NCL is proud to present longtime ally and consumer advocate FCC Commissioner Jessica Rosenworcel with a 2020 Trumpeter Award. Jessica was named as one of POLITICO’s 50 Politicos to Watch and profiled by InStyle Magazine in a series celebrating “women who show up, speak up and get things done.” We couldn’t agree more.

Read on to learn more about what makes her a formidable consumer advocate.

Jessica brings more than two decades of communications policy experience and public service to the FCC. Prior to joining the Commission, she served as Senior Communications Counsel for the United States Senate Committee on Commerce, Science, and Transportation, under the leadership of Sen. John D. Rockefeller IV and Sen. Daniel Inouye. Before entering public service, Jessica practiced communications law in Washington, DC.

Jessica is a native of Hartford, Connecticut. She is a graduate of Wesleyan University and New York University School of Law. She lives in Washington, DC with her husband Mark, and children Caroline and Emmett.

We enjoyed sitting down with her recently for a Q&A.

NCL: What is your top contribution to consumer advocacy?

Jessica: I believe the future belongs to the connected. Everyone needs modern communications to have a fair shot at 21^st Century success. That is why protecting an open Internet, closing the “Homework Gap” for students, and promoting greater opportunity, accessibility, and affordability in our communications services have been top priorities.

NCL: What advice do you have for consumers specifically relating to the circumstances of the COVID-19 pandemic?  

Jessica: The coronavirus pandemic has brought new attention to the digital divide as work, education, healthcare, and more have migrated online. There may have been a time when broadband access was considered nice-to-have, but it’s become absolutely need-to-have in this crisis. It’s essential to maintain some semblance of normal life.

So I have pushed my agency, the FCC, to do more to get consumers online and keep them connected during this crisis. Unfortunately, for far too many, these connections remain out of reach. To take just one example, this pandemic has been especially cruel to millions of students caught in the Homework Gap who have been told to go online for school but who lack the Internet access at home required to make it to the remote classroom. This is an issue that I have championed for years, because it affects both rural and urban America and needs to be addressed if we want to ensure that going forward every community has access to the opportunities of the digital age. Now more than ever, it’s time that policymakers modernize their thinking to ensure that no child is left offline.

NCL: How did you get involved with consumer advocacy?  

Jessica: I like to think that a commitment to public service runs in my family. My father served in the Air Force, later going on to a career as a nephrologist in Hartford. For three decades, he also ran the city clinic for hypertension and kidney failure. My mother has spent more than two decades helping run a soup kitchen in Hartford. And my grandfather before them served in the United States Customs Service in Washington. My great grandfather before that served the public in a different way: he swept the streets of New York. So it is a great honor to serve as a Commissioner on the Federal Communications Commission and to continue a family tradition of service to community and country.

To learn more about Commissioner Rosenworcel, join us on October 6, 2020, for NCL’s annual Trumpeter Awards Program, where we will honor exceptional leaders with distinguished records advocating for consumer and worker rights.

Support NCL with a Trumpeter sponsorship today and help protect, educate, and advocate for tomorrow’s consumers and workers. Your generosity allows NCL to continue to take a stand for the everyday consumer.

And join the conversation about Trumpeter on social media using the hashtag #Trumpeter20.

For more information about sponsorship, contact NCL’s Molly Harman at mollyh@nclnet.org.

 

You likely already know Vicky Nguyen from her reporting on The TODAY Show on NBC, but do you know the variety of consumer issues Vicky has helped bring to light? Vicky is a voice for all consumers, and NCL is proud to present her with a 2020 Trumpeter Award this fall.

Read on to learn more about Vicky and what makes her a formidable consumer advocate. 

Vicky Nguyen is the investigative and consumer correspondent for NBC News, where her stories appear on TODAY, Nightly News with Lester Holt, MSNBC, and News Now. Her national award-winning work has led to multiple state and federal investigations. From food safety to 911 policies at the USPS, Vicky’s work has prompted changes that have improved American lives. Nguyen has received numerous awards for her reporting, including a National Emmy, the Gerald Loeb Award for Business and Financial Journalism, and the duPont Columbia Award for Broadcast Journalism. She graduated as valedictorian from the University of San Francisco. She’s learning to navigate life in New York with her husband and their three daughters. 

 

NCL: What does consumer advocacy mean to you?  

Vicky: Consumer advocacy means working on behalf of the consumer. Giving them unbiased and evidence based information that’s pressure tested. We are all consumers in some way, and we all want the freedom to make choices about what’s best for ourselves and our families. To be a consumer advocate means working to ensure that products and services marketed to everyday Americans do what they say they will do, function safely, and don’t take advantage of consumers’ goodwill and hard earned money.

