June 27, 2020
Three new APC task forces to be appointed
A few of the issues APC is working on will require a detailed response on behalf of the association and our members. We’re appointing three new limited-duration workgroups — they’re expected to convene virtually over the next few months.
Task Force cBHRT. NASEM’s FDA-funded compounded bio-identical hormone replacement therapy study is expected to be released on July 1. APC wants to be be prepared to offer our input on the FDA’s guidance on the issue, so the task force will develop a plan for gathering evidence documenting the effectiveness of cBHRT such as research (existing or new) and patient-outcome data. If FDA is opposed to cBHRT, we want to have demonstrably valid counter arguments ready.
Task Force Compounded Pain Creams. NASEM has already released its study (also funded by the FDA) on the effectiveness of compounded pain creams. Despite being inconclusive, FDA remains opposed to compounded pain creams. The task force will prepare our response to the agency by gathering evidence documenting the effectiveness of compounded topical pain creams and developing our counterarguments to its opposition.
Task Force Third Party Reimbursement. Compounders who are reimbursed by third parties face a variety of challenges. This task force will identify those challenges, make recommendations for addressing them, and “develop or identify tools and resources for assisting APC members” in navigating them.
Remember, APC doesn’t take a position one way or the other on our members’ business models. We exist to help ensure a regulatory framework and legal environment in which every business type can thrive.