Speeding Up the Drug Approval Process Wanted by Biotech Firms

Speeding Up the Drug Approval Process Wanted by Biotech Firms



Leaders of the biotechnology industry wanted the process of bringing drugs to the market quickened. They say that this can be done by broadening the Food and Drug Administration’s mission to include innovation and product safety. The FDA is the agency that analyzes new medicines.

A set of proposals from the biotechnology industry that aims to overhaul the FDA and create new incentives to help fund development of drugs will be unveiled next week in Washington at the Biotechnology Industry Organization, or BIO, 2011 international convention.

BIO president James C. Greenwood yesterday said, “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.”

He was at the Mandarin Oriental Hotel in Boston, attending the CEO Biotech Conference where Senator Scott Brown, earlier in the day, accused the FDA of “crushing innovation” and “throwing a wet blanket” on medical device development and drug discovery.

He said that it does this by going slow in their decisions on new therapies and changing the rules along the way, as well as being completely unresponsive to businesses looking to sell lifesaving technology.

The Republican from the state of Massachusetts told the biotechnology executives, “There’s a complete breakdown between what’s happening at the FDA and what your needs are. It’s money, it’s time, it’s innovation, and right now we’re losing out to competition overseas.”