Follow-Up To Long-Term Care Pharmacy Listening Session
Jane A. Axelrad
Associate Director for Policy (HFD-005)
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Re: Follow-Up To Long-Term Care Pharmacy Listening Session
Dear Ms. Axelrad:
The Senior Care Pharmacy Coalition (SCPC), one of the organizations that participated in the Food and Drug Administration’s (FDA) August 26, 2015 “listening session” on long-term care (LTC) pharmacy (the Listening Session), submits the following supplemental information that FDA requested to further
elucidate LTC pharmacy issues and the potential impacts of FDA’s Draft Repackaging Guidance on LTC patient care.
At the meeting, FDA requested additional information from the industry, including written copies of opening statements; representative text of state “emergency kit” (or e-kit) laws; certain perspectives on product expiration dating; and definitional characteristics that FDA could use to identify LTC pharmacies. We are pleased to respond to that request, and have appended to this letter: (1) the written version of the statement that Robert Warnock made on behalf of the SCPC during the Listening Session (Attachment 1); (2) a summary and certain excerpts of state e-kit laws (Attachment 2); and (3) copies of federal definitions and policies appropriate to define LTC pharmacies (Attachment 3).
In addition to information addressing FDA’s requests for data that were raised at the Listening Session (summarized in Section I below and included as attachments), we also provide specific policy recommendations for ways in which the Draft Guidance could be amended that we believe both meets the
agency’s policy goals and addresses the operational challenges faced by the regulated LTC pharmacy community. Thus, in Section II below, we provide three specific proposed changes to the Draft Guidance, addressing prepackaging generally, automated dispensing, and emergency kits.
Recent Posts
-
House Lawmakers Push Bipartisan IRA Fix To Boost LTC Pharmacy Pay
A bipartisan group of House lawmakers introduced legislation aimed at ensuring long-term care (LTC) pharmacies are paid an adequate supply fee to maintain patient access to prescription drugs for which prices are lowered through the Medicare drug price negotiation program, with the new maximum fair prices (MFPs) for the first group of selected drugs to take effect at the start of 2026.
-
Bill would fix drug-negotiation pricing flaw that undercuts LTC pharmacists’ viability
Lawmakers have proposed a supply fee to bolster long-term care pharmacies facing major revenue losses with the implementation of negotiated prices on 10 commonly prescribed medications Jan. 1.
The Preserving Patient Access to Long-Term Pharmacies Act establishes a $30 per Medicare Part D prescription in 2026 and 2027.
-
Rep. Van Duyne Introduces Bipartisan Legislation to Protect Seniors’ Access to Long-Term Care Pharmacies
Washington, D.C. – Representatives Beth Van Duyne (R-TX), Brad Schneider (D-IL), Buddy Carter (R-GA), Sharice Davids (D-KS), and Deborah Ross (D-NC) introduced H.R. 5031 Preserving Patient Access to Long-Term Care Pharmacies Act, bipartisan legislation to protect access to essential medications and pharmacy services for seniors and other long-term care (LTC) residents in nursing homes, assisted living, and similar […]
Stay in the Know
Get the latest news and updates on issues impacting the long-term pharmacy community.