Gout Disease Control Suffered After FDA-Driven Price Hike: Study

Illustration of physician dispensing med

Pictured: Illustration of physician dispensing medication/Courtesy, iStock, pilli

A study out Tuesday found the price of the gout drug colchicine increased significantly in the last decade due to an FDA policy decision in 2010, leading to lower use and poorer disease control.

The research showed that the large increase in the price of colchicine in 2010 was associated with an immediate decrease in its use, according to research published in the Journal of the American Medical Association.

Patients with gout who were prescribed colchicine switched to cheaper treatments, like allopurinol and oral corticosteroids. The study also found increased emergency department and rheumatology visits for gout over the same period, suggesting poorer disease control.

In 2010, the FDA announced that it would no longer allow the sale of unapproved single-ingredient oral colchicine products, which had been available for decades as an inexpensive generic medication, including colchicine.

As a result, the price of a prescription for the therapeutic gout drug increased nearly 16-fold from $11.25 in 2009 to $190.49 in 2011, according to the study. Out-of-pocket costs for patients who took the drug jumped more than four-fold from $7.37 to $39.49 over the same period. The use of colchicine dropped 17% during this time and 27% over the following decade.

In 2010, the FDA required pharmaceutical companies to submit new drug applications and conduct clinical trials to prove the safety and efficacy of their colchicine products. Takeda Pharmaceuticals was granted exclusive rights to market a branded colchicine product called Colcrys.

This decision had a significant effect on the price of colchicine. Before the FDA's policy change, the average wholesale price of a colchicine tablet was around $0.09. However, once Colcrys became the only FDA-approved colchicine product on the market, the price skyrocketed to around $5 per tablet, making it 50 times more expensive than the generic versions previously available, the study concluded.

The History 

The FDA's decision to require clinical trials and approve only one colchicine product was based on concerns about the safety and efficacy of unapproved versions of the drug, the study explained. However, the price increase sparked criticism from patients and healthcare providers, who argued that it made colchicine unaffordable for many people who relied on it to manage their gout symptoms.

The study’s lead author, Dan Ly, assistant professor of medicine in the division of general internal medicine and health services research at the David Geffen School of Medicine at UCLA, said the policy change had serious consequences, even if unintended.

“A rather unique FDA policy resulted in the loss of competitors to colchicine from the market, which led to an enormous increase in its price,” Ly told BioSpace via email.

“As a result, the use of colchicine dropped. While patients with gout turned to other medications . . . such medications didn’t do exactly what colchicine did and had different side effects, possibly limiting their use. It appears, based on the increase in the number of emergency department and specialist visits for patients with gout, that their disease control got worse. This case of colchicine speaks to the possible clinical consequences of other policies and manufacturer decisions that result in significant jumps in the prices of other drugs.”

Unapproved Drugs Initiative

Colchicine is a medication that has been used for many years to treat gout, a type of arthritis caused by the buildup of uric acid crystals in the joints. Prior to 2010, colchicine was available in the U.S. only as an unapproved drug, meaning that it had not gone through the FDA's approval process for safety and effectiveness.

In 2006, the FDA launched the Unapproved Drugs Initiative (UDI), which aimed to remove unapproved drugs from the market and encourage manufacturers to seek FDA approval for their products. Colchicine was one of the drugs targeted by the UDI program.

As part of the UDI program, the FDA issued warning letters to manufacturers of unapproved colchicine products, informing them that they were in violation of the Federal Food, Drug, and Cosmetic Act. The FDA also announced that it would allow a single manufacturer, URL Pharma (later acquired by Takeda), to market an FDA-approved version of colchicine, Colcrys, to treat gout.

Ly said he came across colchicine pricing information and got interested in “how patients and their clinicians might have responded to this large price increase, like stopping their medication or changing their medication, and what the consequences of this price increase might have been.”

The FDA had historically exercised enforcement discretion with respect to certain drugs, including colchicine. Enforcement discretion means that the FDA may choose not to take enforcement action against a drug product being marketed without FDA approval as long as the drug is considered safe and effective and there is a medical need for the drug.

The price increase seen in the gout drug is likely not an isolated effect, Ly said.

“This type of price increase on previously generic medications can have large consequences on patient health. This might have been a unique policy, but other manufacturer decisions or state or federal policies can lead to a loss in competition, large price increases, changes to medication use and resulting changes in disease control.”

Update: (May 11) FDA declined to comment for this story. 

Lisa Munger is a senior editor at BioSpace. You can reach her at lisa.munger@biospace.com. Follow her on LinkedIn.

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