Drug diversion – issues and identification
Section 505-1 of the FDCA authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS) if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks. Spotting drug diversion within the current reporting system is a major challenge due to limited information on the offending product. Close surveillance of drugs that could be used criminally to immobilize victims is particularly crucial. Drug-facilitated sexual assault (DFSA) is a