 

NCL: What do you see as the biggest challenges facing consumers currently?    

Vicky: The biggest challenge facing consumers has to do with misinformation. How can they spot real news from fake news? Right now the FDA has put out a warning about more than 75 brands of hand sanitizer that contain dangerous levels of methanol, a chemical that can cause burns and blindness, even death if ingested. The CDC is advising Americans to cover their noses and mouths to prevent the spread of COVID-19. But conspiracy theories, false information, and trolls manage to spread quickly on social media platforms, which causes confusion and in some cases, causes people to do things like ingest bleach.

I think it’s hard for consumers to find information they can trust, that is non-partisan, that’s based on facts and evidence, that’s impartial and transparent. My goal is to continue providing credible reporting, and to hold government agencies accountable for their role in protecting consumers. Whether it’s the FDA, FTC, CPSC, or other groups tasked with setting policies or enforcing regulations, journalists must not hesitate to spotlight when those entities are failing consumers. To do so consistently will help us all combat misinformation and give consumers a reliable source of information to make decisions. 

 

NCL: What do you see as your top contributions to consumer advocacy?   

Vicky: As a consumer and investigative journalist, I’m focused on issues that help consumers live healthier, safer, smarter, and wealthier lives. Right now the pandemic has put a spotlight on how to prevent the spread of COVID-19 and protect your family. My contributions come from practical news reports that offer real-life examples, smart tips, and useful information. From how to make, buy and wear masks to the best way to navigate those dental and doctor visits, we’re reporting stories two to three times a week that answer the questions on everyone’s minds: How can schools safely re-open? Is takeout food safe to order? Can we hug grandma?

As we learn more about the novel coronavirus, our reporting is also evolving to help people navigate this new normal and keep themselves mentally and physically healthy. 

Join us on October 6, 2020, for NCL’s annual Trumpeter Awards Program, where we will honor Vicky and other exceptional leaders with distinguished records advocating for consumer and worker rights. 

Support NCL with a Trumpeter sponsorship today and help protect, educate, and advocate for tomorrow’s consumers and workers. Your generosity allows NCL to continue to take a stand for the everyday consumer.

For more information about sponsorship, contact NCL’s Molly Harman at mollyh@nclnet.org.

Join the conversation about Trumpeter on social media at #Trumpeter20

Health Advisory Council June 2020 Member Meeting Summary

On June 19, NCL hosted the Sixth Annual Spring Membership Meeting of its Health Advisory Council—and for the first time in the Council’s history, the meeting was conducted entirely remotely, due to restrictions on gatherings and social distancing.

In light of the COVID-19 pandemic, NCL devoted the program to discussions with experts from the political, public health, and frontline perspectives to gather insights into their experiences of navigating the COVID-19 pandemic. The objective of the panel was to use these combined perspectives to determine what’s needed to create the blueprint for the containment and eradication of COVID-19. 

The program featured an interview (pictured above) with NCL Executive Director, Sally Greenberg, and Representative Jan Schakowsky (D-IL), followed by a panel discussion with Lori Freeman, Executive Director of the National Association of County and City Health Officials (NACCHO), Lisa Stand, Senior Policy Advisor at the American Nurses Association, and Dr. Martha Dawson, President of the National Black Nurses Association.

NCL in conversation with Representative Jan Schakowsky (D-IL)

Prior to our June 19 meeting, NCL Executive Director, Sally Greenberg, sat down with Congresswoman Jan Schakowsky (D-IL) to discuss how COVID-19 has impacted her state and its respective relief efforts. Congresswoman Schakowsky expressed her concerns regarding the void in federal leadership in the COVID-19 response and burden that inaction has placed on frontline essential workers. The Congresswoman also emphasized various provisions that are proposed in upcoming COVID-19 relief packages, like the HEROES Act and implored Republicans to mobilize and join their colleagues in support of the legislation. Representative Schakowsky emphasized that the HEROES Act will include the following protections for consumers:

• $200B in hazard pay funding for essential workers
• Funding for teachers and state municipalities
• $75B for testing, tracing, and treatment
• Another stimulus payment for consumers ($1,200)

Congresswoman Schakowsky also urged that the only way we could encourage change and support for the legislation is if state legislators speak up about the necessity of the passage of the bill. Per Representative Schakowsky, lawmakers and citizens alike will need to galvanize to express the need for funding and protections that will be provided by the HEROES Act.

