Ap­pro­pri­a­tions bill would give FDA $269M boost over FY2018 bud­get

With one day left be­fore the US gov­ern­ment faces an­oth­er shut­down, the House and Sen­ate are poised to pass a sev­en-bill spend­ing pack­age on Thurs­day to fund large por­tions of the fed­er­al gov­ern­ment through FY2019. And Pres­i­dent Don­ald Trump has said he will sign the bill.

The spend­ing pack­age comes near the end of a three-week stop­gap fund­ing mea­sure to al­low the gov­ern­ment to re­open af­ter a record 35-day par­tial gov­ern­ment shut­down that be­gan on 22 De­cem­ber 2018 af­ter Pres­i­dent Don­ald Trump re­fused to sign a short-term spend­ing bill over his de­mand for $5.7 bil­lion for a wall along the south­ern bor­der.

In­clud­ed in the Agri­cul­ture, Rur­al De­vel­op­ment, Food and Drug Ad­min­is­tra­tion, and Re­lat­ed Agen­cies 2019 ap­pro­pri­a­tions bill is $3.068 bil­lion in dis­cre­tionary fund­ing, a $269 mil­lion in­crease over FY2018 lev­els. The in­crease in bud­get au­thor­i­ty, if en­act­ed, would be the largest in­crease the agency has seen since FY2010.

If the FDA is fund­ed at the lev­els set in the fund­ing bill, the agency’s to­tal pro­gram lev­el will be $5.67 bil­lion, in­clud­ing the rough­ly $2.5 bil­lion in user fees the agency is ex­pect­ed to col­lect.

Ac­cord­ing to an ex­plana­to­ry state­ment cir­cu­lat­ed along with the bill, the $269 mil­lion in new fund­ing for FDA in­cludes “$47,000,000 to com­bat the Opi­oid Epi­dem­ic, $38,500,000 to Pro­mote Do­mes­tic Man­u­fac­tur­ing; $12,000,000 for a New Do­mes­tic Drug In­dus­try; $6,000,000 for MedTech Man­u­fac­tur­ing; $50,700,000 for New Med­ical Da­ta En­ter­prise; $25,000,000 for the Growth and Trans­for­ma­tion of Dig­i­tal Health; $43,300,000 for New Plat­form for Drug De­vel­op­ment, in­clud­ing a $5,000,000 in­crease to ful­ly fund FDA’s On­col­o­gy Cen­ter for Ex­cel­lence; $25,100,000 for Mod­ern­iz­ing Gener­ic Drug De­vel­op­ment and Re­view; and $10,000,000 for In­vest­ment and In­no­va­tion for Rare Dis­eases.”

The bill, while in­clud­ing $22.54 bil­lion in “to­tal bor­der se­cu­ri­ty fund­ing” on­ly in­cludes $1.375 bil­lion for 55 miles of phys­i­cal bar­ri­ers along the south­ern bor­der, less than a quar­ter of what Trump is re­quest­ing.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

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Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

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Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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