House passes PDUFA legislation

The House of Representatives passed the new Prescription Drug User Fee Act by voice vote this week, which may accelerate the approval for generic drugs while adding new industry fees and overseas inspections.

The new legislation could allow drug regulators to be more open to new drugs for medical needs that have remained unmet. The drugs could be approved after proving themselves against biomarkers or other standards in mid-stage studies, Fierce Biotech reports.

The bill will now go to the Senate for approval, where legislators seem equally enthusiastic to get the law to President Obama's desk for a signature. The Biotechnology Industry Organization and other lobbying groups were instrumental in crafting parts of the bill.

"I think that the FDA wants it and the industry wants it," Lisa Swirsky, the senior policy analyst at Consumers Union, said, according to Politico. "That's a pretty compelling case for Congress to move it along. And everyone wants to get it out ahead of the election cycle this fall."

The bill would extend market exclusivity on particular new antibiotics by an additional five years. Preferred status for antibiotics could aid new research and development efforts. Multiple biotechnology companies could benefit immediately from the antibiotic exclusivity provision in the proposed legislation.