue of reparations to African Americans. It sounds complicated, but compensation for past wrongs has been doled out many times.  Reparations were paid to Jewish victims of the Holocaust by Germany, to Native Americans in Alaska, to Japanese families interned during WWII, to 911 victims and their families from a taxpayer funded account.

NCL strongly supports HR 40.

While we hope that HR 40 sees the light of day in Congress, in the meantime, let’s not sweep US history under the rug. We can’t heal as a country until we confront the legacy of slavery and the persistent discrimination that followed emancipation. What happened in Washington, DC’s Tenleytown neighborhood in the 1920s is part of that legacy. I’m still learning and hope others are open to learning as well, and in the famous words of Dr. King: “The arc of the moral universe is long, but it bends toward justice.”

Nancy Glick

Alcohol labeling: We’re in it to win it

Nancy GlickBy Nancy Glick, Director of Food and Nutrition Policy

For historians, 2003 will be remembered as the year that the space shuttle Columbia crashed, scientists finished sequencing the human genome, and the U.S. launched war against Iraq.

But 2003 also marks an important milestone for American consumers. In December of that year, three national consumer organizations – the National Consumers League (NCL), Center for Science in the Public Interest (CSPI), and the Consumer Federation of America (CFA) – first petitioned the federal government to require an easy to read, standardized “Alcohol Facts” label on all beer, wine and distilled spirits products. This sparked a 19-year battle that is finally paying off for the estimated 67 percent of Americans[1] who drink alcoholic beverages.

In 2003, the Nutrition Facts label on processed foods and non-alcoholic beverages had been in use for almost a decade (1994) and many consumers said they frequently or almost always read the label. Thus, public acceptance and use of the Nutrition Facts label created built-in public support for an Alcohol Facts label. In fact, polling NCL commissioned in both 2005 and 2007 showed overwhelming public support for comprehensive alcohol labeling. Now, polling consistently shows that 75 percent of Americans think alcoholic beverages should have standardized alcohol content labels and 72 percent say this labeling will encourage responsible alcohol use.

Even more significantly, not knowing what is in a beer, wine or distilled spirits drink increases the risk for overconsumption of alcohol, a serious and costly public health problem. According to the latest research findings, alcohol is a source of empty calories that contribute to obesity,[2] and can impact blood sugar control in people with diabetes.[3] Additionally, alcohol is a roadway killer accounting for about 30 percent of all traffic crash fatalities in the U.S.,[4] and excessive drinking increases the risk of liver disease, hypertension, cardiovascular disease, alcohol use disorders, certain cancers and severe injuries.[5] Consequently, an estimated 140,000 people in the United States die annually from alcohol- related causes,[6] which is why the cost of excessive alcohol use reached $249 billion in 2010 and is likely higher today..[7]

Based on this documented evidence, the 2003 petition, which was also signed by 73 nutrition/public health organizations and experts, called for a label that gives consumers the needed information to make responsible drinking decisions, such as the serving size, amount of alcohol and calories per serving, the percent alcohol by volume, and the number of standard drinks per container. And yet, the lead federal agency that regulates alcoholic beverages – the Alcohol and Tobacco Tax and Trade Bureau (TTB) – deliberated but failed to take meaningful action for almost two decades.

The arcane process started in 2005 with an advance notice of proposed rulemaking, which produced over 19,000 public comments. In 2006, TTB issued another notice of proposed rulemaking on allergen labeling followed by a notice in 2007 on alcohol and nutrition labeling. Unfortunately, however, TTB allowed these proposed rules to languish, ultimately deciding in 2013 to issue a voluntary rule allowing companies to decide what nutrition and calorie information to disclose – and what to keep hidden. Not surprisingly, many manufacturers opted out of TTB’s program so most alcoholic beverage products on the market remain unlabeled or carry incomplete information.

Even with these setbacks, the consumer community kept up the pressure on TTB because the need for alcohol labeling has only increased. This became apparent during the COVID-19 pandemic when a 2020 RAND study charted a 14 percent increase in alcohol consumption among adults over age 30 in one year.[8] Another national study found that excessive (binge) drinking increased by 21 percent during the pandemic, with the potential for 8,000 additional deaths from alcohol-related liver disease by 2040.[9]

And then, the sand started to shift. Also related to the pandemic, consumer demand skyrocketed for hard ciders, some types of beers, wine coolers and the other low-alcohol drinks sold in supermarkets and convenience stores and what consumers saw were complete alcohol labels on these products. This is because low-alcohol drinks fall under the purview of the Food and Drug Administration, not TTB. Armed with this evidence, NCL leaders met online with Department of Treasury and TTB officials in June 2021 and put TTB in the uncomfortable position of having to explain why often the same manufacturers who must put a standardized content label on brands regulated by FDA don’t bother to do so when their products are under TTB’s jurisdiction.

