During ‘Striketober,’ standing up for a USPS that benefits consumers and workers

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By Eden Iscil, Public Policy Associate

Workers across America are taking action to hold employers accountable for low pay and poor working conditions. In what’s being called “Striketober,” 10,000 John Deere employees, 14,000 Kellogg’s workers, and 24,000 Kaiser Permanente staff have gone on strike. Additionally, 60,000 film and television workers belonging to IATSE threatened to withhold their labor, resulting in a deal for more favorable contracts. At NCL, we support workers advocating for better conditions and compensation. 

While it is generating fewer headlines, the actions of US Postal Service employees are just as important for consumer and worker welfare. Recent postal worker employee protests in Minneapolis highlight the indispensable public service these workers provide to millions of Americans daily. Those protests were prompted by a visit from Postmaster General Louis DeJoy, who is infamous for his 2020 attempt to degrade mail services at the same time that COVID-19 necessitated mail-in voting for millions of Americans. Importantly, DeJoy has come under renewed scrutiny for his 10-year plan, which would lead to significantly delayed mail deliveries. 

Given the importance of delivering mail promptly, we urge Congress and the Biden Administration to take a more active role in preventing Postmaster General DeJoy’s continued attacks on the Postal Service. Millions of Americans rely on the Postal Service for delivery of life-saving medication, receipt of their veterans and Social Security checks, and other important mail. Unfortunately, the impacts of DeJoy’s 10-year plan are likely to disproportionately affect rural communities and older Americans.   

We know such policies are harmful to everyday Americans from the many times they were previously attempted. Following DeJoy’s plans for a mail slowdown in 2020, veterans were forced to find alternative access to their medications and 350 million pieces of mail were delayed. We need to challenge such regressive policies that are implemented at an enormous cost to consumers. 

The threat that DeJoy’s recommendations pose to efficient U.S. mail delivery has been known since the summer of 2020. Congress and the Administration must act to get USPS back on the right track. 

Diverse research for a diverse America: The value of equitable, real-world research

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By Sally Greenberg, NCL Executive Director

While the COVID-19 pandemic has led to hardship for all Americans, it is clear that people of color have been disproportionately burdened. Across the health care continuum, addressing this disparity has become part of the broader conversation about the history of systemic racism and the underlying social determinants of health that negatively affect the mental, physical, and economic health of individuals and entire communities.

The pandemic has underscored persistent health disparities, and there is growing recognition that representation in research and clinical trials can have a profound impact on health outcomes. A lack of representation from racially and ethnically diverse groups in research and clinical trials have typically led to gaps in data, missing the opportunity to assess the full impact of various treatments and drugs across a range of populations. The collection and use of real-world research and data to inform the potential use, risks, and benefits of medical products and treatments can ultimately lead to better health outcomes, particularly for those who have been underrepresented in the past.

Existing efforts to improve inclusion

Efforts to expand diversity and representation in medical research are underway in Congress. Policymakers are encouraging the incorporation of Real World Evidence (RWE) in drug development through the recent Cures 2.0 draft legislation released by Reps. Diana Degette (D-CO-1) and Fred Upton (D-MI-6). While the status quo limits us from effectively reaching underserved populations, the proposed legislation would allow studies that include RWE for some drugs after they have been approved. At the heart of this issue is a growing appreciation that the same therapy can affect different populations in different ways, which is why Cures 2.0 supports collecting data that more accurately reflects the unique experiences and needs of patients across diverse populations.

Recognizing the potential for RWE in maternal health

The lack of representative research in the field of maternal health is undeniable, and its implications are staggering. The dismal state of maternal care in the United States reflects how our health care system has failed women of color, including by not adequately studying treatment options to prevent maternal morbidity and mortality. The need for RWE is clear when you consider the persistent disparities in health outcomes that plague minority communities.

Preterm birth and its disproportionate impact on women of color is a stark illustration of the need to make progress on representative research in maternal health. Preterm birth is the second-largest contributor to infant death in America today. Despite the tremendous physical, emotional, and financial toll that preterm birth continues to take on our country — disproportionately so on women and families of color — not enough therapeutic tools currently exist to prevent it.

