Compounding Pharmacies Say FDA Mismanages Compounding Ad Comm

An organization representing compounding pharmacies is criticizing FDA’s management of the advisory committee that recommends drug substances for placement on the list of chemicals approved for use in bulk drug compounding, saying the meetings don’t give due consideration to potential additions and FDA fails to act quickly on recommendations.

The comments come as some telehealth providers face scrutiny for selling compounded versions of weight-loss drugs.

The Alliance for Pharmacy Compounding submitted a comment on potential reforms to FDA advisory committees expressing concerns on FDA’s use of the Pharmacy Compounding Advisory Committee (PCAC).

PCAC advises FDA on issues related to individual substances that can be used as active ingredients in compounding medication, which are included on FDA’s list of bulk drug substances that can be used by compound pharmacies. FDA makes the final decision on which drugs appear on the list.

“There is a prevalent perception among pharmacists that FDA does not give adequate consideration to the scientific and clinical merits of compounded therapies,” APC wrote. “Though the agency continually reminds the public about the risks associated with compounded medications, it rarely reinforces the proper and essential role compounded drugs play in our healthcare system and drug supply chain. Moreover, it seems that the FDA is more interested in dissuading PCAC from adding items to the 503A bulks list than urging it to consider the merits of substances that prescribers believe benefit some patients.”

Pharmacy compounders are currently facing controversy over opposition from GLP-1 manufacturers to mass compounding of their drugs, a practice which is expected to continue even after the drugs fall off FDA’s shortage list. Eli Lilly recently told Inside Health Policy that FDA and state regulators need to intervene to stop compounders from mass producing unapproved copies of its weight-loss drugs, Mounjaro and Zepbound.

ACP also recently released its first best-practices guide for compounding pharmacies, and said it is anticipating the proposal of legislation that would give 503b outsourcing facilities an additional 180 days to continue compounding a drug after it is removed from FDA’s drug shortage list.

PCAC was first established in 1998. Since then, FDA staff has rejected adding 45 chemicals to the compounding list; six of those times, PCAC supported adding the substance. APC said the timeline for FDA to act on recommendations following PCAC votes is unclear.

“Since February 2015, there have been 11 PCAC meetings with votes cast for 61 nominated substances,” the letter says. “However, final decisions on these substances remain pending for extended periods. The FDA issued a final rule in February 2019 and proposed another rule in September 2019. That rule is still awaiting finalization nearly five years later. This leaves 20 items with no proposed rule.”

APC said FDA encourages submission of investigational new drug (IND) applications to sponsors as an alternative to adding a drug to the compound list, but the process is separate, and leaving drugs off the list can undermine patient access.

“Additionally, the FDA's reluctance to accept and formalize PCAC recommendations, as evidenced by the lack of formal notice and comment rulemaking, leaves the impression that the agency has predetermined certain outcomes, rendering the advisory committee process and recommendations merely a formality,” APC wrote. “This perception is reinforced when the agency has used taxpayer dollars ineffectively in promulgating rules banning the compounding of dosage forms that are not currently being compounded.”

The group criticized several other practices surrounding PCAC, saying there is often short notice for meetings that limits stakeholder participation, briefing documents are released only a short time ahead of meetings, and parties who nominate a drug for inclusion on the list have strict time limits for their presentations to the committee, while FDA staff do not. It also says FDA tends to reject applications for pharmacists who practice in patient-facing roles to serve on the committee, leaving out an important perspective.

Among pharmacists, APC says, FDA’s policies have led to “confusion and frustration about the advisory committee's role and the nonbinding nature of its recommendations.”

The organization calls for FDA to introduce more transparency on the committee and more opportunities for communication, and to ensure its processes help promote trust in the committee’s recommendations. -- Jessica Karins (jkarins@iwpnews.com)