Testimony at CDC advisory committee on Moderna COVID-19 vaccine approval

/in , , , , /by

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242

Washington, DC—Today, February 4, 2022, NCL Health Policy Associate Milena Berhane provided oral testimony to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices in support of the approval of Moderna’s COVID-19 vaccine and pediatric COVID-19 vaccines. Her comments appear below.

February 4, 2022

Thank you, Dr. Lee. My name is Milena Berhane, and today I am representing the National Consumers League. Since NCL’s founding in 1899 by social reformer Florence Kelley, we have advocated for the critical role immunizations play in the preservation and improvement of public health. We extend our gratitude to this Committee for the opportunity to present public comments.

An estimated 890,000 Americans have died from COVID-19 during this pandemic that has persisted in the U.S. for the past two years. The COVID-19 virus continues to threaten the health and safety of many, especially vulnerable populations such as the elderly and immunocompromised groups. The currently available COVID-19 vaccines have worked to save lives, and avoid preventable illness, hospitalizations, and deaths in our communities.

The National Consumers League commends the FDA and the CDC on the approval of the Moderna COVID-19 vaccine, which will continue to be a key tool in the public health response to this pandemic. This vaccine has been, and will continue to be, a safe and effective measure to protecting Americans 18 years of age and older.

America’s families are hopeful that the Pfizer COVID-19 vaccine will be granted Emergency Use Approval for children under 5 years of age. Hospitalization of children under 5 years of age has soared, further evidence of the need for expanding vaccine access to children in this age group. Vaccinating children under the age of 5 will protect them from illness, but also protect their families, caretakers, and teachers from contracting COVID-19 as well.

We are also concerned about the widespread drop-in routine childhood immunization rates during the pandemic. According to CDC data released last May, over 11.7 million children have missed doses of their recommended vaccines.  We are particularly worried that our nation’s most vulnerable children, those who qualified for the Vaccines for Children program, are getting caught up at a much slower rate than children with commercial insurance.

The National Consumers League recognizes the extreme importance of immunizations in protecting the health and safety of all Americans, and will continue its efforts to increase vaccine confidence and uptake across lifespan. We look forward to the upcoming recommendations by this committee regarding these COVID-19 vaccines.

Thank you.

###

About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Illicit drugs and the digital marketplace

/in , , /by

By NCL Health Policy Associate Milena Berhane

Technology has brought into the homes of millions of consumers many wonderful tools for accessing the drugs and medical products we need. We, as consumers — at the touch of a few buttons — have access to drugs and devices that would have required far more time and effort to acquire in the past. But with that ease of access, we also have millions of tainted or suspect products peddled to consumers, including counterfeit drugs.

At any one time, there are 35,000 active pharmacies online, according to ASOP Global. Ninety-five percent of them do not comply with applicable laws and pharmacy standards. Counterfeit products sold by this 95 percent are manufactured in often unsafe conditions and contain little or no active ingredients.

Those in charge of online registries could better control this. These registries control the websites that can be set up on the Internet, managing domain name extensions such as .com, .gov, and .org, and .pharmacy. It is critical that Internet registries and registrars monitor the activity on their domains and ensure that illegal activity is prevented.

Consumers look for drugs online for both cost and convenience reasons. It’s understandable that consumers are turning to the Internet for cheaper options when the cost of many prescription drug costs is so high. Those who do undoubtedly don’t understand the risk of illegal online pharmacies; research shows only an estimated 37 percent see little danger in ordering from such a pharmacy. In addition, 7 in 10 Americans incorrectly believe that appearing at or near the top of Internet search results legitimizes such a website.

The COVID-19 pandemic has also played a role in these risks, with an increased sale of online goods, including prescription drugs. About 31 percent of consumers who bought prescription medication online did so for the first time in 2020 because of the pandemic. As a result, now more than ever, we need to ensure that illegitimate online pharmacies are far better regulated, and frankly, put out of business.

The examples are stark. In 2021, the Drug Enforcement Administration (DEA) seized more than 9.5 million counterfeit pills, which is more than what was seized in 2020 and 2019 combined. Due to these high numbers, in late 2021, the DEA warned that “fake prescription pills are widely accessible and often sold on social media and e-commerce platforms — making them available to anyone with a smartphone, including minors.”

