Health Advisory Council Newsletter | 2016 Q3




Welcome to the Q3 issue of the Health Advisory Council Newsletter. This quarter, NCL and Council members have been active on many fronts. Please read on for NCL policy updates, a new Q&A with the Consumer Healthcare Products Association Educational Foundation, member updates, and more.

events.png Save the Date! 11/16 Ensuring Consumer Access to Healthcare Conference 

In response to Health Advisory Council member interest in a policy forum on access, NCL is sponsoring a Nov. 16, 2016 conference on Ensuring Consumer Access to Healthcare. The conference will bring together patient and consumer advocates, healthcare professional organizations, pharmaceutical and healthcare industry representatives, minority groups, insurers, researchers, and government officials for a thought-provoking examination of the current state of healthcare in America, and ways we can improve and increase access to care for all.

Discussion Panels include:

  • Strategies to Address the High Cost of Healthcare: Is Access for All Achievable?
  • The Move towards Value-Based Healthcare to Improve Patient Access
  • Improving Access to Care for Underserved and Minority Populations

Register here today. We hope you’ll be able to join us on Nov. 16! 

1health_icon.png NCL Health Policy at Work 

NCL-AHIP Partnership: MyHealthPlanGuide — In August, NCL announced its new partnership with America’s Health Insurance Plans (AHIP) to create accessible, educational content to help consumers develop the literacy skills needed to better navigate the complex and changing health care system. Central to the partnership is a new interactive website for consumers, named MyHealthPlanGuide, which is slated for launch in early October. We look forward to sharing this resource with you!

Prescription Drug User Fee Act Reauthorization — In August, NCL testified at the FDA Public Meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA VI). NCL expressed its support for the PDUFA program and many of the features of PDUFA VI, while stressing the need for the FDA to remain independent and not compromise its high standards for safety, efficacy, and quality of prescription drugs.

Click here for more NCL health policy updates. 

1spotlight_icon.png Member spotlight

Get to know Health Advisory Council member Consumer Healthcare Products Association Educational Foundation with a new Q&A

1members.png Updates on member programs

Allergan’s Bold Social Contract with Patients. In September, Allergan CEO and President Brent Saunders addresses commitment to innovation, access, and responsible pricing ideals and announces a bold Social Contract with Patients. The social contract is a commitment to live by 4 principles:

  • Principle 1: Invest & Innovate  
  • Principle 2: Access & Pricing  
  • Principle 3: Quality & Safety  
  • Principle 4: Education

Please learn more about these principles here.

Eli Lilly and Company
Today, more than 5 million Americans are living with Alzheimer’s disease. One in nine over the age of 65 has the disease, with the prevalence increasing to almost a third among those age 85 and older. Eli Lilly’s Alzheimer’s Readiness Project is committed to inspiring action by fostering a deeper understanding of Alzheimer’s, its evolving science, and the public health crisis it poses. Through outreach, events and partnerships, the Project strives to be an important partner and voice in the global Alzheimer’s conversation, elevating awareness of the need for and value of advancements in the fight against Alzheimer’s disease. To learn more, visit 

Food and Drug Administration/Center for Drug Evaluation and Research
Drug Safety Labeling Changes (SLC) Database 
Drug safety labeling changes (SLC) data on the Web will now be available much faster for health care providers, health information technology vendors, and the public to view, search, and download.

Prior to September 2016, FDA’s MedWatch program posted safety labeling changes on a monthly basis. Now, the SLCs will be housed in a CDER database and published as close to the day of the labeling supplement approval as possible. Prompt access to these vitally important safety data will ultimately benefit patients as this information will be communicated to their health care providers in a much more timely manner. The new CDER database will include SLC data from January 2016 forward. Data prior to January will continue to be available on the MedWatch Web site. Learn more here or access the database here.

Orange Book Web 2.0
FDA launched an enhanced Web site for the Approved Drug Products with Therapeutic Equivalence Evaluations list – most commonly known as the “Orange Book.” The Orange Book identifies drug products approved on the basis of safety and effectiveness by FDA. Orange Book users include pharmacists, prescribers, industry, Agency employees, and third-party payers.

The redesigned Orange Book has an improved look, feel, and functionality. Commonly used features, such as the search and browse options, can now be found on the home page. New features will help users navigate the Orange Book and customize their research. The new design also displays groups of accordion-like panels, which open to reveal new and enhanced features. It gives users a link to background information, Orange Book publications, and contact information.

The Orange Book first appeared as a print publication in October 1980. Since 1984, it has included information about patents and exclusivity for listed products. In 1997, FDA made the Orange Book database available for searching on the Web. Today “Orange Book” is one of the most searched-for terms on This user-friendly technology is also available as a mobile application, making it easier to access important drug information.

McNeil Consumer Healthcare
McNeil Consumer Healthcare is thrilled to announce the expansion and complete redesign of Grounded in consumer insights and data, the new website has updated content and resources, a new look and feel, and an improved user experience geared to our key audiences. The objective of this site has broadened beyond providing education about the safe use of acetaminophen to providing education about the appropriate choice and use of OTC analgesics and the safe storage and disposal of all OTCs.

