NCL Briefing: measuring the 340B program’s impact on charitable care and operating profits for covered entities

Join the National Consumers League for a panel discussion with experts from Health Capital Group, the Community Oncology Alliance, and Johns Hopkins on this new white paper, which analyzes 340B’s impact on hospital profit margins and charitable care spending and attempts to quantify the amount of program benefits accruing to covered entities, contract pharmacies and patients.

NCL leads effort to encourage FDA to adopt safer standards for OTC hearing aids

March 10, 2022 

Media Contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Katie Brown, katie@nclnet.org, (202) 207-2832 

Washington, DC – Today, National Consumers League (NCL), along with 29 not-for-profit, public health organizations from across the country, sent a letter to the U.S. Food and Drug Administration (FDA) regarding the agency’s ongoing process to establish regulations that will soon allow hearing aids intended for adults with perceived mild to moderate hearing loss to be sold over-the-counter (OTC) without any involvement of a medical professional. As the FDA finishes developing its final OTC hearing aid regulation, we urge the agency to include stronger measures to better protect consumers affected by this new category of medical devices.  

We applaud the FDA for its efforts to provide increased access and affordability through the creation of this new category of hearing aids. At the same time, the FDA must ensure these devices are safe, particularly given that many consumers will purchase OTC hearing aids without knowing their clinical level of hearing loss and not having any support from a medical professional. In addition to hearing loss, many OTC hearing aid users may also have other medical challenges impeding their ability to recognize and/or react to loud or uncomfortable sounds produced by these hearing aids. Under such circumstances, the need to ensure OTC hearing aids fulfill their intended purpose without risking unintended harm cannot be understated. 

The letter states: “To ensure the safety of consumers, we believe the FDA should implement the recommendations of the nation’s leading associations of hearing care professionals, including the American Academy of Otolaryngology-Head and Neck Surgery, American Academy of Audiology, American Speech-Language-Hearing Association, and International Hearing Society. These associations are urging the FDA to lower the maximum sound output to 110 decibels and establish an amplification (or gain) limit of 25 decibels. These associations, as well as respected entities like the World Health Organization and the Centers for Disease Control and Prevention, have made clear that allowing sounds to enter the ears of consumers at the proposed levels can cause serious and permanent hearing damage within mere seconds.” 

Importantly, these recommendations will not have any impact on the FDA’s goal of providing increased access to affordable hearing devices, compromise the effectiveness of OTC hearing aids, or discourage innovation—they will only make them sufficiently safe for consumers with mild to moderate hearing loss.  

Read the full letter HERE. Learn more about the issue here: OTC Hearing Aids- Gain and Output 

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About the National Consumers League (NCL) 

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

 

Talk before you take: The importance of doctor-patient communication before starting a new medication – National Consumers League

92_kamay.jpgWe’ve all been there. Sitting alone in a cold doctor’s office, listening to a re-run of the Dr. Oz show while waiting for your doctor to come back in the room with a diagnosis and prescription in hand. You can’t wait to leave and get back on the path to wellness. And who could blame you? No one likes to wait—especially when you don’t feel healthy. The doctor comes back, hands you your prescription, and gives you a brief overview about what the medication is and the appropriate dosage. But, what happens next is critical. Do you hop off that cold, uncomfortable patient bed and go on your merry way, or do you ask questions? Specifically, questions pertaining to the risks associated with this prescription medication.

While in recent years, the communication gap between healthcare providers and patients has been met with a fair share of commentary, critique, scholarly review and analysis, we are slowly making progress, thanks in part to numerous campaigns and educational initiatives. Recently, the National Council on Patient Information and Education (NCPIE), a non-profit organization, launched a campaign to help bridge the communication gap with Talk Before You Take.

Launched earlier this year, Talk Before You Take highlights the importance of communicating with your healthcare provider about the benefits and risks of prescribed medications before a prescription is written and filled. The specific aims of the Talk Before You Take are to:

  • Understand medication side effects
  • Avoid adverse drug reactions
  • Improve adherence to medicine regimen(s)
  • Live healthier lives

Here are four tips to help guide your conversation with your healthcare provider about prescription medicines:

  • 1. Talk to your healthcare provider and ask questions about the benefits and potential risks of prescription medicines you take.
  • 2. Tell your healthcare provider about all of the medicines you are taking—including over-the-counter medicines, vitamins, and dietary supplements.
  • 3. Tell your healthcare provider about any allergies or sensitivities that you may have.
  • 4. Read and follow the medicine label and directions.

And remember, even if you get home and realize that you still have questions about your prescription medications; it’s not too late. Don’t hesitate to pick up the phone and call your healthcare provider. Because when it comes to your health, there are no silly questions.