Regulators visiting a Roche ($RHHBY) facility in the U.K. found a surprise lurking in the company's computer system: 80,000 uninvestigated adverse reaction reports from the U.S. The reports are on a hodgepodge of drugs made by the Swiss company and include more than 15,000 reports of deaths, with some of the notices dating back 5 years.
In a statement meant to reassure anyone taking a Roche drug, the European Medicines Agency says there is no evidence of any negative effect on patients, yet, and that no action is needed to be taken by doctors or patients. Roche is the world's largest maker of cancer drugs.
The FDA tells The Wall Street Journal that it is working with the EMA to assess the impact. In a mea culpa statement provided to Pharmalot, the company acknowledged the colossal oversight, said it understands how the news might worry consumers, and said it was working to address the mistake. It said some of the reports can be traced to a Genentech "Patient Reimbursement Program in the U.S., which were not sent to the safety department for full evaluation, hence were not reported to the health authorities according to the applicable regulation."
The EMA discovered the problem in May during a "routine inspection of safety reporting systems." It has given Roche until June 27 to come up with a plan on how it will investigate each of the 80,000 reports as well as how it intends to avoid such problems in the future.
The EMA says the reports were collected through the Roche-sponsored patient support program (PSP) that provides financial help to patients who can't afford lifesaving drugs. Reuters says the reports date back to 1997. Patients or doctors often report problems encountered when a drug is being taken. It is then up to the companies to vet those and notify authorities if there is anything about the reaction that is potentially of concern. The agency said it did not know how many of the reports might have been made directly to health authorities.
The EMA says the 80,000 or so cases tied to the PSP were not the only adverse reaction complaints that went unreported by Roche. It says it also discovered another 23,000 unrelated reports in their reporting system and about 600 tied to clinical trials.
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