Health Advisory Council Member Updates | June 2017

Lindsay Clarke, Alliance for Aging Research
The Alliance for Aging Research is continuing to produce educational “pocket films” on a variety of topics, including safe use of OTC pain medications, vaccination in older adults, and volunteering for a clinical trial. The films can be found online at, and the Alliance encourages partners, academics, HCPs, and more to use the films in their outreach and education for patients.

The Alliance has also been continuing to focus on geriatric cardiovascular disease and the unique needs of older adults. On February 22, the Alliance hosted the first-ever National Heart Valve Disease Awareness Day, focused on raising awareness about this deadly disease. A national public opinion survey found that three out of four people know little to nothing about heart valve disease, underscoring the need for a nationwide awareness campaign. More information is available at

Last September—during AFib Awareness Month—the Alliance launched a campaign to help patients and healthcare providers better understand AFib-related stroke risk, and celebrate every year lived with a non-event. We are aware that older AFib patients at heightened stroke risk often don’t receive the treatment they need due to fears of frailty and falls. This campaign at seeks to change the conversation about stroke risk reduction in AFib.

In October, the Alliance will host a geriatric mental health roundtable, in partnership with the UC San Diego Center for Healthy Aging. The discussion will focus on mental health issues accompanying dementia, depression and suicide, and serious mental illness and alcohol abuse. The results of the discussion will be released in a white paper.

Finally, the Alliance is continuing its work on healthcare-associated infections, and will be releasing a white paper on HAIs in long-term care facilities. 

For additional information on any of these projects, please contact Lindsay Clarke at

Lisa Coen, AMAG Pharmaceuticals
AMAG Pharmaceuticals is working to expand beyond its focus on maternal health to the broad spectrum of women’s health. 

Naomi Michaelis, American Society of Health-System Pharmacists (ASHP)
ASHP reported that legislation addressing access to care in medically underserved areas is gaining support in Congress. Efforts to advance H.R. 592 and S. 109 (The Pharmacy and Medically Underserved Areas Enhancement Act) continue as the Patient Access to Pharmacists’ Care (PAPCC) Coalition makes a push to include the bill in a future Medicare legislative package. While the long term agenda for Congress remains somewhat unclear, PAPCC believes there may be an opportunity to insert the bill language into a must pass health care bill such as the Children’s Health Insurance (CHIP) reauthorization. Further, the bills have widespread bipartisan support with more than 180 cosponsors in the House and more than 40 in the Senate. The PAPCC ( is a multi-stakeholder and interdisciplinary initiative. Membership is comprised of organizations representing patients, pharmacists, and pharmacies, as well as other interested stakeholders, including NCL.

In addition, ASHP joins many health care and consumer stakeholders in expressing concern over skyrocketing prescription drug prices. As a lead member of the Campaign for Sustainable Rx Pricing, ASHP has been urging Congress to explore public policies to address this growing problem. CSRxP ( is a non-partisan coalition comprised of hospitals, physicians, nurses, consumers, health plans, pharmacists, and employers.

Sara Skubikowski, Association for Accessible Medicines (AAM)
To better reflect its mission, the Generic Pharmaceutical Association rebranded itself as the Association for Accessible Medicines in February. On June 7, the Biosimilars Council, a division of AAM, partnered with The Atlantic for the third in a series of biosimilar breakfast briefings as part of The Atlantic’s Politics & Policy series. On June 12, AAM released its ninth annual Generic Drug Access & Savings in the U.S. report, which found that generic drugs generated $253 billion in savings for patients and taxpayers in 2016, and $1.67 trillion over the last decade. On the policy front, AAM is supporting the CREATES Act (S. 974/H.R. 2212) and the FAST Generics Act (H.R. 2051), which would address abuses by certain brand companies of the Risk Evaluation and Mitigation Strategies (REMS) and other non-FDA mandated restricted access drug programs to prevent generic competition, which CBO estimates will cost taxpayers between $2.8-$3.3 billion over the next decade.