Today, “17P,” the only FDA-approved treatment to help reduce the likelihood of spontaneous, recurrent preterm birth in the United States is at-risk of being withdrawn from the market in all its forms, including the branded product and five generic versions. Unfortunately there is conflicting evidence from two different clinical trials, one representative of a diverse U.S. population and another studied in a largely white population in Europe. It’s not a straightforward comparison. If 17P is withdrawn, the women most affected by preterm birth, predominantly women of color, would be left without an FDA-approved treatment option.

The FDA is considering the path forward, including additional data collection through leveraging RWE from past patient use. The success of the first (approval) trial for 17P in the impacted communities signals the importance of RWE. Continued access to 17P is, at its core, a matter of health equity. Black women must not yet again be left vulnerable to a system that historically has overlooked them.

Finally, Juneteenth is declared federal holiday

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By Sally Greenberg, NCL Executive Director

Juneteenth, or June 19, is now a federal holiday, thanks to an overwhelming Congressional vote and President Biden’s signing it into law in the past two weeks. And it’s a long time coming. The day marks the emancipation of the last enslaved people in America in Galveston, Texas in 1865, over two years after the Emancipation Proclamation was signed by President Abraham Lincoln.

I’ve heard Juneteenth called Emancipation Day, Freedom Day, and the country’s second Independence Day. It surely is one of the most important anniversaries in our nation’s history.

As a Jew who has observed Passover my whole life, the holiday based on the Book of Exodus celebrating the liberation of Jews from Egypt after 400 years of enslavement, I also celebrate Juneteenth.

As I listened to the radio during a road trip, I heard stories about the newly declared federal holiday. I think most importantly, it’s gotten people talking about a conversation America has never really had: truth and reconciliation about the despicable institution of slavery in the United States and its vestiges: a century and a half of Jim Crow segregation, violence, and rampant, entrenched discrimination against African Americans.

Sadly, this is a conversation too many Americans don’t want to have. Oklahoma passed a law outlawing the teaching of “Critical Race Theory” in state schools. In 2020, President Donald Trump issued an executive order excluding from federal contracts any diversity and inclusion training interpreted as containing “Divisive Concepts,” “Race or Sex Stereotyping,” and “Race or Sex Scapegoating.”

What even is Critical Race Theory? The textbook definition is that CRT acknowledges that the legacy of slavery, segregation, and the imposition of second-class citizenship on Black Americans and other people of color continue to permeate the social fabric of this nation.

Half a dozen other states are considering bills similar to Oklahoma’s. Fox News and other right wing media outlets have tried to use phony scare tactics to discourage discussion of slavery and its generations-long aftermath. The problem is that unless we have those discussions, we will never reckon with the reality that so much of our nation was built on the backs of enslaved people, including the White House. Refusing to discuss this our history of enslavement has a term too: “White Fragility,” defined as white Americans feeling discomfort and defensiveness when confronted with information about racial inequality and injustice. So despite Oklahoma’s law, Biden’s declaring Juneteenth as a federal holiday got people talking—and that’s a good thing.

I liked hearing about Civil Rights Activist Opal Lee, who long advocated for the celebration that started in Galveston to be made a federal holiday.

It was also interesting to learn that there’s a growing discontent within the African American community with symbolic gestures like declaring a federal holiday marking the end of slavery.

On that theme, NCL has endorsed HR 40, a U.S. House bill to set up a commission to study the history of enslavement and reparations to families whose relatives were enslaved. Consider these facts about the legacy of slavery:

We thank President Biden for recognizing that Juneteenth needs to be a federal holiday and was long overdue. Equally important is HR 40, which will provide a way forward for this country akin to the Truth and Reconciliation Commission body established by the South Africa in 1995 to help heal the country and bring about a reconciliation of its people by uncovering the truth in the aftermath of Apartheid.

Slavery is a legacy that all Americans, no matter your racial or ethnic background or when your family arrived in the United States, need to confront. We must not let anger, fragility, backlash, or denial prevent us as Americans from taking the time to really learn about and understand slavery, the Jim Crow laws that followed it, and practices, including lynching, that were used as a tool of terror and white supremacy, and the many lasting repercussions of that terrible history.

