FDA questions Sanofi reporting of side effects

By Reuters
Posted Feb. 22 at 2:26 p.m.

U.S. health regulators have warned Sanofi-Aventis SA’s U.S. unit for failing to submit reports of possible serious drug side effects in a timely manner.

In a Jan. 28 letter made public Tuesday, the Food and Drug Administration said an early response from the drugmaker and its “promised corrective actions are inadequate to address the deficiencies.”

“We remain concerned that your … adverse drug experience reporting system has not been fully validated and may have resulted in inaccurate assessment and untimely submission of 15-day alerts,” FDA said.

Shares of Sanofi were down 3.3 percent, at $33.59, in afternoon trade on the New York Stock Exchange; the NYSE Arca Pharmaceutical Index, which was down 1.5 percent. Sanofi’s shares closed down 2.2 percent in Paris.

The agency uses reports of possible side effects from companies along with other reports to weigh whether “real world” use of a drug shows new or greater complications that could merit label changes, warnings or even withdrawal.

Sanofi spokesman Jack Cox in an e-mailed statement said the company acknowledged the FDA’s observations and is working with the agency to comply.

The FDA’s letter stems from agency inspections of Sanofi’s Bridgewater, N.J., facility in April and May 2010. The agency found the drugmaker had inadequate procedures in place to monitor adverse events and failed to submit serious and unexpected adverse drug experiences by the FDA’s deadline.

It also did not include information on postmarketing studies for several drugs — including its diabetes drug Apidra, colon cancer drug Eloxatin and antibiotic Ketek — in its annual report to the agency, according to the letter, posted on the FDA’s web site.

Information on completed, unpublished clinical trials on drugs such as Apidra, Eloxatin and sleep aid Ambien were also not submitted as required.

Sanofi responded to the agency in June, July and October 2010 with plans to correct the problem, but the FDA on Tuesday told the drugmaker its response was lacking.

The agency called on the company to take prompt action to correct the problem and respond to the agency within 15 days. FDA also said it could make another inspection.

While most warning letters are resolved without incident, the agency can seekĀ  fines and injunctions .

Separately, the FDA also released a warning letter to Sanofi’s German unit regarding manufacturing violations that led to contamination issues.

In that letter, dated Feb. 9, the agency cited the drugmaker for not having proper written or manufacturing procedures to prevent microbiological contamination such as that found in June 2010 with Sanofi’s Apidra.

Its staff also was not properly trained to help prevent contamination, the FDA added.

Sanofi’s Cox said the drugmaker had moved quickly to address the problems and takes the matter seriously.

“The company began addressing the FDA’s recommendations immediately, even before the inspection was completed and has developed a thorough action plan with a monthly regular update of the FDA,” he said, adding that Sanofi “is convinced that these issues will not disrupt its ability to supply products.”

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