We believe that online platforms have the responsibility to enforce their terms and conditions. These registries and registrars are choosing profit over safety by allowing online pharmacies to sell fake drugs and products.

For this reason, the National Consumers League is supporting the DRUGS Act (H.R. 6352/S.3399) which aims to holds Internet registries and registrars responsible for any illegal and illegitimate drugs being sold through their online platforms. Modeled after a pilot “trusted notifier” program, this bill would require registries to suspend a website, conduct an investigation, and then shut the platform down if it is found to be selling illegal substances.

In the meantime, NCL will continue to educate consumers about the dangers of counterfeit drugs. NCL’s FakeRx Action Center provides consumers with the tools to protect themselves from fake drugs and illegal online pharmacies — as well as a place to report counterfeits. Consumers have a duty to do their homework, but we have to make it far harder for fakes and counterfeits to be peddled to unwitting consumers. The DRUGS Act will go a long way to make that a reality.

NCL applauds action to rein in deceptive marketing of contact lenses

/in , , , , /by

February 3, 2022

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242

Washington, DC –The National Consumers League (NCL), America’s pioneering consumer advocacy organization, welcomed the enforcement action undertaken by the Federal Trade Commission (FTC) and the Department of Justice (DOJ) to end the deceptive marketing of contact lenses by Vision Path, Inc.

Vision Path, a direct-to-consumer seller of Hubble contact lenses, will pay penalties and redress totaling $3.5 million to settle charges that it violated the FTC’s Contact Lens Rule and put consumers at risk by failing to obtain proper prescriptions, and neglecting to properly verify prescription information, and by substituting Hubble lenses for those actually prescribed to consumers.

“This action against Vision Path should serve as a warning to any company that disregards laws intended to protect consumers. NCL has been at the forefront of efforts to get Congress and federal regulators to crack down on companies that deceptively market to consumers and illegally substitute their contact lenses in place of those originally prescribed by a patient’s eye doctor,” said NCL Executive Director Sally Greenberg.

The FTC’s complaint alleges that Vision Path engaged in other deceptive practices, such as failing to disclose that “independent” consumer reviews were actually solicited by the company. The FTC also alleges that Vision Path engaged in a deceptive negative-option billing model that encouraged consumers to sign up for 15 pairs of daily-wear contact lenses and then automatically enrolled them in a subscription plan. NCL has long supported legislation, such as the District of Columbia’s landmark Structured Settlements and Automatic Renewal Protections Act of 2018, that would require a consumer’s explicit affirmative consent before such automatically-renewing contracts could kick in.

“Consumers are best served when they work with their health care providers to ensure the most appropriate and safest use of FDA-regulated medical devices, like contact lenses,” said Greenberg. “We are grateful to the DOJ and the Consumer Protection Bureau at the FTC, which led this effort, for their rigorous enforcement of consumer protection laws. While this is an important development, violations of the Contact Lens Rule continue. We will continue to press Congress and federal agencies to ensure that the CLR is being implemented and enforced as Congress intended.”

###

About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL offers support for the Domain Reform for Unlawful Drug Sellers (DRUGS) Act

/in , , /by

January 31, 2022

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242

Washington, DC – The National Consumers League is pleased to support the Domain Reform for Unlawful Drug Sellers (DRUGS) Act (HR 6352), which was introduced on January 7, 2022 by U.S. Representatives Bobby L. Rush (D-Ill.) and David B. McKinley, P.E. (R-W.Va.). The Senate equivalent (S. 3399)was introduced by Senators Marco Rubio (R-Fla.) and Amy Klobuchar (D-Minn.). This legislation aims to create a program that holds internet registries and registrars responsible for illegitimate drugs being sold on their online platforms.

“People of all ages have been affected by the sale of illegitimate drugs on the internet. This issue needs a targeted intervention to avoid further harm and death that results from this problem. Requiring online platforms to take action when they are notified of illegal activity on their domains will help to reduce the number of domains selling illegitimate drugs,” said NCL’s Director of Health Policy Jeanette Contreras.