To view a recording of Sally’s interview with Rep. Schakowsky (D-IL), please click here. 

 

Panel: COVID-19 — A Blueprint for the Containment and Eradication of the Virus

Lori Freeman, MBA, Executive Director of the National Association for County and City Health Officials (NACCHO)

Lori Freeman provided our audience with a deeper understanding regarding the plight of local health departments, a sector of the healthcare system that has been hit hardest, in navigating the pandemic. Lori stated that the biggest challenges local health departments face during this pandemic is reduced workforce over the past decade, resulting in a deficit in the COVID-19 response. To address this concern, NACCHO has been in conversation with Congress to make the case for sustainable, long-term infrastructure, advocating for hazard pay, and addressing social, non-medical determinants that are impacting health care.

When asked about testing, contact tracing, and isolation, Lori stated that isolation is extremely complicated and that it must be addressed at the community level rather than at the state level. The power of the community has to be behind the actions in order to foster sustainable impact in COVID-19 related public health precautions. Lori also shared disturbing news of public health employees being targeted by skeptics of the virus, simply for trying to protect their communities, and lamented over the fact that health related issues have become politicized.

 

Lisa Stand, JD, Senior Policy Advisor at the American Nurses Association (ANA)

Lisa Stand spoke to the needs of frontline workers during the pandemic. As an organization that represents over 4 million nurses nationwide, the American Nurses Association’s (ANA) response to the pandemic has entailed reacting and responding to members and mobilizing to provide information through webinars on issues ranging from Personal Protective Equipment (PPE), ventilators, and self-care resources. Lisa argued that the best way to keep nurses safe is for the public to do all it can to prevent transmission. ANA supports all currently implemented public health measures but requests the prioritization of testing for frontline and essential workers. Lisa also suggested that there is a great need for a targeted approach for economic security for frontline healthcare workers (especially if they get sick), and there is currently a lack of data regarding this.  

 

Martha Dawson, DNP, President of the National Black Nurses Association (NBNA)

Dr. Dawson brought with her the unique and layered perspective of both frontline workers and communities of color response to the pandemic. The National Black Nurses Association (NBNA) represents the interests of over 300,000 Black nurses. During this time, NBNA has educated their membership about the virus, issued primers and Op-Eds, hosted town hall meetings, and encouraged their members to lobby their representatives regarding the lack of resources available to frontline workers during the pandemic.

Similar to Representative Schakowsky, Dr. Dawson argued that there is a lack of leadership at the federal level, which has exacerbated response efforts on the local level. NBNA has tried to fill those voids by extending their community presence and providing necessary services to frontline nurses. Dr. Dawson expressed that the pandemic revealed latent inequities regarding how communities of color access health care, stating that this is a very difficult time for the Black community, as COVID-19 has disproportionately impacted communities of color, with greater consequences for Black patients. Dr. Dawson advised against the premature reopening of states, stating that it is not safe and will only place undue burden on frontline workers and vulnerable communities.  

The panel discussion was followed by a question and answer session with the audience, where members asked our panelists for their views on the furlough of nurses, isolation of older adults, general concerns regarding testing.

To view a recording of the panel discussion and audience Q&A, please click here.

NCL health policy at work

ICYMI: Fifth Annual Winter Membership Meeting

On December 6, NCL hosted the Fifth Annual Winter Membership Meeting of its Health Advisory Council. In light of the growing opioid epidemic, NCL devoted this meeting to exploring innovative and progressive physician prescribing practices and safe opioid disposal. The meeting featured a presentation by Rachel Uzlik CPHQ, Vice President of Clinical Services at Twin Cities Orthopedics (TCO). The presentation highlighted the significance of patient and provider communication regarding expectations of pain levels post-op, risks of opioid usage, and alternatives forms of pain management.

Uzlik shared data demonstrating TCO’s multi-year efforts in reducing opioid reliance by revising their orthopedic practice’s opioid prescription guidelines. She shared that there was initial reluctance by the physicians in the practice who feared reducing opioid prescriptions might negatively impact patient satisfaction. But through careful consumer education and tracking of pain, their study showed that patient satisfaction did not change despite significantly fewer opioids being prescribed.

Click here for a summary of the Rachel Uzlik’s remarks.

 

CBD labeling and consumer implications

NCL, in partnership with Consumer Federation of America and the Community Anti-Drug Coalition of America (CADCA), launched Consumers for Safe CBD on November 19, 2019. The campaign educates consumers about the potential dangers of unregulated CBD products on the consumer marketplace and urges FDA to act to better regulated CBD, including setting safe use level.

