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BIO Suggests Formal Legal Change to FDA’s Mission

June 22, 2011

In an article in The Boston Globe and on Boston.com this morning, Robert Weissman reports that “Biotech firms want drug approval hastened and quotes James Greenwood, the president of the Biotechnology Industry Organization, as follows:

“We want to change the formal legal mission statement of the FDA. The FDA understands that if they approve a product that’s not safe or effective, that’s a failure, and we agree with that. But it’s not deemed a failure if people die because they took too long to approve a product.”

The article also quotes Senator Scott Brown (R-MA) and others as suggesting that the U.S. Food & Drug Administration is insufficiently focused on innovation and overly concerned with the safety of drugs that have life-extending benefits.

Karen Riley — a spokewoman for the FDA — responded by stating that the agency approves 60 to 80 percent of submitted drug applications, that 70 percent of drug candidates fail in mid-stage trials, that 55 percent fail in late-stage trials, and that part of the reason it takes so long to get drugs on the market is the length of companies’ clinical trials.

“This failure in clinical drug development is the root of the pipeline problem,’’ Riley is quoted as saying. “FDA has established standards so that the outcome of the review process is predictable. But scientific uncertainty, especially for highly innovative products and indications, remains high.’’

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