<img alt=“woodcock.june 2011 002.jpg” src=“https://blogs.nature.com/news/woodcock.june%202011%20002.jpg” width=“260” height="176 " align+"right"/>The US Food and Drug Administration (FDA), often denigrated for being slow to approve new drugs for market, has recently been speedier than its European counterpart in approving new cancer drugs, according to a study in the journal Health Affairs released today.
Between 2003 and 2010, the US agency approved 32 new anti-cancer drugs while the European Medicines Agency (EMA), approved 26, the study says. More striking is the difference in times to approval: in the US, the median time between a company’s submission of a new drug application to the FDA and the agency’s marketing approval was 182 days. The analogous time in Europe was nearly twice as long: 350 days. Furthermore, all 23 of the drugs approved by both regulators made it to market in the United States before they became available in Europe.
“I’m pleased, but that doesn’t mean they [at FDA] get a free pass” said Ellen Sigal, one of the three authors of the study, and chair of the advocacy group Friends of Cancer Research. She couldn’t believe the results when she first saw them, she added. “It defied urban legend.”
Janet Woodcock the director of the Center for Drug Evaluation and Research at FDA, spoke with Sigal and others at a panel on Capitol Hill today. “We are not in a contest or a race with the European Union or any of our regulatory partners around the world,” she said.
Still, she added: “It isn’t just your cancer drugs” that FDA approves ahead ot its counterpart. The agency recently examined approvals of novel drugs in the US and Europe in all disease areas, between 2006 and 2010. Forty-three of 57 such drugs were first launched in the United States. “This trend is across all different indications,” Woodcock said. (Woodcock is pictured at left, above, speaking with co-panelist John Marshall, an oncologist at the Georgetown-Lombardi Comprehensive Cancer Center in Washington, D.C.)
Jonathan Leff, a panelist who is managing director ar Warburg Pincus, a private equity investment firm, noted that more than half of the 32 cancer drugs approved by FDA over the seven-year period in question were granted “accelerated approval” — a designation which allows the agency to approve a drug using surrogate endpoints expected to predict clinical benefits — rather than requiring a company to demonstrate the benefits themselves.
It appears, added Leff, that “Europe has not quite been able to apply that flexibility.”
Nonetheless, Leff said, a perception problem remains for FDA, which industry views as giving more weight to the risks of a drug than it does to its benefits. If he were to ask 50 venture capitalists, or the chief executives at 50 biotechnology companies, why investment in the area is diminishing compared to ten years ago, he said, “The answer invariably comes back….`It’s the FDA.’”