Welcome and overview
Sally Greenberg, NCL executive director
Sally Greenberg welcomed the attendees to the Second Annual Spring Membership meeting of the Health Advisory Council. Sally thanked the members of the Council for their support, engagement, and enthusiasm. She then had the pleasure of introducing distinguished speaker Dr. Kathy Hudson, deputy director for science, outreach, and policy at the National Institutes of Health.
Special guest speaker
Kathy Hudson, Ph.D., deputy director for science, outreach, and policy, National Institutes of Health
Dr. Kathy Hudson provided overviews of both the Precision Medicine and National Cancer Moonshot Initiatives and answered questions from Council members.
The Precision Medicine Initiative (PMI) Cohort Program will be the largest longitudinal study ever conducted in the United States and will unlock the door to a wealth of scientific opportunities. The PMI shifts away from the “one-size-fits-all” approach to treating disease and integrates environmental exposures and genetic factors into the development of 21st Century solutions.
The National Cancer Moonshot Initiative is a program established by President Obama to accelerate cancer research. Led by Vice President Biden, the Initiative aims to make more therapies available to more patients, while also improving our ability to prevent cancer and detect it at an early stage. Immediately following the Health Advisory Council meeting, Vice President Biden announced the National Cancer Moonshot Summit, which will take place on June 29 at Howard University. The Summit will bring together scientists, oncologists, donors, and patients and will be the first cancer conference to focus on the broad spectrum of cancers, rather than on one particular form of the disease.
National Consumers League’s health program priorities
Karin Bolte, NCL health policy director
Karin Bolte gave an overview of NCL’s health programs and policy priorities. NCL carries out its health policy work through research, education, advocacy, and convening. NCL’s key priorities are:
- Safe and appropriate use of medicines, including medication adherence, vaccines, counterfeit drugs, and 21st Century Cures/Innovation for Healthier Americans
- Helping consumers to navigate the health care system, including improving healthcare provider-patient communication, promoting health literacy, and improving healthcare transparency—on price, quality, and safety.
- Quality of care, including ensuring that consumer-friendly quality measures are developed, and that there is subsequent reporting by healthcare providers and institutions on compliance with measures and standards, and that patient-centered outcomes are emphasized.
Following the overview of NCL’s health programs, Health Advisory Council Members had the opportunity to share updates on their programs, priorities, and initiatives. Below is a brief summary of member updates.
Kimberly Rawlings, Center for Drug Evaluation and Research, Food and Drug Administration (FDA) -- Kimberly Rawlings reported that CDER’s priorities include reducing abuse of opioid painkillers, drafting pharmacy compounding guidance documents, and the reauthorization of PDUFA, GDUFA, and the Biosimilar User Fee Act (BsUFA). Kim also encouraged Council members to listen to CDER Director Dr. Janet Woodcock’s Director’s Corner quarterly podcasts on a number of topics.
Kimberly Thomas, Office of Women’s Health, Food and Drug Administration (FDA) -- The Office of Women’s Health is continuing its consumer outreach and research to help women make informed health choices. This past January, in conjunction with the NIH, the FDA launched the Diverse Women in Clinical Trials Initiative to raise awareness about the importance of diverse women of different ages, races, ethnic backgrounds, and health conditions participating in clinical trials. The OWH is also working to educate women about safe medication use during pregnancy.
Alicia Subasinghe, Pharmaceutical Research and Manufacturers of America (PhRMA) -- Alicia Subasinghe highlighted a number of PhRMA’s priorities, including PDUFA and GDUFA reauthorization. PhRMA is also encouraging the use of biomarkers and patient engagement as a whole and continues to be active in the conversation on value and patient-centeredness. Alicia explicitly mentioned a desire to reduce regulatory barriers that may prevent patients from getting the best care possible. Consumer education and empowerment, particularly regarding health coverage and health plans, is also a priority for PhRMA.
Dorothy Siemon, AARP -- Dorothy Siemon identified cost and access, transparency, and consumer engagement as priorities of AARP. As older people tend to take more drugs, promoting comparative effectiveness and figuring out ways to help older populations better understand the healthcare system is of high importance.
Nelufar Mohajeri, U.S. Pharmacopeia (USP) -- Nelufar Mohajeri discussed USP’s Verified Program for dietary supplements, as well as a recent roundtable on gummy dietary supplements. USP is also assessing the feasibility of a standard for medical marijuana, developing sterile compounding and handling of hazardous materials standards, and addressing medication labeling and nomenclature issues. USP is engaged in efforts to combat counterfeit drugs and is modernizing 1,600 monographs through public comment.
Jeffrey Ekoma, American Association of Colleges of Pharmacy (AACP) -- Jeffrey discussed AACPs continued dedication to professional and graduate education and identified the reauthorization of the Higher Education Act and creating pipelines for middle and high school students who have an interest in pharmacy as AACP priorities. Interprofessional education is also a priority of AACP, as well as innovations in health.
Rob Nauman, North Carolina Alliance for Healthy Communities -- Rob Nauman explained the expansion of the Script Your Future campaign from a pilot city in Raleigh-Durham to a North Carolina-statewide coalition. He also touched on the importance of leveraging the wealth of information from HAC member organizations and disseminating it to communities.
