In the wee hours of Saturday morning, the U.S. Senate passed its Continuing Resolution to prevent the government from shutting down on Oct. 1. The resolution is a stopgap measure to maintain fiscal year 2012 budget levels for the government through the first six months of 2013.

However, it apparently nullifies user fee increases passed with PDUFA V (FDASIA) earlier this year, potentially depriving the FDA of planned increases in prescription drug user fees, as well as new fees for generic drugs, biosimilars and medical devices.

The House of Representatives passed an amendment allowing the FDA to collect new generic drug fees, but did not address the other fees. If the new fees are not included in its budget, companies may find themselves paying tens of millions in additional fees without the additional FDA support provided for in FDASIA.