FDA's worst-case anemia scenario

Here's a peek into the FDA playbook for tomorrow's advisory panel on Amgen and Johnson & Johnson's anemia drugs. According to documents posted on the agency website, those expert advisors will be asked to consider several limitations on the meds, which have been linked to increased tumor growth and reduced survival among some cancer patients. And the options include yanking FDA approval for that use.

Other possible measures include using the meds only in patients with incurable cancer or certain types of tumors, restricting distribution of the drugs, limiting advertising and promotion, and requiring informed consent.

If the panel recommends cutting off the cancer indication, that would be a huge loss for both companies. Amgen's Aranesp alone sold about $3.61 billion last year--and more than $2.1 billion of that was for use in cancer patients. Though the drugs would stay on the market--they're widely used in kidney-failure cases--and could be prescribed off-label to cancer sufferers, the safety concerns might curtail those scrips and the insurance reimbursements for them.

For those of you who'd like to dig deeper into the FDA's briefing documents for tomorrow's meeting, check out In Vivo's analysis: The blog looks at some arcane metrics for risk-management programs, which the FDA is newly empowered to institute. Funnily enough, the metrics all seem to add up to one thing: Risk management should lead to decreased sales.

- find the FDA's briefing documents [1] (.pdf)
- check out the New York Times article [2]
- read the story [3] in the Wall Street Journal
- see In Vivo's analysis [4]

Related Articles:
Do anemia warnings signal new limits? Report [5]
Study: Anemia meds hike death risk 10%. Report [6]
Medicare: Right to restrict anemia meds. Report [7]
New Medicare cap on anemia drugs could hammer Amgen. Report [8]
FDA: More risks from anemia drugs. Report [9]