In 2019, in response to the growing retail market of untested, unapproved cannabidiol (CBD) products, NCL identified the need for greater consumer education and increased regulation at the federal level. NCL and its partners — Consumer Federation of America and the Community Anti-Drug Coalitions of America — createdConsumers for Safe CBDto help raise awareness of the unregulated CBD marketplace, champion the rights of consumers, and call on government and industry to do more to protect consumers. This year, we will continue to work with key stakeholders to encourage safe CBD food and beverage products and promote a pathway for new therapeutic products through clinically-tested scientific research.
We’ve come a long way since our launch, and FDA is making progress. Newly former FDA Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy recently called for better science, more data, and increased testing to determine the risks and benefits associated with CBD. We are encouraged by the commitments outlined in the FDA statement and look forward to continued collaboration with the Biden Administration and the new leadership at the agency to make the CBD marketplace fair, safe, and healthy for consumers.
Read more about the FDA’s comments on the Consumers for Safe CBD here and sign up for CBD updates from our Consumers for Safe CBD campaign here.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00Melody Merinhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngMelody Merin2021-01-24 20:56:372021-01-25 21:10:42Welcoming FDA’s call for better science, more research on CBD
Knowing the rights, risks and responsibilities of prescription opioid use is an important first step to addressing the opioid epidemic. Whether you are taking medication to treat pain, or have friends or family members who have been prescribed opioids, knowing the facts can help prevent misuse before it occurs.
NCL recently partnered with the Allied Against Opioid Abuse (AAOA) to create a new batch of resources to help educate consumers about prescription opioid safety. The new Consumer Toolkit includes educational materials to help reinforce the need for patients, caregivers, parents, and others to understand their rights, risks, and responsibilities associated with prescription opioid use.
Prescription opioids are medications prescribed by healthcare providers to treat moderate to severe pain for health conditions that cause ongoing discomfort as well as for pain following surgery or injury. Common prescription opioids include:
Oxycodone
Morphine
Hydrocodone
Oxymorphone
Codeine
Fentanyl
If you are not sure if your medicine is an opioid, check your prescription labels to look for generic names. The National Safety Council also provides a helpful chart of medicines that contain opioids. You should always ask your healthcare provider or pharmacist if you are not able to find the name or have questions.
Watch for risk factors associated with prescription opioids, including:
Mixing opioids with other medications, drugs, nutritional supplements or alcohol
Taking more than prescribed
Taking a high daily dose of opioids
Certain conditions such as depression, anxiety, post-traumatic stress disorder, HIV, sleep apnea, or liver or lung disease
Pregnancy
Older age
Family history of substance abuse
Let your doctor know if you or your loved ones have any of these risk factors before filling any opioid prescription.
“Opioid misuse often starts in the home, so safe storage and disposal are key to prevention,” said Sally Greenberg, executive director of NCL. “Make sure that prescription opioids are stored securely and remember to properly dispose of all unused prescription opioids as soon as possible.”
AAOA offers a safe disposal locator for you to find a place to safety get rid of your unused medications. Find details on safe disposal options here.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00NCL staffhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngNCL staff2020-08-07 06:12:432020-11-06 17:03:57Understand the opioid epidemic and protect yourselves and loved ones
As America’s premier consumer advocacy organization, with a rich history of fighting to make the marketplace fair, safe, and healthy for consumers, NCL is hard at work on the most important issues in food and drug safety and to collaborate on improving consumer education.
In recent years, NCL has been observing the CBD, or cannabidiol, marketplace exploding, with products lining shelves of grocery stores, specialty shops—even gas stations. Products were appearing to make many claims or hint at miracle cures, and most consumers had no idea how or whether the products were being regulated. Who is making sure these tinctures, oils, gummies, and lotions are safe, and do they do what they claim?
This is why last year, NCL joined forces with the Consumer Federation of America and the Community Anti-Drug Coalitions of America, to create a national campaign called Consumers for Safe CBD.
NCL had identified a serious need for greater education among consumers about CBD, and that’s why Consumers for Safe CBD was created. Consumers for Safe CBD aims to help educate the public about the risks related to untested, unapproved CBD products on the market, champion the rights of consumers, and call on the U.S. Food and Drug Administration (FDA) and industry to do better to ensure safety and promote a pathway for new products through clinically tested scientific research.
