Margaret Hamburg, the head of the FDA, turned up at Reuters Health Summit with a bullish assessment of both the agency's responsiveness as well as the biopharma industry's improving track record on R&D and new approvals. And she's promising that a new "breakthrough" drug program has the potential to shave three to 5 years off the development process.
"It's a very exciting time in terms of advances in science and technology," said Margaret Hamburg, according to a report from Reuters veteran reporter Ben Hirschler. "That's reflected in products that are really targeted to the underlying mechanism of disease and really make a difference. That also means the development time and review time is getting shortened because when a drug works, our job is easy."
To make her point, Hamburg underscored the rising level of new drug approvals, which hit 39 last year. So far this year 9 new drugs have been OK'd at the FDA, compared to 11 last year, and the EMA has endorsed 13 new drugs against 8 at this point in 2012.
The FDA's new breakthrough category should also prove a tonic, she says. Early talks with drug makers can cut several years off of regulatory review, and developers are being offered an open door policy on any breakthrough drugs that are anointed at the FDA.
Despite the bullish talk, though, Hamburg's remarks are likely to be met with considerable skepticism by many rank-and-file biotech executives. The venture capital crew has complained bitterly for years now that the lengthy approval process has made drug development one of the most expensive and riskiest R&D plays in the world. So far the FDA has largely reserved breakthrough status for Big Pharma programs, with one exception, and there's still no clear understanding about exactly what the developers are getting--aside from considerable media attention.
- here's the Reuters story