Completely clean FDA-industry user fee deal attached to a must-pass government spending bill
With four days left in the fiscal year, FDA-related policy riders approved in both House and Senate committees, at least for now, appear dead, according to the text of a short-term government spending bill unveiled late last night to keep federal agencies open until Dec. 16.
But the absence of riders (both sides previously announced a “practically clean” deal last week) doesn’t mean Democrats are done fighting to add these accelerated approvals and other regulatory reforms for cosmetics, nutritional products and diagnostic tests.
As part of the agreement for a clean CR and user fee deal, Democrats are looking to only authorize certain measures that are tangential to the actual industry-FDA agreements until Dec. 16, which includes all of Title V in the bill text.
Those partial reauthorizations set up a likely battle in mid-December over programs like the Best Pharmaceuticals for Children Program, which allows the NIH to fund studies of off-patent drugs in children, the orphan drug grants that defray the cost of developing rare disease drugs, and certain reporting requirements on pending generic drug applications.
“All four corners [majority and minority leaders in House and Senate] committed to returning to the negotiating table ahead of the December government funding deadline to revisit these key priorities,” House Energy & Commerce committee chair Frank Pallone (D-NJ) said in a statement last night. “I’m going to continue pushing to advance as much of the House-passed legislation as possible.”
But outside of these delayed items (and it’s still unclear who’s opposed to reauthorizing some or all of these measures), Democrats entirely caved to their Republican peers after much discussion and voting on several different reforms, some of which the FDA even seemed almost ready to endorse. The shift came in late July, after Sen. Richard Burr, retiring minority leader on the Senate HELP committee, took a stand on a completely clean user fee bill.
A cloture vote in the Senate, which is likely the first step in getting the continuing resolution to President Biden’s desk, is expected this evening. It’s still unclear which Republicans will join sides with Democrats and pass the spending bill, which needs 60 votes to pass, although insiders don’t expect a government shutdown ahead of the midterm elections.
Burr and Senate HELP committee chair Patty Murray (D-WA) said in a statement on the deal that
there is more work ahead this Congress to deliver the kinds of reforms families need to see from FDA, from industry, and from our mental health and pandemic preparedness efforts. As part of our agreement, we and our House counterparts are committed to continuing that work, and including strong, bipartisan legislation in a robust end of year package.