"No One Asked Us"

So said the medical authority behind the FDA Monitor when I asked him about Colchicine, the ancient Greek remedy for gout.

My Big Fat Greek Medication. source*

             
After my post about Quinine, I began to wonder about other reliable drugs that were around long before the FDA, and what became of them. Starting in the 1930's, any new drugs had to be legally approved by the FDA, while older drugs that were considered safe and effective could remain on the market sans FDA approval.

As recently as 2006, however, the FDA began a new, revolutionary program known as the Unapproved Drugs Initiative. As its name suggests, this new initiative involved the FDA evaluating old, unapproved drugs for safety and effectiveness, even after they had been on the market for years.

But the FDA did more than just conduct tests and put its stamp of approval on products. As this article from the New England Journal of Medicine points out, in the case of colchicine, the FDA granted exclusivity to URL Pharma for a drug that was literally thousands of years old and previously widely available. Since then, URL Pharma raised the price per colchicine tablet from $0.09 to $4.85.

The shocking increase in price- a direct result of the sudden monopoly granted to URL Pharma for a popular drug- affected patients, businesses, and of course the government. Medicaid costs for the drug spiked, going from $1 million to $50 million annually. URL Pharma's successful suit to prevent other companies from selling colchicine only made things worse.

While it may have been unfair for URL Pharma to raise the price that high, it had to pay for an expensive drug trial and give tens of millions of dollars to the FDA. It is clear that the FDA's actions had sweeping implications for the health and finances of millions of people throughout the country.

The title of this blog post was inspired by FDAM's medical authority, who said that at a medical conference, he loudly objected to this particular action on the part of the FDA. As a physician who had prescribed colchicine for years, he saw his patients suffer when it became more difficult to obtain. They were forced to turn to other, less safe drugs, because they could no longer afford colchicine. He felt that this was yet another example of doctors being ignored by the FDA, when they are the ones who directly interact with patients and are ultimately held responsible- by the patients, by themselves, and by the FDA.

This is illustrative of the fact that the FDA, and by extension, the government, is responsible for the high cost of drugs- not the medical profession, and not Big Pharma.