Health Advisory Council Member Updates | Q4 2018

AMAG Pharmaceuticals

AMAG Pharmaceuticals has had a number of significant developments in women’s health in recent months. In late September, AMAG announced it has acquired global rights from Velo Bio, LLC to develop and market digoxin immune Fab (ovine DIF), a polyclonal antibody in development for the treatment of severe preeclampsia in pregnant women. Preeclampsia is a leading cause of maternal morbidity and mortality and adverse neonatal outcomes, affecting approximately 140,000 pregnant women in the U.S. annually. Severe preeclampsia can be life-threatening to both the woman and infant, and impacts approximately 50,000 women per year. Currently, there are no FDA-approved treatments for preeclampsia or severe preeclampsia. AMAG will manage and complete the Phase 2b/3a study. Additionally, AMAG worked with more than a dozen partners to launch the Alliance for Advancing Women’s Health (AAWH) — a new collaborative initiative to advance women’s sexual healthcare by improving the interaction between clinicians and patients about sexual health — on October 1st. Member organizations are working together to empower women with information to seek better sexual healthcare. AMAG is the founding funder and convener of the Alliance.

America’s Health Insurance Plans

AHIP is partnering with the Coalition for Medicare Choices to educate seniors and their families about the benefits of Medicare Advantage and work with Congress to keep health care affordable. CMS predicts more than 22 million seniors will choose to enroll in a Medicare Advantage plan this year – 37 percent of all Medicare-eligible Americans. The more than two million members of the Coalition are sending e-mails, making calls, and meeting with Members on Capitol Hill and in-district to share their stories of how they rely on Medicare Advantage and highlight the importance of fully funding Medicare programs.

Association for Accessible Medicines

The Association for Accessible Medicines (AAM), together with 28 groups, submitted a letter on November 5th to U.S. Trade Representative Robert Lighthizer, Health and Human Services Secretary Alex Azar, and Congressional leadership expressing concern that, if left in its current form, the proposed agreement with Canada and Mexico to revise the North American Free Trade Agreement (NAFTA) will keep drug prices high and out of reach of Americans. The letter states that without changes to the draft agreement – now called the U.S.-Mexico-Canada Free Trade Agreement (USMCA) –USMCA will slow the development of biosimilars in the U.S., increase brand-name drug exclusivity (monopolies) for biologics in Canada and Mexico, and expand protections for brand-name drugs beyond current U.S. law.

The letter demonstrated the widespread concern about delaying patient access to affordable generics and biosimilars in U.S. trade agreements, with co-signers representing a diverse coalition of organizations including AFL-CIO, AARP, Kaiser Permanente, American College of Physicians, American Federation of Teachers, FreedomWorks, Patients for Affordable Drugs, and SEIU. The letter is available at, a website that provides patients with an opportunity to contact their Members of Congress to encourage more prescription drug competition in USMCA to bring down high prices. 

BeMedWise Program at NeedyMeds

With the NCPIE – NeedyMeds transition completed, the BeMedWise program has begun inviting our former NCPIE members and stakeholders to participate in the new BeMedWise Council. The BeMedWise Council partners will work collaboratively to identify and develop highly-relevant BeMedWise programs that support the BeMedWise program’s mission to promote the wise use of medicines through trusted communication for better health. Please contact Deborah Davidson ( if you are interested in learning more about the new BeMedWise Council.

October marked our 33rd Talk About Your Medicines Month (TAYMM). BeMedWise and our health education stakeholders used this nationally recognized health observance month to talk about opioid safety. This year’s theme – Taking Action to Prevent Opioid Misuse and Abuse, focused attention on the magnitude of the problem as well as how patients, their families, caregivers, and healthcare professionals can take action and work together to manage these serious medications and ensure safe and appropriate medicine use, including safe storage and disposal. The TAYMM website features our customary tips/downloads and resources for patients and providers to help stimulate conversations about understanding and avoiding the potential risks and misuse of opioid medications. This year’s program also included a kick-off webinar that is available on the NeedyMeds YouTube channel. Stakeholders and partners received a TAYMM communications planning toolkit, comprised of a news article, social media messages and more to share with their respective constituencies. All of the BeMedWise past “Talk About Your Medicines” month observances, materials, and resources are evergreen, and can be used for health-related events throughout the year.

The BeMedWise program announces a new partnership with the Israeli Chapter of the International Society of Pharmacovigilance (ISOP Israel). As part of the collaboration and ISOP Israel’s efforts to improve patient safety and increase medication adherence, ISOP Israel is planning to translate several BeMedWise educational resources into Hebrew, including the “Talk Before You Take” program tools to support healthcare providers and their patients when communicating about the benefits and potential risks of their medications. One target area where these tools will be implemented is part of an integrated risk management strategy on anticoagulants in a variety of multi-disciplinary settings including hospitals and community pharmacy.

