Biotech officials concealed safety info from FDA

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SAN DIEGO — Officials with a Sorrento Valley-based biomedical device manufacturer admitted in federal court Thursday to failing to provide the Food and Drug Administration with required information that would have cast doubt on the safety of an aneurysm treatment the company developed.

A felony guilty plea for Valor Medical Inc. itself was entered in federal court in San Diego in connection with Neucrylate, which was intended for use in blood vessels in the brain and near the heart.

fdaAdmitting guilt to a misdemeanor version of the same crime were former company CEO H. Clark Adams, 66, and regulatory and clinical affairs manager Cathy Bacquet, 57.

Valor founder Charles Kerber, 77, and chief scientist Peter Friedman, 49, entered into prosecution agreements in which they admitted having known that required information had been withheld from the FDA, according to the U.S. Attorney’s Office in San Diego.

Former Valor consultant Alan Donald pleaded guilty in a related criminal case for his role in failing to submit test results to the regulatory agency. At the time, Donald was a member of the Board of Directors of Valor Medical and paid as a regulatory consultant, court documents state.

U.S. Magistrate Judge David Bartick sentenced Adams and Bacquet to a year of probation each and fined them $5,000 and $2,500, respectively.

A status hearing for Friedman and Kerber is scheduled for Monday. Sentencing for the corporation was slated for Feb. 19.