â€œThe F.D.A. has begun to crack down on the thousands of drugs that have never had to go through the agencyâ€™s stringent approval process, many of them made by small companies â€¦ and those companies are crying foul." According to one such manufacturer, â€œIt 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.â€
The FDAâ€™s response? â€œThis is a public health initiative,â€ said Deborah A. Autor, director of the Office of Compliance at the F.D.A.â€™s Center of Drug Evaluation and Research. â€œSome of these drugs may not be safe. In all likelihood, these companies knew from Day 1 that they were producing illegal drugs.â€
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.
Hereâ€™s a link to the complete article:
My contribution to this reportage, two quotes:
â€œMany of these drugs were grandfathered in when the current approval process was instituted,â€ he said. â€œHowever, that doesnâ€™t give these companies carte blanche â€” they still have to play by the rules.â€
â€œThe earlier you can get all parties to the table, including manufacturers, the better.â€