The long and wind­ing road to reau­tho­riz­ing FDA’s quin­quen­ni­al user fees for pre­scrip­tion drugs, gener­ics, biosim­i­lars and med­ical de­vices fi­nal­ly has a light at the end of it.

While ne­go­ti­a­tions are still on­go­ing on which pol­i­cy rid­ers (ac­cel­er­at­ed ap­proval re­forms, et. al.) may be in­clud­ed, a se­nior GOP com­mit­tee aide con­firmed to End­points News Thurs­day that at the very least, an agree­ment has been reached for the FDA user fee deals, which are good through 2027, to be in­clud­ed in the con­tin­u­ing res­o­lu­tion.

An aide to Sen. Pat­ty Mur­ray (D-WA), the chair of the Sen­ate Health Com­mit­tee, told End­points via email:

Sen­a­tor Mur­ray has reached a deal on a prac­ti­cal­ly clean reau­tho­riza­tion that en­sures Con­gres­sion­al in­ac­tion won’t force FDA to send out pink slips along with some ad­di­tion­al poli­cies. But even af­ter we have ad­dressed this im­me­di­ate chal­lenge be­fore the loom­ing dead­line she be­lieves we can’t, and she won’t, stop push­ing for the kind of re­forms fam­i­lies need to see from the drug in­dus­try and this crit­i­cal agency.

That CR, or short-term spend­ing bill to keep the gov­ern­ment go­ing, needs to get done by the end of next week, and some of the pieces to that puz­zle are fi­nal­ly mov­ing for­ward.

While FDA com­mis­sion­er Rob Califf has re­mained con­fi­dent that such a deal would emerge, the agency pre­vi­ous­ly not­ed that if Con­gress doesn’t fol­low through on its promis­es, on­go­ing PDU­FA dates would dis­ap­pear, and, “More than 3,500 PDU­FA-fund­ed em­ploy­ees would be im­pact­ed, leav­ing few­er than 1,000 full-time em­ploy­ees at CDER and half that many at CBER,” an FDA spokesper­son said.

A PhRMA spokesper­son al­so of­fered a sigh of re­lief, telling End­points that it’s en­cour­ag­ing to see move­ment to­wards get­ting this done be­fore Sept. 30. There were pri­or dis­cus­sions that the FDA might have to dip in­to re­serve funds to keep op­er­a­tions and drug re­views go­ing for an­oth­er month or so.

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.