ASTRAZENECA FACING STATE, FEDERAL PROBES
The attorneys general of California and Alaska have issued subpoenas to AstraZeneca seeking information about its marketing practices for Seroquel (quetiapine fumarate), and the SEC has made an "informal inquiry" to the company regarding payments to foreign doctors and government officials, the company said.
AstraZeneca said it is "in the initial stages of responding" to the two state attorneys general. The company made the announcement Oct. 26 in its third quarter financial report, just six days after the FDA approved Seroquel for treating patients with depressive episodes associated with bipolar disorder. No other details were available in the report, and a company spokesman declined to elaborate on the announcement.
A spokesman for the California Office of the Attorney General confirmed that the office had issued a subpoena to AstraZeneca, but said he could not comment any further on any ongoing investigation. A spokesman for the Alaska Department of Law said he could not comment on whether there has been any subpoena or whether any investigation is ongoing. However, according to AstraZeneca, the Alaska attorney general's office wants information on Seroquel's safety and efficacy in addition to information on the company's marketing practices.
Seroquel was previously approved for treating acute manic episodes associated with bipolar I disorder and for the treatment of schizophrenia. According to AstraZeneca, the new approval means that the drug is now "the first and only single medication approved by the FDA to treat both depressive and manic episodes associated with bipolar disorder."
As to the SEC inquiry, the company said it "is cooperating fully." A spokesman for the SEC said agency staff can neither confirm nor deny the existence of any ongoing investigation.