Compounding, provider status, PDUFA V (the fifth reauthorization of the Prescription Drug User Fee Act), the NSURE (Nonprescription Sage Use Regulatory Expansion) Initiative, REMS (Risk Evaluation and Mitigation Strategies), and CMS activities were among the countless pharmacy issues mentioned in the Legislative and Regulatory Update session on Saturday and the FDA Update session on Sunday at the 2013 APhA Annual Meeting & Exposition in Los Angeles.
Pharmacy opportunities for funding as well as considerations when applying for funding were described on Monday at a third education session, Evolving Opportunities in State and Federal Programs.
Referring to the issue of compounding in FDA Update, Ilisa B.G. Bernstein, PharmD, JD, Deputy Director, Office of Compliance, Center for Drug Development and Research, FDA, said that the agency’s efforts, while working with CDC, to contain the fungal meningitis outbreak last fall was the most intense period of her 25-year career. She referred to current law on compounding, with its patchwork of state laws and regulations and history of conflicting court decisions, calling the regulatory gray area between federal and state oversight “just not appropriate for the evolving industry … and inadequate for patient safety.”
Bernstein then mentioned a December 2012 intergovernmental meeting involving FDA and all 50 states from which the agency heard very loudly that FDA needs to improve communication with the states, greater clarity between states and FDA roles is needed, and more resources at the state level are needed. She described the path forward for compounding, including consideration of new legislation based on a risk-based framework proposed by FDA and discussed among the agency and all 50 states at a December 2012 intergovernmental meeting.
Related to Congress, the Association’s lobbying efforts on compounding were discussed by APhA Senior Lobbyist Michael Spira at Legislative and Regulatory Update. APhA continues to meet with House and Senate staffers at both their and the Association’s request; Congress’s understanding of compounding has improved considerably because of pharmacy serving as a resource to Members of Congress and their staff, and the difference in understanding has been like “night and day,” Spira explained. Compounding legislation has been introduced, and pharmacists should expect to see additional legislative action this year. APhA has policy from its House of Delegates on compounding, he added.
With a brief overview of the profession’s provider status efforts, Spira continued his legislative section of the packed APhA Government Affairs team–hosted session. He explained that provider status—pursuing and obtaining coverage for pharmacists’ patient care services—was a top priority for APhA, and that the national pharmacy groups have been working together on a multipronged strategy to be guided by draft provider status principles currently under development. Meanwhile, the move away from fee-for-service to pay for performance and the drumbeat for the “doc fix”—a permanent fix to the sustainable growth rate, which is a widely reviled formula for Medicare payment to physicians—creates an opportunity for provider status for pharmacists.
During FDA Update, Bernstein unpacked the comprehensive FDA Safety & Innovation Act (FDASIA), signed into law in July 2012, which includes the often referenced PDUFA V. That’s because PDUFA, along with a reauthorized user fee program for medical devices and two new user fee programs for generic drugs and biosimilar products, comprise the first four titles of FDASIA.
A theme running through the FDA Update session, FDASIA also included titles for permanently reauthorizing provisions for pediatric drugs and devices, new abilities for accelerating drug approvals, and expanded early notification requirements for drug shortages—an issue that most in the audience were affected by, based on a show of hands. “It’s fortuitous that FDASIA was coming up,” Bernstein said, noting that FDASIA served as timely vehicle to include provisions to address drug shortages.
The NSURE Initiative—which aims to address the undertreatment of common diseases or conditions by allowing certain prescription drug products to be available OTC through conditions of safe use such as pharmacist or other health professional interventions or use of innovative technologies—was not ready to be put into FDASIA when that was moving through Congress, according to Bernstein. So FDA is moving forward with existing regulatory authority, meaning NSURE is not a third class of drugs; drugs are still either OTC or prescription. (It would require a manufacturer to submit such an application for FDA review.) She noted that APhA had “significant input” at a March 2012 public hearing and in the comments.
Improvements to REMS— risk evaluation and mitigation strategy programs that FDA can require to ensure the benefits of a drug outweigh its risks, which was signed into law under PDUFA IV in 2007—were within the PDUFA V agreement among FDA and manufacturers that outlines how FDA intends to spend user fees and authorized as part of FDASIA.
These REMS improvements reflected APhA’s advocacy efforts, said APhA Senior Director of Government Affairs Marcie Bough, PharmD, the other speaker for the Legislative and Regulatory Update. REMS improvements included earlier dialogue about REMS in the drug review process, and improved standardization and integration into medical and pharmacy practice technologies and workflows.
During FDA Update, Bernstein referred to a FDA REMS open forum to gather feedback from frontline pharmacists that took place Saturday in collaboration with APhA. She said the agency received good feedback related to the lack of consistency across REMS programs and that standardization is needed given the growing number of REMS programs. She added that FDA is working to ensure that REMS programs are better integrated into the existing workflow and trying to standardize REMS programs.
In Legislative and Regulatory Update, Bough highlighted CMS activities related to essential health benefits and state activities to implement health care reform provisions, Medicare Part D revisions, and proposed enhancements to medication therapy management services. She also noted ongoing activities with the CMS Center for Medicare and Medicaid Innovation to reduce hospital readmissions and opportunities to engage pharmacists in medication reconciliation and care transitions.
The Evolving Opportunities in State and Federal Programs education session was hosted by three speakers from the Pharmacy Society of Wisconsin and the University of Mississippi School of Pharmacy.
According to Leigh Ann Ross, PharmD, Associate Dean for Clinical Affairs and Chair of the Department of Pharmacy Practice at the University of Mississippi School of Pharmacy, potential funding sources at the state level include Medicaid, state health plans, the state department of health, and even the state department of education. Potential funding sources at the federal level include the National Institutes of Health, CDC, the Agency for Healthcare Research and Quality, the Health Resources and Services Administration, and the Administration for Children and Families.
More potential funding sources include foundations such as the APhA Foundation, the National Association of Chain Drug Stores Foundation, the Community Pharmacy Foundation, pharmaceutical industry foundations, the W.K. Kellogg Foundation and the Robert Wood Johnson Foundation. Places to look for opportunities, even if funding does not flow directly from them, include other entities such as the National Alliance of State Pharmacy Associations and PQA (Pharmacy Quality Alliance).
Target areas for funding pharmacy-related projects include community-based participatory research, patient-centered medical home models, collaborative care models, patient care transitions, quality best practices, medication safety, medication adherence, and telehealth and telepharmacy, Ross told attendees. Finally, things to consider when applying for grants include setting up the project to demonstrate positive outcomes to advance the profession; incorporating prior data into the proposal; using regional or local data and not just national data to support significance and relevance; providing a sound rationale for the composition of partnerships and clearly describing how funding is divided among partners; and paying attention to barriers to community participation.