FDA proves yet again that they can be bought

You never know when a DEAL might come along. It seems we have price wars going on between major retailers right now. Could price wars between the drug companies themselves be far behind? What will happen with the new Congress?
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FDA proves yet again that they can be bought

Postby jimithy » Thu Oct 07, 2010 4:49 pm

Single-ingredient oral colchicine has been used to successfully treat gout for thousands of years. It has been bottled and sold as a treatment for gout for at least hundreds of years.

The 1938 Food, Drug, and Cosmetic Act required that all NEW medications to be approved by the FDA for safety before being introduced on the market, but it allowed drugs that were already on the market to still be sold. This "grandfather clause" allowed useful meds such as aspirin, colchinine, etc. as well as untold numbers of useless nostrums on the market in 1938 to still be sold without FDA approval. The law hasn't changed but FDA employees (all of them are allowed to receive up to $50,000 per drug company PER YEAR) often like to bend it in ways that would make a double jointed circus performer jealous.

Despite a few thousand years of data about people using single-ingredient oral colchicine to treat gout, it was not until July 29, 2009 that the FDA officially announced what physicians have long known — that the drug colchicine can effectively treat acute flares of gouty arthritis.

A big surprise to people who don't follow the money flowing to FDA employees... The FDA not only approved colchicine but also granted one of the drug companies selling it as " Colcrys" (Philadelphia-based URL Pharma), 7 YEARS of market exclusivity for this ancient drug when used as a prescription medication. URL Pharma showed their appreciation to the loyal customers of Colcrys, by raising the price from $0.09 per pill to $4.85 (the gigantic increase possibly could to help pay their loyal consultants... who are often FDA employees).

Well it has been a year... so FDA employees can legally receive yet another $50,000 per drug company. Surprise, Surprise!! The FDA announced last week that all competitors of Colcrys were to be immediately yanked from the market. URL Pharma has once again shown their appreciation by raising the price to $5.70 per pill! (that is the lowest cost from a reputable online pharmacy that I could find).

The FDA said that GENERIC single-ingredient oral colchicin could remain on the market but since URL Pharma has a multi-year exclusivity on any prescription version... it is not surprising that I cannot find any available generics. All the major chains that I looked at have stopped selling generic single-ingredient oral colchicin (and any other type).

Note that the FDA press release (below) says they are halting the sale of "unapproved single-ingredient oral colchicine". They are smart enough to know that few people know about the 1938 Food, Drug, and Cosmetic Act... which clearly states that colchicine does not require FDA approval.

For Immediate Release: September 30, 2010
Media Inquiries: Elaine Gansz Bobo, 301.796.7567, elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA orders halt to marketing of unapproved single-ingredient oral colchicine
Drug commonly used to prevent gout, treat gout flares, and treat Familial Mediterranean Fever (FMF)

The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).
http://www.fda.gov/NewsEvents/Newsroom/ ... 227796.htm
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