December 16, 2022

Leaders talk adverse events reporting with FDA

In a listening session this week with FDA officials, APC leaders outlined a draft of an adverse events reporting framework for 503As that could be incorporated into legislation in the next Congress. Still speculative for now, such legislation could eliminate the requirement that FDA sign an MOU with states regarding interstate shipments of compounded medications. It anticipates replacing the MOU—and having to cajole states sign it—with a requirement for reporting by pharmacies that ship more than 50 percent of their compounded drugs out of state and implementing reporting of adverse events by all 503As, among other possible measures.

The AE framework, developed by an APC work group earlier this year, would require reporting by pharmacies of “serious” adverse events (as defined in CFR 310.305) via the same NABP portal that was developed for reporting of interstate shipments under the MOU. The proposed framework would shield pharmacies from disciplinary action based simply on the filing of an adverse event and would require pharmacies to conduct and substantiate a reasonable investigation of the reported adverse event. It would also prohibit entities from denying certification or accreditation based merely on the reporting of adverse events by a pharmacy.

“Embracing reasonable AE reporting requirements could enhance the credibility of the compounding profession—’reasonable’ being the magic word, of course,” said APC’s Scott Brunner, “By limiting the reporting to only ‘serious’ adverse events, we shield pharmacies from specious charges, and by requiring investigation and reporting back, we can gain better, more nuanced root cause data than what can be derived from FDA’s FAERS database currently.”

Other issues discussed with FDA in the listening session include recent guidance on compounding beta lactams, FDA’s attempts to reclassify DTE as a biologic, APC’s patient-reported outcomes initiative, and the agency’s progress in speeding the closing of 483 files.