Brown Wants Tighter Oversight of API Outsourcing

Senator Sherrod Brown (D-OH) has called on the U.S. Food & Drug Administration (FDA) to explore tighter oversight of outsourcing of the production of active pharmaceutical ingredients (APIs) to overseas manufacturers:

• In wake of new report showing dangerous gap in drug safety efforts, Brown calls on FDA to tighten oversight of pharmaceutical company outsourcing is a media release issued by Sen. Brown's office late on June 27.

The release contains the full text of a letter from Sen. Brown to FDA Commissioner Margaret Hamburg. The letter includes comments on three categories of potential "user fee" that could be assessed on US drug manufacturers and API manufacturing facilities to cover the costs of increased efforts by the FDA to monitor the quality of APIs.