Health Advisory Council Member Updates | Q2 2018


As AARP’s 60th anniversary approaches, the new AARP Brain Health Fund is investing $60 million in the Dementia Discovery Fund (DDF) to disrupt dementia by supporting innovative research into dementia prevention and treatment.

One in 10 people 65 and older in the United States have Alzheimer’s or another form of dementia. Despite decades of research, there is still no cure for dementia and few effective ways to treat symptoms of the disease. The Dementia Discovery Fund takes a new approach to dementia research by exploring other possible causes of the disease and applying treatment insights gained from other areas, such as cancer research, to develop new dementia drugs.

AMAG Pharmaceuticals

AMAG Pharmaceuticals recently announced FDA acceptance of its New Drug Application (NDA) for bremelanotide, a first-in-class melanocortin 4 receptor agonist designed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is the most common type of female sexual dysfunction, affecting approximately six million premenopausal women in the U.S. HSDD is characterized by persistent low sexual desire (or libido) that is associated with distress, often negatively impacting women’s emotional health, intimate relationships, and overall quality of life.

Additionally, AMAG and the March of Dimes recently announced a strategic corporate partnership focused on a shared commitment to improve maternal health and birth outcomes, as well as to reduce health inequities. Through the partnership, AMAG will participate in the March of Dimes Prematurity Campaign Collaborative and support the expansion of the March of Dimes’ Supportive Pregnancy Care (SPC) model, an innovative group prenatal care program.  

America’s Health Insurance Plans

AHIP has had a busy quarter with its ongoing Modern Medicaid Alliance efforts as well as the launch of its Coverage@Work campaign, a nationwide effort to bring employer-provided coverage to the forefront by highlighting the critical role this type of coverage plays in improving Americans’ health and financial security. Nearly 180 million workers, their families, and American businesses depend on employer-provided coverage for their health and financial protection. The program has evolved into one of the country’s essential lifelines for insurance, with an overwhelming majority of Americans reporting high-satisfaction with their coverage. Over the next year, the Coverage@Work campaign and advertising effort — which can be viewed here — will highlight innovative partnerships between health plans, employers, and employees nationwide.

American Society of Health-System Pharmacists

The American Society of Health-System Pharmacists (ASHP) is committed to addressing the day-to-day challenges that drug shortages create in our healthcare system. From sodium bicarbonate to small volume parenteral solutions to injectable opioids, shortages of critical medications dangerously interfere with the ability to care for patients. Following the Drug Shortages Roundtable ASHP convened in November 2017, ASHP has continued its longstanding efforts to highlight the impact of these shortages and raise the awareness of Congress and other healthcare decision makers about the need for a long-term solution. ASHP has sent letters to and met with key legislators, pushed officials at the Drug Enforcement Administration to ease restrictions on the production of injectable opioids, and worked with the FDA and many other concerned organizations to advocate for needed changes. ASHP recently launched the Enough is Enough campaign, which is designed to promote grassroots engagement of its members with federal legislators to educate policymakers on shortages and to advocate for effective solutions. 

Association for Accessible Medicines

AAM continues to urge Congress to pass the bipartisan CREATES Act, which will stop the anti-competitive practices that are costing patients billions. Most recently, on June 14th, the Senate Judiciary Committee passed the CREATES Act (S 974) on a strong bipartisan basis, and took a critical first step toward making real progress on the problem that U.S. patients care the most about: high drug prices. With a strong vote out of committee, one-third of the Senate now publicly supports this market-based solution—as do 86 stakeholder organizations representing patients, providers, consumers, industry, civil society groups, and many others committed to increasing competition and lowering prescription drug costs for patients. You can find more information about REMS abuse—which costs patients and taxpayers more than $5 billion each year—and the CREATES Act, including a list of supporters and cosponsors, online here.

