AMCP Urges Expanded Pharmacy Role and Flexibility in REMS

AMCP Urges Expanded Pharmacy Role and Flexibility in REMS

With Increasingly Complex Drugs, One-Size-Fits-All Regs Put Patients at Risk 

Alexandria, Va., July 25, 2013 — The Academy of Managed Care Pharmacy (AMCP) today proposed an expanded role for managed care pharmacists in administering the Food and Drug Administration’s Risk Evaluation and Mitigation Strategies (REMS) program. The professional association also urged FDA to adopt flexible regulatory rules and a standard electronic process for the program. An AMCP statement was submitted in conjunction with testimony by Mary Jo Carden, AMCP Director of Regulatory Affairs, before a two-day FDA meeting on standardization and health care integration in REMS.

“The FDA has an opportunity to enhance patient safety and outcomes by recognizing the important role that managed care pharmacists do and can play in administering complex and specialty medicines,” said AMCP’s CEO Edith Rosato. “AMCP members have been involved with REMS since its inception and are well positioned to help the FDA evaluate REMS programs by conducting health outcomes and effectiveness research utilizing readily available prescription and health information.”

  • In its testimony and statement, AMCP pointed out that medications with REMS are increasingly handled by specialty pharmacies, often requiring administrative burdens over and above those of regular prescriptions. These steps may be duplicative of safety and efficacy requirements put in place by managed care organizations. “Currently, these additional administrative responsibilities are not associated with additional dispensing fees, service fees, or other compensation to pharmacists or pharmacies. Therefore, AMCP again urges that FDA consider a compensation mechanism for pharmacists and pharmacies for administering REMS,” the AMCP statement read.
  • AMCP’s statement also urged FDA to adopt flexible REMS protocols, such as those being developed by the National Council for Prescription Drug Programs. “A standardized regulatory approach would be too limiting and cannot anticipate every REMS protocol, now and in the future. As medications become more complex and biosimilars are introduced to the market, FDA and the industry must collaborate to ensure their safety and efficacy. ... [T]herefore, FDA should provide flexibility in the approach to designing REMS protocols.”
  • Noting that FDA has completed only one federally required evaluation of a REMS program, AMCP proposed that “FDA utilize managed care organizations to conduct the necessary evaluations and research on REMS programs, including health care outcomes. Managed care organizations have access to comprehensive patient information and REMS information that may be used as the basis for this research. With appropriate funding, managed care organizations also can implement the appropriate systems to conduct this research.”

AMCP’s statement was submitted in response to FDA Notice for Docket Number FDA–2013–N–0502 (Federal Register May 22, 2013). The statement may be read in its entirety at

About AMCP
The Academy of Managed Care Pharmacy (AMCP) is a national professional association of pharmacists and other health care practitioners who serve society by the application of sound medication management principles and strategies to improve health care for all. The Academy's nearly 7,000 members develop and provide a diversified range of clinical, educational and business management services and strategies on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit. AMCP will celebrate its 25th anniversary in 2013. More news and information about AMCP can be obtained on its website, at 

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