Canadian Pharmacies Benefit From Huge Jump in Price of Gout Drug

Concerned that older drugs that have been in use since before the inception of a stringent approval process in the 1960's may not meet current standards for safety, effectiveness, quality and labeling, the Food and Drug Administration (FDA) launched the Unapproved Drug Initiative in 2006.

 

Under this initiative, the consumer protection agency ordered pharmaceutical companies manufacturing unapproved drugs to either undergo rigorous and expensive clinical trials to obtain approval for the drugs, or to remove them from the market. In return, those companies winning approval would be given exclusive market rights for a time period, to allow them to recoup their investment.

 

Among the many older commonly prescribed drugs that have never gone through the formal FDA review and approval process are morphine, phenobarbital, nitroglycerine, and the gout medication colchicine. Colchicine has been widely used in many countries since the 1930's, and won FDA approval in combination with a second gout medication, probenicid, in the early 1980's, but has never been approved as a single ingredient medication.

 

One of over twentyUSpharmaceutical companies manufacturing generic colchicine, URL Pharma, successfully underwent the rigorous approval process and received exclusive rights to market its brand name colchicine, Colcrys, in 2009. The FDA awarded URL Pharma exclusive rights to market colchicine for gout for three years, and for familial Mediterranean fever for seven years. In 2010, all other American pharmaceutical companies were ordered to stop manufacturing the gout drug within 45 days, and to stop shipping it within 90 days.

 

The price of one colchicine tablet soared from 9 cents to almost $5, a move that is projected to increase state Medicaid costs for the gout drug from $1 million to $50 million. The response was a public outcry, including pointed queries to URL Pharma from a number of Members of Congress. URL Pharma has expanded its patient assistance and co-pay programs to allow price breaks for those in need of the gout medication who were hardest hit by the immense price hike, but still faces a great deal of public criticism.

 

TheAmericanCollegeof Rheumatology (ACR) was one of the organizations that protested the steep increase as unjustified. The ACR encouraged other pharmaceutical companies to enter the market with their own branded version of colchicine, and announced in 2010 that at least one other manufacturer would be seeking FDA approval.

 

In the meantime, generic colchicine continues to be manufactured and sold cheaply and legally across the border inCanada. Online Canadian pharmacies are rushing to persuade American customers to buy colchicine fromCanada, stepping up advertising and educational efforts, discounting prices, and offering pharmacy savings coupons.

 

For example, the Canadian pharmacy Big Mountain Drugs is offering 100 .5 mg generic colchicine tablets for $29 US, along with a 5% Pharmacy Rewards Program and a $5 pharmacy savings coupon on a partner site, onlinepharmacycoupons.com. American gout patients can obtain a three-month supply of colchicine for gout through an online Canadian pharmacy with a current valid prescription.

 

Consumers are advised to ensure they are dealing with a reputable onlineCanadapharmacy by ensuring it does not offer drugs without a prescription, does not sell controlled substances such as narcotics, has clear contact information including a physical address, has a licensed pharmacist available to answer questions, and is accredited by the Canadian International Pharmacy Association.