The U.S. Senate yesterday approved an omnibus, $1.012 trillion budget bill that includes the restoration of some $85 million in user fees from medical device and pharmaceutical companies that was held in abeyance by sequestration.
President Barack Obama, who has until midnight tomorrow to sign the measure into law, is expected to quickly add his signature after the 72-26 vote in the Upper Chamber.
The bill includes $2.55 billion for the FDA, which is a 3.7% increase over the watchdog agency’s fiscal 2013 budget.
Seventeen Senate Republicans crossed the line to approve the measure, including 11 co-sponsors of a bid to repeal the medical device tax, but most GOPers followed minority leader Sen. Mitch McConnell’s (R-Ky.) nay vote.
The budget deal, brokered after 6 weeks of negotiations between the House and Senate appropriation committees, was approved by the GOP-controlled Lower Chamber this week on a 359-67 vote.
Reps. Leonard Lance (R-Calif.) and Anna Eshoo (D-Calif.) questioned the legality if the Office of Management & Budget’s decision to sequester the user fees, which industry pays to cover the cost of product reviews by the FDA.
"Because user fees are 100 percent private sector dollars and cannot be used to pay down the deficit, it’s critical that appropriators recognized that these funds are targeted specifically for the approval of safe and effective drugs and devices and should not be entangled in the sequester," Eshoo said in prepared remarks. "I will continue to push the administration to allow the FDA to access their user fees in full so that patients receive the best care possible."
"The action by the U.S. House to correct the sequester of the FDA user fees now ensures that the agency will have the tools and resources to ensure that millions of Americans will continue to benefit from medicines and medical devices that are safe and effective," Lance added. "The release of these funds will benefit patients, public health and medical innovation."