Rules of the Game

According to an article in today’s edition of the New York Times …

“The F.D.A. has begun to crack down on the thousands of drugs that have never had to go through the agency’s stringent approval process, many of them made by small companies … and those companies are crying foul." According to one such manufacturer, “It has no regard for the cost or damage they do to small businesses. There are estimates that only a few of us will make it.”

The FDA’s response? “This is a public health initiative,” said Deborah A. Autor, director of the Office of Compliance at the F.D.A.’s Center of Drug Evaluation and Research. “Some of these drugs may not be safe. In all likelihood, these companies knew from Day 1 that they were producing illegal drugs.”

A trade group representing about 50 small to medium-size companies has submitted a bill to Congress that would create a cheaper and simpler process for gaining F.D.A. approval. Mr. Blansett claimed the cost could run up to $5 million for a new drug application.

Here’s a link to the complete article:

http://www.nytimes.com/2007/10/18/business/18hunt.html

My contribution to this reportage, two quotes:

“Many of these drugs were grandfathered in when the current approval process was instituted,” he said. “However, that doesn’t give these companies carte blanche — they still have to play by the rules.”

And

“The earlier you can get all parties to the table, including manufacturers, the better.”

Important issue.