Playing Footsies: The FDA and URL Pharma - The Shocking Story of Colcrys (colchicine

[Kooky Korky, BSN, RN]

Colchicine used to cost 9 cents per pill. 9 pennies. Pretty affordable. It now costs $4.85 per pill.

Why? Because the FDA gave exclusive marketing rights for colchicine to URL Pharma for the years of 2009 - 2012. It was a reward for having done safety and efficacy studies. However, the exclusivity will likely live on much beyond 2012. Why again?

Any other pharmaceutical firm that would like to share the market will have to repeat the studies, according to 3 pharmacists (at CVS, Thrifty, and the VA) I spoke to about this. And cost is prohibitive, apparently.

This repeat study requirement tells me that 1. We should not trust the URL studies. 2. The FDA blessing of URL's study means nothing.

A Little History

Colchicine usage pre-dated the existence of the FDA. FDA has slowly but surely been getting around to testing drugs in this category so it can say "yea" or "nay" about them.

Guess what. Colchicine proved effective at treating gout, pericarditis, and other conditions, for which it has been used since at least the 1800's in America.

But to recoup study expenses, what used to be a very inexpensive and effective treatment now costs way, way more than it used to. Someone good at math can figure out the % of the increase.

Oh, URL offers some coupons and some assistance for those who need it and can't afford to pay $120 for a 30 day supply. But what a colossal mess for those who are not aware of these programs and those whose pharmacists and doctors fail to remember to inform them about available discounts - or who themselves are not even aware of same.

This is just one example of the politics of health care, one example of why we should not put blind faith in the FDA or any other government bureaucracy or in big Pharma.

See Wikipedia, my major source, for colchicine information.

P.S.

Essentially the same situation exists with albuterol, the life-saving asthma rescue drug.

When fluorocarbons were ordered out of the inhalers, the pharmacies took advantage of this situation to charge far more for the inhalers than they previously were charging. Why? Same drug. But, according to pharmacists, it was a different formulation, therefore no generic existed. Uh, albuterol is generic. This is another example, I believe, of fiscal footsies, a game played at the expense of patients.

Please write to your elected representatives in state and federal Congress and let them know how much you'd appreciate them bringing back sanity and fairness to situations like this and how much you'd like to vote for them again for doing so.

If you don't write to them, they won't know about the problem, so please take action asap. Thank you.

[tnbutterfly - Mary, BSN]

Moved to Nursing and Patient Medications for more response.

[Kooky Korky, BSN, RN]

Thank you, tnbutterfly.

[somenurse]

Oh yeah, the FDA and Big Pharma are in bed together for a long long time now.

So many aspects of the FDA being mostly owned by Big Pharma, will impact the meds we pass in many ways,

but, this article about the hows and why's of one particular meds prices being affected, is interesting, i will check that out.