Christeen Moburg, Astellas
Entering its second year, the Astellas Oncology C3 Prize® is once again calling for applicants from all over the world and from all backgrounds to submit their ideas for innovations to change cancer care. The C3 Prize, which aims to inspire and foster innovative, non-medical, non-treatment ideas, is offering $100,000 in unrestricted grants and access to mentorship to bring the brightest ideas to life. The Grand Prize Winner will receive a personal business consultation with Robert Herjavec, star of ABC’s Emmy Award-winning television show Shark Tank, technology entrepreneur, and cancer caregiver. Each runner-up will receive a $12,500 grant from Astellas, and all the finalists will receive a one-year nights and weekends membership to MATTER, a healthcare innovation community. Applications are being accepted at through August 21, 2017.

Mark Gibbons, Caregiver Action Network (CAN)
Caregiver Action Network (CAN) recently released a video series on Chronic Obstructive Pulmonary Disease (COPD), and will be releasing another series on Multiple Sclerosis (MS). With a grant from the Patient-Centered Outcomes Research Institute (PCORI), CAN just completed its first training in its Equipping You for Success: Training for Family Caregivers in Team-Based Medical Decisions program. The training program is designed to help caregivers and patients be better informed and thus better prepared to make treatment decisions based on comparative effectiveness research.

Mary Leonard, Consumer Healthcare Products Association (CHPA)
Know Your Dose Campaign: The Know Your Dose (KYD) campaign’s latest cold and flu rally was a resounding success. Since launching in November 2016, the rally has generated nearly 77 million impressions—more than triple the previous year’s rally. Dr. John Whyte of U.S. FDA’s Center for Drug Evaluation and Research has been highly engaged, recently authoring OTC Medicines: What Parents Need to Know, which highlights the importance of safe use, storage, and disposal of over-the-counter medicines. In March, the foundation released the findings of its nationwide survey showing a positive trend in consumer knowledge of acetaminophen safe use. Over the past six years: more people than ever are aware of how to use products containing acetaminophen safely and effectively, while avoiding the risks of accidental overdose and liver damage.

Up and Away Campaign: Poison Prevention Week: The CHPA Foundation partnered with CDC’s Medication Safety Program to reinforce awareness of safe medicine storage during Poison Prevention Week (March 19-25). The campaign featured a digital toolkit and educational materials that were disseminated and shared through the PROTECT Initiative, an innovative collaboration bringing together public health agencies, private sector companies, professional organizations, consumer/patient advocates, and academic experts to develop strategies to keep children safe from unintentional medication overdoses. The efforts garnered more than 2 million impressions and featured pickup from media outlets throughout the nation.

Sloane Salzburg, Council for Affordable Health Coverage (CAHC)
The Council for Affordable Health Coverage (CAHC) has issued recommendations to ensure insurance market stabilization and longer-term health care reform. CAHC has recently launched a new initiative called Prescriptions for Affordability, which is advocating for bipartisan policy solutions to lower drug costs. Prescriptions for a Healthy America (P4HA) is advocating for a medication adherence-specific regulatory safe harbor to the anti-kickback statute. In addition, P4HA recently celebrated a win when the Senate Finance Committee included an amendment to S. 870, the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act, which would provide Medicare Parts A and B claims data to Part D Plans in order to enhance the effectiveness of current and future medication management programs.

Marsha Henderson, FDA Office of Women’s Health (FDA/OWH)
FDA/OWH’s Diverse Women in Clinical Trials Initiative continues to raise awareness about women of different ages, races, ethnic backgrounds, and health conditions participating in clinical trials. In May, OWH released new foreign language clinical trials factsheets. A research paper on women and cardiovascular disease trials is forthcoming. OWH’s Resources for You and Your Baby initiative is also working to provide consumers with information on safe medication use. The Medicines and Pregnancy webpage was updated with new consumer tips and graphics in English and Spanish. OWH also released new web buttons that partners can use to connect pregnant women who use medicines to FDA’s Pregnancy Exposure Registry web portal.

