Monday, September 3, 2012

Allowing import of needed drugs from Canada

Last year I wrote about a well-intended FDA policy about colchicine, a drug used since ancient times for gout, and now for other serious conditions, such as Familial Mediterranean Fever. As an ancient treatment widely used prior to formation of the FDA, colchicine did not require FDA approval as a new drug. Then in 2009, the FDA granted approval to URL Pharma for Colcrys, its version of colchicine, based on randomized controlled trials the company conducted. Because colchicine had never been subjected to the FDA approval process, Colcrys was, in a technical sense, a "new" drug approved for a "new" indication - treatment of gout and FMF - despite the centuries of prior use, and by regulation was entitled to market exclusivity. In 2010 the FDA ordered all other manufacturers to cease production and marketing of their versions of colchicine.

Unfortunately, Colcrys is not effective for some patients with Familial Mediterranean Fever. To maintain their health these patients need the generic form, which must be imported from abroad. A friend recently told me about the new roadblock a family member is encountering. Here's the letter that went to the patient's senators:
I am writing with regards to the recently passed Food and Drug Administration Safety and Innovation Act (S. 3187). The bill includes a provision (Section 708) that may prevent me from being able to import my prescription from Canada, which I depend on for my health and quality of life.
This legislation authorizes the seizure and destruction of safe prescription drug imports valued under $2500. I have a prescription for generic colchicine for a rare genetic disease which I have, Familial Mediterranean Fever. When I tried the US brand of colchicine, Colcrys, I experienced extreme side effects and a relapse of symptoms, resulting in a month of illness, including an overnight stay in the hospital with high fevers and dehydration. Through this experience, my doctor and I discovered that it is essential that I be able to access an alternative brand of colchicine. Due to an FDA ruling, all brands of colchicine except Colcrys were taken off the US market several years ago. I now depend on my prescription from Canada for my health and well being.

When I am able to take colchicine imported from Canada, I have no symptoms and live a normal, healthy life. Without access to this medication, I will experience fever episodes lasting from several days to a month, pain, and inability to eat. It will compromise my ability to finish graduate school, where I am currently working on a challenging program. It will put me at risk of future complications from my genetic disorder.

I am extremely concerned that when Section 708 of Act 3187 is implemented, I will lose access to my direly needed medication. Please let me know what you plan to do to change Act 3187 to allow me to continue my life. Thank you for your time and consideration.
I don't fault the FDA's intentions. But in a country of 300 million people, it will be the rare policy that applies to all in a fair manner. Justice requires a robust exception process in situations like the dilemma of FMF patients who require the generic drug.

The patient did her part in putting the issue onto the public table. Now it's up to the FDA to respond.


eric said...

"The Colchicine Debacle" by B. Joseph Guglielmo, PharmD, and an editorial by Rita Redberg, MD, in the Feb 11, 2013 edition of JAMA Internal Medicine finally address this issue in a major medical journal. Guglielmo states, "Financial incentives, including market exclusivity are meant to encourage discovery of NEW (emphasis mine) molecular entities and bring them to market."

Jim Sabin said...

Hi Eric
Thank you for the reference. I'll aim to read it in the next week or so and may then write another post based on it.