A new website at www.4safeCBD.org was launched with extensive consumer information. As part of the launch, NCL released a new national survey of voters, that showed 83 percent supported FDA regulation of CBD products. The launch was well-received by the media. Sally gave over 20 television interviews and Patricia conducted 8 radio interviews across the country. The announcement of the coalition also appeared in print and social media. Sally presented the survey findings at a Congressional Briefing on CBD on December 6, 2019, and at a CBD Summit on January 15.

 

Policy spotlight: CBD summit recap

NCL’s Sally Greenberg (pictured at right) participated in a panel discussion moderated by Aimed Alliance’s Stacey Worthy on “Reflections from Consumers, Patients and Healthcare Providers,” and shared important data on the many risks related to CBD products and the need for FDA action to protect consumers. What ultimately sets this issue apart from many other debates—and makes it frightening—is not the lack of public education on CBD, but rather a lack of accurate public education. Many consumers claim to “know” that CBD has a positive effect on serious medical issues, and incorrectly assume that what’s available at their local supermarket or CVS is safe for consumption. This is particularly startling given that, according to one speaker, some recent tests of CBD products uncovered higher levels of lead than found in residents’ homes in Flint, Michigan. Keynote speaker, Congressman Andy Harris (R-MD), partly in jest, described the current situation as a “delay of game.” Marketing is moving ahead, research is not, and FDA has yet to define the rules.

 

Script Your Future Medication Adherence Team Challenge

On January 20, NCL launched the 2020 Script Your Future Medication Adherence Team Challenge. The Team Challenge in an interprofessional public health competition that convenes students of pharmacy and other schools of health professions to raise awareness about poor medication adherence.

Student health professionals from 34 schools across 16 states will compete until March 20 to conduct outreach in their communities to address nonadherence as a critical public health issue. NCL has restructured the Team Challenge’s award structure to incentivize the use of personal technology to encourage medication adherence, via a new Technology Innovation Focused Award. And Teams are also being asked to include Vaccine education in their outreach efforts (read more below).

Since the Challenge began in 2011, more than 18,800 future health care professionals have directly counseled nearly 78,000 patients and reached more than 26 million consumers about the importance of medication adherence. Stay tuned to learn of the 2020 Team Challenge winners this May.

SPECIAL REQUEST: If you are interested in being a reviewer of Team applications to help determine the winners of this year’s Challenge, please reach out to Nissa Shaffi at nissas@nclnet.org. We’ll ask you to spend a few hours in April to review applications for the awards.

 

Counterfeit drugs consumer education campaign

On December 5, NCL launched FakeRX, building on NCL’s successful Fraud.org website. This new online action center serves as an ongoing resource to help consumers avoid fraudulent online pharmacies and give them tools to report any suspicious medications to authorities. Please contact Nissa Shaffi at nissas@nclnet.org for information about how your organization can help spread the word about this resource-rich platform to educate consumers on making smart decisions. This project was made possible by our generous funders (Allergan, Eli Lilly, Gilead, Pfizer, PhRMA, and Celgene) and content was developed in close collaboration with FDA MedWatch.

 

Vaccine advocacy 

NCL continues to promote the importance of vaccines to protect consumers’ health. For the Script Your Future Medication Adherence Team Challenge, NCL is encouraging teams to include messaging regarding vaccine adherence, including vaccines across the lifespan and completion of series, throughout their community outreach. NCL has consulted with officials from CDC’s National Center for Immunization and Respiratory Disease division to curate messaging for student health professionals to use in communicating with the general public.

In November 2019, NCL participated in a tweetstorm with the Adult Vaccine Action Coalition (AVAC), encouraging the public to get their flu vaccine during the holiday season. The tweetstorm contained resources, as well as emphasized the negative impact that the flu can have on families and the general public.

 

Surprise billing

NCL continues to advocate for Congressional legislation that will offer consumer protection from surprise bills – those charges billed to a consumer when the insured individual inadvertently receives care from an out-of-network provider. In collaboration with other consumer organizations through the No Surprises: People Against Unfair Medical Bills coalition, NCL has been keeping up the pressure on Congress to pass this important bill this year. 

In October, NCL participated in two health care leadership roundtables in response to the Trump Administration’s executive order to increase price transparency. Patricia Kelmar, NCL’s Director of Health Policy, presented at both the Healthcare Leadership Council and the United Healthcare Executive Roundtable, and continues to work with HLC to represent consumer priorities in price transparency.

