Scott Got­tlieb aced his con­fir­ma­tion hear­ing, vow­ing to main­tain R&D gold stan­dard

Scott Got­tlieb – April 5, 2017 Zach Gib­son/Get­ty Im­ages


Sen­ate De­moc­rats didn’t waste any time in rais­ing their ob­jec­tions to Scott Got­tlieb as the next FDA com­mis­sion­er.

Sen­a­tor Pat­ty Mur­ray (D-Wash­ing­ton) start­ed her re­marks at Got­tlieb’s con­fir­ma­tion hear­ing this morn­ing voic­ing her con­cerns about “whether you can with­stand po­lit­i­cal pres­sure” in main­tain­ing an un­bi­ased, sci­ence-based ap­proach in main­tain­ing the gold stan­dard on safe­ty and ef­fi­ca­cy re­views of new drugs.

Mur­ray com­plained that sen­a­tors had on­ly days to re­view Got­tlieb’s “un­prece­dent­ed fi­nan­cial en­tan­gle­ments” in the phar­ma in­dus­try — with dozens of drugs from the com­pa­nies he’s worked with head­ed to the FDA — as well as more than 800 list­ed pub­li­ca­tions which “raise con­cerns about po­ten­tial con­flicts of in­ter­est.”

Scott Got­tlieb this morn­ing on Capi­tol Hill at his nom­i­na­tion hear­ing. (CRED­IT: C-SPAN/End­points News)

Got­tlieb, though, came pre­pared to re­but those sug­ges­tions, mak­ing promis­es to main­tain an in­de­pen­dent FDA com­mit­ted to find­ing new ef­fi­cien­cies at the agency while mak­ing sure that all the new prod­ucts the agency ap­proves are safe and ef­fec­tive, meet­ing the agency’s long-term gold stan­dard on R&D.

“I’ve seen the im­por­tance of the FDA’s work as both a doc­tor and a pa­tient,” Got­tlieb, a can­cer sur­vivor, said in his open­ing state­ment. He added that his in­vest­ments and en­deav­ors were aimed at im­prov­ing health­care in the US. Some have worked, oth­ers didn’t and many oth­ers are still in de­vel­op­ment.

Re­gard­less of those ties, he vowed to be an “im­par­tial and in­de­pen­dent ad­vo­cate for the pub­lic health” main­tain­ing a rig­or­ous ap­proach to re­view­ing drugs. “We’re at an in­flec­tion point in bio­med­ical sci­ence,” he added, and the chal­lenge at the FDA will be get­ting the most bang for its reg­u­la­to­ry bucks.

“We should re­ject the false di­choto­my that it all boils down to a choice be­tween speed and safe­ty.” Bet­ter ef­fi­cien­cy and safe­ty are both pos­si­ble, he said, while main­tain­ing the gold stan­dard. And he added that “it’s in­cum­bent on us to have a world class work force,” hir­ing the best for reg­u­la­to­ry work, which Sen­a­tor Lamar Alexan­der not­ed was Got­tlieb’s pick as his most im­por­tant chal­lenge.

Got­tlieb al­so helped soothe any in­dus­try con­cerns that he might want to come in as an abra­sive re­former, work­ing at odds with staff.

“I think every­thing is a bot­tom-up ap­proach in the agency,” he told the law­mak­ers. “The ideas re­al­ly need to come from the ca­reer staff in the cen­ters.” That’s go­ing to be a chal­lenge as the agency re­cruits re­place­ments for a line­up of se­nior agency of­fi­cials who are due for re­tire­ment.

Got­tlieb promised to bring best prac­tices to those ar­eas in the FDA that have been lag­ging. There’s been an “un­even adop­tion” of the break­through drug pro­gram, he added, which now re­quires broad adop­tion.  The prospec­tive com­mis­sion­er al­so said that while he was not crit­i­cal of Phase III, there is a pos­si­bil­i­ty with new tech­nol­o­gy to com­press Phase II and Phase III in­to an adap­tive de­sign.

And, as ex­pect­ed, he rel­ished the prospect of tack­ling a slew of com­plex gener­ics await­ing an ap­proval at the FDA. Many drugs are sold at high prices, he said, but should be sub­ject to com­pe­ti­tion.

A few days ago Got­tlieb care­ful­ly de­lin­eat­ed ties to some two dozen bio­phar­ma com­pa­nies he’s been work­ing with over the past eight years of the Oba­ma ad­min­is­tra­tion. He’s worked with Glax­o­SmithK­line, Ver­tex and Bris­tol-My­ers, so you can check the box on in­dus­try con­flicts of in­ter­est that De­moc­rats will con­demn.

Among Got­tlieb’s oth­er lines of work, the for­mer deputy FDA com­mis­sion­er penned a se­ries of ar­ti­cles on bio­phar­ma for Forbes, and the Dems have been giv­ing them a close look. Two pieces float­ed to the top of the read­ing list. One cen­tered on his pro­pos­al to move re­spon­si­bil­i­ty for iden­ti­fy­ing the opi­oid sup­pli­ers who were break­ing the law from the DEA to HHS. The oth­er dealt with his crit­i­cism of the REMS pro­grams, which set up post-mar­ket­ing safe­ty pro­grams to lim­it risks seen in cer­tain drugs.

Add it all up, says Sher­rod Brown (D-Ohio), and you find some­one who will “roll over for his Big Phar­ma friends,” as The Hill re­ports.

Re­pub­li­cans, though, were large­ly con­tent to lim­it their com­ments to praise for the nom­i­nee and his three young daugh­ters, who were seat­ed be­hind the can­di­date. And it’s the Re­pub­li­cans who have the votes to make this hap­pen.

The in­dus­try, mean­while, has made it clear that af­ter hear­ing some of the ideas backed by oth­er com­mis­sion­er can­di­dates like Jim O’Neill – who’s sug­gest­ed ap­prov­ing drugs as soon as they’re de­ter­mined safe — Got­tlieb is the best can­di­date by far. In a snap poll of qual­i­fied End­points News sub­scribers, 87% of the 580 who reg­is­tered an opin­ion backed Got­tlieb’s nom­i­na­tion.

So you can ex­pect most peo­ple in bio­phar­ma to keep their fin­gers crossed for Got­tlieb.

Bot­tom line: Got­tlieb came well pre­pared for every ques­tion, care­ful not to step be­yond the bound­aries of the com­mis­sion­er’s job when in­vit­ed to com­ment on Oba­macare. His an­swers were pol­ished and prac­ticed, leav­ing lit­tle room for un­ex­pect­ed at­tacks. And he de­flect­ed crit­i­cism eas­i­ly, promis­ing to avoid any po­ten­tial con­flicts of in­ter­est.

Bar­ring a last minute sur­prise, Got­tlieb’s con­fir­ma­tion as the next FDA com­mis­sion­er is all but guar­an­teed.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

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While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

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The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

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Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

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Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.