A step forward on privacy legislation

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By Sarah Robinson, Public Policy Manager

Earlier this month, NCL joined other consumer advocates and industry stakeholders in an event to highlight our consensus that Congress must act to create strong federal consumer privacy rights urgently. We joined colleagues at the 21st Century Privacy Coalition, the Business Software Alliance, and Common Sense Media in calling on Congress to commit to passing comprehensive privacy legislation by the end of the 117th Congress. In a virtual press conference, the groups, along with Rep. Jan Schakowsky (D-IL), Rep. Gus Bilirakis (R-FL), and Sen. Richard Blumenthal (D-CT) agreed that Congressional action to strengthen consumers’ privacy rights is long overdue.   

The Washington Post Editorial Board highlighted our event stating, “the surprising degree of consensus around not only the general necessity of nationwide data protections but also the particulars” makes taking action a “no-brainer.” A recent poll from Morning Consult revealed 80 percent of both Democrats and Republicans said Congress should make privacy a “top” or “important” priority in 2021.

There is bipartisan consensus and agreement from organizations across the spectrum that Congress must act. NCL’s message at the event is that it is now time to craft legislation that gives consumers back control over their personal data. At the event, Rep. Schakowsky, the chairwoman of the House Subcommittee on Consumer Protection and Commerce, announced her intention to hold a series of bipartisan roundtable discussions to examine ways to pass comprehensive privacy legislation. NCL is ready and eager to participate in those conversations to help ensure that a comprehensive bill gives all consumers strong, enforceable privacy rights.  

While passing legislation this Congress is a priority, NCL made clear that we are not going to simply bargain away long held principles on data privacy. NCL believes that in order to protect the privacy and security of consumers’ personal data, the legislation must not preempt stronger state laws, must include strong enforcement provisions, including a private right of action and provide consumers with strong substantive privacy rights. The right legislation will include effective enforcement mechanisms that safeguard privacy rights for consumers and enshrine rules of the road for businesses.  

We applaud Reps. Schakowsky and Bilirakis, and Sen. Blumenthal for their leadership and their commitment to continue fighting for comprehensive privacy legislation. We hope to continue to cooperate with this esteemed group as we work to achieve our shared goal. 

Giving a voice to women facing preterm birth

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By Sally Greenberg, NCL Executive Director

Born out of our historical focus on reducing health inequities in the United States, and a nearly year-long movement to preserve access to approved therapies that fight premature birth, NCL supported the launch of the Preterm Birth Prevention Alliance (PBPA), which brings together a coalition of 15 patient advocacy organizations who share concerns about the grave state of preterm birth in the United States and its disproportionate impact on Black, Indigenous, and women of color.

For the past decade, hydroxyprogesterone caproate, commonly called “17P,” has been the only available FDA-approved treatment option to reduce the risk of recurrent preterm birth. Patients and the healthcare providers who serve them currently have access to one branded and five generic versions of the prescription product. However, in 2020, the FDA proposed withdrawing all forms of 17P, based on conflicting efficacy data from two studies composed of vastly different populations — one inclusive of women in the U.S. most vulnerable to preterm birth and one not. Both studies showed that this class of treatment is safe for both mother and baby.

Despite multiple formal requests to consider additional data and alternate ways to study the efficacy of this class of drugs before effectively depriving women of access, FDA made its recommendation without engaging the most important stakeholders—patients who are at the highest risk and their providers. And even after a recently published meta-analysis showed that 17P injections reduced the risk of preterm birth before 34 weeks in high-risk women with singleton pregnancies, FDA persisted in its recommendation.

The Alliance was formed to stand up for the needs of moms and babies of every race and ethnicity and urge regulators to hear directly from women facing prematurity and their providers about their real-world experiences — in a public hearing — before making a decision on withdrawal.

We believe that evidence of efficacy for Black, Indigenous, and women of color in the United States — who are at highest risk of adverse outcomes — should be more determinative than a lack of demonstrated treatment efficacy on primarily white women from other countries. And we believe that more inclusive studies and data are needed, across more racially and ethnically diverse patient populations, to better understand the causes and impact of disparate outcomes in preterm birth.

Alliance partners currently include:

  • 1,000 Days
  • 2020 Mom
  • American Association of Birth Centers
  • Black Mamas Matter Alliance
  • Black Women’s Health Imperative
  • Expecting Health
  • Healthy Mothers, Healthy Babies Montana
  • HealthyWomen
  • Miracle Babies
  • National Birth Equity Collaborative
  • National Black Midwives Alliance
  • National Consumers League
  • National Partnership for Women & Families
  • Sidelines High-Risk Pregnancy Support
  • SisterReach

Organizations or advocates concerned about the needs of women facing prematurity — whether you are a healthcare professional, maternal and infant health advocate or a health equity champion — are invited to join us and add your voice to this effort.

