When Is On-Label Speech Off-Label Promotion? Par Links The Two In Suit Against FDA
Executive SummaryPar Pharmaceutical Inc.’s First Amendment suit against FDA offers a new approach to battling government allegations of off-label marketing.
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Par will pay $45 million for off-label promotion of Megace ES and enter a corporate integrity agreement that restricts incentive compensation for sales reps; the firm also drops its suit against FDA and removes descriptions of conversations with government officials from its court filings.
Parties have stayed their litigation as they continue to hammer out a potential global resolution that would also settle DoJ’s investigation of Megace sales and marketing practices.
FDA says Par’s suit challenging its off-label promotion regulations is unfounded since the agency would not take action against speech to doctors who prescribe Megace ES for both approved and unapproved uses. FDA also lays out the rationale for its off-label promotion rules from DESI to Prempro.