Generic drugmakers have acknowledged to the GAO that their inability to access samples of reference drugs because of distribution limitations under certain risk evaluation and mitigation strategies (REMS) delayed or discouraged them from developing generic drugs.
In practice, generic companies report that many reference drugmakers are now requiring a safety determination letter, which involves a lengthy delay and still doesn’t compel the company to supply samples. About half of approved REMS place limits on distribution.
“Officials from all four of the generic drug companies we interviewed told use that their inability to access samples of reference standard drugs with [ETASU] measures that limit distribution either delayed or discouraged them from developing generic drugs,” GAO reported. [FDANews]