A contentious compounding fight reignites

For the last few years, small-scale compounding pharmacists and a surprisingly large, bipartisan group of lawmakers have been blasting FDA on and off over certain drug compounding rules. Drama seekers rejoice: That fight is reigniting.

Welch, the Vermont Democrat, and Rep. Morgan Griffith (R-Va.) are circulating a letter addressed to soon-to-be acting FDA Commissioner Ned Sharpless, asking the FDA to rework a contentious draft agreement between states and FDA on regulating compounding, STAT has learned.

Griffith also introduced legislation last week that would force FDA’s hand on the issue. The International Academy of Compounding Pharmacists, the group behind the Griffith bill, is planning a Washington lobby day in May to push for it.

If you’re a STAT Plus subscriber you also know that Julie Dohm, FDA’s top compounding official who took a firm stance on this issue, left the agency last month for a K Street law firm. It remains to be seen whether her successor will be more willing to compromise with small-scale pharmacies. Read more.