December 17, 2021

Congressmembers to FDA: On cBHT, remember the patient

In a joint, bipartisan letter this week, 22 members of Congress urged FDA to “craft patient-centered policies that preserve treatment options” related to compounded hormones. That communication is a result of efforts by APC and its members to educate members of Congress about FDA’s implicit threat to restrict compounded hormones.

The letter asserts that the recommendations of the flawed NASEM report on compounded hormones “would interfere with the practice of medicine and prevent practitioners from treating their patients with therapies that they determine are best for their patients.”

Key points in the letter were that continued access to compounded hormones is key and that the personalized therapies that compounding provides are essential given the limited number of FDA-approved manufactured hormone products on the market.

Signatories on the letter include nine Democrats and 11 Republicans. In addition to lead sponsors Jennifer Wexton (VA) and Jaime Herrera Beutler (WA), signers included: Brian Fitzpatrick (PA), Buddy Carter (GA), Gregory Murphy (NC), Kathy Castor (FL), John Moolenaar (MI), Mark Pocan (WI), Dutch Ruppersberger (MD), Chris Stewart (UT), Beth Van Duyne (TX), Gary Palmer (AL), Markwayne Mullin (OK), Diana Harshbarger (TN), Julia Brownley (CA), Morgan Griffith (VA), Chellie Pingree (ME), Neal Dunn (FL), Ron Kind (WI), Peter DeFazio (OR), Bonnie Watson Coleman (NJ), and Michael Burgess (TX).