Spending Bill Clears House, Keeping Priority Review Voucher Hopes Alive

 

The $1.2 trillion budget package will now move to the Senate, which is expected to hold a vote next week.

The U.S. House of Representatives has greenlit a massive $1.2 trillion spending bill that, if ultimately passed, could keep the government open past its Jan. 31 deadline—and restart the FDA’s rare pediatric disease priority voucher program.

The package will now move to the Senate next week for a final vote.

The consolidated spending proposal—which lumps the budget of the Department of Health and Human Services together with that of the defense, labor, education and transportation departments—easily cleared House scrutiny with a 340–88 split.

If it passes the Senate vote, the spending bill will also renew the pediatric rare disease priority review voucher program, which incentivizes companies to advance medicines for conditions that affect only a small patient population. Approvals of certain rare disease therapies reward drugmakers with a ticket they can use to either speed up the review of a future product or sell for liquidity.

https://www.biospace.com/policy/rare-pediatric-disease-vouchers-pbm-reform-up-for-vote-in-house