President Barack Obama put his pen to the Food & Drug Administration Safety & Innovation Act today, making it the law of the land that the user fees medical device companies pay to have the FDA review their products more than doubles.
The med-tech industry and the federal watchdog agency spent months hashing out the terms of the deal, which ultimately boosted the user fees from $295 million over 5 years to $595 million, in exchange for the FDA meeting performance goals.
The White House signed off on the agreement in March, setting the stage for wrangling in and between the House and Senate before the upper chamber approved a reconciled bill June 25.
"We commend the president and the bipartisan efforts of Congress to enact this legislation, which is an important step toward maintaining a transparent and efficient FDA review process that will foster the development of innovative technologies," said Gail Rodriguez, executive director of the Medical Imaging & Technology Alliance, in prepared remarks.
Steve Ubl, CEO of med-tech industry lobby AdvaMed, was quick to laud the new user fee regime as an evolutionary step forward.
"This user fee agreement really isn’t your father’s user fee agreement,"Ubl said the day after the Senate approved the final bill. "It’s the first user fee agreement to include goals that are focused on total review times, from the first time of submission at the agency to when the agency makes the final decision on a PMA or 510(k). The agreement for the first time includes a provision we refer to lovingly as ‘no submission left behind,’ which requires the agency to meet with companies if the agency misses a performance goal."
