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

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...