HHS and FDA Propose New Drug Importation Plans
In response to rising drug pricing, HHS and FDA have announced a plan to create two potential pathways to import drugs originally intended for foreign markets.
The first pathway would allow states, wholesalers or pharmacists to submit to FDA plans for demonstration projects outlining how they would import Health-Canada approved drugs. The demonstration projects would be time-limited and require regular reporting.
There would also be additional safety requirements on labeling, tracking and entry following importation, HHS says, as well as post-importation requirements on adverse event reporting, recall procedures and CGMP for certain manufacturing activities, such as relabeling.