Learn more and join the Alliance: https://nclnet.org/pbp/

Consumers face an unfair disadvantage at the pharmacy counter

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By Sally Greenberg, NCL Executive Director

Everywhere we turn these days, we find ourselves wondering if we are getting a fair deal. Americans continue to suffer the economic consequences of a year-long global health pandemic, and many of us are trying to stick to the essentials and stretch our dollars where we can. As COVID-19 has reminded us, there aren’t many issues families face that are more significant than access to health care.

Families can’t go without essential prescriptions and often wonder why the price seems to go up each time they go for a refill. In fact, we are likely paying more than necessary at the pharmacy counter, but we don’t often know — or even think to ask — why.

A variety of factors drive drug costs, some of which are obvious: the cost of research and development, distributing the product, the pharmacies’ profits – but there is one far less known cause of price increases: PBMs, short for pharmacy benefit managers.

Most people have never heard of PBMs, and PBMs like it that way. They are billion-dollar companies that control more than 80 percent of the prescription drug formularies, (formularies are the lists of drugs that a health plan allows its members to access) — in the United States.

Because of their outsized role, too often PBMs determine how much consumers, businesses, government agencies, and others pay for medicines. As originally conceived, PBMs were meant to help ensure that patients get a fair deal by:

  • working with manufacturers to ensure rebates (or savings) for medications
  • working with insurance companies to determine which medications are covered
  • working with pharmacies to set the price points and help reimburse pharmacies for dispensing prescriptions.

In theory, PBMs should be lowering costs for everyone. However, as they have evolved and grown, they’ve become greedy and self-serving entities, scooping up discounts for themselves and throwing consumers under the bus. All the while, their profits continue to soar as they are all among the top Fortune 500 companies.

Sadly, PBMs have also found ways to manipulate the system and put their own profits first.

Insulin is a prime example. Diabetes patients who need their medication to survive are increasingly left with fewer options for treatment. When PBMs get involved, consumer costs increase.

One recent analysis found that the total value of rebates and discounts for insulin on an annual basis amounts to more than $5,000 per patient. Another report explained that the net price on one insulin product — what the company earns as revenue — declined by 53 percent since 2012, while the list price increased 141 percent. As the WSJ story explains, this is in part due to PBM middlemen meddling. In order to ensure formulary positions (which PBMs control), companies are paying more and more each year.

Consumers don’t know where high drug prices come from and they shouldn’t have to — the system needs to deliver affordable, accessible, safe and effective medications without any entities taking an unfair or hidden profit. The stakes are too high as we look ahead to the health challenges that millions face with the Covid pandemic.

NCL joins with many other groups, including America’s Agenda, United Food and Commercial Workers International Union, HMC Healthworks, Union of Bricklayers and Allied Craftworkers, National Community Pharmacists Association, National Alliance of State Pharmacy Associations, Diabetes Leadership Council, and Diabetes Patient Advocacy Coalition in helping to expose hidden, and frankly, indefensible profits being directed to the coffers of PBMs — money that should be redirected to bring drug prices down for patients and consumers.

Let’s all ask hard questions about PBMs’ role in our healthcare system and whether we can’t be using the profits they are taking to lower drug costs. Share this story with others. Talk with your friends and family. Ask your local pharmacist questions.

Consumers – not PBMs — should come first at the pharmacy counter. Stay tuned for more from us on this, and let’s continue the conversation.

Does your baby’s food contain toxic metals?

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By Nailah John, Program Associate

As a mother, I once fed my baby with baby food only to later be told that some baby foods contain toxic metals at levels that exceed what experts and governing bodies say are safe. Congressional investigators have found dangerous levels of toxic heavy metals in many popular baby food brands. The World Health Organization says that the top 10 chemicals of concern for infants and children include arsenic, lead, cadmium, and mercury.  This exposure to heavy metals in childhood is linked to permanent dips in IQ, an increased risk of future criminal activity, and damaged long-term brain function.

