FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Council Calls for FDA to End Study of Foreign Drug Importation

Nov. 13, 2018
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Importing prescription drugs to cut U.S. drug prices and improve access to medicines poses safety risks, the Council for Affordable Health Coverage (CAHC) argued, warning the FDA against expanded drug importation policies.

In a letter to FDA Commissioner Scott Gottlieb, the industry group questioned the agency’s July 19 announcement of a work group to develop temporary policies for drug importation to deal with drug shortages. The work group was charged with identifying regulatory and legislative requirements needed to help the FDA assess the safety and effectiveness of imported drugs and encourage generics.

CAHC expressed concern about the integrity of the drug distribution chain — with the possibility of counterfeit or unsafe drugs getting into the nation’s supply — and a lack of data showing that importing certain drugs would drive down prices.

“No data we have seen would result in lower costs for consumers,” the council said. “Absent any new data, we see little reason to roll the dice on a risky scheme when other solutions are at hand.”

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