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Alexandra Kitson is an associate in the Governmental Practice in the firm's New York office.

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On June 27, 2023, the Food and Drug Administration (FDA) issued its final guidance for the presentation of “Quantitative Efficacy and Risk Information” in direct-to-consumer (DTC) promotional labeling and advertisements for prescription drug, biological products, prescription animal drugs, and OTC animal drugs (collectively, “Promotional Communications”).[1] As identified in both the 2018 Draft Guidance and this final guidance, the FDA has seen an increasing trend of quantitative presentations of efficacy and risk in Promotional Communications submitted to the Agency. OPDP has been taking a close look at these types of claims, focusing on quantitative data in in their only untitled letter of 2023. As further discussed in our June blog post, in their letter to Xeris Pharmaceuticals, OPDP raised concerns regarding percentages that overstated the efficacy of the drug, Recorlev® (levoketoconazole) by omitting necessary context needed to understand the quantitative data.[2]

Continue Reading FDA Releases Final Guidance on Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements

About

Alexandra Kitson is an associate in the Governmental Practice in the firm's New York office.

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