The Congressional Budget Office last week scored a U.S. Senate bill to re-up the user fee agreement between the medical device and pharmaceutical industries, saying it would add $740 million to the budget and a negligible amount to the deficit over 2017 to 2022.
The “FDA Reauthorization Act of 2017” would see medical device companies put up a collective $1 billion in user fees, which pharma firms putting up another $8 billion for drug reviews, the budget office estimated. That money, the fees companies pay to have the federal safety watchdog review their products, would offset most of the increase in net discretionary spending, according to the CBO. The bill would raise direct spending by $13 million and lower revenues by $2 million from 2017 to 2022 but raise the total deficit by a paltry $15 million from 2017 to 2027, the CBO estimated.
The Senate bill differs from the Trump administration’s proposal, which would double medical device user fees to $2.4 billion in a bid to lower taxpayer funding of the FDA.
The medical device portion of the bill would require the FDA to set up electronic submission of 510(k) clearance and pre-market approval bids, modify how the agency evaluates and approves those applications and tracks device safety. The CBO estimated that those provisions would require more than 200 full-time equivalent employees at an average of $300,000 annually, or $60 million a year, plus another $7 million for IT and other expenses. In all, over 2018 to 2022, those provisions would raise the FDA’s costs by $243 million, the CBO estimated, including:
- $152 million to revise inspection standards
- $32 million to update procedures including the way the FDA receives data and the evaluation of some clinical data
- $20 million to increase communication with device makers on export certificates
- $20 million for pilot programs on collecting and evaluating post-market data
- $11 million for a risk-based inspection schedule and to reauthorize inspections by accredited bodies
- $8 million for new regulations creating a path for over-the-counter hearing aids