June 1, 2012
On May 30, 2012 the House passed the reauthorization bill for FDA user fee programs that will help fund the review of prescription drugs and medical devices. This will also create programs for generic and biologic drugs.
The Senate passed its version of the bill last week in a 96-1 vote. The two bills are largely similar; however, they differ in a few areas. For instance, the Senate has “placeholder” language to create a national drug tracking system in order to cut down on counterfeit drugs and the House did not include this language because of the high cost and inconvenience it would create for the drug industry.
A conference committee is expected to reconcile the two versions of the user fee bill to be sent to the president for his signature by July Fourth.
The SNM will bring you updates as they come