BIPARTISAN EFFORTS MAKE THEIR MARK ON THE FDA

On Wednesday, the House passed the reconciled version of the Food and Drug Administration (FDA) User fee reauthorization bill (S. 3187)! 

The reconciled bill is a bipartisan success for the House and Senate leadership, but also for everyone who will benefit from the program’s reauthorization. The user fee reauthorization bill reauthorizes the FDA’s ability to collect user fees for five years. The FDA currently collects user fees for prescription drugs and medical devices. This reauthorization creates two new user fee programs for collecting user fees from generic drugs and generic biologic drugs.  The user fee program is designed to prevent drug shortages and speed-up federal approval of medicines (including lower-cost generics) by creating additional funding from appropriated funds. For fiscal year 2013, the user fees expected to fund the FDA with $1.386 billion dollars!

The other part of the FDA budget is made up of appropriation funding from Congress. In April, the Senate Appropriations Committee released their funding recommendation for the Food and Drug Administration (FDA) for the upcoming fiscal year 2013.The appropriations committee recommended $2.524 billion in funding for fiscal year 2013—a $24 million increase over fiscal year 2012. 

The DC Public Policy Office spent the year advocating for a 6% increase over fiscal year 2012 funding. But, this actual recommendation calls for almost a 10% increase in funding! When the country is facing a budget crisis, we are thrilled that the Senate Appropriations Committee sees the importance of funding the FDA! Although neither the user fee bill nor the appropriations bill has been signed into law, we are thrilled with the additional budget, as it means a quicker review of many treatments for people living with MS!