Black Women’s Health Imperative

Black Women’s Health Imperative recently released its inaugural legislative agenda, Black Women Vote: The 2018 National Health Policy Agenda to build upon Black women’s political influence, ballot power, and commitment to civic participation for upcoming elections. The agenda is based on four pillars: Access to Quality and Affordable Health Care; Equitable Responses to Public Health Emergencies; Sufficient Diversity in Clinical Research; and Increased Funding to Support HBCUs. To ensure that our agenda is disseminated and accessible to all Black women, BWHI co-sponsored a series of conversations in several cities including Atlanta, Richmond, Baltimore, Boston, Raleigh, and Morgan State University, focusing on issues of concern to Black women. The purpose of these gatherings is to share the policy agenda and hear directly from the women who are affected by the issues addressed in the agenda.

BWHI has also taken a leadership role on maternal mortality affecting Black women by participating in Op-Eds, press releases, and supporting legislation focused on maternal mortality. In addition, BWHI has strengthened its collaboration with the Clean Water for All Coalition (CWAC) by expanding the voice of Black women in environmental health policy through the release of the Environmental Report: Water, Health and Equity.

Finally, BWHI was mentioned in two different news articles entitled “New Policy Agenda Aims at Educating Black Voters” by the Washington Informer and “Black women are galvanizing the vote in the booth and on the ballot in the midterm elections” by the Grio.       

Consumer Healthcare Products Association Educational Foundation

In October, the Up and Away campaign leveraged the Halloween holiday season and “candy confusion” to increase awareness and knowledge of safe medicine storage. The campaign issued a press release in English and Spanish with 310 placements; posted a digital matte release with more than 1,000 placements; and conducted a national radio media tour with nine stations featuring the foundation’s Mary Leonard and spokesperson Dr. Kathleen Wilson, helping us reach 27.5M consumers with our Up and Away messages. In addition, we conducted outreach to local and national news, securing national coverage from ABC National News, reaching 600,000 viewers across 50 local ABC News channels. We also secured a printed piece in the El Nuevo Herald in Florida that reports to the third largest Hispanic population in the country. Finally, the campaign launched paid media on Facebook and Instagram, reaching 800,000 parents and caregivers with our safe medicine storage messages during Halloween.

FDA Office of Women’s Health

The FDA Office of Women’s Health (OWH) developed two new consumer publications this year. The Women and Pain Medicines fact sheet provides information to help women make safe decisions regarding pain medication use. The Caring for Others: Resources to Help You fact sheet includes tips for caregivers and other FDA resources to help keep a loved one safe and on track with their treatments.

Over the next few months, OWH will refresh the overall look of our publications, ensuring that we continue to provide women timely and free health information in a clear and easy-to-read format.

At NCL’s December 3, 2018 Health Advisory Council Meeting, Marsha Henderson, FDA’s Associate Commissioner for Women’s Health, announced that she is retiring from the agency at the end of the year. We will miss Marsha, but look forward to continuing to work with the OWH staff in the years ahead.   

Healthcare Distribution Alliance and Allied Against Opioid Abuse

Earlier this fall, Allied Against Opioid Abuse (AAOA) collaborated with a team of physicians at the Johns Hopkins Hospital on an educational video to help patients prepare for and manage post-surgery pain. To watch the video, click here.

In coordination with its pharmacy partners, AAOA also developed a suite of tools to help pharmacists engage with and educate patients about the safe use, storage, and disposal of prescription opioids. The AAOA Pharmacy Toolkit is available online here. To get a sense of the toolkit in action, read this blog post featuring California pharmacist Katie Bass.

For more information on AAOA activities or to get involved with the organization, please contact Lee Lynch (

The Healthcare Distribution Alliance is the founding member of Allied Against Opioid Abuse.


HealthyWomen’s policy blog has recently explored important health insurance and access to care-related issues connected to women’s health. Phyllis Greenberger, Senior Vice President for Science and Health Policy, recently wrote on ensuring access to pain management while confronting the opioid epidemic, and her most recent blog urges Congress to act now to pass the “donut hole” fix for the Medicare Part D prescription drug program. With open enrollment health insurance season in full swing, Beth Battaglino, RN, CEO, and Mike Miller, MD, HealthyWomen Senior Policy Advisor, shared insights on what our audience needs to know when choosing a health care plan.

In early October, Mike Miller, MD, Senior Policy Advisor, with Paul Samuels, Director and President, Legal Action Center, participated in a panel discussion focused on women and the opioid epidemic at the annual Women in Government Healthcare Summit. This presentation focused on expanding medication-assisted treatment for opioid addiction and state strategies to advance reform. Resources for Strengthening Families and Communities by Improving Access to Treatment for Substance Use Disorder, a toolkit created by HealthyWomen and the Legal Action Center, was highlighted as an educational tool for legislators on the frontline. AT Forum also interviewed Dr. Miller for an article published online in November titled “Toolkit Helps Women State Legislators with Opioid Bills.”

