Court sides with FDA in Van­da clin­i­cal hold suit

The US Dis­trict Court for the Dis­trict of Co­lum­bia on Fri­day ruled in the FDA’s fa­vor in a case brought by Van­da Phar­ma­ceu­ti­cals con­cern­ing a par­tial clin­i­cal hold placed on a study of the com­pa­ny’s in­ves­ti­ga­tion­al drug tradip­i­tant in De­cem­ber 2018.

In the de­ci­sion, Judge John Bates de­nied Van­da’s mo­tions for sum­ma­ry judge­ment and re­fused to al­low the fil­ing of an am­i­cus brief by the Hu­mane So­ci­ety that chal­lenged the FDA’s jus­ti­fi­ca­tion for an ad­di­tion­al an­i­mal study.

In a state­ment Fri­day, Van­da said it is re­view­ing the de­ci­sion and “will de­ter­mine the ap­pro­pri­ate next steps.”


The dis­pute cen­ters on the FDA’s de­ci­sion to place a hold on a 52-week open-la­bel ex­ten­sion to a Phase II study of tradip­i­tant to treat gas­tro­pare­sis un­til Van­da con­duct­ed a nine-month non­ro­dent tox­i­c­i­ty study to sup­port the use of the drug in hu­mans be­yond 12 weeks.

In April 2018, Van­da first sought a 52-week ex­ten­sion to its ini­tial four week Phase II study but re­duced the ex­ten­sion to eight weeks af­ter the FDA said it did not have enough safe­ty da­ta to sup­port tradip­i­tant’s use in hu­mans be­yond three months.

Van­da sought to ex­tend the study by 52 weeks twice more in 2018 be­fore the FDA placed a par­tial clin­i­cal hold on the tri­al, in­sist­ing that nine-month non­ro­dent tox­i­c­i­ty stud­ies “are re­quired … per the [In­ter­na­tion­al Coun­cil for Har­mon­i­sa­tion] ICH Guid­ance for In­dus­try : M3(R2) Non­clin­i­cal Safe­ty Stud­ies for the Con­duc­tion of Hu­man Clin­i­cal Tri­als and Mar­ket­ing Au­tho­riza­tion for Phar­ma­ceu­ti­cals.”

On 5 Feb­ru­ary 2019, Van­da sued the FDA over the par­tial clin­i­cal hold, al­leg­ing that the FDA failed “to ar­tic­u­late an ad­e­quate sci­en­tif­ic ba­sis” for the hold and in­sist­ing that the rec­om­men­da­tions in the ICH guid­ance are non-bind­ing. In re­sponse to the suit, FDA asked the court for a vol­un­tary re­mand to “ad­dress cer­tain pro­ce­dur­al is­sues” in the com­plaint.

Af­ter re­view­ing Van­da’s pro­pos­als, the FDA is­sued a re­sponse con­clud­ing that “ex­ist­ing tradip­i­tant stud­ies in non­ro­dents con­tain suf­fi­cient trou­bling in­di­ca­tions of tox­i­c­i­ty such that—while short­er-term hu­man stud­ies may be safe enough to pro­ceed—FDA needs to see if those tox­i­c­i­ty mark­ers in­crease dur­ing long-term non­ro­dent stud­ies be­fore al­low­ing long-term hu­man stud­ies,” and pro­vid­ing a sci­en­tif­ic ra­tio­nale for its re­quest for a nine-month non­ro­dent study.


In the de­ci­sion, Bates re­ject­ed Van­da’s ar­gu­ment that the jus­ti­fi­ca­tion for the clin­i­cal hold made in the FDA’s re­mand re­sponse is “im­per­mis­si­ble post hoc ra­tio­nal­iza­tion,” find­ing that the re­mand re­sponse was made by prop­er de­ci­sion­mak­ers at the FDA and that the re­sponse ap­pro­pri­ate­ly ex­pand­ed on the agency’s ear­li­er de­ci­sion.

