February 4, 2022

APC leaders meet with FDA officials

APC leaders met virtually this week with FDA Center for Drug Evaluation and Research (CDER) officials to discuss APC proposals related to adverse event reporting, strengthening the 503B business model, and finding common ground on a narrow, permanent pathway for 503As to source shortage drugs to hospitals and clinics. It was the second such meeting in two months, both initiated at the invitation of CDER director Gail Bormel.

“One of the reasons we’re here is to cultivate trust between APC and the agency,” APC President Dave Miller told FDA representatives. “Our hope is that we can work together, in concert, on a range of issues that will advance FDA’s policy agenda and, frankly, ours as well.”

Other issues discussed on the call were APC concerns about FDA’s slowness is closing out 483s and warning letters and the prospect of restrictions on compounded hormones.

“We do understand that the agency has concerns about compounded hormones,” APC Treasurer Alexander Pytlarz told officials. “But you certainly don’t have a strong case for the kind of over-the-top, across-the-board restrictions called for by the NASEM report. So we ask you to go slow. Allow us time to provide you with good data – both from patients and researchers. And then, we’d ask that you not act unilaterally, but that you’d seek counsel from pharmacists and prescribers alike before you make any decisions on compounded hormones. The beneficiaries of these therapies number in the millions – women, men, and many in the transgendered community as well. Any effort to restrict their ability to access treatment based on flimsy science is not likely to go over well.”

Agency officials asked a number of questions and seemed interested in APC’s proposals. “The best outcome right now,” said APC Board Chair Mike Blaire after the meeting, “Is that we agreed to keep talking.”