Walden, Burgess hail FDA law reauthorizing user fee programs

Months of bipartisan work spearheaded by congressional members that included GOP leaders from the U.S. House Energy and Commerce Committee paid off when President Donald Trump on Aug. 18 signed the FDA Reauthorization Act (FDARA) of 2017 into law.

Specifically, H.R. 2430 renews the Food and Drug Administration’s (FDA) medical product user fees, which the federal watchdog agency charges medical device and pharmaceutical companies to help cover its costs for reviewing their products.

The roughly $1 billion in total user fees that stand to be collected from these companies will ensure the FDA has the tools it needs to make sure Americans get safe, effective drugs, medical devices, and treatments, said U.S. Republican Congressmen Greg Walden of Oregon and Dr. Michael Burgess of Texas in a joint statement this week.

“This law will encourage new medical innovations, bring lower cost drugs to market faster, improve the regulatory review process for devices and treatments and, most importantly provide certainty to patients and the health industry,” the representatives said.
And paired with implementation of the 21st Century Cures Act, they added, the FDARA will “deliver much-needed hope to patients everywhere.”

Rep. Walden, chairman of the Energy and Commerce Committee, and Rep. Burgess, chairman of the Energy and Commerce Subcommittee on Health, were among the House leaders who worked with leaders on the Senate Health, Education, Labor and Pensions Committee to release a discussion draft of FDARA in April that proposed reauthorizing the user fee agreements.

Walden said the FDARA consists of four individual user fee programs: the Generic Drug User Fee Amendments, the Biosimilar User Fee Act, the Prescription Drug User Fee Act, and the Medical Device User Fee Amendments. “Packaged together [they] will deliver results for patients and ensure we remain the leader in medical innovation,” Walden said.

At the same time, the FDARA will bring lower-cost generic drug alternatives to market faster by simplifying the review process and modernizing clinical trials, he added.

Additionally, the new law ensures “there’s dedicated staff working to develop, review and deliver treatments for patients with rare diseases,” said Walden.

“Make no mistake: We do all this while maintaining FDA’s gold standard for patient safety,” he said.
Saying he was “proud to see this commonsense, bipartisan legislation become law,” Burgess thanked fellow Health Subcommittee members “for their unwavering work on this legislation, overcoming distractions and setbacks to ensure that we could deliver on our promise to the American people.”

Added Walden: “At a time when the media is convinced that Congress isn’t working, we’re proving them wrong.”