 

Air ambulances and overcharges

Patricia attended the meeting of the Air Ambulance and Patient Billing Advisory Committee (AAPB Advisory Committee) on January 15 and 16. This 13-member committee is tasked with making recommendations “to improve the disclosure of charges and fees for air medical services, better inform consumers of insurance options for such services, and protect consumers from balance billing.” In preparation for the committee meeting, Patricia has met with Altarum, American Heart Association, Families USA, AHIP, CEPR (Center for Economic Policy Research) and the National Association of Insurance Commissioners as well as representatives of the for-profit air ambulance industry to discuss consumer priorities.

 

CDC PROTECT

In November, NCL participated in the 12^th annual CDC Prevention of Overdoses and Treatment Errors in Children (PROTECT) Taskforce meeting in Atlanta (photo at right). NCL represented the consumer voice in the diverse stakeholder meeting of researchers, pharmaceutical manufacturers, and patient and provider groups. Meeting attendees discussed innovations in child-resistant packaging for OTC medications, as well as action items for pediatric medication safety.

 

 

The Alliance for Aging Research

The Alliance for Aging Research and the Eldercare Locator released a new fact sheet that highlights the importance of staying safe at home during the coronavirus crisis. The resource details how patients, caregivers, and their loved ones can safe and healthy during this public health emergency. The fact sheet is available to download here. The Alliance and National Foundation for Infectious Diseases jointly developed and released a resource that addresses commonly asked questions and answers related to the coronavirus. The resource titled, “Common Questions and Answers About COVID-19 For Older Adults and People With Chronic Health Conditions”, is available to download here.

There are more than 600 Area Agencies on Aging around the U.S. that provide home and community-based volunteer services for older adults. Due to the COVID-19 crisis, many requests for volunteer services have increased since older adults are staying home to protect themselves. Many of the volunteers that provide these services are older adults themselves, so the drop off in volunteers has been significant. 

To help address the gap in services, the Alliance for Aging Research is currently working with the National Association of Area Agencies on Aging to connect potential volunteers and area agencies to assist older adults and individuals with disabilities with meal prep/delivery, check-in calls and grocery assistance amid the COVID-19 crisis. If you are interested in volunteering, or would like to circulate this opportunity, see below for more details.

In need of volunteers for older adult assistance amid COVID-19 pandemic

There are more than 600 area agencies on aging around the U.S. that provide home and community-based services for older adults. Requests for important volunteer services have increased since older adults are staying home to protect themselves, including:

• delivery
• check-in calls, and
• grocery assistance

Many of the volunteers that typically provide these services are older adults themselves, so the drop off in volunteers has been significant. The Alliance for Aging Research is connecting potential volunteers with local agencies through the National Association of Area Agencies on Aging.

To volunteer, a previous basic background check is required, along with a kind heart and time to help. If you are interested in volunteering to assist older adults in your region, this is what we need from you:

• Services from the list above that you would like to provide
• Name, Email, and Location (city/town and state)

Please reach out to Kelsey Allcorn at kallcorn@agingresearch.org directly if you are interested, as soon as possible. Thank you!

 

AMAG Pharmaceuticals, Inc.

AMAG has worked closely with key opinion leaders to increase education for two of its products – Intrarosa and Vyleesi – and is grateful for their efforts to share data with the scientific community. Highlights of recent publications include “Instruments for Screening, Diagnosis, and Management of Acquired HSDD,” published in the Journal of Women’s Health, which examines screening and diagnostic tools available for the assessment of hypoactive sexual desire disorder. A second manuscript, “Hypoactive sexual desire disorder (HSDD) is not “female erectile dysfunction (ED)”: challenges with the characterization of HSDD in women based on a systematic literature review,” was published in Current Medical Research and Opinion and the abstract, “Effect of Bremelanotide on Ambulatory Blood Pressure When Administered for Up to 16 Consecutive Days,” is featured in the May issue of Obstetrics & Gynecology. A new animated educational video, designed to help providers better understand the underlying etiology of HSDD, was also recognized as a 2020 Muse Creative Award gold winner. Additionally, at the American Urological Association’s virtual annual meeting, the abstract “Prevalence of Urinary Tract Infections in Women with Genitourinary Syndrome of Menopause and the Impact of Vaginal Prasterone on the Rate of Urinary Tract Infections,” was featured. The on-demand poster and accompanying voice recording can be accessed here.

