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DESI to 505(b)(2) Raises Drug Costs

FDA is trying to remove unapproved new drugs from the market. This past year the FDA approved URL’s colchicine. Previously, FDA announced it was taking action against unapproved colchicine on the market. We have commented on these actions in this blog.

A recent article in Kaiser Health News questions whether the approval of these DESI drugs is good public policy. URL charges $4.50 per tablet according to the article, while the previously unapproved products could be obtained under the Wal-Mart $12 per 90-day supply. Some say that is price gouging, others say that is the price of drug development.

Clearly it costs less to make a product that is unapproved. The FDA is charged with evaluating the risk – benefit. When the FDA moved to remove the unapproved colchicine it cited 120 deaths from interactions of colchicine with other drugs. Prior to the extensive testing conducted by URL, physicians couldn’t be sure which co-administered drugs were potentially hazardous. Also, the correct dose wasn’t established. Thus, URL spent millions of dollars to obtain adequate safety and efficacy information. It would seem fair that URL should be able to recover their investment and make a profit. The law provides for exclusivity in the case where clinical trials are required for approval, as in this case. URL has 3 years to recoup their costs before facing generic competition.