AAM’s Biosimilars Council recently released a white paper offering policy recommendations to promote the development of a robust biosimilars market in the United States. Breaking Through on Biosimilars: Delivering More-Affordable, Innovative Medicines to America’s Patients, highlights the current regulatory, legislative, market and education challenges to ensuring patients gain access to these innovative, life-saving treatments. The white paper also provides solutions to current challenges in biosimilars market development including:

  • Hurdles intended to thwart competition, such as restricted access to reference products, patent abuses and trade agreement provisions that extend monopolies;
  • Obstacles to market-based competition once the FDA has approved an application, including naming, labeling and interchangeability rules, and reimbursement issues; and
  • Efforts to disseminate misinformation to patients and health care professionals to slow biosimilar uptake.

Bristol-Myers Squibb

Bristol-Myers Squibb has been focused on Medicare Part D access issues and analyzing and responding to the Administration’s Drug Pricing Blueprint and RFI.  

Caregiver Action Network

Caregiver Action Network (CAN) has been conducting workshops entitled “Family Caregivers Matter: Shared Decision Making for Family Caregivers.” The workshops teach caregivers about caregiving tools, creating patient and family centered goals, and shared decision-making. The next workshops will be held on 7/22 in Chicago and 7/29 in Los Angeles. 

Duke-Margolis Center for Health Policy and the Medication Adherence Alliance 

Three priorities for the Duke-Margolis Center for Health Policy and the Medication Adherence Alliance in the next year are:

  • Improve health policy (nationally and locally) to support medication access and management;
  • Improve communication between providers and patients/caregivers; and
  • Improve patient skills for medication use/management/adherence.

FDA’s Center for Drug Evaluation and Research (CDER)

In May 2018, CDER updated its webpage on the Disposal of Unused Medicines. This highly visited page is designed to help consumers determine the best disposal method for their medications. An interactive infographic was created to help consumers walk through the decision-making process associated with medication disposal and includes links to valuable resources, such as drug takeback options and the FDA’s flush list.

FDA’s Office of Women’s Health

The FDA Office of Women’s Health (OWH) held “The Great Debate: What is Enough … Women in Clinical Trials? on May 16, 2018. Featuring two cardiologists, Dr. Ellis F. Unger, FDA’s Center for Drug Evaluation and Research (CDER), and Dr. Rita F. Redberg, University of California San Francisco Medical School and Chief Editor of JAMA Internal Medicine, the debate centered on cardiovascular disease clinical trials and the challenges and complexity of the question, “What is enough?” when determining participation of women in these trials.

FDA and OWH staff authored a publication titled, “Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs.” Published in the Journal of the American College of Cardiology, this study examined clinical trial inclusion/exclusion criteria, women’s participation, and the reported safety and efficacy by gender for pivotal cardiovascular disease trials submitted to the FDA supporting marketing applications over one decade (2005-2015). 

The OWH Research and Development program accomplishes its goals largely through its intramural research project, which addresses knowledge gaps in regulatory science pertaining to sex differences and health conditions unique to women. OWH developed the Research Impact and Outcomes Framework as a guide to developing an organizational impact and outcomes measurement tool for program assessment and reporting.

In the fall, OWH will be hosting a scientific conference on sex and gender differences in the misuse and abuse of opioids and tobacco.

Healthcare Distribution Alliance

The Healthcare Distribution Alliance continues to work with partners across the pharmaceutical supply chain and healthcare sector to educate consumers about prescription opioids through Allied Against Opioid Abuse (AAOA). HDA launched AAOA in February 2018 with the goal of helping to solve the opioid abuse epidemic by educating consumers about the rights, risks and responsibilities associated with prescription opioids.  

A recent Morning Consult survey, commissioned by AAOA, underscored the gap in education and awareness about the safe and appropriate use of pain medication. The findings demonstrated how imperative it is to equip consumers and their families with the latest information on safe use, storage, and disposal of prescription opioids. 

Through AAOA, HDA is working with national partners as well as local communities to provide education and create awareness. Check out this video to learn more about AAOA’s local programs and partnerships. To learn more, visit Pease contact Lee Lynch ( if you are interested in getting involved with AAOA.