Lastly, OWH is supporting new activities mandated by the 21st Century Cures Act, including the HHS taskforce on the inclusion of pregnant and lactating women in clinical trials and the response to the opioid epidemic—with a focus on women and pain management.

Tom Wallace, Eli Lilly and Company
Eli Lilly remains committed to developing an Alzheimer’s treatment and is also involved in raising awareness of the disproportionate impact Alzheimer’s has on women, both as patients and as caregivers. People might not know it, but Eli Lilly is the second largest animal health company. As such, Lilly is working on antibiotic resistance and food security issues.

Kelly Cox, Johnson & Johnson
J&J has a diverse portfolio of products, ranging from Ebola and HIV vaccines to OTC sunscreen and acetaminophen. As a result, J&J is working on a broad spectrum of issues, including improving standards for cosmetic safety and supporting the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Amendments (MDUFA). Ebola highlighted the risk of pandemics that currently exists, and J&J cosponsored a June 20 discussion of Unseen Enemy—a documentary that recently aired on CNN about the increased threat of epidemics and the important policy challenges facing our country and our global allies. In addition, in February 2017, Janssen Pharmaceuticals released its 2016 U.S. Transparency Report that includes information on pricing and other business practices, covering everything from discovery to the commercialization of pharmaceuticals.  

Lee Lynch, Lynch Advocacy Solutions/Reservoir Communications Group
Lee is currently working with the Modern Medicaid Alliance to raise awareness of the value provided by Medicaid. She is also working on the safe distribution of drugs and behavioral health screenings.    

Brian Isetts, University of Minnesota College of Pharmacy
Since his Health Policy Fellowship at CMS, Dr. Isetts has maintained a focus on national initiatives to help patients and families become confident medication users. Here are a couple of links that provide helpful information in support of our national Patient-driven Medication Management agenda: CMS Campaign for Meds Management and the American Society of Health-System Pharmacists’ Medication Use Recommendations to the Choosing Wisely Campaign.

Bruce A. Leicher, Momenta Pharmaceuticals
Momenta is focused on the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and on the discovery and development of novel therapeutics for autoimmune indications. The company currently has seven biosimilars in development. On the policy front, Momenta seeks to use innovation to develop affordable medicine for patients. A current policy initiative is to support proposed legislation (Fast Generics Act or the CREATES Act) to end the anticompetitive practices of some companies that deny access to their products for use in generic or biosimilar development programs.

Anne Wilson, Mylan
Mylan has one of the broadest and most diverse generic medicine portfolios, with more than 7,500 marketed products in areas including oncology, cardiovascular disease, diabetes, HIV, and autoimmune diseases. Mylan is committed to making high-quality medicines available to everyone who needs them, and manufactures 80 billion doses of medicine annually. On the policy front, Mylan supports a robust biosimilar pathway and reimbursement, as well as pathways for complex generics.

Michael Wittke, National Alliance for Caregiving
In February, the National Alliance for Caregiving released a research report titled Dementia Caregiving in the U.S. Dementia caregivers shoulder more caregiving responsibilities than do other caregivers. They help with a wider variety of activities and spend more hours per week providing care. On average, dementia caregivers provide care for 28 hours per week. Dementia Caregiving in the U.S. analyzes the experiences of providing unpaid care in the United States to a relative or friend diagnosed with Alzheimer’s disease, dementia, or other mental confusion, with the goals of both understanding the experiences of people caring for someone with dementia and identifying approaches to enhance and support this unique caregiving experience. The National Alliance for Caregiving draws its analyses from the nationally representative study Caregiving in the U.S. For more information on the National Alliance for Caregiving, please visit   