The DRUGS Act would require internet registries to take immediate action when they receive notice from “trusted notifiers” that one of their domain names is being used to sell drugs illegally online. Agencies that are considered “trusted notifiers” include the Food and Drug Administration (FDA), the Department of Justice (DOJ), the Department of Homeland Security (DHS), State Attorneys General, and State Boards of Pharmacy, among others. After receiving a notice, the online platforms would have to suspend the domain from operating, to allow for an investigation before resuming online sales. The domains would have the option to appeal, by providing evidence of lawful operation.  

This legislation is a monumental step in ensuring that online platforms are held accountable for allowing illegal online pharmacies to be created, and shutting down those that already exist and operate. The DRUGS Act is modeled on a successful FDA pilot program, which resulted in the takedown of nearly 30 domain names used to offer illegal opioids online in 2020.

###

About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NEW RESEARCH: CBD companies exploiting academic partnerships for marketing purposes

/in , , , /by

January 20, 2022

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242

Washington, DC—The Journal of Studies on Alcohol and Drugs today released new research that reveals the various tactics cannabidiol (CBD) companies use to thwart the Food and Drug Administration (FDA) review process and assert that their therapeutical claims are backed by science.

The study, The Use of Academic Research in Medical-Cannabis Marketing: A Qualitative and Quantitative Review, illuminates the need for FDA regulatory approval and stronger oversight to address the risks to consumers and patients alike when companies exploit that system. The findings reveal nearly 1,000 health claims touting CBD’s ability to mitigate symptoms or treat mental health, autism, pain, sexual health, AIDS, cancer, COVID-19, and more, providing just a snapshot of the current, unregulated marketing tactics being used to mislead the public.

The research was commissioned by Consumers for Safe CBD, a campaign spearheaded by the National Consumers League and conducted by Data Science Solutions. The research took place in the summer of 2020 and was published today in the Journal.

“It’s important that consumers understand what they’re up against when it comes to the current marketplace,” said Sally Greenberg, Executive Director of the National Consumers League. “Day in and day out we see CBD products promoted by celebrities and ‘health experts’ who have no clue what is truly in the products they push. This research helps give a snapshot of just how many misleading claims are out there and will help consumers better understand how to identify — and know to question — marketing red flags.”

“Unfortunately, many CBD manufacturers talk quite a bit about research, but have rarely engaged in the kind of large-scale randomized controlled trials necessary to establish that a drug is safe and effective,” said Theo Caputi, M.P.H, M.SC. author of the study. “CBD products are flooding the retail marketplace — readily available to consumers — and this review shows a serious need for adequate research and testing to ensure safety of these products and effectiveness for the claims companies are making.”

Most of the top medical marijuana companies analyzed:

  • use the existence of academic partnerships and observational relationships in an effort to legitimize health claims, despite having little to no clinical trial activity;
  • routinely use academic research in marketing strategies (“research as marketing”) to mislead the public; and,
  • evade FDA approval process by creating their own pseudo-approval process, making products appear legitimate, safe, effective, and eligible for insurance coverage for a range of health claims through these “research as marketing” tactics.

“It is alarming to see so many companies purposefully evading the FDA process — the gold standard in consumer protection — and making therapeutic claims with little to no real, clinical evidence,” said Greenberg. “Many of these companies have received warning letters from the FDA, yet these harmful and misleading tactics continue. It’s time for Congress to empower FDA to use its full authority to protect consumers. Consumers for Safe CBD will continue to serve as a watchdog to ensure CBD products are safe and effective.”

The CBD market continues to grow despite the FDA stating that CBD cannot be generally regarded as safe (GRAS) for use in food and beverage products. According to a Statista report, CBD sales in the U.S. reached $4.6 billion in 2020. By 2026, the market is expected to grow to $16 billion. Consumers, through these “research as marketing” tactics, have been led to believe that CBD has both medical benefits and health maintenance effects. However, there is only thorough, scientific-backed proof of medical benefits in the one and only FDA-approved CBD prescription drug product available.

