U.S. Subpoenas Bayer’s Records on Recalled Drug
The Defense Department issued Bayer a subpoena demanding documents related to the German drug company’s withdrawn cholesterol drug Baycol, the company said Thursday.
Bayer voluntarily recalled Baycol, now linked to more than 100 deaths related to a fatal severe muscle condition called rhabdomyolysis, in August 2001.
In January, the Pentagon’s defense criminal investigation arm demanded documents relating to Baycol, also known as cerivastatin, the company said in a filing with the Securities and Exchange Commission.
Bayer had held a contract with the Defense Department to provide the medication.
“Preliminary conversations with the Justice Department indicate that this is a joint Department of Defense/Food and Drug Administration investigation relating to cerivastatin,” Bayer said in its filing.
A company spokeswoman said she could not comment further but confirmed the probe previously had not been disclosed.
“Bayer is not aware of any charges or complaints filed in connection with this inquiry. Bayer believes it has acted responsibly and fulfilled its responsibilities to the U.S. government, and will work cooperatively to provide the information requested,” the company said in the filing.
The FDA said it could not comment on the existence of any investigations.
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