colchine, Colcrys, FDA

Games Pharaceutical Companies Play: Part 2

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Games Pharaceutical Companies Play: Part 2

Several people have asked me about the dramatic jump in cost for colchine products.  After being available generically for over a century, colchicine is now only available as Colcrys®.  The Colcrys story is a despicable variant of the Auragan debacle (See Games Drug Companies Play:  Part 1).  It involves the unholy alliance of the FDA and the pharmaceutical industry.  Thanks to congress, the FDA's budget is tied to drug sales - the FDA charges a fee for reviewing a new drug for approval and then collects an annual fee as long as the drug is marketed.  Because colchicine was a part of the U.S. Pharmacopeia (an independent review organization) prior to the creation of the FDA, manufacturers were not required to obtain FDA approval for its distribution.  This meant that it was available generically for pennies per tablet. 

This was not a good thing in the eyes of the FDA, since no pharmaceutical company had paid an approximately $1.5 million new drug approval application fee, nor were any companies paying the FDA's required annual establishment fee of nearly half-a-million dollars or its $86,000 fee for permission to manufacture and distribute the product.  To deal with this "generic problem" the FDA launched the "unapproved drugs initiative" in 2006.  The "unapproved drugs initiative" offers exclusivity to any company that applies for and obtains FDA approval for an established drug that has not previously gone through the FDA approval process.  Never mind that these drugs are almost universally safer and more effective than newer "FDA Approved" drugs because they have withstood the test of time.

Enter URL Pharma.  The company commissioned a study to demonstrate the efficacy of colchicine (something that has been known for decades), and submitted the study to the FDA.  Based on the study, which used plain old colchicine, the FDA granted URL Pharma exclusive rights to sell colchicine under the brand name "Colcrys" for 3 years.  Since URL Pharma is now the only brand of colchicine approved by the FDA for treatment and prevention of gout it is able to charge $5.00 per pill.  (The FDA ordered all other cochicine manufacturers to cease production in 2010.) 

Does Colcrys contain additional ingredients to make it more effective than other colchicine products?  No.  It's plain old colchicine.  Did the company come up with a new and more effective vehicle to make the colchicine more available?  No.  It's plain old colchicine, with one significant difference - It's FDA APPROVED!!!

URL Pharma has created a financial windfall for itself, and as Colcrys' profits soar, so does the FDA's budget.  FDA officials pat themselves on the back for their great job of assuring cochicine's efficacy; patients get taken to the cleaners.  Deston Therapeutics (Games Drug Companies Play:  Part 1) could have done the same, but refused purchase protection from the FDA by submitting an application for approval and paying the required fees.  Therefore the FDA decided to make an example of them.  Don't be surprised if a wiser company decides to ante up and get FDA approval for A/B drops, forcing the other generics out of the marketplace.

For more on the story see .

Dale Peterson, M.D.