“It is arguably unethical and certainly misleading for commercial entities to use the legitimacy of early scientific research — and the announcement of such endeavors — as a marketing tool,” Caputi added, “In fact, this ‘research’ used — or even simply announced in press releases — is not nearly substantial enough to ensure safety and effectiveness of these products for therapeutic use. We must rely on the rigorous FDA approval process to be sure these products meet the gold standard for safety and efficacy.”

Click HERE to read the full study in the Journal of Studies on Alcohol and Drugs.

To  learn more about the risks of unregulated CBD, visit 4safecbd.org.

###

About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Script Your Future launches eleventh annual student competition for innovations in medication adherence

/in , , /by

January 18, 2022

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242

Washington, DC—Today marks the launch of the eleventh annual Script Your Future Medication Adherence Team Challenge, a two-month-long intercollegiate competition among pharmacy student teams and faculty for creating solutions to raise awareness about medication adherence as a critical public health issue. The Challenge, hosted by the National Consumers League (NCL), is returning to university campuses across the country building on a decade of successful student competition and innovation. 

The Challenge is an integral part of Script Your Future, a campaign launched by NCL and its partners in 2011 to combat the problem of poor medication adherence in the United States, where nearly three out of four patients do not take their medication as directed. In addition to medication adherence, in 2022 teams will counsel patients on vaccine confidence and safe drug disposal. 

Both faculty and student participants from last year’s awarded teams have reflected on their experiences in the Script Your Future program: 

“The Script Your Future Team Challenge was a great way for our pharmacy students to collaborate with other health professional students and positively impact our community by being a part of the COVID-19 response efforts, vaccinating thousands of individuals against COVID-19, addressing vaccine hesitancy, as well as providing patient education regarding medication adherence. We appreciate the opportunity the Challenge offered our students, and we are looking forward to participating again this year!”  

—Lisa Hong, PharmD, Associate Professor, Loma Linda University School of Pharmacy 

“Participating in Script Your Future was a refreshing experience and helped me and my students step outside of our frustration with the COVID-19 pandemic and do something about it. It was wonderful to have the opportunity to work with colleagues and students from other programs toward a single goal. Everyone, especially the students, really stepped up and thought outside the box to achieve the goals of Script Your Future.”  

—Erin Gysbers, PA-C, Didactic Director, Assistant Professor, Loma Linda University 

“I am extremely proud of the efforts of our team to achieve vaccination rates as high as 96 percent in our community. This is just a small testament to what we are all capable of in contributing to keep our communities safe and I am excited for future efforts.”  

—Joseph Velasco, PharmD Class of 2022, Loma Linda University School of Pharmacy  

“The Script Your Future Team Challenge has given me the opportunity to create numerous online resources to help patients with their medication adherence and to increase their COVID-19 vaccine confidence. This experience challenged me to work creatively with our WesternU’s AMCP Research and Education committee to not only create helpful infographics, but to widen the accessibility of these resources through QR codes and a texting service. These electronic tools gave patients improved access to our helpful resources on our very own WesternU AMCP Health Helper website. We also expanded onto social media and physically delivered our resources to pharmacies, local communities, and schools in Pomona, California. Participating in this program has been an experience that will resonate through my future career.” 

—Andrew Pham, PharmD Class of 2024, Western University of Health Sciences College of Pharmacy  

As the nation continues to navigate the COVID-19 pandemic, Script Your Future teams are encouraged to build their campaigns centering around vaccine confidence to help address hesitancy and mitigate further spread of the coronavirus. Teams are encouraged to tailor their outreach towards chronic health issues including cardiovascular disease, hypertension, diabetes, and respiratory illnesses. Challenge administrators also welcome the inclusion of other disease groups that would benefit from medication adherence-related interventions. Teams are also encouraged to integrate messaging on the importance of safe drug disposal. Patient counseling on this topic will help patients to know how to properly and safely dispose of their medications after they are no longer needed.  

Through March 28, inter-professional teams—including student pharmacists, nurses, doctors, and others—will implement creative approaches to outreach in their communities to raise awareness and improve understanding about medication adherence. At the end of the Challenge, teams submit entries for review by national partner organizations, and winners are recognized for their efforts to improve medication adherence. 

