A pair of Democratic Congressmen has asked Johnson & Johnson and Amgen stop DTC advertising of its anemia medications to cancer patients until the FDA can complete a safety review of the drugs.
Rep. John Dingell of Michigan, who serves as chairman of the House’s Committee on Energy and Commerce, and Rep. Bart Stupak, also of Michigan, fired off letters to both drugmakers requesting them to end financial incentives to doctors related to anemia drugs and to turn over documents related to promotional efforts.
The anemia drugs, Amgen’s Aranesp and Epogen and J&J’s Procrit, have come under increased scrutiny after clinical trials raised questions about their safety in certain cancer patients. Earlier this month, the FDA issued revised product labeling in the form of a “black box” warning for anemia drugs, also known as erythropoiesis-stimulating agents (ESAs), in cancer patients.
Both Amgen and J&J confirmed the receipt of lawmakers’ letters in published reports.
“Amgen will fully cooperate,” Amgen spokesman David Polk told Bloomberg.com. “…The well being of patients is the company’s top priority.”
However, Amgen has never used DTC advertising to promote Aranesp or Epogen, Polk said. The company also said it does not offer financial incentives to doctors to boost prescriptions of the drug.
Ortho Biotech, the J&J unit that sells Procrit, stopped DTC TV advertising two years ago, spokeswoman Stephanie Fagan told Bloomberg.com.
Before that, Procrit TV commercials in aired in 2001 and told consumers the drug could help boost their energy and provide “strength for living.”
Aranesp is Amgen’s best-selling product, generating $4.1 billion in global sales during 2006. Aranesp and Epogen together account for an estimated 47% of Amgen’s 2006 revenue.
The three drugs together had combined US sales of $10 billion in 2006, according to IMS Health.