There are several age old drugs that have been around before the FDA existed and the agency is trying to get research and information on how the drug reacts and calculate dangers to include dosage and other safety information compiled. In this instance to make up for their research the drug price has now sky rocketed and can put it out of reach for many. Did we get a good trade off here? Colchicine has been around for years to treat all types of conditions to include gout.
It’s almost too bad that the NIH can’t handle situations as such as it seems that would be the logical place to do a study to be fair on drugs that existed before the FDA came into being. This happened to another drug about 3 years ago and I can’t remember which one it was. In economic times as such, this was not welcome and the anticipated sales are around 1/2 a billion. BD
There are about 1,000 medications on the market that predate the existence of the Food and Drug Administration and therefore were never approved. FDA official Deborah Autor spoke to CBS News as head of the office of unapproved drugs. "Well, for me, unapproved drugs present current risks," Autor said. "We don't know what's in them. We don't know if they're going to work properly. We don't know how they're made and that's a real concern."
Hundreds of thousands of people take Colchicine each year. The FDA said over the past 40 years, 169 deaths have been linked to the medication. A company called URL Pharma decided it would take the ancient drug, sold for 10 cents a pill, and test it as part of an FDA program to either approve these drugs or get them off the market.
CBS News medical correspondent Dr. Jon LaPook reports the medication is now called Colcrys, and costs McGrath $62.16. "Almost doubled the amount I paid, and it cost my insurance company $244.74," McGrath said.