Not long after this meeting, the Treasury Department conducted its own review and on February 9, 2022, issued a report, Competition in the Markets for Beer, Wine and Spirits, that advanced the importance of labeling information to foster competition within the beverage alcohol industry. The report contains several recommendations, including the recommendation that “TTB should revive or initiate rulemaking proposing ingredient labeling and mandatory information on alcohol content, nutritional content, and appropriate serving sizes.”

This was encouraging news, so NCL doubled down, combining forces with CSPI and the Consumer Federation of America to get TTB to mandate alcohol labeling across the board. Recognizing that public pressure alone will not ensure success, the organizations turned to Congress, hosting briefings for lead staffers of the House and Senate appropriations committees with jurisdiction over TTB’s budget and sending a joint letter to key Congressional leaders from 23 consumer, health/nutrition, and alcohol policy organizations about the need for mandatory alcohol labeling. This led to report language in the draft House and Senate 2023 appropriations bills that encourages TTB to initiate a final rulemaking.

The last step was filing a lawsuit against TTB in the United States District Court for the District of Columbia on October 3, 2022, asking the court to direct TTB to grant or deny the 2003 petition within 60 days. The lawsuit was a gamble, but it worked: on November 17, 2022, TTB accepted the 2003 petition and committed to publish three rulemakings covering mandatory nutrient and alcohol content labeling, mandatory allergen labeling, and mandatory ingredient labeling within the next year.

However, this is not the end of the story. The proposed rules will be accompanied by open public comment periods where we can anticipate that segments of the alcohol industry will be aggressive in fighting robust consumer labeling.  Therefore, NCL will also be actively engaging a wide range of stakeholders to weigh in on behalf of consumers so the American public to have access to standardized and complete labeling information on beer, wine and distilled spirits. It has taken 19 years to get to this point, but our message is clear: alcohol labeling is long past due, consumers overwhelmingly want to see it, and we will stay in the fight until alcohol labeling is a reality.

[1] Gallup. Alcohol & Drinking. July 2022

[2] U.S. Department of Agriculture and U.S Department of Health and Human Services. Dietary Guidelines for Americans, 2020-2025. 9Th Edition. December 2020.

[3] Emanuele NV, et al. Consequences of Alcohol Use in Diabetics. Alcohol Health Res World. 1998; 22(3): 211–219.

[4] National Highway Traffic Safety Administration. Risky Drunk and Drugged Driving Statistics.

[5] U.S. Centers for Disease Control and Prevention. Alcohol and Public Health. Last reviewed April 14, 2022. https://www.cdc.gov/alcohol/fact-sheets/alcohol-use.htm

[6] U.S. Centers for Disease and Control Prevention. Deaths from Excessive Alcohol Use in the U.S. Page last reviewed April 14, 2021. https://www.cdc.gov/alcohol/features/excessive-alcohol-deaths.html . Accessed June 2, 2022.

[7] U.S. Centers for Disease Control and Prevention. Alcohol and Public Health. Page last reviewed April 14, 2022. https://www.cdc.gov/alcohol/features/excessive-drinking.html. Accessed June 2, 2022.

[8] Pollard MS, et al. Changes in Adult Alcohol Use and Consequences During the COVID-19 Pandemic in the US. JAMA Netw Open. 2020;3(9):e2022942.

[9] Julien J, et al. Effect of increased alcohol consumption during COVID-19 pandemic on alcohol-associated lover disease: A modeling study. Hepatology. Vol. 75; Issue 6; June 2022; 1480-1490.

Promising new therapies are giving hope to Alzheimer’s patients and families, so why limit access?

Sally Greenberg

By Sally Greenberg, Executive Director

For years, Alzheimer’s patients, families, and caregivers have battled a condition with no treatment options. This year alone, an estimated 6.5 million Americans age 65 and older are living with Alzheimer’s.

The good news is, we’ve recently seen remarkable progress in the fight against Alzheimer’s disease as innovative treatments demonstrated the ability to halt disease progression in a major clinical trial and proved to curb cognitive decline. These therapies targeting the buildup of amyloid beta plaque in the brain (one of the telltale signs of Alzheimer’s) have shown promise for so many patients and families facing this fatal diagnosis.

The first such therapy was approved by the U.S. Food and Drug Administration (FDA) in June of last year. This should give us all hope for a brighter future, but this progress may be moot if regulatory barriers hinder patient access.

Rather than ensure broad coverage through the Medicare program – as is the case for nearly every other type of drug that receives FDA approval – the Centers for Medicare and Medicaid (CMS) decided this spring to restrict access to these new Alzheimer’s treatments only to patients participating in approved clinical trials. This puts severe limitations on coverage for an entire class of innovative Alzheimer’s disease treatments, with CMS in direct conflict with the FDA, whose medical experts approved the drug as safe and effective.

In fact, this puts the FDA’s entire accelerated approval pathway in the crossfire, sounding an alarm to millions of patients hoping for medical breakthroughs.

No one is arguing the therapy is a miracle cure, but that’s not how new therapies tend to work. History has shown that when it comes to serious conditions with high unmet medical needs, even small improvements are critical.

