June 16, 2024
FDA listened, we spoke
The FDA held a listening session on the “Use and Processes of Advisory Committees” on Thursday. APC’s Tenille Davis and PCCA’s AJ Day were there. Our comments to the FDA covered our concerns about the agency’s Pharmacy Compounding Advisory Committee (PCAC). We want that committee to give greater consideration to the merits of compounded therapies, provide more transparency in its decision-making, and improve its engagement with stakeholders.
To give you the gist, here’s a quote from her presentation:
[T]here is a prevalent perception among pharmacists that the FDA does not give adequate consideration to the scientific and clinical merits of compounded therapies. Though the agency continually reminds the public about the risks associated with compounded medications, it rarely reinforces the proper and essential role compounded drugs play in our healthcare system and drug supply chain.
