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A draft rule, we’re told, is headed to the Office of Management and Budget for its mandatory review, and so we should likely anticipate an announcement of a proposed rule soon.
Here's the thing: We don’t yet know what’s in the proposed rule. No one does outside FDA. All we have is this abstract, which is startling in what it may not explicitly say.
Could this be the agency’s long-anticipated move, based on the now-discredited 2020 NASEM report the agency commissioned, to restrict compounded hormone therapy? Or could this be something else? At the moment we are not yet sure, but rest assured, your APC public policy team will be reviewing it and will likely be discussing it with FDA – including raising the issue with FDA’s Gail Bormel in her appearance at CCH on September 19.
In a 2021 survey, 77 percent of compounders said cBHT was one of their top lines of compounded products. The patient base we collectively serve with those therapies likely numbers in the millions. And they’re counting on us to represent them.
If you compound hormones, your reasons for attending CCH likely just grew exponentially. Raising this matter with your member of Congress is urgent and essential to our ability to influence what is or is not included in a final “demonstrably difficult to compound” rule – or even quash such a rule altogether.
I urge you to get registered while there’s still time for us to schedule your Hill appointments.
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