The judge al­so re­ject­ed Van­da’s as­ser­tion that the FDA “se­lec­tive­ly opened the record up­on re­mand, adding new stud­ies that sup­port its po­si­tion but fail­ing to add stud­ies ref­er­enced in Van­da’s com­plaint or in a let­ter mailed by the Hu­mane So­ci­ety.” Ac­cord­ing to the rul­ing, “the re­mand mo­tion did not re­quire FDA to con­sid­er ad­di­tion­al ev­i­dence from Van­da; (2) no le­gal au­thor­i­ty re­quired FDA to con­sid­er ad­di­tion­al ev­i­dence form Van­da or the Hu­mane So­ci­ety; and (3) Van­da de­lib­er­ate­ly de­clined to take ad­van­tage of the ad­min­is­tra­tive means avail­able for in­tro­duc­ing its de­sired ev­i­dence in­to the record.”

Van­da’s claim that the FDA ap­plied the ICH guid­ance as a bind­ing leg­isla­tive rule is al­so tossed out. “Though some of FDA’s com­ments pre-re­mand sug­gest­ed that the ICH Guid­ance im­posed a ‘re­quire­ment’ on Van­da, even the ini­tial clin­i­cal hold let­ter did not re­ly on the ICH Guid­ance as the le­gal source of au­thor­i­ty—in­stead, it cit­ed the con­trol­ling reg­u­la­tion as the ba­sis for the hold,” the judge wrote, not­ing that the ICH guid­ance “is a gen­er­al pol­i­cy state­ment” and not a leg­isla­tive rule re­quir­ing a no­tice-and-com­ment rule­mak­ing process.

Ad­di­tion­al­ly, the judge re­ject­ed Van­da’s as­ser­tion that the FDA failed to demon­strate that ca­nine stud­ies are pre­dic­tive of ef­fects in hu­mans.

“Van­da’s ar­gu­ment is un­per­sua­sive for the ba­sic rea­son that the statu­to­ry and reg­u­la­to­ry scheme here ex­plic­it­ly con­tem­plates that the re­sults of an­i­mal stud­ies are pre­dic­tive of the re­sults of hu­man tri­als,” the judge wrote.

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The 20 un­der 40: In­side the next gen­er­a­tion of bio­phar­ma lead­ers

“Each generation needs a new music,” Francis Crick wrote in 1988, reflecting back on his landmark discovery. Crick was 35, then, in 1953, when he began working with a 23-year-old named James Watson, and 37 when the pair unveiled the double helix. Rosalind Franklin, whose diffraction work undergirded their metal model, was 32.

The model would become the score for a new era in biology, one devoted to cracking the basic structures turning inside life. Subsequent years would bring new conductors and new rhythms: Robert Swanson, 29 when he convinced a 39-year-old Herb Boyer to build a company off his work and call it Genentech; Phillip Sharp, 29 when he discovered RNA splicing and 34 when he co-founded Biogen; Frances Arnold, 36 when she pioneered directed evolution; Feng Zhang, 31 when he published his CRISPR paper.

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Chart-top­ping ven­ture cash? Strong deal flow? In the month Covid-19 ripped around the globe? Yup

It turns out that even sending everyone from the CEO to rank-and-file staffers home to work in the middle of a Category 5 pandemic wasn’t enough to put a crimp in the flow of venture cash into biopharma. And even dealmaking held its own against the howling winds of misfortune — largely because a group of savvy players was quick to adjust to the new reality.

Our deal expert Chris Dokomajilar ran the numbers for us on a month-to-month basis and found that not only was venture money flowing during the panicky month of March, but it was also hitting home in record sums compared to the last 26 months of deal flow.

Say what?

As you can see in the top chart below, Dokomajilar outlined how the industry racked up $2.41 billion in total for March, just barely ahead of one other topper during the heady days of August 2018.

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FDA Commissioner Stephen Hahn and President Donald Trump at a press briefing on March 19, 2020. (AP Images)

Biotech ex­ecs warn that the FDA is fum­bling their re­sponse to the Covid-19 open-door promise, de­lay­ing progress

A few days ago the FDA touted a procedure for Covid-19 meds that committed the agency to immediate action for developers, formalizing a high-speed response that’s been promised for weeks.

Bioregnum Opinion Column by John Carroll

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It would be the ultimate high-speed regulatory pathway from Phase I to approval. Red tape was banished.

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“The first response is this form letter everyone gets,” says one biotech CEO who’s reached out to the FDA on Covid-19. And when you try to cut through that, the ball gets dropped as it is passed from top officials to the frontline staff actually charged with getting things done.

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GSK's Hal Bar­ron buys a $250M stake in George Scan­gos' Vir and makes a bee­line to the clin­ic with Covid-19 an­ti­bod­ies

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