September 25, 2023
Compounders make 162 congressional visits, gain bill sponsors
APC’s Compounders on Capitol Hill 2023 wrapped up Wednesday, having added a half dozen new sponsors to its drug shortage legislation in the House and cultivated serious interest in the bill language from a handful of Senate offices.
In addition to Hill visits, the event included conversations with FDA’s Office of Compounding Quality & Compliance Director Gail Bormel, and Angels for Change founder Laura Bray.
In an interview format presentation, APC’s Scott Brunner queried Bormel on a range of issues, including an FDA-proposed (but as yet not publicly released) rule awaiting review at OMB that would both create new criteria for inclusion on the “demonstrably difficult to compound” list and add certain items to that list.
“Because of our interest in protecting compounded hormones, our antennae went up on this one,” Brunner told the OCQC director. Though she would not say exactly what is in the proposed rule, Bormel provided context for it by indicating that it represents the necessary rulemaking resulting from items that were recommended for inclusion on the list by the Pharmacy Compounding Advisory Committee over the past several years. She also reiterated that any action on compounded hormones would be via consideration and recommendation by PCAC.
Here’s CCH 2023 by the numbers (with comparison to 2022):
Also, CompPAC events hosted during CCH raised $25,525 to support pro-compounding members of Congress.