FDA Commissioner Margaret Hamburg is concerned that a federal budget freeze that has left the agency "stranded in Fiscal 2012" will harm the tenuous accord forged between the FDA and the medical device industry.
"Sequestration has added an unexpected burden to us at a critical time," she said in remarks at the Massachusetts Biotechnology Council’s annual meeting in Boston, "I am, frankly, a little bit worried about how all of this will affect industries willingness to come to the table as a full partner 5 years from now when we re-negotiate the user fee levels and programs."
The federal watchdog agency lost $210 million, or about 5.1% of its $4.1 billion 2013 budget, as a result of sequestration, a bargain between the White House and Congress. Included in those cuts were the user fees medical device and pharmaceutical companies pay in order to ensure timely reviews of new drugs and devices.
Hamburg said the agency was not expecting user fees to be included in the automatic spending cuts initiated last September by the Office of Management & Budget, according to the Alliance for a Stronger FDA.
Hamburg said she was "guardedly optimistic" that Congress could use a mechanism called "anomalies" in passing another continuing resolution to fund the government through 2013, which could potentially restore some of those user fee dollars to the FDA’s budget.
But the the OMB’s decision to tamper with medical device and pharmaceutical user fees could sour the pool for future user fee negotiations, Hamburg warned.
Last June Congress passed the MDUFMA reauthorization, which doubled medical device user fees from $295 million over 5 years to $595 million. That deal came after several months of tense negotiations with industry.
For its part, the medical device industry said it is prepared to "stand together, shoulder-to-shoulder" with the FDA to fight negative impacts of sequestration.
"Everyone knows how much effort we’ve put in towards improving performance in the device center and highlighting the role the agency plays in maintaining our global leadership," AdvaMed president Steven Ubl said recently. "Simply put, I think we’ve come too far to see these gains unraveled due to ill-considered approaches [to federal spending]."