Amgen Inc. and Johnson & Johnson have been told by lawmakers to halt consumer advertising and financial incentives to doctors related to its anemia medications until safety reviews have been completed.
Representative John Dingell, a Michigan Democrat and chairman of the House Committee on Energy and Commerce, sent letters to chief executives of both companies expressing his concern about the anemia drugs, including Amgen's Aranesp and Epogen, and Johnson & Johnson's Procrit. Dingell also asked the companies to turn over documents related to promotion efforts.
Amgen spokesman David Polk said Wednesday that the company does not do direct-to-consumer advertising for either drug. It also doesn't give direct financial incentives to doctors who prescribe them, although the company has offered Aranesp discounts to cancer doctors. The company is complying fully with any requests or investigations related to the drugs, Polk said.
The FDA's Oncology Drugs Advisory Committee is scheduled to meet May 10 to consider the safety of the three anemia drugs.
A U.S. Food and Drug Administration advisory committee is set to meet May 10 to consider the safety of the three anemia drugs.
At issue are safety concerns regarding higher-than-approved doses and "off label" uses of the drugs, which are most commonly used to treat anemia in patients undergoing dialysis or undergoing chemotherapy for cancer. Recent studies are suggested an increased risk of death, blood clots, strokes and heart attacks in patients undergoing treatment for off-label uses, such as those with less severe cancer.
Aranesp is Amgen's best-selling product, and when combined with Epogen, accounted for nearly half of the Thousand Oaks-based biotech's revenue in 2006. Shares in Amgen closed up $1.17, or 2 percent, to $60.60 in trading Wednesday on the Nasdaq.
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