Last year, Team Challenge student health professionals were met with unique circumstances, hurdles, and obstacles as they navigated the historic COVID-19 pandemic, which resulted in school closures, event cancelations, and a host of other challenges. In spite of this, more than 5,000 future healthcare professionals and volunteers from 78 participating health professions schools participated. Collectively, the teams directly counseled close to 150,000 patients and vaccinated over 134,000 consumers, nationwide. Since the Team Challenge began in 2011, more than 18,800 future healthcare professionals have participated, reaching nearly 26 million consumers. 

Last year’s national award winner was University of Charleston School of Pharmacy. Other schools winning category-specific honors included: University of the Sciences School of Pharmacy; Loma Linda School of Pharmacy; Howard University College of Pharmacy; Wilkes University Nesbitt School of Pharmacy; University of Pittsburgh School of Pharmacy; and Western University College of Pharmacy. Additional participating schools received finalist and runner-up status across a variety of award categories. 

The Team Challenge is sponsored by the American Pharmacists Association (APhA), the National Association of Chain Drug Stores (NACDS) Foundation, and the National Community Pharmacists Association (NCPA). 

To learn about previous winners, visit Script Your Future’s online home. 

For more information on the Challenge, visit the Team Challenge community website. 

Tweet along with us during the Team Challenge using #SYFchallenge, and follow the campaign @IWillTakeMyMeds. 

###

About National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

About Script Your Future

Script Your Future is a campaign of the National Consumers League (NCL), a private, non-profit membership organization founded in 1899. NCL’s mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information about the Script Your Future campaign, visit ScriptYourFuture.org. For more information on NCL, please visit nclnet.org.

Jeanette Contreras portrait

Reason to celebrate: No more surprise medical bills in the new year!

/in , , /by

By NCL Director of Health Policy Jeanette Contreras

Consumers have grown to expect surprise medical bills as a given in the fragmented U.S. healthcare system. Even people with large employer-sponsored health insurance coverage could expect to receive a surprise bill for an out-of-network medical service. A 2021 report from the U.S. Department of Health and Human Services outlined how more than half of U.S. consumers reported recently receiving an unexpected medical bill — many related to essential services like childbirth, elective surgeries, or emergency services. Thanks to the No Surprises Act, signed into law as part of the Consolidated Appropriations Act of 2021, surprise medical bills will be a thing of the past.

Beginning January 1, 2022, federal protections ban surprise medical bills any time a person receives emergency care, including some non-emergency services. For example, the new law bans out-of-network charges for out-of-network providers who work at an in-network facility. It also requires that cost-sharing for emergency services, like co-pays and co-insurance, be based on in-network rates.

Healthcare providers and facilities will be required to give patients easy-to-understand notice regarding out-of-network care, explaining that it could be more expensive. Providers will also need to tell patients whom to contact if they think the provider or facility has violated the surprise billing protections. Patients will be able to dispute a claim if they receive a medical bill that is higher than the estimated cost given in advance of care.

Whether or not a patient has insurance, they can submit a complaint about a medical billing issue if they have a question or are concerned that their provider may not be following the new rules. For more help, consumers can go to the CMS.gov webpage to submit a claim online or call the No Surprises Help Desk at 1-800-985-3059, 8am-8pm ET seven days a week; (TTY: 800-985-3059).

NCL offers support for Increasing Access to Biosimilars Act (S. 1427)

/in , , , /by

December 16, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242

Washington, DC—The National Consumers League (NCL) is pleased to support the Increasing Access to Biosimilars Act (S. 1427), as introduced by Senators Michael Bennet (D-CO) and John Cornyn (R-TX). This Act directs the U.S. Department of Health and Human Services (HHS) to launch a pilot program that increases Medicare payments for providers who use biosimilars. Representative Tony Cárdenas (D-CA) introduced a similar bill (H.R. 2869) in the House of Representatives.

Since 2014, the growth in pharmaceutical spending has been primarily driven by increased spending on biologic drugs. Biosimilars demonstrate no clinically meaningful differences in terms of safety, purity, and potency against their FDA-approved biologic counterpart, and are generally 15 percent to 35 percent lower in price. Therefore, biosimilars pose great potential to reduce health care costs.

