Up until the late 2000s, millions of American gout sufferers could buy colchicine, a long-established prescription drug to treat the painful ailment, for about 9 cents a pill.
By 2010, the price soared to about $4.50 a pill for the same medication, which had been used safely and effectively since the 1800s.
The reason for the spike was that in 2009, the Food and Drug Administration approved a branded version of colchicine called Colcrys and granted URL Pharma three years of market exclusivity for gout and seven years for familial Mediterranean fever, a much less common indication. That move forced the cheaper, older versions off the market. There are now generic versions on the market. But the price remains much higher than it was in 2009 -- $180 for 30 capsules at Walgreens.
Colchicine's product and price change grew out of an FDA initiative launched in 2006 to encourage drug companies to identify old drugs that had never received FDA approval and take them through the agency's approval process. Most of these products entered the market prior to the government's more rigorous standards established in 1938 and 1962.
The goal of the FDA program was to better establish the safety and effectiveness of these products. The agency estimated in 2006 there are several thousand drugs being marketed without its approval.
There are lots of reasons for the nation's rising prescription drug spending, which increased 6.3% from August 2015 to August 2016, according to the Altarum Institute. But you wouldn't think one of them would be that the federal government is actively encouraging drug companies to slap higher price tags on old, cheap products. But that's exactly what's happening.
I first reported on the colchicine price spike in 2009, and found that patients and physicians around the country were fuming about the FDA's role in the sudden, fiftyfold price increase for the drug. “They've made the price astronomical and it's not right,” one patient told me.
“It was greed, pure and simple,” a patient commented on the GoodRx prescription savings blog last November.
Last month, Politico Pro reported that other drugmakers have followed URL down this lucrative path, winning FDA approval for old, “unapproved” drugs and boosting the price. One such product is potassium chloride, used since the 1940s to treat low potassium in the blood. Endo obtained the exclusive market rights to the liquid version last year, knocking seven cheaper products off the market. The wholesale price nearly doubled in one year.
Another such product is neostigmene methylsulfate, long used to reverse the effects of anesthesia after surgery. When Flamel Technologies won FDA approval for the long-established product in 2013, it raised the price from $17 a vial to nearly $100 today.
Then there's vasopressin, used in cases of cardiac arrest. Its price shot up tenfold after Par Sterile won approval for a branded version in 2013.
Experts say it's generally desirable to have older drugs go through the FDA vetting process. But they question whether that review is worth it if it means patients have to pay much higher prices.
FDA officials acknowledge that prices go up after it approves older drugs and grants market exclusivity, but they say Congress does not allow the agency to consider costs in its drug-approval or safety-related decisions.
A 2010 New England Journal of Medicine article concluded there is no evidence that the FDA's approval of the branded colchicine product improved public health. The authors recommended that the agency reserve such actions for situations where the approval process would substantially improve disease management.
A study in the Journal of General Internal Medicine last year found after the introduction of the new, higher-priced colchicine product, the odds of patients receiving the drug within 30 days of gout diagnosis declined, and their average monthly prescription costs rose from $418 to $651.
Dr. Sean Fahey, a rheumatologist in Mooresville, N.C., said the higher colchicine prices have caused financial hardship for his gout patients and created medication compliance problems, particularly for [people in high-deductible plans and for Medicare patients] who aren't allowed to use the drug companies' discount coupons.
“When they could no longer afford colchicine, they started having more flare-ups and bigger issues with joint pain and swelling,” said Fahey, who serves as chairman of the American College of Rheumatology's insurance committee. “Then they wouldn't be able to go to work.”
Fahey called it “truly an unforeseen, unintended consequence that a drug company was able to utilize this so much to their advantage.”
In their blog post, the FDA officials expressed the wish that drugmakers will do the right thing by the public. The FDA “welcomes manufacturers' sensitivity to pricing of these newly approved versions,” they wrote.
Their hope is touching but probably misplaced.