Historically, the FDA has notified drug manufacturers outside of the United States of drug inspections weeks or even months ahead of time. The Senate Committee on Finance believes this gives foreign drug facilities ample time to correct or conceal noncompliance. However, U.S.-based drug manufacturers aren’t afforded the luxury of pre-announced inspections. According to a recent SIDLEY article, a newly introduced bill wants to eliminate the delay between notice and inspection for manufacturers abroad.
In Mid-January, Republican Senators from Indiana and Iowa introduced the Creating Efficiency in Foreign Inspections Act. Their hope is to eliminate the domestic disadvantage, and bring manufacturing back to the U.S. for a stronger supply chain for drugs and other pharmaceutical products. The bill in its current form is sponsored solely by Republicans, and likely won’t see approval in the Democrat-controlled Congress. That said, depending on the results of the November elections, the bill could resurface.