In conjunction with the consumer site, McNeil also launched the Get Relief Responsibly® Professional Resource Center: Targeted to healthcare professionals (HCPs), the site aims to empower HCPs to make appropriate OTC analgesic recommendations and to encourage safe use dialogue with their patients. With the re-launch of the new, unbranded, McNeil is proud to offer direct pathways to many of its partner organization websites and resources. If you have any questions or are interested to learn more, please reach out to Leily Saadat-Lajevardi at

Medication Adherence Alliance
The Medication Adherence Alliance is an organization comprised of representatives from consumer advocacy groups, community health providers, non-profit groups, the academic community, decision-making government officials and industry representatives. Launched in early 2016, The Medication Adherence Alliance’s new website,, serves as a comprehensive repository of up-to-date adherence resources. From patient tools to new research findings to updates on related policies, the website provides a wealth of information for the health care community on medication adherence. Features include:

  • Patient and Provider Toolkits: Including a variety of products patients and providers can use to encourage medication adherence;
  • Adherence Facts: Key information for all members of the health care community;
  • Promising Practices: A compilation of current practices, as well as practices under development, that aim to help patients remain adherent; and
  • Research Compendium: Consisting of original research, reviews and meta-analyses and commentaries.

Upcoming Conference: Suboptimal Medication Use and Population Health – Intersection of Research, Implementation, and Policy 
The Suboptimal Medication Use and Population Health – Intersection of Research, Implementation, and Policy Conference will be held in Washington DC, December 5-6, 2016. The conference will assemble a variety of stakeholders representing diverse backgrounds (payers, patients, researchers, policymakers and government officials) to identify and disseminate practical and effective strategies to improve population health through better medication use. Conference details and registration information are coming soon.

National Association of Nurse Practitioners in Women’s Health
Call for public comment: Women’s Preventive Services Initiative draft recommendations

The Women’s Preventive Services Initiative (WPSI) Advisory Panel* and Multidisciplinary Steering Committee have released draft recommendations for women’s preventive health care services, including the HRSA-sponsored Women’s Preventive Services Guidelines. The draft recommendations are available for public comment from September 1-30, 2016. Please consider reviewing and contributing your feedback on these draft recommendations. Click here to enter your comments. 

*The WPSI is overseen by an Advisory Panel comprised of representatives from The American College of Obstetricians and Gynecologists (ACOG) and three other major professional organizations representing the majority of women’s health care providers, including the American Academy of Family Physicians (AAFP), American College of Physicians (ACP), and National Association of Nurse Practitioners in Women’s Health (NPWH). The Advisory Panel guides the work of the WPSI and ensures that the initiative delivers a consistent message.

National Council on Patient Information and Education (NCPIE)
Talk About Your Medicines Month (October 2016) – This October marks the 31st annual observance of “Talk About Your Medicines Month” by the National Council on Patient Information and Education (NCPIE) to call attention to the impact that high-quality patient – healthcare provider communication can play in promoting better medicine use and better health outcomes. This year’s theme: Let‛s Talk About Polypharmacy: America’s Other Drug Problem, casts a spotlight on a significant and growing medication safe use issue – POLYPHARMACY, the use of 5 or more medications by the same person at the same time – putting patients at increased risk for drug interactions and side effects. Coming soon on will be tips and resources for patients and providers to help manage polypharmacy including a “Are you at risk for harm by polypharmacy” checklist. Please contact Deborah Davidson at if you are interested in receiving the 2016 TAYM Month communications toolkit. 

The U.S. Pharmacopeial Convention (USP) launched the next generation of its Food Fraud Database (FFD 2.0) to help food manufacturers and retailers make informed decisions about ingredients in their portfolio that may have a greater potential of being adulterated. The goal is to provide brand protection, increase consumer trust and support new food safety regulations recently finalized by the FDA.

Food fraud, also referred to as economically-motivated adulteration (EMA), is a global economic and public health problem, costing industry an estimated 10 to 15 billion dollars annually and affecting as much as 10 percent of the global food supply. 

USP’s FFD 2.0 provides hazards reports on specific adulterants, making it easier for manufacturers and retailers to quickly identify ingredients with a known history of adulteration with potentially hazardous substances. For more information on the FFD 2.0 and other food fraud prevention tools, including standards, training and advising services, visit

1listen.png We want to hear from you!

Online members-only discussion board – We encourage you to take advantage of the online members-only communications portal, where members may share news, suggestions, and ideas directly with each other. Log on here. If you haven’t already, you will be instructed to create an account in order to view discussion items. The members-only forum is only visible to people who have been given access privileges.

Thank you for your continued interest in the Health Advisory Council!
Please stay in touch! Feel free to contact Karin Bolte ( or Amy Sonderman (


National Consumers League
Published September 28, 2016