Foreign Inspection Program Feels the Freeze

In the past week, the news media reported on President Trump’s meeting with some leaders of big pharma and among the themes discussed were the lowering of drug prices, cutting regulation, speeding up drug approvals and bringing jobs back to the U.S.  Previous postings have pointed out how the administration’s current freeze on Federal hiring may have the unintended effect of slowing drug approvals (see here). Also of interest is last December’s GAO report on FDA’s Foreign Drug Inspection Program, which reported that as of July 2016, 46% of the authorized positions in FDA’s foreign offices were vacant. The GAO also found that 33% or 1,000 of approximately 3,000 foreign drug establishments due for inspection have never been inspected, and that FDA plans to inspect all of these establishments over the next 3 years.  It is unclear how long the hiring freeze will last or how it may impact the inspection program.  Nevertheless, the uninspected drug establishments should be prepared for a rigorous initial FDA inspection.