EMA Probes Roche For Reporting Failures
By Ed Silverman // October 23rd, 2012 // 8:40 am
Three months after the European Medicines Agency found that Roche failed to report tens of thousands of adverse events in connection with its various drugs, including 15,161 patients deaths, the agency is now initiating what its calls an infringement procedure at the request of the European Commission (read the statement).....
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Roche probed for not reporting
side effects
LONDON (AP) -- Europe's top drug regulator announced Tuesday
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 drug maker. European regulations
lay out numerous requirements for pharmaceuticals, including reporting suspected
side effects and submitting such cases to officials.
Eight of the drugs involved are used for the treatment of
cancer, including breast cancer. They include Avastin, Herceptin, Tarceva, and
Xeloda. The flu drug Tamiflu was also included in the list.
British authorities brought the problem to the attention of
the European authorities in May after noticing "serious shortcomings" in how
Roche AG reported potential side effects.
Regulators said about 80,000 reports by consumers of
possible adverse effects to drugs sold in the U.S. had not been properly
analyzed. Among those reports were over 15,000 deaths, though it was unclear if
those deaths were caused by Roche medicines.
The regulator said there was no evidence that users of
Roche's drugs were at risk.
The European Medicines Agency did not state what the side
effects were but said it was more concerned that these 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 officials
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 five percent of its sales revenue in the
European Union from the preceding year. Shares in the company fell 2 percent on
Tuesday.
The European Commission, the executive body for the
27-country EU, asked the European Medicines Agency to begin the infringement
process. In a statement, the European Medicines Agency said it will further
investigate the allegations against Roche.
The agency sent Roche a detailed letter listing the
allegations against them and is now awaiting the company's response. Officials
have 18 months to finish their investigation. After that, it will be up to the
European Commission to decide whether Roche should be penalized.
Daniel Grotzky, a Roche spokesman, said the company was
working with the EMA to provide more information and it did not want to
speculate on the outcome of the investigation. Roche said patient safety was "of
paramount importance" and that it was possible some of the potential side
effects may have been reported to European officials in other ways, such as
reports from doctors.
"Both the EMA and other health authorities have consistently
said there is no change to the safety profile of our drugs," Grotzky said.
He said Roche recognized that some adverse events had not
properly been reported in the past.
"We are taking measures within the company...to make sure
this does not happen again," he said.
Related
Roche Company investigations
Drug giant probed for not disclosing 15,000 patient death reports: Roche under investigation by UK watchdogs after 80,000 'adverse reactions'
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