Health Advisory Council Newsletter | Fall 2015

Welcome to the second issue of the Health Advisory Council Newsletter!

Mark your calendar for our end-of-year Council event: a briefing and holiday reception, featuring remarks by Dr. Robert M. Califf, Deputy Commissioner for Tobacco and Medical Products, U.S. Food and Drug Administration (FDA), recently nominated to be the next FDA Commissioner. Please join us on Monday, Dec. 7 at 4 pm at the Omni Shoreham Hotel in Washington, DC to hear from Dr. Califf, and network with other Council members. Please RSVP by Dec. 1 here!

 NCL health policy at work

Script Your Future Campaign – “So Simple, So Hard” was the theme of a medication adherence conference hosted by NCL in September in Sacramento, CA. Sponsored by the Agency for Healthcare Research and Quality (AHRQ), the speakers and attendees explored the challenges and barriers to medication adherence and highlighted tools and strategies to improve adherence and health outcomes, especially among underserved populations. NCL gathered more than 80 stakeholders including health care professionals, community health workers, advocates, industry representatives, policy makers, and researchers. Conference participants heard from researchers and experts on adherence and engaged with each other about possible collaborations and solutions. Click here to view conference presentation slides and video.[1]

In addition to the research conference, Script Your Future California partnered with the California Chronic Care Coalition and the California Pharmacists Association to conduct an informational briefing hosted by state Senators Richard Pan, MD and Jeff Stone, PharmD on Oct. 21in Sacramento. “Chronic Disease and Medication Non-Adherence: Problems worth Solving,” featured evidence based strategies to improve outcomes and reduce costs when treating people with chronic diseases, with a focus on Comprehensive Medication Management. In addition to the state Senators, speakers included Sloane Salzburg, Council for Affordable Health Care, Prescriptions for a Healthy America; Assistant U.S. Surgeon General Pamela Schweitzer, PharmD; the University of Southern California’s Steven Chen, PharmD; and Michael Hochman, MD, with AltaMed Health Services. Briefing materials are available here. 

PDUFA VI – NCL was one of two consumer groups invited by the FDA to be part of a panel  at a public hearing on the reauthorization of the Prescription Drug User Fee Act (PDUFA) at the FDA this summer. Under PDUFA, the pharmaceutical industry provides resources for FDA to review medications.  As part of her comments, Sally Greenberg, NCL executive director, made the case that there is a difference between patients and consumers, in how they view and weigh risks. A patient suffering from a serious illness is far more likely to take on greater risk to get the benefits from a specific treatment. A consumer, on the other hand, may refrain from taking a high-risk drug or choose a lower-risk drug for a moderate to mild illness or condition. The difference in risk assessment between patients and consumers is critical when considering the policy implications in the sixth reauthorization of PDUFA. 

Health insurance marketplace – NCL was part of an Alliance for Health Reform briefing in July called “Empowering the Consumer as the Ultimate Health Care Stakeholder.” The briefing, the first in a two-part series on the role of consumers and patients in our healthcare system and co-sponsored by NCL, explored questions such as: How is the evolving insurance marketplace affecting the choices consumers have when selecting a health plan, whether through a health insurance exchange, employer, or other mechanism? What information do consumers need to select a plan that is right for them? Rebecca Burkholder, NCL vice president of health policy, provided an overview of the consumer experience in today’s health care system, patients’ priorities in making health care and coverage decisions, and the challenges patients face in selecting a plan.

21^st Century Cures –  NCL was recently part of a group of patient and consumer advocates who met with FDA officials, including Acting FDA Commissioner, Dr. Stephen Ostroff, and  nominated FDA Commissioner, Dr. Robert Califf, regarding concerns about the 21^st Century Cures Act. The Act , passed the House in July,  intends to accelerate the discovery, development, and delivery of new drugs and devices. The legislation is currently being reviewed by the Senate HELP Committee. While some aspects of the bill could speed up the development of and access to new drugs, NCL and other consumer and patient groups have expressed concern that it could ultimately lower standards for approval of many medical products, placing patients at unnecessary risk. The current version of the bill would allow consideration of drug approvals based on clinical experience, replacing scientific data from large numbers of patients in well-designed and controlled clinical trials. Advocates also fear approval standards for medical devices could become less rigorous. As a part of a patient and consumer coalition, NCL is working to ensure that the bill provides greater access to medications without sacrificing safety.  

FDA approves first female treatment for low libido – This fall, NCL welcomed an announcement from the FDA of its approval of the first-ever treatment for women’s low libido. Approval of the drug—flibanserin, which will be sold under the name ADDYI—came nearly four decades after the condition of HSDD (Hypoactive Sexual Desire Disorder), which it will treat, was first recognized in scientific journals. For months, NCL and other advocates had been calling for FDA to consider the treatment option because it would be the first of its kind for women. In October 2014 and June 2015, NCL Executive Director Sally Greenberg testified in support of treatments for patients suffering from HSDD.

Reagan Udall Foundation Board – NCL is a member of the Congressionally created Reagan Udall Foundation board formed to support the FDA. RUF is a private public partnership that works on a variety of projects, including analyzing FDA data for safety signals on drugs, devices and other products regulated by the FDA. 

