COMMENTARY--A LICENSE TO STEAL

by Bill Breakstone, January 7, 2011


The drug colchicine has been in use as a treatment for gout “flare ups” for over 50 years. Its entry into the drug market predated the establishment of the Food and Drug Administration; thus colchicine existed as an unapproved product, not a generic drug.

In July of 2009, the drug company URL Pharma, a division of AR Scientific, Inc., received formal approval from the FDA for their drug “Colcrys.” I have a bottle of this drug, and the label indicates that its only ingredient is “colchicine.”

During the first week of October 2010, the FDA announced that it was ordering unapproved colchizine products off the market, and that it was granting exclusivity to URL Pharma’s Colcrys for a three year period, commencing on January 1, 2011.

The Senior Editor of the online news service MedPage Today, John Gever, wrote the following on October 6, 2010:


“With last week's announcement by the FDA that it was ordering unapproved colchicine products off the market, the year-old debate over the agency's handling of the popular gout treatment has flared anew.

The wisdom of granting periods of marketing exclusivity to the maker of Colcrys, the sole approved form of colchicine, was debated in the letters section of the Oct. 7 issue of the New England Journal of Medicine by two top FDA officials and two physicians at Brigham and Women's Hospital in Boston.

And the American College of Rheumatology (ACR) reiterated concerns first expressed in 2009 about price hikes associated with the approval of Colcrys and the impending removal of much cheaper unbranded colchicine products.

The FDA's action against the unapproved products has been expected since URL Pharma received formal approval of Colcrys in July 2009.

At the time, the FDA indicated that makers of other, unapproved colchicine products would either have to submit marketing applications or take their products off the market. It cited a decades-old policy requiring that the safety and efficacy of drugs that were on the market in the 1950s, when the agency won full authority to regulate them, would eventually have to be proven. There were dozens of such drugs, including colchicine.

That requirement was largely ignored until 2006, when the FDA began to crack down on some of these "grandfathered" drugs, such as hydrocodone-containing cough syrups.

Under the stricter policy adopted in 2006 and backed up by legislation enacted by Congress, the agency indicated that it would provide incentives for companies to submit marketing applications for drugs in the targeted classes.

Specifically, the FDA would grant three years of marketing exclusivity to the first company to receive a formal approval, or seven years if the drug was for an orphan disease.

The agency also indicated in a guidance document that it would ordinarily wait one year after granting an approval before taking action against unapproved products. That, the FDA argued, would give their manufacturers a chance to submit their own applications or take steps to wind down production and inform customers in an orderly way.

In June, Aaron Kesselheim, MD, and Daniel H. Solomon, MD, published a letter in the NEJM berating the FDA for the negative impact that patients with gout and familial Mediterranean fever would suffer as a result of this policy as applied to colchicines. Colcrys has three years of exclusivity in treatment of acute gout flares and seven years for familial Mediterranean fever, an orphan disease. The drug is also approved for preventing flares, with no exclusivity. Whereas the unapproved products cost around 10 cents a pill, Colcrys comes with a sticker price of nearly $5a pill, Kesselheim and Solomon wrote."


I personally have plenty of experience with both gout as a disease and drugs that are used in treatment thereof, a malady that I have suffered from for the past ten years. I have taken up to this point two medications: colchicine and allopuranol, and since beginning the course of using both of these drugs, have not suffered one flare up of gout.

However, when I ordered a refill of colchicine the other day, the pharmacist informed me that the drug had been “pulled” by the FDA and that she would substitute the new FDA approved medication. When I noticed the price thereof, I went through the roof! Colchecine had cost me roughly $5.00 per refill. This new medication, Colcrys, ran me $82.00!

The FDA denies any responsibility for the pricing or cost of any of its approved medications. They maintain their sole responsibility is insuring the safety of the products it approves. They also claim that the enabling legislation regarding its “crackdown” on unapproved substances put them in the proverbial straight jacket. This argument is pure bunk. If the effect of granting exclusivity to a drug company is to increase the cost of a bottle from $9.00 to $485.00, what the FDA has done is issue a license to steal from the consumer, who faced with such outrageous costs, will forego a medication that had proved effective, safe, and affordable if used as instructed by physicians.

Letters will be going out to Senators Schumer and Gillibrand post haste.

For more information on this subject, see: (1) FDA New Release of September 30, 2010; (2) Letter from Drs. Kesselheim and Solomon to the FDA published in the June 2010 Issue of the New England Journal of Medicine; (3) Letter to Drs. Kesselheim and Solomon from Dr. Janet Woodcock of the U.S. Department of Health and Human Services dated March 3, 2010; (4) New York Times article “Purging the Pharmacy of Unapproved Drugs” by Natasha Singer dated March 26, 2010; and (5) MedPage Today article “Controversy Over Colchicine Price Hikes” by John Gever dated October 6, 2010.