EMERGO SUMMARY OF KEY POINTS:

• The US Senate’s proposals for FDA user fee reauthorizations do not include a $1 billion fee increase like that proposed by President Trump.
• Bills currently under consideration in Congress would add resources to the FDA and overhaul some of the agency’s medical device oversight activities.
• Lawmakers are aiming to get a final FDA user fee reauthorization bill to President Trump for final approval in summer 2017.

The US Senate’s version of a bill reauthorizing Food and Drug Administration user fees over the next several years diverges markedly from President Trump’s budget proposal to increase user fees by $1 billion in 2018 alone.

The Senate’s FDA Reauthorization Act of 2017 would fund FDA activities both through Congressional appropriations and user fees, whereas Trump’s proposed 2018 budget would rely solely on user fees to fund the agency.

What the Senate bill would do, and cost

According to a recent analysis by the Congressional Budget Office (CBO), provisions of the Senate bill targeting the FDA’s oversight of medical devices expand upon changes mandated by the 21^st Century Cures Act signed into law in late 2016. The Senate’s reauthorization bill would include changes such as:

• Establishing a capability to accept medical device regulatory submissions via electronic format
• Modifying agency methods and procedures for inspecting domestic and foreign manufacturing facilities for quality system compliance
• Updating regulatory processes for collecting post-market and clinical data from US market registrants
• Launching pilot programs for post-market data collection and monitoring
• Developing risk-based approaches to schedule and prioritize medical device establishment inspections

These and related actions would require additional staffing resources at the FDA, ultimately increasing the agency’s operating costs for medical device-related regulatory oversight by $243 million between 2018 and 2022, states the CBO.

Again, the Senate’s proposals and funding mechanisms differ heavily from what the Trump administration has put forth: massive user fee increases coupled with FDA reforms intended to ease or expedite premarket reviews so that manufacturers can commercialize faster in the US.

The Senate bill must still be voted on and then reconciled with similar legislation moving through the House of Representatives. Congress has traditionally held ultimate authority regarding FDA user fee reauthorizations, making it more likely that some or all of the Senate bill’s proposals will become law rather than enactment of the steep fee increases included in Trump’s 2018 budget.

Related US FDA regulatory information:

• US FDA consulting support for medical device and IVD companies
• US FDA Establishment Registration consulting
• FDA Quality System Regulation (QSR) audit support