With Bipartisan Support, FDA User Fee Reauthorization Passes the House

The House of Representatives passed the FDA Reauthorization Act of 2017 with a voice vote, indicating the strong levels of bipartisan support for the bill that will reauthorize the user fee programs that fund the FDA.

After a majority of the House voiced their vote to pass the Act, the House Energy and Commerce Committee delivered the news in an enthusiastic tweet that ended with the hashtag “#Bipartisanship.” Likewise, FDA Commissioner Scott Gottlieb, MD, tweeted that he was “grateful” for the bill’s passage and thanked the bill’s sponsor US Rep. Greg Walden (R-Oregon) and co-sponsor US Rep. Frank Pallone (D-New Jersey), who had urged their colleagues to pass the legislation.

The Act, known in the House as HR 2430, reauthorizes 4 programs that allow the FDA to collect fees from pharmaceutical and medical device manufacturers that pay for the agency’s premarket review process. It also includes amendments aimed at expanding access to experimental therapies and increasing generic drug competition.

The 5-year user fee agreements last passed in 2012 are set to expire on September 30, 2017. Prior to today’s vote, the lack of legislative activity around reauthorization had sparked concerns that the FDA would be forced to lay off employees or suspend its work if the fee agreements were allowed to lapse.

“We worked long and hard to get this accomplished in a timely fashion, in particular so the personnel at the FDA are not threatened in any way,” explained Pallone shortly before the vote, according to House transcripts. In his final remarks calling on his fellow lawmakers to support the bill’s passage, Walden lauded the bipartisan efforts to develop the “lifesaving legislation.” He explained that it would allow drugs to be approved and reach the market sooner, “and the quicker we get that innovation to market, the more we can reduce costs and save lives.”

Despite the Act’s smooth passage through the House today, it still must be approved by the Senate and signed by President Donald Trump before the end of July in order to avoid potential layoffs or interruptions. Senators from both sides of the aisle agreed with House lawmakers on the importance of swift passage in a press release issued this April, but the Senate has not yet announced a timeline for holding a vote on the bill.

The bill could encounter another obstacle if and when it reaches the president’s desk. Prior to today’s vote, the White House issued a policy statement supporting the bill’s provisions to speed up the review process and the broader goal of reauthorizing the user fee programs, but voicing concerns with some other components.

According to the president’s budget, the FDA’s premarket review process should be 100% financed by user fees paid by the manufacturers, while the current House bill would require taxpayer resources to bolster the user fees. The statement also raised issue with the provision extending market exclusivity. In conclusion, the White House wrote that it “looks forward to working with the Congress to expand access to affordable, lifesaving drugs and medical devices in a thoughtful manner.”

Some groups called on the Senate and President Trump to get the reauthorization passed and made law as swiftly as possible, including the National Health Council and the National Organization for Rare Disorders. A statement from the groups applauding the Act’s passage in the House cited the positive components of the new bill, such incorporating real-world evidence in reviews and amplifying the patient voice during drug development, as important reasons to avoid delaying reauthorization. “People with chronic and rare diseases and disabilities simply cannot wait,” the statement concluded.