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in Section I below and included as attachments), we also provide specific policy recommendations for ways in which the Draft Guidance could be amended that we believe both meets the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 Thus, in Section II below, we provide three specific proposed changes to the Draft Guidance, addressing prepackaging generally, automated dispensing, and emergency kits.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
-
Negotiated drug prices would force LTC pharmacists out of business, cost taxpayers billions, coalition says
If Congress does not pass proposed legislation to address the cost to long-term pharmacies related to negotiated drug prices, it could cost taxpayers up to $4.8 billion in increased healthcare costs over the next decade, the Senior Care Pharmacy Coalition said this week.
-
Op-ed: Long-term care pharmacies matter to rural Idaho
Access to health care in rural Idaho is critical, which is why I’m concerned about a serious problem facing our long-term care communities. Because of changes in drug pricing, as of Jan. 1, we may see 60% of America’s long-term care pharmacies close.
-
IRA Drug Supply Fee Bill For LTC Pharmacies Could Prevent $4.8B Cost To Taxpayers
Long-term care (LTC) pharmacies are stepping up their calls for Congress to pass the bipartisan, bicameral Preserving Patient Access to Long-Term Care Pharmacies Act with the release of a new analysis Monday (Nov. 17) by the Senior Care Pharmacy Coalition (SCPC) that found failure to ensure LTC pharmacies are not negatively impacted when new maximum fair prices for select Medicare Part D drugs become effective next year may cost taxpayers up to $4.8 billion in increased health care costs over the next decade.
Stay in the Know
Get the latest news and updates on issues impacting the long-term pharmacy community.