Today the European Medicines Agency (EMA), Europe’s equivalent to the FDA, announced that it was investigating deficiencies in medicine-safety reporting by Swiss drug maker Roche. This announcement was in the wake of an inspection by British regulators that highlighted problems with their reporting system. The main issue has to with certain medicines that were part of a financial reimbursement program in the United States.
This pronouncement by the EMA was brought about because of a routine check on safety reporting which found Roche had not sufficiently looked into 80,000 reports that were linked to a company-sponsored patient support program dating back to 1997 to check if those incidents should have been reported as suspected adverse reactions. 15,161 deaths included in these reports may have been connected to Roche’s drugs.
Roche gave this statement: “Roche acknowledges it did not fully comply with regulations and appreciates the concerns that can be caused by this issue for people using its products.”