Sheppard partner Dominick DiSabatino spoke with Corporate Counsel in connection with the legal and regulatory implications of an FDA advisory committee’s recommendation to allow compounding pharmacies to sell six currently unapproved peptides. Despite objections from FDA science staff regarding the lack of sufficient safety and efficacy data, DiSabatino noted that the recommendation appears likely to advance, stating, “I don’t see a lot of game scenarios where they don’t get on.”
DiSabatino also suggested there may be an “openness to maybe some kind of middle ground” in which the peptides are approved with safeguards designed to track adverse events and allow regulators to quickly remove products from the market if necessary.
Addressing potential litigation risks, DiSabatino observed that plaintiffs’ attorneys could pursue claims tied to alleged injuries from compounded peptides, noting, “You could imagine having the plaintiffs’ bar having tons of creative ways for individuals injured by these products to seek remuneration of some sort.”
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