Biden signs stopgap funding through next week as negotiators prep for larger omnibus bill
President Joe Biden this afternoon signed a stopgap funding bill that will keep the federal government open through the end of next week while House and Senate appropriators hash out a year-long solution.
The Senate yesterday evening passed the stopgap bill by a vote of 71-19, following a House vote on Wednesday of 224-201 in favor. The bill includes several punted reauthorizations for another week. The provisions include $6.9 million in orphan drug grants for next year and another $5.7 million for the reauthorization of the Best Pharmaceuticals for Children program.
But House and Senate appropriations leaders are putting together a much larger, $1.7 trillion omnibus bill for next year that needs to get done before next Friday, and will likely include longer reauths for those items and more.
In fact, the bill could potentially include all sorts of FDA- and pharma-related provisions — everything from accelerated approval reforms to ways to improve diversity in clinical trials to an overhaul of lab-developed test regulations — depending on how the spending levels are set.
Senate Appropriations Committee Chair Patrick Leahy (D-VT) said in a statement on Tuesday that he and vice chair Richard Shelby (R-AL) and House Appropriations Committee Chair Rosa DeLauro (D-CT) “reached a bipartisan, bicameral framework that should allow us to finish an omnibus appropriations bill that can pass the House and Senate and be signed into law by the President.”
Details of what’s in that final package, text of which could arrive as soon as Monday, have been hard to come by.
Yale’s Reshma Ramachandran, board chair of the nonprofit Doctors for America, told Endpoints News that there are, “Positive signs from both sides of aisle on AA [accelerated approval] reforms and even clinical trial diversity.”
Senate Majority Whip Dick Durbin (D-Ill.) told Politico today that an overhaul of the way the FDA regulates dietary supplements is off the table. But pretty much anything else — from AA reforms to an overhaul of the way lab-developed tests are regulated — could be on the table.
The Alliance for a Stronger FDA added in an email on Friday:
A number of possible add-ons could impact FDA, notably whether House E&C and Senate HELP can negotiate an agreement on the policy and program language stripped from the September’s user fee reauthorizations. Even if such an agreement is reached, uncertainty remains whether it will be added in the omnibus in the face of dozens of Members and interest groups trying to add their priorities to the Omnibus bill.