 

American Society of Health-System Pharmacists (ASHP) — COVID-19 Resource Center

ASHP is committed to supporting our members, as well as their healthcare team colleagues and patients, in response to the COVID-19 pandemic and is regularly communicating updates on this crisis. We have opened access to our evidence-based online resources and tools on ashp.org, making them widely available to all pharmacists and healthcare professionals, and our COVID-19 Resource Center is updated frequently and includes ASHP’s Evidence Table for COVID-19 treatments as well as our advocacy communications. ASHP has also launched a new COVID-19 Community on Connect, which serves as a forum for any healthcare providers to ask questions, share experiences, post resources, and more.

 

BeMedWise

During the early weeks of the COVID-19 Coronavirus pandemic, BeMedWise.org saw a significant increase in visitors seeking information about the safety of NSAIDS (such as ibuprofen) for treating worsening COVID-19-like symptoms. To help consumers and patients better understand safe and appropriate OTC use (acetaminophen and NSAIDs) if they are experiencing mild cold or flu-like symptoms, the BeMedWise Program at NeedyMeds developed a website page – Pandemic tips for treating mild symptoms with OTC‘s, and resource links from key BeMedWise stakeholders, including the FDA’s public health communication stating “At this time, FDA is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms.” BeMedWise disseminated this information with a social media toolkit to the BeMedWise Supporters and Partners. BeMedWise also developed an informational web page on Hydroxychloroquine.

The NeedyMeds’ Research Department has put together a one-stop COVID-19 Resource Center to help those experiencing financial hardships and struggling with healthcare expenses due to the COVID-19 coronavirus. If your organization or company offers a resource that offers medical assistance, please send that information to COVID-19 Resources so that we can add it to the NeedyMeds COVID-19 Resource Center.

To learn more about our initiatives including opportunities to collaborate on webinars, educational program development and the 35^th Annual Talk About Your Medicines Month (TAYMM) in October, contact Deborah.Davidson@needymeds.org. The TAYMM theme for 2020 is Medication Adherence. Read the latest NeedyMeds blogs including: Acetaminophen Facts and Safety Information.

 

CDC PROTECT | Centers for Disease Control and Prevention (CDC)

PROTECT partners, Drs. Dan Budnitz and Preeti N. Malani, recently co-authored a JAMA Patient Page on safe medicine storage. Each year, approximately 50,000 children younger than 6 years are brought to emergency departments after unintentionally taking medicine when a caregiver was not watching. It is always important to be attentive to keeping medicine safely stored away from children, especially as families are currently spending more time at home together due to COVID-19.

The Up and Away campaign also promoted ways to keep children safe around medicine in the home during a March 2020 Poison Prevention Week rally. This year’s strategy centered around: highlighting new research from the Journal of Pediatrics about accidental ingestions; engaging a celebrity voice through a video featuring Miss America 2020, Camille Schrier; and conducting a radio media tour with campaign spokesperson Dr. Kathleen Wilson, a member of the American Association of Nurse Practitioners. Overall, the rally garnered over one million impressions.

 

Consumer Healthcare Products Association (CHPA)

Educational Foundation amplifies medicine safety education during COVID-19

In April, the CHPA Educational Foundation launched a COVID-19 FAQ page on KnowYourOTCs.org to provide answers to some of the most common questions consumers have regarding the pandemic, while also reiterating our safety messages related to safe use, storage, and disposal.

To promote the page, we developed a short, animated video identifying the types of OTC products to have on hand during the pandemic, including fever-reducers and cough medicines. To date, we have seen about 2,500 visits to the page and we continue to update the FAQ with information in real-time.

In addition, with families sheltering in place, schools and daycare centers closed, and parents multi-tasking, the risks of accidental medicine ingestions have increased. Thanks to a generous donation from Johnson & Johnson, we are amplifying education for the Up and Away campaign to promote safe medicine storage nationwide and protect young children. We are currently promoting our highest impact content through a paid media buy, targeting both English and Spanish-speaking families across the nation on Facebook and Instagram. To date, the targeted buy has garnered more than 1 million video completions.

 

Food and Drug Administration (FDA): Center for Drug Evaluation and Research

Janet Woodcock on Twitter

Janet Woodcock, Director, Center for Drug Evaluation and Research, communicated on the Twitter platform in March. She goes by @DrWoodcockFDA on Twitter.

COVID hand sanitizer initiative and kids accidentally drinking hand sanitizer

The agency has issued three guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020. These include a policy for compounding of certain alcohol-based hand sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities, as well as manufacturing firms.

As a result of the agency’s significant flexibility, more than 1,500 additional manufacturers have registered with the agency to produce hand sanitizer (as of April 27, 2020). The addition of denaturants to alcohol is necessary to render the product more bitter and less appealing to ingest, particularly for young children. This is important to ensure the safety of FDA-regulated products for consumer use. More information about safety concerns can be found here.

