Amgen and Johnson & Johnson will be required to publicize the life-threatening risks of their anemia drugs, under the latest government-imposed safety precautions to snare the blockbuster biotech drugs.
Under plans unveiled Tuesday, the drugmakers will work with doctors to document that cancer patients are briefed on the risks of the injectable medications before receiving Amgen's Aranesp and Epogen or Johnson & Johnson's Procrit.
The long-anticipated safety plan was developed with the Food and Drug Administration, following a highly publicized meeting on the drugs' safety in March 2008.
Company executives said the process was bogged down by the number of parties involved in vetting the plan — including doctors, hospitals and speciality clinics.
"There was a complexity here that spans multiple areas of clinical practice," said Amgen Vice President Roy Baynes, in an interview with The Associated Press. "So it's just taken an awful lot of time to work through this."
Amgen and J&J will be required to register each cancer doctor who prescribes their drugs, and educate them on using the drugs appropriately. To continue prescribing them, physicians must discuss the risks of the drugs before giving them to patients.
The plan will take effect in late March, according to the companies.
The drugmakers will also distribute a consumer-friendly pamphlet on the risks of their drugs to all cancer patients.
The three medicines at issue are multibillion dollar sellers because of their ability to boost oxygen-carrying red blood cells, reducing the need for painful blood transfusions. Prior to the introduction of Procrit and Epogen in 1989, blood transfusions were a necessity for patients with severe anemia.
But sales have fallen sharply since 2007, when the FDA added the first of several safety warnings to the drugs, based on evidence they can cause tumor growth and hasten death.
The new requirements only apply when the drugs are used in chemotherapy patients, who often struggle with fatigue from anemia during treatment. Specifically, the FDA wants to highlight the risks for patients with cancers of the breast, lung, head and neck and cervix.
The drugs are also used by kidney dialysis patients and the FDA is looking into the safety of that use.
Over the last three years, the FDA has repeatedly strengthened warning labels on anemia drugs amid concerns they hurt survival in cancer patients, especially at higher doses. Current drug labeling advises doctors to use the lowest doses possible.
Sales of the three drugs, known as erythropoiesis stimulating agents, fell nearly 30 percent between 2006 and 2008, according to health care data firm IMS Health. The drugs had combined sales of $3.1 billion during the first half of 2009.
Tuesday's announcement has been anticipated by Wall Street for nearly two years, and is unlikely to impact the financial outlook for either company.
Thousand Oaks, Calif.-based Amgen manufactures all three drugs. Procrit is sold by Johnson & Johnson's Centocor Ortho Biotech division, under a longstanding agreement between the companies.
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