Gay Johnson/Lilly Pinto, National Association of Nurse Practitioners in Women’s Health (NPWH) -- NPWH is currently working to address the lack of women’s health providers in military facilities, as well as addressing the lack of services for rape, sexual assault, and harassment victims on college campuses and in the military. Gay also announced that NPWH will be hosting a Women’s Health Summit in the fall to raise awareness about older women and their access to care.
Jillanne Schulte, American Society of Health-System Pharmacists (ASHP) -- One of ASHP’s main priorities is working to have pharmacists recognized as medical providers. ASHP is also working on opioids, substance abuse and misuse, antimicrobial and antibiotic resistance, and compounding. Jillanne also announced ASHP’s summer meeting, which will be held in Baltimore, and their Midyear Clinical Meeting which will be held in December in Las Vegas.
Bri Morris, National Community Pharmacists Association (NCPA) -- Bri Morris reported that there are currently 1.6 million people enrolled in Simplify My Meds, NCPA’s medication adherence program. NCPA will continue to help community pharmacists provide quality care to their patients, and work towards achieving provider status for pharmacists.
Colleen Creighton, Consumer Healthcare Products Association (CHPA) -- CHPA continues to promote the safe use, storage, and disposal of drugs through the Know Your Dose and Up and Away campaigns. Both campaigns have had a significant impact on consumers, with 22 million impressions for the Up and Away campaign in this year alone. CHPA continues to utilize the messaging toolkits sent by the CDC and recently did a materials and messaging push during Poison Prevention week. The next safe storage push will be in June, which is National Safety Month.
Katie Allen, Horizon Government Affairs -- Katie Allen highlighted the various coalitions that Horizon runs, including the Council for Affordable Health Coverage, Prescriptions for a Healthy America, and Clear Choices. Katie announced that Horizon launch a new campaign, Prescriptions for Value on Drug Pricing, this summer. The purpose of this coalition is to convene ALL stakeholders to participate in the discussion about drug pricing. The pharmaceutical industry is particularly encouraged to participate as an integral part of the conversation.
Lee Lynch, Lynch Advocacy Solutions, LLC -- Lee Lynch discussed effective care coordination and medication adherence through the Medicare Advantage Care Coordination (MACC) Task Force. She also discussed the importance of innovations in Medicaid and bringing awareness to specific issues including preterm labor and behavioral health.
Karl Uhlendorf, Astellas -- Karl Uhlendorf highlighted a few of Astellas’ priorities, including PDUFA, MACRA, the Part D Demonstration Project, 21st Century Cures, and continuing the value-based framework discussion. This April, Astellas hosted its second annual Patient Advocacy Summit, which focused on patient-centeredness, quality measures, how to incorporate the patient voice in the value discussion, and best practices for the patient advocacy community. Karl also announced the launch of Astellas’ new interactive, patient-focused website, Changing Tomorrow Together, as well as their Patient Advocacy Advisory Committee, which currently has 13 members.
Aimee Gallagher, Society for Women’s Health Research (SWHR) -- Aimee Gallagher announced that the SWHR will release a report in August on the top 10 topics relevant to women living with diabetes. In October at the University of Colorado, SWHR will sponsor a conference focused on women’s health, diabetes, and cardiovascular disease. Aimee also mentioned a few of SWHR’s upcoming projects that will tackle issues such as perinatal health, oral health, and ingredient safety.
Erin Mackay, National Partnership for Women and Families (NPWF) -- NPWF is currently focused on MACRA and the shift from volume-based to value-based care. Erin also discussed NPWF’s Get My Health Data campaign, which promotes patient access and supports patients in asking for and receiving their digital health data.
Mara Gandal-Powers, National Women’s Law Center (NWLC) -- Mara identified reproductive rights and access to coverage of abortion and birth control as priorities of the National Women’s Law Center. Mara also called attention to coverher.org, which is a NWLC resource for women who may still be paying out-of-pocket for their preventive services.
Lindsay Clarke, Alliance for Aging Research (AAR) -- Lindsay Clarke announced that the Alliance for Aging Research will be celebrating its 30th anniversary this September. The AAR will continue to work on issues that impact older populations, including safe medication selection, use, storage, and disposal, vaccine education, and stroke prevention.
Deborah Davidson, National Council on Patient Information and Education (NCPIE) -- NCPIE will continue to work with SAMHSA on prescription drug abuse prevention and awareness, and with the FDA on the Talk Before You Take campaign. NCPIE also completed a consumer health project with Pfizer last year on self-care. Deborah discussed the campus dialogues NCPIE sponsored at colleges across the country. Each dialogue focused on a particular student population, such as Asian or Native American students. The reports from these dialogues will be released soon.
Michele Oshman, Eli Lilly and Company -- Michele Oshman said that exploring the burden of care and determining the challenges facing everyday people across the healthcare spectrum is of particular interest to Lilly. Lilly also hosts quarterly Dialogues on Discovery events, and recently hosted one on value models.
Grace Whiting, National Alliance for Caregiving -- Grace Whiting announced that the National Alliance for Caregiving will release a White Paper on cancer caregiving on June 20.
Karin Bolte thanked the Health Advisory Council Members for attending and for their continued support of NCL. She asked members to send her topic and speaker recommendations for NCL’s Fall Policy Forum on Access to Healthcare.