“Cannabidiol, commonly referred to as CBD, is being used in a growing number of consumer products and is illegally sold in stores and on the Internet,” said NCL Executive Director Sally Greenberg. “We’re working to educate consumers and ensure accurate labeling, clear guidelines, and further research to protect against unknown and known risks of CBD products.”
NCL and its partners continue to raise awareness among consumers, policymakers, and regulators about the health risks associated with the unregulated CBD marketplace, in particular with the unproven health claims and often inaccurate labeling of products on the market today. Beyond the known health risks associated with unregulated CBD, there are a number of unscrupulous marketing tactics that prey on unsuspecting consumers. This includes false and dangerous claims that CBD has medical benefits that can prevent and stop the spread of the COVID-19.
By warning consumers about these false claims, participating in media interviews and publishing op-eds across the country, highlighting important research and reports, and sending letters to several retailers, state Attorneys General and Members of Congress, the campaign is working to protect consumers across the country from unapproved and potentially dangerous CBD products.
“We need to better understand the potential health benefits of CBD, but this can only be accomplished through clinical testing and scientifically validated methodologies,” said Greenberg. “We need the FDA to step up for consumers and for the public health.”
The time for action is now. CLICK HERE for more information about the Consumers for Safe CBD effort.
https://nclnet.org/wp-content/uploads/2020/08/NCL-logo.png00NCL staffhttps://nclnet.org/wp-content/uploads/2020/08/NCL-logo.pngNCL staff2020-08-07 06:07:132020-10-23 18:11:15Consumers for Safe CBD is working to protect, educate Americans
PBPA Commends HHS Funding to Support Maternal and Infant Health
The Preterm Birth Prevention Alliance (PBPA), a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, applauds the U.S. Department of Health and Human Services (HHS) for awarding nearly $350 million to states across the country to improve support for safe pregnancies and healthy babies.
“For far too long, U.S. maternal health care has lagged behind that of other developed countries, particularly for women of color,” noted Sally Greenberg, Executive Director of the National Consumers League. “This additional funding will enable local health departments and nonprofits to better address the health care needs of the most vulnerable mothers and their babies.”
The funding, awarded by HHS’ Health Resources and Services Administration (HRSA), will support home visiting services, increase access to doulas, address infant mortality and maternal illness, and improve data reporting on maternal mortality.
“Maternal health care in the U.S. has consistently failed women of color,” Greenberg continued. “We applaud HHS for this additional funding that will help to improve the maternal health for all mothers and babies, especially women of color and those most at-risk.”
The funding announcement follows the release of a report by the U.S. Commission on Civil Rights which found that Native American women are more than two times more likely to die from pregnancy-related complications than white women in the U.S. This disparity was further exacerbated for Black women in the U.S., who are three to four times more likely to die from pregnancy-related complications than white women.
“In addition to expanding programs to support maternal health, we must increase representation from racially and ethnically diverse groups in research and clinical trials, particularly those studying treatment options to prevent maternal morbidity and mortality,” said Greenberg. “The need for the additional HHS funding and the report from the Commission on Civil Rights clearly illustrate how critical representative research and real world evidence are to ensuring all mothers and their babies have the same opportunity for the best possible health outcomes.”
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.
PRETERM BIRTH PREVENTION ALLIANCE APPLAUDS FDA’S GRANTING OF HEARING FOR THE ONLY FDA-APPROVED THERAPIES TO REDUCE RECURRENT PRETERM BIRTH
WASHINGTON, DC, August 26, 2021 –
Preterm Birth Prevention Alliance a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, commends the U.S. Food and Drug Administration (FDA) for granting a public hearing to discuss 17P, the only FDA-approved class of branded and generic treatments to reduce preterm birth in indicated patients.
We appreciate the FDA’s willingness to hear directly from individuals facing prematurity and the providers who treat them about their experiences with 17P,” said National Consumer League’s Executive Director Sally Greenberg. “It is an important step towards better understanding variations in efficacy across diverse populations and ensuring all women have an equal chance at the best possible outcomes.”
