FDA announces shortage drug imports, draft REMS guidance

Baxter Healthcare Corp. will temporarily import from the United Kingdom certain amino acid drugs in short supply in the United States, beginning with limited quantities in the next few weeks, the Food and Drug Administration announced last week. In other news, FDA last week released draft guidance aimed at making it easier for brand and generic drug companies to implement a shared risk evaluation and mitigation strategy. FDA can require drugs associated with serious risks to implement a REMS with elements to assure safe use. In such cases, current law requires brand and generic drug companies to try to reach agreement on a shared system REMS. “As we work to make it easier to engage in a shared system REMS, we’ll be looking more specifically at how we can address situations where innovator firms may be leveraging the single, shared system REMS requirement to block or delay generic competition,” said FDA Commissioner Scott Gottlieb, M.D. The agency will accept comments on the draft guidance through Jan. 8.