Some pediatricians and children’s health experts say that heavy metals are found in soil and contaminate crops grown in it. Heavy metals can also get into food during manufacturing and packaging processes. However, the amount that is allowed in baby food products exceeds the limit. The nonprofit Healthy Babies led a national investigation and found that 95 percent of baby foods tested contain toxic chemicals. Fifteen foods accounted for half the risk, with rice-based foods at the top. Making these food and lifestyle changes can help reduce toxic metal residue:

  • Choose rice-free snacks over rice-based ones. Try a frozen banana or a chilled cucumber instead of rice-based teething biscuits.
  • Opt for oatmeal over rice cereal.
  • Give tap water over fruit juice.
  • Rather than sticking strictly to baby food made from sweet potatoes and carrots (which contain higher levels of metals), opt for baby food made from other fruits and vegetables.
  • Make your own baby food by buying, washing, and blending your own fruits and vegetables.
  • Don’t get stuck in the baby food phase. Baby food is meant to be transitional, used only for a few months. Introduce your babies to sources of protein like fish—salmon, tuna, cod, whitefish, and pollock.
  • Visit the pediatrician often in the first two years of your child’s life. This can help to identify any developmental problems.
  • Limit heavy metal exposure in other ways. Heavy metals are also found in peeling or chipping paint in older homes built before 1978.
  • Don’t smoke or vape as secondhand and even thirdhand smoke (or residue from smoking on furniture or clothes) may expose children to metals like cadmium and lead.

While individuals can do their part, the most significant changes will have to come through enforced legislation and stronger regulations on baby food. According to the recent congressional report, toxic metals in tested baby food eclipse safe levels, “including results up to 91 times the arsenic level, up to 177 times the lead level, up to 69 times the cadmium level, and up to 5 times the mercury level.” The report recommended that the Food and Drug Administration require baby food manufacturers to test their finished products for toxic heavy metals and label products that contain them. One of the most powerful ways of creating change is by calling your Member of Congress and urging them to use their voice to address the issue of heavy toxic metals in baby foods. As a mother, I plan to do so and so should you.

The evolution of American alcohol policy — and what’s next

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By Nailah John, Program Associate

Alcohol is consumed by billions of consumers the world over. Humans drink alcohol for many reasons, including enjoying the taste or coping with stress while others consume alcohol because of social influences. More than 85 percent of people around the world consume alcohol. America’s alcohol policy has seen many ups and downs over many decades from prohibition in the 1920s to the end of prohibition in 1933, National Minimum Drinking Age Act in 1988, the Alcohol Beverage Labeling Act 1988 (ABLA), and the continued efforts for a “Nutritional Facts Label” on all alcoholic beverages by consumer advocacy groups.

Every other consumable product on the supermarket shelves is required to have a Nutritional Facts Label. That label has a list of required information about a food’s nutrient content, such as the calories, protein, vitamins, fat, sugar, sodium, and fiber. This is critically important consumer information for guiding healthy choices.

After Prohibition In 1935, the Federal Alcohol Administration governed alcohol regulation. In 2003, the Alcohol and Tobacco Tax and Trade Bureau (TTB) was formed, and alcohol continued to be regulated by this federal agency. Since the 1970s, consumer advocacy groups have worked for a comprehensive label on all alcoholic products. In 2003, the Center for Science in the Public Interest (CSPI) and the National Consumers League made a hard push for a nutritional facts label. Manufacturers asked for voluntary labels, making the argument that putting nutrition facts on all bottled of alcohol would make consumers think that alcohol was nutritious. In 2004, TTB sided with manufacturers and issued guidelines that allowed them to list calories, carbs, protein, and fat­—but only if they wished to do so voluntarily. In 2021, NCL and other groups are recommitting ourselves to this consumer information campaign.

The Dietary Guidelines 2020-2025 lay out the existing recommendations for sugar and alcohol, which recommend moderate alcohol consumption––up to one alcoholic drink per day for women and up to two per day for men. The CDC warns that alcohol consumption is associated with a variety of short and long-term health risks: high blood pressure, various cancers, motor vehicle accidents, violence, and sexually risky behavior. The CDC guidelines also note that pregnant women should refrain from alcohol consumption and that those with certain condition should avoid alcohol. That is true as well with certain medications.

More than half—55 percent—of Americans say they have had alcohol in the past month. An estimated 14.5 million American adults age 12 and older battled an alcohol use disorder, or 5.3 percent of this population. The bottom line is that if you drink, do so in moderation per the CDC and DGAC guidelines. And join with consumer advocates fighting for a nutritional facts label to be put on all alcoholic beverages.

