Risk management programs and reimportation

Executive Summary

FDA shares concerns about the potential for reimportation to circumvent the distribution program set up for RU-486, McClellan says, but concern extends to all drugs covered by risk management programs. "This is a general concern about the safety of drugs that are imported that we don't regulate." During House debate on reimportation, PhRMA suggested to pro-life groups that they may have a stake in the vote based on the potential that the bill would ease access to RU-486 (1"The Pink Sheet" July 28, 2003, p. 13)...