LONDON -- Europe's top drug regulator announced yesterday it is taking action against pharmaceutical giant Roche for allegedly failing to properly report the side effects of 19 drugs being used by U.S. patients.
It is the first time the European Medicines Agency has begun a so-called "infringement proceeding" against a drugmaker. European regulations lay out numerous requirements for pharmaceuticals, including reporting suspected side effects and submitting such cases to officials.
British authorities brought the problem to the attention of European authorities in May, noting "serious shortcomings" in how Roche AG, based in Switzerland, reported potential side effects.
Regulators said about 80,000 reports by consumers of possible adverse effects to drugs sold in the United States had not been properly analyzed. Among them were more than 15,000 deaths. It was unclear whether Roche medicines caused those deaths.
The European Medicines Agency did not specify the side effects but said it was more concerned that potential reactions were not properly reported.
"It could have been anything like a rash on your hand to something more serious," including death, said Monika Benstetter, an agency spokeswoman. "There was a failure in the system," she said, noting they didn't have information on how many of the side effects may have been reported.
If Roche is found to have violated its reporting requirements, it could be fined up to 5 percent of its sales revenue in the European Union in the preceding year.
The European Commission, the executive body for the 27-country EU, asked the European Medicines Agency to begin the infringement process. The agency said it would investigate the allegations against Roche further.
The agency sent Roche a detailed letter listing the allegations and is awaiting the company's response. The agency has 18 months to finish its investigation. Then it will be up to the European Commission to decide whether Roche should be penalized.
Roche spokesman Daniel Grotzky said the company was working with the EMA. He said Roche recognized that some adverse events had not been reported properly. "We are taking measures . . . to make sure this does not happen again," he said.