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Off-Label Worries Could Be Solved By Studies, Not Speech Reg Overhaul, FDA Suggests

 
• By Brenda Sandburg

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.

In response to Par Pharmaceutical Inc.’s lawsuit challenging its off-label promotion regulations, FDA says it would not object to speech about Megace ES (megestrol acetate) to doctors working in settings where the drug is prescribed for both approved and unapproved uses. But the agency also points out that Par declined to pursue clinical trials recommended by the agency to obtain approval of the drug for the off-label indications.

Par filed suit against FDA in October putting forth the novel argument that the agency’s rules prohibit on-label speech about...

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