Healthy Skepticism Library item: 8990
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Perrone M.
Reps. Ask J&J and Amgen to Stop Drug Ads
Associated Press 2007 Mar 22
http://www.iii.co.uk/investment/detail?type=news&code=cotn:BARC.L&it=&articleid=6032097&action=article
Full text:
Lawmakers Ask J&J and Amgen to Hold Off Promoting Top-Selling Drugs During Safety Review
WASHINGTON (AP) — A pair of Democratic congressmen called on drug makers Amgen and Johnson & Johnson to stop advertising their best-selling anemia drugs while regulators look at the potentially deadly effects of overprescribing them.
Reps. John Dingell and Bart Stupak, both of Michigan, issued letters late Wednesday requesting Amgen, which markets blockbusters Aranesp and Epogen, and Johnson & Johnson, which makes Procrit, cease advertising their products until a Food and Drug Administration panel meets in May to assess the safety of the drugs.
The letters ask both companies to report to Congress details on how they market their anemia drugs and any financial incentives paid to physicians to prescribe them.
Johnson & Johnson spokeswoman Stephanie Fagan said the company stopped marketing Procrit directly to consumers in July 2005.
“We do not provide financial incentives for physicians to prescribe our products, including Procrit,” Fagan said in a statement. “Consistent with industry practice, we do provide discounts that comply with federal regulations.”
A spokesman for Amgen said the company has never used direct-to-consumer marketing to promote Aranesp and Epogen, nor has the company given money to physicians to prescribe the drugs.
“Obviously we will cooperate fully and we look forward to sharing the requested information regarding our medicines,” said Amgen spokesman David Polk.
The three products had combined U.S. sales of $10 billion in 2006, according to IMS Health.
The lawmakers wrote that an estimated $700 million in annual sales of the drugs comes from uses not approved by the FDA. Dingell chairs the House Energy and Commerce Committee and Stupak chairs its subcommittee on oversight.
Last week, the FDA announced the drugs would carry new “black box” warnings, the most serious warning the government issues, cautioning doctors to be more careful prescribing the medicines.
Known as erythropoiesis-stimulating agents, the drugs are primarily used to treat anemia in patients with kidney failure and in cancer patients undergoing chemotherapy. Anemia is a blood disorder caused by a shortage of healthy red blood cells.
FDA pointed to recent studies showing that using doses higher than the recommended levels of the drugs can increase risk of death, heart trauma and blood clots. When used in cancer patients with anemia not caused by chemotherapy — a use not approved by FDA — studies showed increased risk of death even when the drugs were prescribed at normal levels.
Several analysts cut their price targets for Amgen following FDA’s announcement, and UBS lowered the company’s rating.
The Energy and Commerce Subcommittee on Oversight met Thursday morning to question FDA Commissioner Andrew Von Eschenbach and others on how the government ensures the safety of drugs.
Shares of Johnson & Johnson fell 20 cents to $61.03 in Thursday afternoon trading on the New York Stock Exchange. Shares of Amgen Inc. fell 6 cents to $60.54 on the Nasdaq Stock Market.