Medicare Advantage Care Coordination (MACC) Task Force – Despite the fact that two-thirds of Medicare beneficiaries have two or more chronic conditions, care for many of these individuals is fragmented. Beneficiaries often shuffle between numerous providers in multiple care settings, including doctors’ offices, the ER and hospital facilities. Without sufficient coordination across these various points of care, the health issues these beneficiaries are already facing may be compounded. NCL recently joined the MACC Task Force, an initiative founded by the Association of Health Insurance Plans, which is a collaboration of leading aging, caregiver, patient and provider organizations addressing the critical issue of care coordination. In October the Task Force launched the Care for Us Project, a campaign to build awareness around best practices related to care coordination and disease management of specific chronic conditions prevalent among Medicare beneficiaries

NCL staffing news

Health policy staff changes – After 14 years at NCL, Rebecca Burkholder, vice president of health policy, will be departing in early 2016 to start a new career in Thailand,  focusing on international development work. “I have truly appreciated having the opportunity to work on consumer health issues at NCL and to collaborate with so many well-respected organizations,” Burkholder said. NCL welcomes suggestions for potential candidates or other considerations as we look to fill this position. You can access the job description here. We look forward to introducing our new Director of Health Policy to the Health Advisory Council in 2016! 

Meet our new Linda Golodner Food Safety & Nutrition Fellow, Ali Schklair!

Ali is a graduate of Smith College and is from Cape Elizabeth, ME. She joined NCL staff in September after her time at the Nurse Practitioners in Women’s Health as a Continuing Education Coordinator.

“I came to NCL from an organization that works with health care providers, and it was interesting for me to switch over to an organization that supports consumers. Joining NCL with previous experience working with providers allows me to look at issues in full scope,” said Ali.

Schklair’s time at NCL has overlapped with the FDA’s new rules for the Food Safety Modernization Act (FSMA). This gave her the opportunity to learn about food safety during a very pivotal time. Read her thoughts on the final preventive control rules here.

 Member spotlight

Get to know two Health Advisory Council members–NCPIE and Lilly–with new Q&A’s. 

 Updates on member programs

National Council on Patient Information and Education (NCPIE) – Boy Scouts’ Safe Medicine Use Program. The Boy Scouts of America are joining efforts to promote safe medicine use with the new SCOUTStrong Be MedWise Award program, providing Scouts the opportunity to earn a patch for learning about responsible use of medicines. Created in collaboration with the National Council on Patient Information and Education, (NCPIE) the lessons involved in earning the patch–like learning how to read, understand, and follow a medicine label–can set youth on a course of responsible medicine use they can carry forward for the rest of their lives. The curriculum is also publicly available for educators and youth initiatives.

United States Pharmacopeia (USP) – Fight against food fraud. Globalization of food supply chains has helped make possible the wonderful, diverse, and affordable food supply that we all enjoy today. At the same time, it has increased the complexity, scale, and dynamics our food system, opening new doors of opportunities for fraudulent adulteration. To help manufacturers and regulators identify the ingredients most vulnerable to fraud in their supply chains and choose effective mitigation tools to combat economically-motivated adulteration, the USP recently released its Food Fraud Mitigation Guidance. Learn more about this tool and its potential impact on USP’s Quality Matters blog.

McNeil Consumer Healthcare – OTC Safety Program for 5^th and 6^th Graders. McNeil is thrilled to share the news of the launch of the 4^th year of the OTC Medicine Safety program. This program, developed in partnership with Scholastic and the American Association of Poison Control Centers, is an evidence-based educational program tailored towards 5^th and 6^th grade students with the goal of providing free resources to teachers, school nurses, community leaders, and families to support the education of tweens about the responsible use and storage of medicines. Research shows that students begin to self-medicate at 11 years old; if not equipped with the knowledge and training to make responsible choices around OTC use, they can form unsafe habits. Visit scholastic.com/OTCmedsafety to explore the new and improved website experience and the extensive host of optimized resources available – all available for free – to teachers, nurses, parents, and community leaders. Reach out to Leily Saadat-Lajevardi at lsaadat@its.jnj.com for materials to help you promote the program!

Consumer Healthcare Products Association (CHPA) – Acetaminophen Awareness Coalition “Double Check; Don’t Double Up” Campaign. Acetaminophen is found in more than 600 over-the-counter (OTC) and prescription medicines, including many that treat cough, cold, and flu symptoms. It’s safe and effective when used as directed, but there is a limit to how much you can take in one day. Taking more than directed is an overdose and can lead to liver damage. Taking two medicines with the same ingredient could be harmful. That’s why it’s important to read and follow the label every time you take a medicine. Double check; don’t double up! Find out more at KnowYourDose.org

CHPA survey on consumer knowledge About OTCs. In September, the CHPA Educational Foundation released the results of its national survey, conducted to identify consumers’ knowledge gaps around the appropriate use, storage, and disposal of oral OTC medicines. The survey was conducted online by Harris Poll in February 2015 among 2,002 U.S. adults 18 and older who have used or purchased oral OTC medicines in the last six months. Learn more at KnowYourOTCs.org

CHPA’s Up and Away Campaign. Pediatrics, the official journal of the American Academy of Pediatrics, in September reported a declining number of emergency department (ED) visits for unsupervised medication exposures in young children since 2010. After rising steadily from 2004 through 2010, the number of ED visits for these exposures peaked in 2010. According to the article, after 2010 this trend reversed, and visits decreased by an average of 6.7 percent annually. Through Up and Away and Out of Sight, a campaign led by CHPA’s Educational Foundation and the U.S. Centers for Disease Control and Prevention’s PROTECT Initiative, CHPA continues to remind parents and caregivers to store their medicine up and away and out of the reach of children. For more information, visit UpAndAway.org. 

 We want to hear from you!

We are seeking Advisory Council member input on events and activities for 2016. Feel free to contact Amy Sonderman with any ideas or suggestions (amys@nclnet.org).