FDA and Drug Makers Target Unapproved Medications

In 1938 federal law began requiring that new drugs be approved for safety prior to marketing. In 1962 the laws required that drug makers also prove the effectiveness of new drugs before they could be introduced to the market. The FDA reported in 2006 that several thousand drugs are available that preceded these laws and that are currently still sold without any FDA approval.

In recent years the FDA has been targeting these medications and asking drug makers to submit new formulas for review to replace the previous prescriptions. Drug maker URL Pharma has been working with the FDA to produce a new and approved version of its drug Colchicine (used mostly to treat gout). While the FDA and URL Pharma tout increased public safety, critics claim the move is bad for consumers since it results in dramatically increased prescription prices.

Colchicine has been available through pharmacy chains for approximately $11 for a 90-day supply. The new replacement product, Colcrys, sells for $4.50 per tablet. URL Pharma is working on discount programs for consumers who meet specific income guidelines but similar changes should be expected for the several thousand drugs currently without FDA approval. Drug makers are rushing to create approved forms of the medications that will carry primary production formulas for a number of years and push out the previously unapproved generic versions.

http://www.kaiserhealthnews.org/Stories/2009/December/29/FDA-approval.aspx