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Elaine Blais, JD: The FDA and Communications About Biosimilars


Elaine Blais, JD, partner at Goodwin and head of the litigation department in Goodwin’s Boston office, discusses what power the FDA has to regulate communications about biosimilars made by innovator drug companies.


The FDA has some power to regulate communications about biosimilars that might be made by branded companies, and they get that power from their power to regulate advertising in this space. We’ve seen citizen petition by folks like Pfizer asking FDA to get involved in managing the communications around the safety and efficacy of biosimilars. Hard to tell yet what FDA will do about that.

We know from the legislative fight around the [Biologics Price Competition and Innovation Act, BPCIA] that FDA really wants to stay out of litigation, and it may be the case of what we end up with seeing is the [Federal Trade Commission, FTC] or the [Department of Justice, DOJ] getting involved as we’ve seen in the Hatch-Waxman space, where there are examples of companies who have made significant misrepresentations about their product versus prior products or generic versions of their product, and have seen themselves faced with numerous litigations filed by a state attorney general, the FTC, the DOJ, the plaintiff’s bar, and competitors and the like. We may see that before we see FDA do much.

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