Insulin switching to BLA March 23, 2020

Insulin, pancreatic enzymes, and several other protein products had their applications transitioned from new drug applications (NDAs) to biologic license applications (BLAs) on March 23, 2020. These drug products are considered biological products that had to be transitioned to the BLA pathway due to the “Deemed to be a License” provision of the Biologics Price Competition and Innovation Act of 2009. Given the complexity of protein molecules and limitations of current analytical methods, it may be difficult for manufacturers of proposed protein products to demonstrate that the active ingredient in their proposed product is the same as the active ingredient in an already approved product through the ANDA pathway. With the switch to BLAs, sponsors can now seek approval of products that are biosimilar to, or interchangeable with, these transitioned products. More information about the transition and provision can be found here.

Nitrosamines in OTC ranitidine/nizatidine and product removal

Recalls due to the presence of nitrosamines in ranitidine products have been occurring over the last several months. On April 1, 2020, however, the FDA requested for all sponsors to voluntarily remove all ranitidine products from the market. The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S. Some nizatidine products have also been recalled, although a market withdrawal has not yet been requested from the FDA. More information about recalls, market withdrawals, and safety alerts can be found here.

Rx-to-OTC Switch

 Thus far in 2020, three products completed Rx-to-OTC Switch:

1. Voltaren Arthritis Pain (diclofenac sodium), a topical gel
2. Pataday Twice Daily Relief (olopatadine hydrochloride, 0.1%), and
3. Pataday Once Daily Relief (olopatadine hydrochloride, 0.2%). Eye drops for temporary relief of itchy eyes due to certain allergens. More information about products that have completed Rx-to-OTC Switch can be found here.

 

FDA Office of Women’s Health (OWH)

On November 26, 2019, the Office of Women’s Health (OWH) announced the selection of Kaveeta Vasisht MD, PharmD, as the Associate Commissioner for Women’s Health. Dr. Vasisht joined OWH in early 2019 and initially served as the Acting Associate Commissioner and Deputy Director. Under her leadership, OWH has worked to advance the health of women through scientific programs, policy development, research and outreach that incorporates an understanding of sex differences.

Dr. Vasisht is board certified in both internal medicine and adult endocrinology and holds a Doctor of Pharmacy degree. She received her training in internal medicine and adult endocrinology, diabetes, and metabolism at The University of Chicago Hospitals. She has also completed a hospital pharmacy practice residency. Dr. Vasisht obtained her medical degree from the University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School. Prior to joining OWH, Dr. Vasisht served as the Deputy Director for the Division of Clinical Trial Quality in the Office of Medical Policy, FDA Center for Drug Evaluation and Research (CDER). She began her career at the FDA as a medical reviewer in CDER’s Division of Metabolism and Endocrine Products. She combines her patient care, regulatory review, and policy experience to promote and protect the health of women.

Additionally, this past February, OWH recognized American Heart Month with the launch of a new heart health educational video. This educational video is part of the office’s new KNOWH the Difference campaign, which focuses on sharing important knowledge and news on women’s health (KNOWH). The new video, titled “Getting A Beat On What Women Know About Heart Health” can be viewed here: www.fda.gov/womenshearthealth. Finally, during the month of May we celebrate National Women’s Health Week 2020. Please refer to our webpage for tips to help you manage your health and updated resources like our NWHW digital partner social media toolkit.

 

Healthcare Distribution Alliance (HDA)

Allied Against Opioid Abuse (AAOA) was honored to sponsor the recent Rx Drug Abuse & Heroin Summit (Rx Summit). This annual event (held virtually in 2020) is attended by thousands of leaders in the drug abuse and prevention space. AAOA participated in this year’s virtual exhibition hall to connect with leaders across the country working to prevent the misuse and abuse of prescription opioids in their communities.

Resources focused on safe storage and disposal have been increasingly important as we are all staying home during COVID-19. While this year’s DEA Prescription Drug Take Back Day was canceled, AAOA continues to provide tips for consumers to safely store and dispose of prescription opioids. We encourage you to share our consumer resources with your networks to help educate patients and their families during this challenging time.

AAOA also interviewed Anne Burns of the American Pharmacists Association (APhA) to learn more about how APhA and pharmacists across the country are working with patients to mitigate the prescription opioid epidemic. The Q&A addresses how APhA is keeping pharmacists informed about the opioid epidemic and the important role they play in educating patients and their caregivers on everything from dosage to safe storage and disposal.