Gay Johnson, National Association of Nurse Practitioners in Women’s Health (NPWH)
NPWH’s fourth annual Women’s Sexual Health Course for NPs took place June 8-11, 2017, in Baltimore, MD. Registration is now open for the 20th annual Premier Women’s Healthcare Conference, being held October 11-14 in Seattle, WA. NPWH is one of four partners in the ACOG-led Women’s Preventive Services Initiative, dedicated to improving the well-being of women across the country by providing updated recommendations, and developing new ones, for the Women’s Preventive Services Guidelines. NPWH is also working to address the shortage of women’s health providers, and is committed to bringing WHNPs voice to the table. Finally, Healthy at Any Age: A Summit on Women’s Health After 50 will reconvene in the fall.

Susan Pilch, National Community Pharmacists Association (NCPA)
NCPA is currently working on Medicare Part D and fees charged to pharmacists by Pharmacy Benefit Managers (PBMs) after the point of sale. This practice raises out-of-pocket costs to beneficiaries and is disruptive to pharmacists.

Deborah Davidson, National Council on Patient Information and Education (NCPIE)
Celebrating its 35th anniversary, NCPIE recently launched its new website, With a grant from Pfizer Consumer Health, NCPIE will release a report on self-care in the coming weeks.

Erin Mackay, National Partnership for Women & Families (NPWF)
As Theresa Chalhoub mentioned during the Panel discussion at NCL’s Health Advisory Council meeting, the National Partnership for Women & Families is on the Steering Committee of the Protect Our Care coalition, which is focused on protecting the Affordable Care Act. In addition, the National Partnership is working on delivery system reform and improving access to medical records for patients. Unfortunately, patient portals, as they currently exist, often cause confusion and frustration for patients. The Partnership is also participating in efforts to reconcile and exchange digital medication lists, which will help improve medication adherence and care coordination.

Ernie Boyd, Ohio Pharmacists Association (OPA)
As the Script Your Future – Ohio Coordinator, the Ohio Pharmacists Association (OPA) is well aware that only about one-half of Americans take their medications as prescribed. This contributes to the overall burden and toll of chronic disease on the population and to a vast portion of unnecessary health care and costs. These issues motivated Ohio-based CareSource, one of the country’s largest Medicaid managed care plans, to offer a medication therapy management (MTM) benefit to all of its beneficiaries. Total savings from the program, including avoided hospitalizations, emergency department visits, and other unnecessary health care consumption, yielded an ROI of $4.40 for every $1 spent. Building on these results, Ohio has been working to have pharmacists recognized and reimbursed as healthcare providers. In Ohio, pharmacists can now administer all CDC-recommended vaccinations as well as long-acting mental health medications. Another new law allows collaborative agreements with physicians, allowing pharmacists to manage and modify a patient’s drug therapy, including prescribing and ordering lab tests for medication management. OPA is also actively engaged in trying to address the opioid abuse epidemic, which claimed the lives of 4,000 Ohioans last year.

Myisha Gatson, Pharmaceutical Research and Manufacturers of America (PhRMA)
PhRMA recently launched its Go Boldly campaign on biopharmaceutical innovation, which highlights innovative research and technological breakthroughs of America’s biopharmaceutical industry and the people behind the fight to prevent, treat, and cure disease. PhRMA is working to secure policies that will support the modernization of the drug and discovery process, as well as value-driven healthcare purchasing. PhRMA is working to ensure additional oversight and reforms to the 340 B program. Finally, PhRMA is working to educate the public and policy makers on the dangers of drug importation.

Amy Sonderman, U.S. Pharmacopeial Convention (USP)
Responding to the concern and need for consistent quality in dietary and nutritional supplements, USP founded the Dietary Supplements Quality Collaborative (DSQC). This multi-stakeholder partnership is pursuing consensus-based initiatives focused on public and private efforts to improve the quality of products marketed as dietary supplements. In addition to DSQC, USP is working on updating its sterile compounding standards. USP also launched the Quality Institute, a major new initiative that will generate research and evidence to better inform conversations relating to the value of quality.