User fee legislation promises better access, speedier reviews at FDA

Bipartisanship is a rare sight in Congress these days, but a top tier of politicos in Washington D.C. says they've managed to hit the sweet spot with new user fee legislation being taken up by the Senate this week. That note of harmony is likely to sing the bill through to passage, triggering promises of significant improvements related to FDA access and cooperation in drug and device development.

As noted by Bloomberg today, the PDUFA reauthorization bill of 2012 calls for a 6% bump in fees from drugmakers. There's also a $1.5 billion contribution from generic drugmakers in exchange for a commitment to shorten the prolonged review times--30 months on average--generics face at the regulatory agency. Devicemakers are doubling down on their fees, looking for easier access to regulators as they plot development programs. And for the first time there's a new source of fee income that will flow from the fledgling biosimilars industry, which is developing the first generation of biologic copies.

The biopharma industry has been hammering away at the FDA for months now, accusing the agency of dragging their feet on drug reviews or blindsiding them with unexpected challenges. Under PDUFA 2012 regulators promise to commit to offering more meetings and advice on trial designs with an eye to speeding the approval process. 

"Drug developers feel there really is value in getting FDA's perspective early to avoid surprises in an application review," Catalyst Healthcare Consulting President Nancy Bradish Myers tells Bloomberg. By getting more access early on, drugmakers believe they can improve the odds of an initial approval, without having to go back to the drawing board to gather more data. 

Dig down into the legislation, and you'll also find a commitment to speed approvals for new drugs that address serious or life-threatening diseases, offering a willingness to use surrogate endpoints to extend approvals rather than waiting for data on some of the gold standard endpoints that have been in place for years.

It's unlikely, though, that the legislation's commitment to greater transparency and efficiency at the agency will translate into broad happiness in the industry with the FDA. Hurt by the steadily rising sums spent on drug development and frequently stung by caustic regulatory reviews, the industry is always likely to have a wary take on regulatory reviews and cooperation. And faced with a history of safety issues related to new drugs, the FDA is likely to continue to remain skeptical when it hears industry criticism.   

- here's the story from Bloomberg