Greenwood was attending the CEO Biotech Conference at the Mandarin Oriental Hotel, where earlier in the day Senator Scott Brown accused the FDA of “crushing innovation’’ and “throwing a wet blanket’’ on drug discovery and medical device development by delaying decisions on new therapies, changing the rules along the way, and being unresponsive to businesses seeking to sell lifesaving technology.
“There’s a complete breakdown between what’s happening at the FDA and what your needs are,’’ the Massachusetts Republican told the biotechnology executives. “It’s money, it’s time, it’s innovation, and right now we’re losing out to competition overseas.’’
Brown said the agency’s slow pace also limits job creation by Massachusetts companies.
FDA officials said yesterday that the agency already focuses on innovation. They pointed to an April speech by Commissioner Margaret A. Hamburg in which she said, “Our job is both to ensure the safety and efficacy of FDA-regulated products and to take real steps to foster the scientific innovation that will lead to tomorrow’s new breakthrough products.’’
Addressing Brown’s criticism, FDA spokeswoman Karen Riley said part of the reason it takes so long to get drugs on the market is the length of companies’ clinical trials. She said the agency approves 60 to 80 percent of submitted drug applications, but most experimental treatments never get that far — 70 percent of drug candidates fail in mid-stage trials and 55 percent fail in late-stage trials, Riley said.
“This failure in clinical drug development is the root of the pipeline problem,’’ she said. “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.’’
