SINGAPORE--Japan's Ministry of Health, Labor and Welfare (MHLW) scolded Gilead Sciences Inc. ($GILD) for its failure to report overseas adverse drug reaction (ADR) cases involving three drugs within the required timeframe.
The ministry on Feb. 13 said that three drugs--sofosbuvir, a fixed-dose combination of ledipasvir and sofosbuvir, and idelalisib--are under development for Japan, but already sold abroad. Under the Pharmaceuticals and Medical Devices Law, companies that already sell drugs must file ADR reports within 7 days of when patients die and within 15 days for deaths or serious conditions caused by already-known ADRs.
Gilead failed to report a total of 735 ADR cases--674 (89 deaths) for sofosbuvir, three (0 deaths) for the ledipasvir-sofosbuvir combination, and 58 (22 deaths) for idelalisib--the ministry said, adding that the company has rectified the situation.
"Gilead would like to offer its sincere apologies for any inconveniences the company may have caused to patients and their families, medical personnel who participated in the clinical trials, and the public," the company said in a statement.
"We take this business improvement instruction very seriously, and will assure thorough regulatory compliance and appropriate remedial actions to prevent future recurrences and strive to regain public trust."Gilead entered the Japanese pharmaceutical market in October 2013. In June last year, it filed a new drug application for sofosbuvir.