Price for Ancient Remedy Skyrockets Following FDA Approval

Colchicine has been used to treat gout and other inflammatory conditions for thousands of years. It is a toxic natural product originally extracted from plants and first used in ancient Egypt for the treatment of rheumatism and swelling. The drug is also one of the 1,000 medications on the market that predate the existence of the Food and Drug Administration (FDA) and thus was never approved for use. Now the medication is called Colcrys and the price to buy it is going through the roof, causing much concern from the hundreds of thousands of people taking Colchicine each year.

Over the past 40 years, the FDA announced that 169 deaths have been linked to the medication due to concerns over its efficacy and how it is made. The company URL Pharma undertook the ancient medication, sell it for 10 cents a pill, and test it as part of an FDA program to either approve these drugs or remove them from the market.

FDA official Deborah Autor, head of the office of unapproved drugs said URL Pharma “spent tens of millions of dollars in order to present data necessary for that approval and in the process, there were some important things that came out of the approval process.” She added, “We discovered a lot of people were being excessively dosed with Colchicine.” To reward URL Pharma’s efforts, the FDA gave the company exclusive rights to sell the medication, but many health care providers are extremely against the FDA ruling.

“The reward that they got seems far out of proportion to the work that they did,” said Dr, Edward Fundman, a rheumatologist who’s been prescribing Colchicine for 30 years. The doctor went on to say that both he and his colleagues were outraged that this company could take advantage of the FDA process and virtually appropriate the drug for its own purpose. “Even if a patient is not paying the full price out of pocket, their insurance company is paying for it,” Fundman stated.

While research did clarify safety and dosing information, URL Pharma started with a pre-existing drug as opposed to other companies who develop drugs from scratch and study thousands of patients for years. According to Prime Therapeutics, the cost of an average 23-day prescription of URL Pharma’s exclusive drug has risen from less than $6.72 to a whopping $185.53.

Furthermore, IMS Health found that, if the number of Colchicine prescriptions nationwide were added up, the cost of URL Pharma’s price hike could exceed half a billion dollars over just one year. URL Pharma has started a program to assist patients who cannot pay the new high price and, so far, 60,000 people have asked for help.

When asked if she anticipate such a tremendous price increase, Autor thinks, “companies have control over the pricing and we certainly hope that they would take into account the interest of consumers and not price them unreasonably.” Still, Autor was “surprised that they set the price that high.”

Around the Web

FDA Approval of Ancient Remedy Sends Price Soaring [CBS News]

Price of Ancient Gout Remedy Goes Up 2,600% After FDA gives Approval to Drug that Has Been Used for Thousands of Years [Daily Mail]