The Increasing Access to Biosimilars Act would create a new pilot program administered by the Center for Medicare & Medicaid Innovation (CMMI) that aims to encourage physicians to prescribe less expensive biosimilars through shared savings. Shared savings is a payment strategy that offers providers a percentage of any net savings generated in order to reduce health care spending overall.

The following statement can be attributed to NCL’s Health Policy Director Jeanette Contreras:

“This legislation would not only broaden access to cost-saving biosimilars and reduce unnecessary spending on costly biologics, but it could also foster greater competition. In addition, it signals to future participants the viability of the biosimilars market, which is a win for consumers.

NCL believes that well-aligned payment incentives can steer providers toward cost-saving behavior with the overall objective of reducing Medicare expenditures. We strongly urge Congress to pass the Increasing Access to Biosimilars Act as the FDA continues to approve new biosimilars to market at increasing rates.”

###

About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Abortion: The continuous fight for reproductive freedoms

/in , /by

By NCL Health Policy Intern Grace Mills

Grace Mills is a DC native, completing her undergraduate education at American University in Washington, DC. Her major is Public Health, with a minor in Spanish language. She will graduate in May 2022.

Women in the United States have been fighting for reproductive rights for decades. Activists like Margaret Sanger and Mary Ware Dennett argued during the early part of the 20th Century that women must be in control of their reproductive choices; the book “The Birth of the Pill” documents their crusade. Officials tried to prevent these two and many others from speaking and publishing about human sexuality, reproduction, and contraception. In the succeeding decades, activists pioneered the right to contraception, the right to abortion, and the right to bear a child.

Several landmark cases are worthy of mention. In Griswold v. Connecticut (1965), the Supreme Court ruled that a state’s ban on the use of contraceptives violated the right to marital privacy. In 1971, in the case of United States v. Vuitch, the Court rejected the claim that a statute permitting abortion only to preserve a woman’s life or health was unconstitutionally vague. It concluded that “health” should be understood to include considerations of psychological as well as physical well-being. The following year, in Eisenstadt v. Baird, the Supreme Court struck down a Massachusetts law limiting the distribution of contraceptives to married couples whose physicians had prescribed them. This decision established the right of unmarried individuals to obtain contraceptives.

In 1973, Roe v. Wade was a challenge to a Texas law prohibiting all but lifesaving abortions. The Supreme Court invalidated the law on the ground that the constitutional right to privacy encompasses a woman’s decision whether or not to terminate her pregnancy. Characterizing this right as “fundamental” to a woman’s “life and future,” the Court held that the state could not interfere with the abortion decision unless it had a compelling reason for regulation. NCL strongly supports the landmark protections in this case, including a woman’s right to control her own reproductive destiny.

Sadly, Roe v. Wade has been under attack from the right since 1973. After the Trump Administration’s Supreme Court appointments, there is a 6-member majority that appears to favor overturning Roe vs. Wade. States will have the right to pass far more restrictive laws than what Roe allowed for constitutionally. There will always be states that protect women’s right to choose and access to abortion, however, the issues lies in women living in states with restrictive laws or lack of money and/or resources to get to an abortion clinic.

This flies in the face of what the public wants. Indeed, a recent Gallup poll show Americans’ support for abortion in all or most cases at 80 percent in May, only slightly higher than in 1975 (76 percent), and the Pew Research Center finds 59 percent of adults believe abortion should be legal, compared to 60 percent in 1995. The share of Americans in Gallup’s poll who say abortion is morally acceptable reached a record high of 47 percent in May, up from a low of 36 percent in 2009, and a Quinnipiac poll found support for abortion being legal in all or most cases reached a near-record high in September with 63 percent support.

Many red states have recently passed some of the most restrictive and punitive abortion laws. In March of 2018, former governor of Mississippi Phil Bryant, signed into law the strictest abortion ban in the country up until that point. The law bans abortion at 15 weeks (about 3 and a half months), even in cases of rape or incest. But a federal district court judge shut the law down, and the U.S. Court of Appeals for the Fifth Circuit backed the court’s decision. This law is what was challenged in the Supreme Court last week.

