Why The FDA Should Say No To These Drugs - Matthew Herper

My colleague Robert Langreth and I recently walked up to the studios of the Forbes Video Network to try to capture the kind of discussion that has been annoying our office mates for years. Our first two topics: should the Food and Drug Administration rescind approval for Roche’s Avastin for breast cancer, and will the obesity drugs being developed by Arena Pharmaceuticals, Orexigen, and Vivus ever get approved?

I made the case that not only should the FDA revoke Avastin’s breast cancer approval, but that it would actually hurt small biotechnology companies if it does not. Avastin was approved to treat breast cancer under a process called accelerated approval, which allows cancer drugs to reach patients faster, and over the objections of an FDA advisory committee.

But more recent studies have been lackluster. If the FDA doesn’t show it is willing to withdraw approval when a new drug doesn’t pan out, it could make FDA staffers and advisors more timid about granting these conditional approvals.

There’s also another big question: will Medicare stop paying for Avastin in breast cancer if approval is withdrawn? Nobody really knows. There could be another battle ahead, which could have implication for cancer drug companies like Novartis and Eli Lilly.

Arena

Bob and I are both pretty skeptical of drugs to treat obesity — they’ve just been so hard to develop. But whereas I think all of the current batch of obesity treatments could eventually get approved, albeit with heavy restrictions and low sales, Bob is skeptical that Arena’s lorcaserin, with its low efficacy and novel mechanism, will ever make it. For more on our arguments, watch the videos.

via blogs.forbes.com

Posted via email from Jack's posterous