The Down Side of FDA Regulation

I was not familiar with the history of the FDA before today. I know it now because I looked it up. I was inspired to look it up after reading an article in today's WSJ about a drug that has been used for years to treat gout. You may recall from an earlier post that gout is a form of arthritis - one of the inflammatory types. Gout flare ups can be very painful. The drug name is colchicine and several generic versions exist. The pill has been relatively cheap over the years, and I mean YEARS. It has always been prescribed off label because it was never tested or approved for use by the FDA.

This blog consistently discusses the FDAs rules on drug testing. A company that wishes to put a drug on the market has to get an application from the FDA for a new drug and must conduct experiments and clinical trials to prove that the drug is safe, that it is effective and often, that it is safer or more effective than a drug already on the market. The drug can then be marketed for the specific condition the company made its FDA request. The drug can be used for whatever a clinician chooses. So the second part of that has been happening with cholchicine - and it only costs five or ten dollars a month. At least until now.

One of the companies that makes the drug decided that they did want to market it for treatment of gout - or the painful episodes that gout can produce. They did their trials and completed all their paperwork, learning a few things about this drug that are indeed helpful to know. For example, it interacts with certain other drugs and certain doses are more effective than others. It did indeed get approval to market the drug for gout treatment. So what do you think happened? It now has a brand name, Colcrys, and costs nearly ten times as much. Whats more? The company that did their due diligence, URl Pharma, wants all the other versions of this drug taken off the market - as it has the new drug patent rights. (interestingly, in February of 2008 another form of this same drug, which was taken as an injection, was banned by the FDA)

In reading Jonathan Rockoff's article I learned that the FDA did not start regulating drugs until this one was already being used and that it was grandfathered in. That peaked my interest.

In case you are equally intrigued, here is a time line on the FDA website of how it came into existence and the amendments and findings that were monumental over the years. It was not until 1962 that drugs had to be found safe and effective, approved by the FDA and were than allowed to be marketed. Drugs already on the market at the time were not really grandfathered in, as I can tell, but were expected to be reviewed in a timely manner. There just was not a systematic protocol for doing so - and as oft happens, it did not get done.

I read and AP article by Ricardo Alonso-Zaldivar and Frank Bass as well. They noted some statements by one of my favorite congress persons, Charles Grassley. In that piece, there was some discussion on how these unapproved medications are paid for with our tax dollars in the Medicaid and Medicare programs. I have no idea if the Patient Protection and Affordable Care Act (Health Care Reform) has a provision to address this issue or not, but it is clear that unapproved drugs need to be identified, evaluated for safe use and in some cases banned.

Sen. Grassley had considered introducing legislation to mandate disclosure - meaning, if you were prescribed a drug that was unapproved, you'd have to be told. Another suggestion was that the FDA compile a master list of the unapproved drugs - and then of course, target them for review. I do not know where these matters stand today - but you could probably find out by viewing Charles Grassley's web page.