Par Pursuing Settlement Of FDA Suit And DoJ Off-Label Investigation
This article was originally published in The Pink Sheet Daily
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.
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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.
At least nine complaints have been filed against the agency since March, most involving market exclusivity claims; lawyers expect innovators will be pursuing more cases as patents expire and biosimilars emerge.
Par will be acquired by private equity firm TPG in $1.9 billion deal if no other suitors come forward with a better offer over the next month.