May 15, 2007
J&J, Amgen under fire for anemia drug marketing amid safety concerns
Marketing practices of anti-anemia drug makers Amgen and Johnson & Johnson came under criticism as an outside panel called for more limits to the drugs’ labeling.
The Wall Street Journal reported that two former J&J sales reps are claiming in a lawsuit that their former employer padded its profits on Procrit by offering rebates to doctors while urging reps to push higher doses than those approved.
Documents show Ortho Biotech “created complex purchasing programs offering doctors discounts and cash rebates,” according to the WSJ. Since Procrit is an infused drug, doctors buy the drug, administer it in their office and collect payments from insurers or the government. Discounts offered by drug firms can increase doctors’ margins—a potentially illegal practice under antikickback laws.
In addition to those allegations, The New York Times ran an exposé about “hundreds of millions of dollars” in payments J&J and Amgen make each year to cancer physicians, dialysis centers and other big users of Procrit and Amgen’s Aranesp. The payments are legal, notes the Times, but few outsiders know their real size and critics claim the cash influences doctors to over-prescribe the drugs.
Over the last few years, the report adds, the payments have risen as the companies compete for market share.
As commotion swirled around these promotional practices, Medicare yesterday said it is considering limiting reimbursement for the drugs, which are indicated to prevent the need for blood transfusions in chemotherapy patients. Under a proposal, Medicare would pay only for their use to treat anemia in certain cancers but not to prevent the condition. A decision is expected by Sept. 14.
That announcement followed other bad news for this product category, known as erythropoiesis-stimulating agents. Last week an outside advisory panel to the FDA voted to put additional restrictions on the labels of the drugs. Among the recommendations, the committee voted 12 to 5 that the drugs should be barred from use by patients with certain types of cancer until more is known about their safety; 15 to 2 that there should be more restrictions in general if the drugs remain on the market; and 17 to 0 that more studies were needed.
That last vote—to conduct additional studies—might turn out to be very costly and time-consuming for the firms. (The FDA typically follows its panel’s advice but is not bound to do so.)
Amgen would be especially hard hit by the loss of its anemia drugs. Last year, Aranesp had sales of $4.1 billion, while its other anti-anemia drug, Epogen, had sales of $2.5 billion. They accounted for 46% of Amgen’s 2006 revenue.
J&J, as a more diversified company, could absorb such a blow more easily. Procrit generates sales of $3.2 billion for J&J, or about 6% of its total. Procrit and Epogen have the same active ingredient. J&J sells Procrit under license from Amgen.
Aranesp and Epogen are also used to treat anemia caused by kidney disease, and that indication will be dealt with in a future advisory committee meeting.
The recommendations follow a string of published studies showing that the drugs may be unsafe at commonly used doses. And in March, the FDA put a back-box warning on their labels, saying the products should be used at the smallest dosage that lets anemic patients avoid blood transfusions.