COVID vaccine: Credit where credit is due

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By Sally Greenberg, NCL Executive Director

It’s almost a miracle. We now have safe and effective vaccines to fight SARS CoV2, commonly known as COVID-19, the devastating illness that has swept across the globe and—as of January 16, 2021—has killed more than 390,938 Americans and infected 23.5 million in less than a year.

Nearly 40 percent of those who’ve died were beloved older Americans in long-term care facilities, where the disease spread like wildfire, and who were often unable to say goodbye to loved ones.

Sadly, many who contracted the illness and survived spent lengthy hospital stays clinging to life on respirators. Of those who recovered, millions report COVID’s debilitating long-term effects. The United States has four percent of the world’s population but nearly a fifth of its recorded coronavirus deaths—the most of any country. Think of this: we have lost in less than one year eight times the number of Americans who died in the whole Vietnam war, and nine times the number who die in car accidents each year.

But now there’s light at the end of the tunnel because, in record time, America’s pharmaceutical companies have successfully developed safe and highly effective vaccines. Since the SARS CoV 2’s grip over America in late March of 2020, all medical experts could talk about—beyond washing hands, wearing masks, and social distancing—was getting a vaccine to prevent this illness. But vaccines typically take many years to develop so, we were told, don’t hold your breath. And yet here we are.

Consumer groups and members of Congress have been known to criticize the pharmaceutical industry. I get it; too many drugs are expensive and out of reach for millions of Americans, and that must be addressed. But it’s also important to acknowledge value of the public private partnership and the vast resources these companies have put into the R&D and bringing to market life-saving vaccines.

The COVID-19 pandemic is a prime example. The leading vaccines developed for COVID-19 are here, thanks to the dedication of industry leaders and scientists. Pfizer CEO Albert Bourla shifted the company’s focus to singlemindedly developing a COVID vaccine, leveraging its substantial scientific and medical expertise, as well as 20 years of research on previous SARS-like illnesses. Pfizer committed hundreds of millions of dollars of its own resources to building a manufacturing network, and companies agreed to share their knowhow. These efforts were critical in achieving an effective and safe vaccine in record time. And in creating a distribution system that could maintain the very cold temperatures needed to preserve, especially the Pfizer vaccine, before it is administered.

Our government doesn’t have the resources to make that happen alone. Yes, something close to $10 billion in taxpayer dollars through Operation Warp Speed went to companies to assist with the rapid development of a vaccine, but Pfizer didn’t accept government funding for the initial development of the vaccine (though the company did receive $1.95 billion for manufacturing and nationwide distribution of 100 million doses).

And now we have Moderna, which also received more than $1 billion in funding, joining Pfizer in making available a two-dose vaccine that is safe and 95 percent effective, with Johnson & Johnson, Merck, and Novavax not far behind with vaccines that may only require one dose. The public-private partnership model works. And consumers won’t have to pay to receive these shots. Experts tell us we should have five vaccines available by March or April, which is important because it gives healthcare providers options for different populations.

The next challenge is getting it into the arms of enough of us so that we can reach herd immunity, which means at least 60-70 percent of the population needs to be vaccinated.

And while this process has been disappointingly slow, this is largely because states haven’t been given adequate resources from the federal government to support a massive vaccination program. That said, more than a million Americans and counting have now been vaccinated and, under the incoming Biden-Harris Administration and a Democratic Congress, vast additional resources will be going to support for states and localities. The good news for vaccines is that there is high demand for the shots. My own Washington, DC community has offered thousands of appointments for shots online in the morning and they are taken immediately.

We have many to thank for this vaccine’s rapid development, but we must acknowledge the success of this uniquely American public-private partnership. We applaud the heroic work of Pfizer, Moderna, and the other companies to speed R&D and clinical trials of thousands of patients, to ensure a vaccine that is safe and effective. And kudos also to the trusted scientists at FDA and CDC for reviewing the data, ensuring the safety and efficacy of the vaccines, and approving them.

