Tuesday, July 17, 2012

China - No abnormalities found in Roche Company investigations

No abnormalities found in Roche Company investigations

(People's Daily Online) 08:15, July 17, 2012

Recently, U.K. media reported that the multinational pharmaceutical enterprise Roche Company is being investigated emergently by European drug supervision departments for concealing the report of 15,000 drug fatalities and 65,000 adverse drug reactions.

The State Food and Drug Administration of China (SFAD) said on July 11 that it was paying close attention to this incident, and according to China's adverse drug reaction monitoring, no abnormality has been found regarding the drugs involved in the incident.

According to sources, this incident involves eight kinds of drugs, which are mainly used for treating such diseases as the mammary cancer, intestinal cancer, hepatitis, skin diseases and eye diseases.

Of these drugs, the Herceptin for treating mammary cancer, Mabthera for treating malignant lymphoma, Pegasys for treating hepatitis C, Avastin for treating rectal cancer and Tarceva for treating lung cancer are sold in China.

These drugs have been in the Chinese market for several years or even more than 10 years.

The SFDA said that no abnormality has been found in China's adverse reaction monitoring on the drugs involved in this incident. After the incident occurred, the Roche Company made a statement on July 11, saying that the incident of 15,000 adverse reactions of no safety assessment reported by the media was only limited in an U.S. project supported by patients.

According to the current assessment by the Roche Company, there is no sign showing drug products of the Roche Company are unsafe. Medical experts said that normally medicines must be tested by three institutions, namely the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Medicines and the U.K.

Healthcare Products Regulatory Agency (MHRA) before they are exported to China. However, these medicines must also pass through the State Food and Drug Administration of China. As Chinese people are different with foreigners in physique characteristics, foreign data cannot be directly used in China and must pass through China's testing institutions.


Related:@ Pharmalot

EMA: Roche Failed To Report Lots Of Side Effects

In any event, the EMA is telling Roche to ensure that all known, reportable adverse events are immediately reported to the appropriate EU authorities as required by law and the drugmaker must confirm to the agency that this has been done, both for products in clinical trials and for marketed products. Roche must also to submit a revised, comprehensive action plan by June 27 for evaluating and reporting all outstanding cases and plans for corrective measures to ensure advere events are reported correctly in the future. This includes evaluation of each of the 80,000-plus reports received by the patient support program in the US.

We asked Roche for comment ---
UPDATE: A Roche spokeswoman wrote this: "In January and February 2012, the UK Medicines and Healthcare products Regulatory Agency (MHRA) conducted a routine inspection of Roche’s global pharmacovigilance processes at Roche’s site in Welwyn....continue reading @ Pharmalot

@ FiercePharma.com

Roche, Genentech overlook 80,000 adverse reaction complaints

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.

- here's the EMA statement
- and the Wall Street Journal story
- read the Reuters story

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