Amgen receives subpoena over promotional activity

THOUSAND OAKS, Calif.—Amgen received a subpoena from the New York attorney general regarding the pharmaceutical company’s promotions and other activities, according to a May 22 regulatory filing.

The May 10 subpoena is also seeking documents related to Amgen’s sales and marketing activities, medical education, clinical studies, pricing and contracting, license and distribution agreements and corporate communication, according to May 22 filing with the U.S. Securities and Exchange Commission. “Amgen intends to fully cooperate in responding to the subpoena,” the filing said.

On May 11, a class-action shareholder litigation suit was filed against Amgen in the U.S. District Court for the Central District of California. The suit alleges that Amgen and individual defendants made false statements that resulted in a fraudulent scheme and course of business operated as a fraud or deceit on purchasers of Amgen publicly traded securities, according to the same regulatory filing.

Amgen was served with a shareholder demand on May 14 to establish a special litigation committee to investigate potential breaches of fiduciary duties, according to the SEC filing.

And on May 16, the U.S. Senate Committee on Finance wrote a letter to Amgen requested a briefing to discuss the media reports about the marketing and safety of erythropoiesis-stimulating agents (ESAs), the filing said.

Sen. Chuck Grassley (R-Iowa) specifically requested documents and discussion about whether Amgen completed responses to U.S. Food and Drug Administration data requests, whether the company sponsored clinical trials that showed evidence of serious adverse events, whether Amgen told the FDA about studies related to the use of the anemia drugs Aranesp and Epogen in improving patients’ quality of life, and what actions the company has taken to inform doctors and patients of new safety risks surrounding ESAs.

On March 9, the FDA issued a black-box warning that outlined new safety information, which included updated product labeling for ESAs. The FDA pointed to recent studies with ESAs that have shown a higher chance of serious and life-threatening side effects and a greater number of deaths in patients treated with ESAs.