A special thanks is due to two esteemed FDA directors: former director Dr. Scott Gottlieb and our current FDA head Dr. Stephen Hahn, who gave us the straight scoop this past year and promised and delivered on FDA’s integrity and reliance on science throughout the process. And of course, we owe a deep debt of gratitude to our national hero, Dr. Anthony Fauci, who provided honest, science-based advice to the American people throughout these tense and trying times, despite pressure from the Trump Administration to play down the pandemic. Americans clearly agree, as evidenced by “Thank You, Dr. Fauci” signs on lawns across America!

The FDA must create a win-win path leading to new data on 17P and protect access for pregnant mothers

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By Sally Greenberg, NCL Executive Director

You may never have heard of hydroxyprogesterone caproate or “17P”—it’s a mouthful, but the role it has played in the lives of thousands of pregnant mothers and babies is easy to understand. For nearly a decade, it has been the only FDA-approved therapy to reduce the risk of recurrent preterm birth. It is available to women and their healthcare providers in both branded and generic prescription versions.

I have personally spoken with healthcare providers whose patients have had longer pregnancies thanks to 17P and a longer pregnancy can be a very good thing. As we noted in a letter we signed, along with 15 leading women’s and children’s health advocates, and sent to the FDA a few months ago, premature birth is the leading cause of infant death in the U.S. and has devastating effects on families and is very costly to our health care system. Among those babies who do survive, short and long-term complications can accompany preterm birth.

Prematurity also has a very significantly disproportionate impact on women of color. It is not something to take lightly. In fact, the preterm birth rate among U.S. black women is 49 percent higher than the rate among all other women. Factors associated with being African American—including experiencing institutional racism, racial health inequities, and higher psychosocial stress—contribute to prematurity.

One would think that preserving access to the one branded and five generic forms of 17P would be a priority for the FDA. Yet shockingly, earlier this week, the FDA proposed that all versions of 17P (branded, generics, and compounded for this indication) be withdrawn from the market.

The Center for Drug Evaluation and Research (CDER) within the FDA made this recommendation despite the fact that 17P has a very strong safety profile (two trials and a decade of use by U.S. women and their providers bear that out). It also made its recommendation without meeting with affected women or providers who have personal experience with the benefits of 17P, without comprehensively considering alternative methods to assess which patients benefit most, and without, in our view, fully accounting for the unique needs of black women, who face a rate of preterm birth in the U.S. that is about 50 percent higher than the rate of preterm birth among white women.

To be fully transparent, 17P does have conflicting efficacy data from two clinical trials with markedly different patient populations: the first of which included a majority of U.S.-based African American women (59 percent). This was the trial that led the FDA to approve 17P for use in the U.S. in 2011, and another which included data of a population of women, most of whom lived in the Ukraine and Russia, and few of whom (7 percent) where African American.

There are questions on the table about who specifically benefits most from 17P and those questions do need to be answered. But access to 17P should not be compromised without substantial evidence that there is lack of benefit in the appropriate population and we don’t believe that evidence exists today. We strongly believe that the FDA should accept any request for a hearing in order to allow providers and patients an opportunity to discuss these concerns in more detail.

The FDA was provided with a proposal to keep 17P on the market and gather data to determine which populations of pregnant women benefit most from the therapy. The company that makes the branded version of 17P provided a detailed plan for generating additional data and predictors of benefit in women with a history of recurrent preterm birth.

Utilizing alternate ways to evaluate and define the patient populations that benefit most from 17P while allowing continued access to those in need seems like a win-win approach, especially considering the fact that the second, predominantly international based clinical trial was conducted outside of the U.S. because U.S. healthcare facilities refused to give their patients a placebo rather than 17P, and the same would undoubtedly happen if another clinical trial was attempted on American soil.

We’re talking about pregnant women and babies, not just ‘clinical trial participants.’

As our nation continues to grapple with the effects of the pandemic on our health and lives, evidence has shown that there may be an increased risk of preterm birth and pregnancy loss among pregnant women with COVID-19, particularly pregnant women of color. And while no single solution will improve maternal and infant health outcomes, only one proven intervention currently exists to help pregnant women prevent a recurrent preterm birth.

By factoring in the experiences of mothers and providers, the FDA can continue upholding its strong history of regulatory integrity while taking a necessary, comprehensive view of 17P’s real-world clinical implications on pregnant women and their newborn babies. We urge the FDA not to leave at-risk pregnant women and their healthcare teams without a path forward in the middle of a pandemic.
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