FDA User Fee Programs Renewed

The Senate on June 26 overwhelmingly passed the FDA Safety & Innovation Act (S. 3187) reauthorizing the agency’s drug and medical device user fee programs for five years, beginning in fiscal 2013. The legislation now heads to President Barack Obama to be signed into law.

The bill cleared the House of Representatives on June 20. S. 3187 adds about $6 billion in user fees to FDA’s drug and device review budgets over the reauthorization period. Without such fees, FDA would be forced to lay off staff, and reviews of new drugs and devices would be significantly delayed. Current FDA user fee programs expire on Sept. 30.

The legislation also includes measures related to drug safety and drug shortages. In addition, it authorizes, for the first time, user fee programs for generic drugs and biosimilars, the generic equivalents of biologic drugs.

The pharmaceutical and generic drug industries played a key role in shaping the legislation (C&EN, June 11, page 22). Although they welcome the final bill, they are disappointed that Congress could not agree on a provision that would have established a national system for tracking drugs throughout the global supply chain.

Advocacy groups, on the other hand, criticize the bill for containing too many industry-friendly provisions, including relaxed conflict-of-interest rules for experts serving on FDA science advisory panels. “This bill largely stresses speed over safety and special interests over the public interest,” says Celia Wexler, a senior representative with the Union of Concerned Scientists’ Scientific Integrity Program.