Brian J. Isetts, PhD, BCPS, Professor at the University of Minnesota College of Pharmacy

Brian J. Isetts, PhD, BCPS was recently appointed to serve a two-year term on the Centers for Medicare & Medicaid Services (CMS) – Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). The MEDCAC advises CMS on whether specific services and medical items are reasonable and necessary under Medicare law. There are currently 66 voting members on MEDCAC for the 2018-2020 biennium selected based upon expertise and qualifications in fields such as genetic testing, clinical epidemiology, psychopharmacology, health care economics, patient advocacy, and other relevant fields and professions.

National Association of Nurse Practitioners in Women’s Health

The National Association of Nurse Practitioners in Women’s Health (NPWH) held its 21st Annual Premier Women’s Healthcare Conference in October, attracting over 700 attendees for our largest conference yet. NPWH continues to work to advance older women’s health care with planning meetings for our Healthy at Any Age Coalition and anticipates an official Coalition launch in May 2019. To learn more about the coalition, click here. If you are interested in joining the Coalition, please email

National Community Pharmacists Association

Medication disposal

Together with the NCPA Foundation, which received a large donation of Sharps TakeAway envelopes from Cardinal Health and operates the website, NCPA promotes dispensing and disposal habits that keep unused opioids and other prescription drugs from being misused or flushed into our water supply. NCPA encourages members to promote and participate, to the extent practical, in DEA’s twice annual drug takeback events.

Combatting the opioid public health emergency

As a result of efforts on the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (aka the opioid relief package), NCPA was present at the signing of the bill by President Trump. Included are provisions that require e-prescribing for Schedule II through V controlled substances under Medicare Part D, starting in 2021, call for educational materials on safe controlled substance dispensing practices for pharmacists, and preserve patient pharmacy choice. In addition to collaborating on the opioids package, NCPA is a partner in Allied Against Opioid Abuse, a coalition of organizations that have funded development and dissemination of resources to help pharmacists engage with and educate patients and prescribers about the safe use, storage, and disposal of prescription opioids.

NCPA’s Senior Vice President of Government Affairs Karry La Violette offered input on industry efforts to combat the opioid epidemic at a recent meeting at the U. S. Department of Health and Human Services. La Violette and representatives of the National Conference of Pharmaceutical Organizations (NCPO) met with Assistant Secretary for Health Admiral Brett Giroir, M.D. to discuss ways the NCPO can assist the Administration. NCPA is a member of NCPO, a coalition of organizations and associations that represent more than 300,000 pharmacy practitioners and pharmaceutical scientists, and companies engaged in health care delivery, as well as pharmacy regulators and educators.

Drug pricing

The 2020 Medicare Part C/D Pricing Proposed rule was released Monday, November 26. While NCPA is in the process of analyzing the proposed rule in order to submit comments, the initial impression is that it contains important changes to drug pricing calculations that will lower patients’ out-of-pocket costs at the pharmacy counter and make the Part D market more competitive and efficient. It also calls on Part D Plans to implement a real-time benefit transaction that would provide prescribers who service its beneficiaries with complete, accurate, timely, and clinically appropriate patient-specific real-time formulary and benefit (F&B) information (including cost, formulary alternatives, and utilization management requirements).

National Partnership for Women and Families

In honor of National Family Caregivers Month, the National Partnership for Women and Families released a new fact sheet The Female Face of Family Caregiving and blog post to highlight these unsung superheroes. Check them out and learn what we can do to better support the 25+ million women who provide care to family members or friends. 

One way to supercharge caregiving is with tools like mobile health apps that make it easier to access, compile, and coordinate health information. We’re excited to share a video that explains how digital health tools can help the Care-Coordinators-in-Chief in our lives.

Network for Excellence in Health Innovation

The Network for Excellence in Health Innovation (NEHI) has released Health Care Without Walls: A Roadmap for Reinventing U.S. Health Care. By combining technologies such as telehealth with a reconfigured workforce, the report says, the nation’s health care system could be transformed into one that better anticipates individuals’ needs; works to keep them as healthy as possible; and brings prevention and care out of conventional institutional settings into peoples’ homes, workplaces, and other convenient locations. “Not all health care will or should move outside of the traditional institutional settings, such as doctors’ offices and hospitals,” said Susan Dentzer, NEHI’s President and CEO. “We’ll still want to be treated in intensive care units and trauma centers when we’re very sick or injured. But much of health care is about exchanges of information, rather than the traditional laying on of hands. And those exchanges of information about health care can increasingly take place virtually — making it more convenient and accessible for all of us.” The report draws on the collective insights of approximately 200 individuals, including leaders of five separate work streams focused on technology, the health care workforce, payment, regulatory, and human factors issues. More information is available on NEHI’s web site at