The NEJM carried this important article in June – Incentives for Drug Development — The Curious Case of Colchicine
The implications of market exclusivity for the public health can be substantial. After the FDA approved Colcrys, the manufacturer brought a lawsuit seeking to remove any other versions of colchicine from the market and raised the price by a factor of more than 50, from $0.09 per pill to $4.85 per pill.4 These increased prices directly affect the availability of the drug to patients with gout or FMF who have long been using colchicine safely in an evidence-based manner. Exclusivity can also affect health care delivery more broadly. According to the Centers for Medicare and Medicaid Services, state Medicaid programs filled about 100,000 prescriptions of colchicine in 2007 and paid approximately $1 million for the drug. Use of the new brand-name colchicine could add as much as $50 million per year to these insurance programs' budgets at a time when they are addressing the rising costs of health care by reducing some services or raising eligibility thresholds.
You really must read the entire article. I suspect that you (like me) will have extreme outrage over this decision. Let me repeat – 10 cents a pill increases to $5 per pill. This is the same drug people. This drug was old when I was a medical student in the early 70s.
The WSJ weighed in on Friday – FDA Warns Certain Gout-Drug Makers to Stop, And Soon
Colchicine has been a gout remedy so long that its use preceded the FDA, and so the several companies that made and sold it didn’t need agency approval to do so. But last year, a Philadelphia company called URL Pharma won FDA approval for its colchicine product, Colcrys, to treat acute gout pain.
How can we decrease medical costs when our protector agency – the FDA – makes such an inane decision? One question – WHAT THE HELL ARE THEY THINKING?