Drugmakers Ready to Pay More to Wait Less

The Food and Drug Administration has reached a tentative agreement with the pharmaceutical and biotech industries that would provide the agency with more money for reviews and safety monitoring of new drugs.

The industry and the FDA have been negotiating over the reauthorization of the Prescription Drug User Fee Act since early this year. PDUFA was first enacted in 1992 to help the FDA speed up the drug review process. The current version of the law, amended in 1997, expires at the end of September. The law requires drug companies to pay application fees used to offset the cost of the drug review process. These user fees currently run as much as $300,000 per application.

While PDUFA generally has cut drug review times almost in half since 1992, approval times have begun to creep back up in the last three years. Why? It depends on whom you ask. FDA critics say the agency has been too obsessed with safety, to the point where drug reviews are dragging on far too long, or even worse, good drugs are being kept off the market. ...