As bi­par­ti­san talks for a longer-term gov­ern­ment spend­ing bill con­tin­ue, House Ap­pro­pri­a­tions Chair Rosa De­Lau­ro (D-CT) to­day filed a one-week con­tin­u­ing res­o­lu­tion to keep the gov­ern­ment fund­ed and avert a shut­down on Fri­day at mid­night.

The short-term Band-Aid al­so in­cludes sev­er­al reau­tho­riza­tions that are of in­ter­est to the phar­ma in­dus­try as they had been cut out of a re­cent­ly passed FDA-in­dus­try user fee deal, which was tagged on­to the last short-term fund­ing ex­ten­sion.

The idea be­hind those ex­clu­sions from the user fee deal was to make time for adding in oth­er re­forms re­lat­ed to ac­cel­er­at­ed ap­provals, reg­u­lat­ing lab-de­vel­oped tests and cos­met­ics, and more.

This time around, how­ev­er, those oth­er rid­ers may not be hitch­ing a ride.

In­stead, the De­Lau­ro bill in­cludes $6.9 mil­lion in or­phan drug grants (up from $6.3 mil­lion last year) to de­fray the costs of de­vel­op­ing drugs for rare dis­eases or con­di­tions, in­clud­ing qual­i­fied test­ing ex­pens­es. The grants pro­gram, run by FDA, has fund­ed clin­i­cal re­search since 1983, in­clud­ing tri­als that led to the ap­proval of more than 80 prod­ucts.

An­oth­er $5.7 mil­lion (about $500,000 more than last year) would be au­tho­rized, if the De­Lau­ro bill pass­es, for the reau­tho­riza­tion of the Best Phar­ma­ceu­ti­cals for Chil­dren pro­gram, which in­cen­tivizes spon­sors with ad­di­tion­al mar­ket­ing ex­clu­siv­i­ty to com­plete pe­di­atric clin­i­cal stud­ies. As of ear­ly June, the FDA is­sued more than 500 writ­ten re­quests for such pe­di­atric tri­als.

In ad­di­tion to sev­er­al med­ical de­vice-re­lat­ed reau­tho­riza­tions (e.g. hu­man­i­tar­i­an de­vice ex­emp­tion), it al­so in­cludes a week­long reau­tho­riza­tion of the part of FDA law that al­lows the agency to re­quire cer­tain drug and bi­o­log­ic ap­pli­ca­tion hold­ers to make safe­ty-re­lat­ed la­bel­ing changes based on new safe­ty in­for­ma­tion that be­comes avail­able af­ter an ap­proval.

The bill al­so reau­tho­rizes a sec­tion of the FDA Reau­tho­riza­tion Act of 2017 that re­quires the FDA to re­port on cer­tain gener­ic drug ap­pli­ca­tions sub­ject to pri­or­i­ty re­view or with a com­pet­i­tive gener­ic ther­a­py des­ig­na­tion.

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

The DC Circuit Court has struck a blow against the pharmaceutical lobbying group PhRMA and other plaintiffs’ attempt to stop states from importing drugs from Canada.

Joined alongside public health group Partnership for Safe Medicines and advocacy group Council for Affordable Health Coverage, PhRMA was rebuffed by Judge Timothy Kelly on Monday, who dismissed the civil suit due to a lack of standing.