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FDA Grants Company Monopoly on Ancient Drug


From CBSNews:

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.

IMS Health gave CBS News the number of Colchicine prescriptions nationwide. Add it all up and the cost of URL’s price hike – over just one year – could exceed half a billion dollars.

With the higher price, URL has started a program to assist patients who can’t pay. So far, 60,000 have asked for help. URL declined a request for an interview, but in a statement said its research “dramatically reduced adverse reactions” from Colchicine.

“Did you anticipate that the pricing was going to go up 50 times?” LaPook asked Autor.

“I think that 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.”

So was the hike unexpected at the FDA?

“I think that is their decision,” Autor replied. “I think we were surprised that they set the price that high.”

Read the whole thing here.


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