Last week, the FDA agreed to grant Covis Pharma, the manufacturer of the branded 17P product Makena its request for a public hearing to discuss 17P. Hydroxyprogesterone caproate—or “17P”—has been approved since 2011 and is the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth in the United States. In 2020, the FDA proposed withdrawing 17P in all its forms, including the branded product and its five generic versions, based on conflicting efficacy data from two studies composed of vastly different populations, one predominantly inclusive of women in the U.S. most vulnerable to preterm birth and one not.
“Mothers and birthing people deserve access to the best possible treatments to prevent preterm birth. We cannot achieve birth equity if we study pregnant women as a monolith,” said Blythe Thomas, Initiative Director of 1,000 Days. “It is only by systematically researching the real-world, post-market impact of 17P on individuals from a variety of racial and ethnic backgrounds, while maintaining access for all affected, that we can reduce disparities in maternal and infant health.”
While the hearing date has not yet been set, the Alliance looks forward to sharing the perspectives of affected individuals and their physicians with the agency once the hearing is scheduled and will continue to advocate for at-risk moms and babies of all races and ethnicities.
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ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE
The Preterm Birth Prevention Alliance (PBPA) is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, the 15 partners in the PBPA seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org
LEADING PATIENT ADVOCATES LAUNCH PRETERM BIRTH PREVENTION ALLIANCE TO PROTECT CRITICAL ACCESS TO THE SOLE FDA-APPROVED CLASS OF THERAPIES TO REDUCE RECURRENT PRETERM BIRTH
WASHINGTON, DC, April 20, 2021 – Today, the National Consumers League (NCL), along with a coalition of patient advocacy organizations dedicated to advancing the health of mothers and infants, announced the launch of the >Preterm Birth Prevention Alliance.
Members of the Alliance are joining forces in an effort to preserve patient access to the only Food & Drug Administration-approved class of treatments for pregnant women who have previously had an unexpected, or spontaneous, preterm birth. Together, Alliance members seek to ensure that the Food & Drug Administration (FDA) hears concerns from the full range of stakeholders about the potential risks and impact of withdrawal for at-risk pregnant women and their providers.
For the fifth year in a row, the U.S. preterm birth rate has increased (to 10.2 percent of births), and preterm birth and its complications were the second largest contributor to infant death across the country. Preterm birth also represents a significant racial health disparity, with Black women in America experiencing premature delivery at a rate 50 percent higher than other racial groups throughout the country.
However, in 2020, the FDA >proposed withdrawing hydroxyprogesterone caproate, commonly called “17P” or “17-OHPC”, the only FDA-approved class of branded and generic treatments to help prevent the risk of preterm birth in women with a history of spontaneous preterm birth. The FDA is currently determining whether to hold a hearing on the status of 17P, based on conflicting efficacy data from two studies composed of vastly different patient populations, one inclusive of women in the U.S. most vulnerable to preterm birth and one not.
“We’re fighting for a more inclusive healthcare system that gives everyone an equal chance to have the best outcomes possible,” said Sally Greenberg, executive director of the National Consumers League. “We don’t believe that removing 17P from the market without gaining a better understanding of who could benefit the most from its use is in the best interests of patients, nor their healthcare providers, particularly as there are no other approved treatment options available.”
To date, 14 organizations have joined NCL to advocate for the health interests of at-risk pregnant women and infants, including: 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 Partnership for Women & Families; Sidelines High-Risk National Support Network; and SisterReach.
“As a trained obstetrician and gynecologist, I know firsthand the impact of preterm birth on Black women and birthing people. I also know that racism – not race – is the driving factor leading the disproportionate impact of preterm birth on Black women and birthing people thereby exacerbating systemic inequities in maternal and infant health. To achieve birth equity, which is the assurance of the conditions of optimal births for all people with a willingness to address racial and social inequities in a sustained effort, we must work to protect and uphold a standard of care for spontaneous, recurrent preterm births and ensure it remains accessible and affordable for all who stand in need,” added Dr. Joia Crear Perry, founder and president of the National Birth Equity Collaborative.
The Preterm Birth Prevention Alliance is calling for the FDA to grant a public hearing to fully consider all of the data, additional research methods, and stakeholder perspectives before deciding whether to withdraw approval of this critical class of therapies. The health of America’s moms and babies warrants the utmost care and consideration.
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ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE
The Preterm Birth Prevention Alliance is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, we seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org.
Initial support for the Preterm Birth Prevention Alliance is provided by Covis Pharma.
