AUGUST SLIPPED AWAY — The first of two busy periods in Washington this fall is upon us, with several pharma policy action items on the docket for the next few months. Here’s a quick look at the biggest issues awaiting Congress’ return next week: Priority review vouchers: Reauthorizing the priority review voucher program for rare pediatric diseases is the most time-sensitive item, with its mandate lapsing at the end of the month. The program aims to expedite drug development for those diseases by granting vouchers for expedited regulatory review to drugmakers that win approval for rare pediatric disease products. Companies can redeem them later for a different product or — if they don’t use them — sell them to other manufacturers. The House Energy and Commerce Committee was scheduled to mark up a bill to re-up the program in June, but the meeting was canceled over an unrelated disagreement concerning privacy legislation. The Health Subcommittee approved the measure on a party-line vote in May after it was wrapped into separate legislation to expand children’s access to cancer drug trials. Committee Chair Cathy McMorris Rodgers (R-Wash.) has said reauthorization of the program is a high priority, making it likely she’ll continue pushing for it before she retires at the end of this Congress. And the White House has included the program on its so-called anomalies list of expiring programs it wants lawmakers to extend alongside an appropriations package, an industry lobbyist granted anonymity to share sensitive information told Prescription Pulse. BIOSECURE Act: House leadership placed the legislation, which would effectively ban Chinese biotech firms from doing business in the U.S., on the suspension calendar for when the chamber returns next week. That means it can’t be amended on the floor and needs a two-thirds majority vote to pass. Industry analysts tracking the bill expect it to pass this year, likely alongside the annual defense authorization package. FDA funding: Agency appropriations run out on Oct. 1, and the prospects of lawmakers advancing a standalone Agriculture-FDA spending measure before then are nil. A continuing resolution would hold agency activities not funded by user fees at fiscal 2024 levels. The White House’s funding anomalies list doesn’t include any extra money for agency programs. PBM oversight: The consensus we’ve heard from industry sources tracking various legislative efforts targeting pharmacy benefit managers is that their best chance at getting through Congress in some form is on a catchall spending package. Those measures include the House-passed bill tackling both hospital and PBM transparency and a Senate Finance-backed bill aimed at increasing PBM oversight within Medicare. If lawmakers punt an omnibus until sometime before Christmas as expected, that’ll give proponents an opening for one last push before a new Congress takes over in January. IT’S WEDNESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Are you back in town after the August lull? Let your morning hosts know so we can grab coffee together! Reach out and send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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