From 10 cents to $2 a pill: the program that sent Rx costs soaring and what’s being done to fix it

Chuck Peterson was hit by sticker shock when he went to buy a needed prescription for his arthritis: A two-month supply of colchicine would cost him $225 out-of-pocket. The full six-month course, recommended by his rheumatologist, would cost him more than $600.

“My reaction was ‘goodness gracious,’ or maybe something I couldn’t say in polite company,” he told KHN.

The cost was in part because of a program called the “Unapproved Drugs Initiative” that ensured older drugs went through an approval process with the Food & Drug Administration (FDA). Colchicine was one of those drugs. Created in 1938, it was older than the FDA. No manufacturer ever took it through the approval process, but it was grandfathered in.

Then, in 2006 under the Unapproved Drugs program, the FDA approved a branded version of colchicine and gave the manufacturer seven years of exclusivity. There was no competition for the drug – and the cost soared to about $4.50 a pill. Eventually, generic competitors were approved, and the cost of the pill has dipped, but it’s still much more expensive.

In November, the federal government ended the Unapproved Drugs Initiative, saying it drove up drug costs and caused shortages. Now, the FDA is considering if it should replace it. Drug policy experts would like to see the Biden administration develop alternatives so that drugs that are on the market are safe and effective. One way that could happen is if the FDA worked with health care providers to collect and analyze data from their own patients.

Drugmakers have instead pushed for the FDA to continue approvals and grant market exclusivity — which drives prices up.

The back and forth over the Unapproved Drugs Initiative is not just a policy issue — it affects how doctors are treating patients. A rheumatologist in Omaha switched some of his patients to other, more affordable anti-inflammatories, but they can impact kidney function and blood pressure.

“I would love to see colchicine drop to the old days of pennies per pill through generic availability,” said Dr. Marcus Snow, who heads the American College of Rheumatology’s Committee on Rheumatic Care. “But I’m not expecting that.”

What do you think? Have your prescription prices gone up over the years? Share your story with Voices for Affordable Health here.