Beth Battaglino, RN, CEO, presented ““Strengthening Families and Communities: Improving Access to Medication-Assisted Treatment for Substance Use Disorders,” with Paul Samuels, Director/President, Legal Action Center, at the Women in Government National Legislative Conference, plenary session, June 21, in San Francisco. Beth and Paul conveyed to state policy makers from across the country the importance of improving access to medication-assisted treatment (MAT) — now considered the gold standard for treating opioid-use disorder. For women, the impact of opioid use disorder is especially acute, and Beth highlighted the effects barriers to MAT have on women, families, and communities. Both Beth and Paul encouraged policy makers to examine how their states are navigating these issues and to develop plans to address them. 

On June 13, HealthyWomen hosted “Alla Nostra Salute! To Our Health!” dinner program and silent auction at the Embassy of Italy. The program celebrated innovation in women’s health, advocacy, and women’s health research with remarks by keynote speaker John Whyte, MD, MPH, on the state of diversity in clinical trials. Esteemed speakers also presented on a range of topics from non-opioid-based pain management for women from a physician’s and a consumer’s perspective, sex influences on brain and body, research on Zika virus and pregnancy, and the importance of access to preventive care and screenings for women.

HealthyWomen also hosted the panel, “Women & Clinical Trials: Past, Present & Future,” May 16 at the Women’s Health Empowerment Summit: Breaking Barriers, Changing Futures, with the Coalition for Women’s Health Equity, convened by Hadassah.

National Association of Nurse Practitioners in Women’s Health 

NPWH recently held its second Healthy at Any Age Summit and is in the process of forming the Coalition on Older Women’s Health. If you or your organization are interested in learning more information about the Summit or Coalition, please email Additionally, NPWH just concluded its fifth annual Women’s Sexual Health Course for NPs and looks forward to its 21st Annual Premier Women’s Healthcare Conference, as well as the launch of its Patient Portal, later this year.

National Council on Patient Information and Education (NCPIE)

On June 8, 2018, after completing a formal dissolution process and transfer of a broad range of educational assets including the primary website,, ground-breaking research and the annual “Talk About Your Medicines” month observation in October, the National Council on Patient Information and Education (NCPIE), organized in 1982, has merged these resources with a like-minded 20 year old national non-profit group NeedyMeds, based in Gloucester, MA. The NeedyMeds mission — to help people find assistance with the cost of medications and healthcare services complements NCPIE’s mission of over 35 years — to promote safe and appropriate use of medicines through trusted communication for better health.  

NeedyMeds will now be able to expand its consumer and patient education and provide information across the entire medicine use continuum: access to needed medicines; safe and appropriate use of medicines; safe storage of medicines; and safe disposal of unused medicines. NeedyMeds provides information on all the pharmaceutical patient assistance programs (PAPs), copay programs, and other types of financial assistance for those experiencing a hardship paying for medications and healthcare costs. The NeedyMeds website is visited by 13,000 – 14,000 visitors most weekdays. All of the data is free, easy to access, and updated regularly. The toll-fee helpline receives around 6,000 callers per month. All access is anonymous. As part of its expansion into health education, NeedyMeds has three additional websites:

  • Safe Needle Disposal— This site contains information on how to safely and legally dispose of home-generated used sharps.
  • HealthWeb Navigator — A site with reviews of health-related websites that will relaunch soon with a new look.
  • Findcare — A site containing free/low-cost/sliding-scale clinics.  

Deborah Davidson, with nearly 20 years of NCPIE experience, has joined NeedyMeds as a full-time staff member, where she will be responsible for managing the evolution of the BeMedWise program under the auspices of NeedyMeds. Ray Bullman, who has led NCPIE for more than 33 years as Executive Vice President, is helping with the transition as a volunteer advisor.  


On May 23, 2018, on the sidelines of the 71st World Health Assembly in Geneva, USP launched the Medicines We Can Trust Campaign, which seeks to generate a sense of urgency by raising awareness of the scope and impact of the problem of poor quality medicines, and inspire collective action by unifying a diverse and broad coalition of partners. Organizations can join the campaign by signing up here.

Verde Technologies 

New Health Advisory Council member Verde Technologies is committed to developing research-based scientifically proven solutions to reduce drug abuse, misuse and negative environmental impact. Its Deterra Drug Deactivation System deactivates drugs using activated carbon, rendering them inert, unavailable for misuse, and safe for the environment.