To learn more or become a partner, visit our website (www.AgainstOpioidAbuse.org) and follow AAOA on Twitter (@AAOA_Tweets).

 

Johnson & Johnson

At Johnson & Johnson, we’re mobilizing our global reach, deep scientific expertise, and extensive partnerships to address the critical needs of families, communities, healthcare professionals and our employees around the world while working toward mitigating and ultimately ending the COVID-19 pandemic. We are committed to bringing a safe and effective vaccine to the public on a not-for-profit basis for emergency pandemic use. Our vaccine development technology and strong global manufacturing capabilities provide us a unique ability to rapidly develop vaccine candidates and upscale production to ensure we can get it in the hands of those who need it most as quickly as possible. Johnson & Johnson has:

• Selected a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020
• Significantly expanded the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA)
• Signed strategic collaboration agreements to accelerate and rapidly scale the company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine.

Additionally, Johnson & Johnson is mobilizing to provide equipment, training, our products, and financial donations to support organizations and health care workers on the front lines. Among other initiatives, the Johnson & Johnson Family of Companies and the Johnson & Johnson Foundation committed $50 million dollars to support and supply frontline health workers – from meals to protective equipment, extra training to mental health support. This commitment expands upon a $250 million multi-year commitment made earlier this year to support those at the frontlines guided by the Johnson & Johnson Center for Health Worker Innovation.

 

National Community Pharmacists Association (NCPA)

NCPA’s top priority has been supporting the nation’s COVID-19 response by working to ensure that the community and long-term care pharmacists on the frontlines in this pandemic have what they need to continue serving their patients. NCPA has advocated successfully for provisions in the Families First Coronavirus Response Act, Coronavirus Aid, Relief, and Economic Security Act, and Paycheck Protection Program and Health Care Enhancement Act that support community and long-term care pharmacists. NCPA has been heavily involved in collaborative efforts with the Administration, Centers for Medicare & Medicaid Services (CMS), and other federal agencies to ensure that regulatory guidance supports pharmacists’ ability to participate fully in COVID-19 response efforts related to testing, compounding hand sanitizer, and providing vaccinations.

NCPA continues to urge CMS to end some of the most harmful pharmacy benefit manager (PBM) activities during the COVID-19 crisis, such as direct and indirect remuneration (DIR) fees. Also, due to the COVID-19 pandemic, oral arguments in Rutledge v. PCMA, the landmark case on whether Arkansas (and by extension other states) can adopt meaningful regulations on relationships between PBMs and pharmacies, have been delayed and will be rescheduled for a later date. NCPA continues to work with the Arkansas Pharmacists Association in monitoring and supporting this case.

 

United States Pharmacopeia (USP)

USP is helping to accelerate the work of scientists and manufacturers developing vaccines and treatments, supporting front line workers impacted by shortages of critical drugs and personal protection equipment and helping to build a more resilient global medicines supply chain. Below are several recent USP announcements and other initiatives related to COVID-19. Please feel free to share these updates, as appropriate, with your constituents and to contact Amy Sonderman (amy@usp.org) for further discussion.

• Supporting frontline healthcare workers:

1. • Developed Operational Considerations for Sterile Compounding, to include assigning beyond-use dates for compounded sterile preparations to mitigate drug shortages, as well as considerations for certification and recertification of primary and secondary engineering control and cleaning and disinfecting a facility.
   • Created a comprehensive toolkit for hand sanitizers to support pharmacies, manufacturers, and others, including distillers, seeking to address hand sanitizer shortages.
   • Responded to shortages of garb and personal protective equipment (PPE) for compounding with conservation strategies. USP also donated 4,000 critical N-95 and surgical masks to practitioners involved in direct patient care.
   • Due to current shortages, USP is accepting comments on a Draft Compounded Preparation Monograph to help facilitate patient access for Hydroxychloroquine Sulfate Compounded Oral Suspension.

• Helping scientists and manufacturers accelerate the development of COVID-19 treatments, vaccines, and essential medicines with free technical assistance and resources:

1. • USP scientific experts are offering free technical assistance to developers of COVID-19 vaccines and treatments, as well as free access to general chapters and monographs to support the public health response to the COVID-19 pandemic. Register today for a free live webcast on May 19 at 11 a.m. ET to learn about USP lessons learned from our public outreach and have your questions answered.
   • USP is working to ensure an uninterrupted supply of reference standards, including enhanced shipping and customer service.
   • USP is offering a 75% discount for education courses on dosage form quality, including specifications, analytical method validation, and pharmaceutical quality practices. Courses are available virtually and on-demand.