A Drugwonks reader writes (relative to the recent Pew report on FDA's need for more authority for overseas inspections and related matters):
There is another answer here. Section 801 of the FDCA, which has been revised recently to reflect the global reality, establishes an algorithm for FDA review of imports that priorities scarce resources according to product type, existence (or not) of registration, and other factors. The provision even addresses importation in cases of medical emergency and personal-use importation. It reflects careful attention from Congress – and makes clear that products originating ex-US get heightened scrutiny precisely because they’re not coming from inspected facilities. Asked and answered, people. Or should I say “by the people.”
There is another answer here. Section 801 of the FDCA, which has been revised recently to reflect the global reality, establishes an algorithm for FDA review of imports that priorities scarce resources according to product type, existence (or not) of registration, and other factors. The provision even addresses importation in cases of medical emergency and personal-use importation. It reflects careful attention from Congress – and makes clear that products originating ex-US get heightened scrutiny precisely because they’re not coming from inspected facilities. Asked and answered, people. Or should I say “by the people.”