Perhaps the most extreme is S.B. 8, the Texas law that went into effect on September 1, 2021 that prohibits abortion after “cardiac activity is detectable,” which is usually around the 6-week mark (about 1 and a half months). The law has a vigilante justice component, letting Texans sue anyone they believe is violating the law and/or is involved in an abortion in some way. This includes anyone who provides transportation to the abortion (even an Uber driver could be culpable) or a physician that performs the abortion after 6 weeks. This is the most draconian legislation so far, in part because many women do not even know they are pregnant at just 6 weeks.

S.B. 8 specifically does not allow state officials to enforce the law, authorizing only private citizens to do so, by suing an abortion provider for damages of ten thousand dollars for each procedure performed — what several Justices referred to, during oral arguments on November 1st, as a “bounty.” The Supreme Court will likely have the chance to review a challenge to the constitutionality of this law, but that’s a few years away and until then, the law remains in force.

NCL strongly supports women’s access to reproductive, abortion and maternal care. We understand that lack of access is directly related to a wide range of health disparities in the United States. It is no surprise that people of color in the United States have less access to the care they need and have more health complications. This is true for reproductive care and family planning. Black and Hispanic women have much higher abortion rates than white women largely directly related to a higher rate of unintended pregnancy.

These facts raise the question about what more can be done to provide women of color better maternal care and family planning resources. We need to reverse the pattern of inequality. NCL supports funding for sex education, full access to maternal care, and family planning to provide women with services, information and resources necessary to make informed decisions about their reproductive health and prevent any unnecessary health risks.

The tenuous hold we have on the right to abortion in every state, with the Mississippi law likely to get the thumbs up from the anti-choice Supreme Court, puts all women at risk. The Texas law is that much more draconian. We lament these attacks on women’s access to health care — especially poor women — that these restrictive abortion laws represent. Lastly, making abortions a crime won’t stop them from happening, it will only drive abortion back into the back alley and make it once again, a dangerous procedure that puts women’s health and safety at risk.

Jeanette Contreras portrait

Listen up: FDA’s proposed OTC hearing aid rule

/in , , /by

By NCL Director of Health Policy Jeanette Contreras

Whether it be listening to your grandchildren share a story or having dinner with a friend, many consumers rely on devices to help them hear and understand speech every day. Hearing loss is something that we need to be mindful of at all ages, and as consumers, we look to our nation’s regulators to make sure these devices are safe to use.

Some people with hearing loss are able to work closely with hearing care professionals to finely adjust their hearing aids at sound levels that enable them to hear speech at comfortable levels without causing any harm. But, as more Americans struggle with their hearing, accessible hearing aids becomes increasingly important. Proposed regulations by the Food and Drug Administration will allow hearing aids to be sold over-the-counter to adults with mild-to-moderate hearing loss, a step forward in making them more affordable and accessible.

While these regulations are positive for access, the FDA’s proposed thresholds for volume or output for over-the-counter hearing devices are more in line with those for earbuds people use to listen to music for short periods than they are for hearing aids that are worn for several hours a day. These draft rules would allow a maximum sound output level of between 115 and 120 dBA, which is the equivalent to the volume of a chain saw. According to the CDC, exposure of sounds at 120 dB could become dangerous in as little as nine seconds. As you can imagine, being exposed to this level of sound for long periods of time is unsafe and could increase hearing loss and significantly damage the ear.

Hence, there is widespread concern among hearing care professionals that allowing an unnecessarily high level of amplification can lead to further hearing loss. Leading hearing care associations recommend a maximum output limit of 110 dBA for OTC hearing aids and establishing a gain limit of 25 dB.

As the leading consumer healthcare organization, we applaud the FDA’s efforts to increase access to hearing aids for those who need them. We do hope that the FDA will adjust its proposal, so it is in line with the recommendations of hearing care professionals before finalizing the regulations. Consumers shouldn’t be concerned that they may find their situation worsened by devices that are intended to help.

To learn more about gain and output and how to protect yourself from hearing loss, check out our new infographic.