Accelerated approval first surfaced during the AIDS crisis, when HIV was a death sentence and there were no treatments. AIDS advocates demanded something – anything — despite minimal benefits “because we have nothing now and no hope.” The first AIDS treatments in the 1980s were grueling regimens with serious side effects, but they had to start somewhere. Today, as medicines have evolved, HIV-positive patients require one pill a day and can live with the disease.

The same is true for Duchenne’s Muscular Dystrophy, a terminal disease that lands young boys in wheelchairs often before they reach 10 years old. Approval of the first drug to treat Duchenne’s met significant controversy in 2016 because it was minimally effective. Yet, the FDA approved it because these patients had no hope. Today there are five treatment options for the disease that slows down the progression and buys time.

And in 2001, a game-changing therapy for chronic myeloid leukemia received approval; the treatment helped to spur innovation in what became targeted therapies for cancers.

The science and medical ecosystem will continue to naturally progress, moving us from zero treatment options to medicines that mitigate symptoms, to treatments that halt disease progression, and eventually, cures. This is true in the Alzheimer’s space, but by limiting access to an entire class of Alzheimer’s treatments, CMS is putting future scientific breakthroughs at risk and creating a ripple effect throughout the entire healthcare system. This new promising drug class will only be available to those with the financial wherewithal to pay thousands of dollars out of their own pockets.

With this precedent, any drug that emerges from the rigorous development pipeline could be deemed too expensive or too early in the discovery phase. CMS acting as the final arbiter on what new treatments will be made available and overriding the scientific judgment of FDA experts should concern all of us.

As we look ahead toward a new Congress, our lawmakers can and should put pressure on CMS to keep pace with the science and give hope to Alzheimer’s patients and families.

Guest Blog: Urgent push to get the Senate to pass the Pregnant Workers Fairness Act by end of year

By Robin Strongin

Pregnancy discrimination in the workplace is real and it’s dangerous.  But, if the Senate acts quickly, it can pass S. 4431, the Pregnant Workers Fairness Act (PWFA) which provides reasonable accommodations for pregnant and postpartum workers.

The legislation, which has already passed in the House, enjoys strong bipartisan support and has garnered wide-ranging support from business associations, the US Chamber of Commerce, labor unions, faith organizations, civil rights organizations, maternal health groups, and others.  The US Conference of Catholic Bishops has stated that “These and other efforts to protect pregnant workers and new mothers should be applauded as they demonstrate a respect for life, family, and the dignity of workers.”

NCL stands with these organizations in urging the Senate to pass the legislation.  Pregnancy discrimination in the workplace is not only medically dangerous, but disruption to a woman’s career hurts her earning power and has implications for the labor supply.  More than 85 percent of women will become mothers at some point in their working lives, the majority of whom cannot afford not to work.

Despite passage of the federal Pregnancy Discrimination Act (PDA) of 1978, employer bias against pregnant women still exists, especially when it comes to employers providing reasonable accommodations to pregnant workers.

In early February 2022, the Bipartisan Policy Center and Morning Consult conducted a survey of 2,200 adults on the prevalence of pregnancy discrimination in the workplace. The survey found that “pregnancy discrimination is common across race, incomes, and other demographics, causing fear about informing employers about a pregnancy and leading many pregnant workers to consider a career change. These trends are particularly elevated among younger women and those who are currently working.”

Key Results:

  • Nearly 1 in 4 (23%) mothers have considered leaving their jobs due to a lack of reasonable accommodations or fear of discrimination from an employer during a pregnancy.
  • 1 in 5 mothers (20%) say they have experienced pregnancy discrimination in the workplace.
  • Adults are witnessing pregnancy discrimination in their workplaces.
  • Over 1 in 5 mothers have been afraid to tell an employer about a pregnancy.
  • A comparable portion of adults report that their partner or spouse has experienced pregnancy discrimination at work.

In their November 10, 2022 letter to the Senate Majority and Minority Leaders, urging swift passage of the Senate bill, the bipartisan members underscored what pregnancy discrimination looks like, and the terrible toll it takes:  …”a warehouse employee in Tennessee who suffered a miscarriage after lifting heavy boxes and being denied light duty; a retail worker in Kansas who was fired because she needed to carry a water bottle to stay hydrated, and a hardware assembler in Ohio who was terminated after her doctor recommended she not lift more than 20 pounds.”

Advocates are raising the alarm: if the Senate doesn’t enact the bill by the end of this year, opposition from Republicans over a lack of religious exemptions could jeopardize the passage of the legislation as Republicans take over the House.

The bill that passed the House did so with a strong bipartisan vote of 315 – 101.  And the Senate bill enjoys strong bipartisanship as well, according to Senate HELP Chair, Patty Murray (D-WASH), who is working across the aisle to get it passed.

If a stand-alone vote in the Senate doesn’t materialize, backers of the bill are considering its inclusion in the year-end spending package. Sen. Bill Cassidy (R-LA) warned, “The clock is ticking… This is a bipartisan bill that’s pro-mothers, pro-healthy pregnancies, and pro-workers,”…”Let’s get it through the Senate by the end of the year.”