FDA Gives Company Sole Rights to Ancient Remedy

SILVER SPRING, Md. – Scott McGrath, 24, suffers from a painfully inflamed lining of the heart. Four months ago, the price of his medication suddenly went through the ceiling.

Sixty tablets of Colchicine used to cost him $34.83, and cost his insurance company nothing.

CBS News medical correspondent Dr. Jon LaPook reports the medication is now called Colcrys,and costs McGrath $62.16. “Almost doubled the amount I paid, and it cost my insurance company $244.74,” McGrath said.

“The drug is no longer being sold by anyone but a single company, and that explains the price increase,” McGrath said.

Colchicine has been used to treat gout and other inflammatory conditions for thousands of years. How could one company gain a monopoly?

There are about 1,000 medications on the market that predate the existence of the Food and Drug Administration and therefore were never approved. FDA official Deborah Autor spoke to CBS News as head of the office of unapproved drugs. “Well, for me, unapproved drugs present current risks,” Autor said. “We don’t know what’s in them. We don’t know if they’re going to work properly. We don’t know how they’re made and that’s a real concern.”

Hundreds of thousands of people take Colchicine each year. The FDA said over the past 40 years, 169 deaths have been linked to the medication. A company called URL Pharma decided it would take the ancient drug, sold for 10 cents a pill, and test it as part of an FDA program to either approve these drugs or get them off the market.

“One company chose to seek FDA approval and they 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,” Autor said. “We discovered a lot of people were being excessively dosed with Colchicine.”

Unlike companies that develop drugs from scratch and study thousands of patients for years, URL Pharma started with a pre-existing drug. Its research did clarify safety and dosing information. In return for the studies, the FDA granted URL exclusive rights to sell the medication.

“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.

Fundman said the conversations among his colleagues was, “Just outrage that a company could take advantage of this FDA process and basically appropriate the drug for its own purpose. Even if a patient’s not paying the full price out of pocket, their insurance company’s paying it. Medicaid and Medicare have to pay for it. We’re all paying for it.”

How much are we paying? URL declined to speak about its sales so we went to a drug benefits manager called Prime Therapeutics. It told us the cost of an average 23-day prescription – including pharmacy charges – has risen from under $6.72 to $185.53…


Bryce Shonka is Liberty Voice's new Editor and also serves as the Deputy Director for Tenth Amendment Center. He is happy to be producing content for a new audience and from a new place (Seattle, WA).

1 Comment

  1. Alan

    October 13, 2011 at 8:47 am

    This is so typical of American regulators and corporations. I am just waiting to hear that air and water have been patented. Of course these brilliant inventions will be approved by the FDA, and the use ( not sale) of that naturally occurring stuff will be banned. Why do you put up with those who have managed to rob the world’s average people of Zillions of dollars by a process designed by the robbers and applauded by those wonderful people who have proven beyond doubt that they have no integrity and no brains. Of course if they are allowed to pollute the air and the water that is even better. Now they can prove that their inventions are far superior to anything that existed in the past, when people still has freedom of choice and brains.

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