NCL health policy updates | Health Advisory Council Newsletter | Summer 2015

Access  to medications, health care, information, coverage – is a prominent theme among members as a priority, as well as in the issues we are addressing at NCL. And with the recent decision by the U.S. Supreme Court in King v. Burwell, access to health care for millions under the Affordable Care Act will continue, even while we work to ensure consumers have access to critical medications and treatments they need. The Supreme Court’s 6-3 vote is a major victory for consumers nationwide.

Vaccines  Meningitis B (MenB) outbreaks on college campuses has been a devastating public health issue in recent years. The FDA recently approved two MenB vaccines, and, in June, the CDC’s Advisory Committee on Immunization Practices (ACIP) met to decide on recommendations as to who should receive them—only high-risk populations or broader populations. NCL spoke at the ACIP meeting in favor of a routine, or broad, recommendation to ensure access to this vaccine before a deadly outbreak occurs. Dozens of speakers addressed the ACIP, including survivors of the disease as well as relatives of victims, all urging the committee to recommend routine vaccinations for young adults ages 16-23. Ultimately, the CDC declined to give a broad recommendation for the MenB vaccinations, recommending instead that decisions to vaccinate adolescents and young adults be made at an individual level with healthcare providers. NCL is disappointed with the decision and stands with patients and their families in support of protecting young people from the devastating consequences of MenB.

Flibanserin – NCL has championed women’s health and gender equality for decades and recently applauded the vote by the FDA advisory committee to recommend approval of the drug Flibanserin for low libido in women, or female sexual dysfunction (FSD). The most common FSD condition is loss of sex drive, or HSDD. At present, there are no FDA-approved drugs to treat FSD. Although there has been a diverse range of opinions concerning the drug, NCL presented testimony at the recent FDA meeting in favor of approving this treatment, and in support of giving women the same access to treatment for HSDD as provided to men, who now have 26 drugs for sexual dysfunction. 

Script Your Future Campaign  The Script Your Future campaign announced the winners of its 2015 Team Challenge, an annual competition that encourages health profession students and faculty across the nation to develop creative ideas, events, and initiatives to raise public awareness about the importance of medication adherence. NCL is proud to announce that this year’s Challenge winners were the University of Pittsburgh School of Pharmacy, University of Maryland School of Pharmacy, University of Charleston School of Pharmacy, and the Northeast Ohio Medical University College of Pharmacy (NEOMED). NCL continues to fulfill frequent requests for medication adherence materials, including Public Service Announcements and wallet cards that help patients keep track of their medications and provide basic questions for patients to ask their HCPs about the medication they are taking.  

21st Century Cures – The 21st Century Cures Act was introduced in Congress to focus on accelerating the discovery, development, and delivery of new drugs and devices. 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 this legislation could ultimately lower the 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. And 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.  

Cosmetics – Cosmetics reform is long overdue. The current cosmetic product legislation, or the Federal Personal Care Products Safety Act, has remained unchanged since its enactment in 1938. Senator Dianne Feinstein (D-CA) and Senator Susan Collins (R-ME) are co-sponsoring new legislation that would give the FDA broader oversight of personal care products and more authority over companies to disclose adverse product reactions reported by consumers. Consumer groups, including NCL, are encouraging lawmakers to include additional measures to the bill that will help to ensure enhanced consumer protections.

New navigating healthcare marketplace site – NCL is partnering with a communications firm and Anthem to develop a new resource to help Americans navigate a complex and changing health care system. The content will focus on such decisions as choosing a health plan, selecting providers, sorting through drug formularies, and the information needed to make informed choices.

Biosimilars – Biosimilars, which are essentially identical versions of biologic drugs, are complex medicines made from living cells that treat deadly and debilitating diseases. It is good news for consumers that biosimilars are expected to enter the U.S. marketplace in the coming weeks. The first biosimilar for Neupogen, which reduces the risk of infection from chemotherapy for cancer patients, was approved by the FDA in March. NCL has a long history of advocating for increasing affordable access to lifesaving medicines. Biosimilars hold great potential for saving consumers money and increasing their access to lifesaving treatments.

PDUFA VI – Under the Prescription Drug User Fee Act (PDUFA), the pharmaceutical industry provides resources for the FDA to the review medications. The legislation expires in 2017 and, in order for the agency to continue to collect these user fees, it must be reauthorized. NCL has been asked by the FDA to be part of a panel on July 15 at the FDA headquarters in White Oak to represent the consumer perspective as part of this reauthorization process.

NCL continues to monitor other issues related to medication safety: compounding pharmacies, counterfeit drugs, dietary supplements, the safe use of pain relievers, and more.