FDA nom­i­na­tion in hand, Got­tlieb pre­pares to dis­en­tan­gle him­self from a long list of bio­phar­ma jobs and in­vest­ments

Steve Burd (R), pres­i­dent and CEO, Safe­way, Inc. and Scott Got­tlieb (L), res­i­dent fel­low at Amer­i­can En­ter­prise In­sti­tute par­tic­i­pate in a Sen­ate Health, Ed­u­ca­tion, La­bor and Pen­sions Com­mit­tee hear­ing on Capi­tol Hill, June 11, 2009 in Wash­ing­ton, DC. (Cred­it: Mark Wil­son/Get­ty Im­ages)


Scott Got­tlieb wasn’t idle dur­ing the eight years of the Oba­ma ad­min­is­tra­tion. With De­moc­rats in the White House and Re­pub­li­cans out, the for­mer agency of­fi­cial turned to a busy ca­reer work­ing with quite a range of bio­phar­ma in­vestors and com­pa­nies.

Now that Got­tlieb has se­cured Trump’s nom­i­na­tion as the next FDA com­mis­sion­er and lined up an April 5th hear­ing at the Sen­ate, he’s be­gun the process of un­wind­ing those in­vest­ments and busi­ness re­la­tion­ships in bio­phar­ma. Got­tlieb filed a dis­clo­sure form yes­ter­day with the Of­fice of Gov­ern­ment Ethics that will sure­ly pro­vide fod­der for a De­mo­c­ra­t­ic at­tack dur­ing his con­fir­ma­tion hear­ings.

And there’s a lot to see.

Got­tlieb’s con­sult­ing work with Glax­o­SmithK­line is well known, and he’s put the phar­ma gi­ant on a long list of com­pa­nies he will steer clear of dur­ing his first year as com­mis­sion­er, re­cus­ing him­self from any FDA ac­tion re­gard­ing GSK. He’s al­so been a board mem­ber of Me­dA­vante, a med­ical de­vice com­pa­ny. Me­dA­vante owes him some com­pen­sa­tion, he says in the ethics form, but he’ll for­feit that if it doesn’t ar­rive ahead of his con­fir­ma­tion. And if it does, he’ll re­cuse him­self for two years.

There were board po­si­tions with Tolero and the clin­i­cal di­ag­nos­tic lab Com­bi­Ma­trix, which he re­signed from last De­cem­ber. And he set up a com­pa­ny to com­plete a sin­gle con­sult­ing con­tract with Bris­tol-My­ers Squibb. More con­sult­ing was done for Ver­tex and he wrote a se­ries of ar­ti­cles for Forbes.

He al­so has a po­si­tion with Amer­i­can Pathol­o­gy Part­ners and Col­lec­tive Health, but he plans to re­sign from those po­si­tions once he is con­firmed, then re­cuse him­self from ac­tions re­lat­ed to those com­pa­nies.

There are stock op­tions in Gradalis, Glytec and Strike Bio. He’s re­signed re­cent­ly from po­si­tions at Gradalis and Strike, and plans to re­cuse him­self from all three, di­vest­ing his in­vest­ments in 90 days af­ter he is con­firmed as com­mis­sion­er.

Got­tlieb was a part­ner at T.R. Win­ston, a bou­tique in­vest­ment bank, where he picked up in­vest­ments in Cell Bio­ther­a­py, An­gion Phar­ma­ceu­ti­cals, Chan­ti­cleer Hold­ings and:

  • Em­maus Life Sci­ences
  • In­spyr Ther­a­peu­tics
  • Kure
  • Lil­lis En­er­gy
  • Neu­ral­stem
  • Phar­ma-Bio Serv
  • Pros­et­ta Bio­sciences
  • So­cial Re­al­i­ty
  • Syn­the­sis En­er­gy Sys­tems
  • Tivor­san Phar­ma­ceu­ti­cals

All of that will go when he gets the nod from law­mak­ers.

He will still need to re­sign from po­si­tions at Amer­i­can En­ter­prise In­sti­tute, the New York Uni­ver­si­ty School of Med­i­cine, the So­ci­ety of Hos­pi­tal Med­i­cine, the BDO Cen­ter for Health­care Ex­cel­lence and In­no­va­tion, and Daichii Sankyo US.

(Whew.)

And he’ll re­cuse him­self from any ac­tions in­volv­ing all of them.

Chances are that the De­moc­rats will do what it can to paint these ties as an ex­am­ple of Got­tlieb’s too cozy re­la­tion­ship with an in­dus­try he plans to reg­u­late. But with the Re­pub­li­cans in charge of Con­gress and the White House, and bio­phar­ma of­fer­ing sol­id sup­port for the nom­i­na­tion, it’s un­like­ly he’ll be blocked.

The in­dus­try learned to yearn for Got­tlieb at the helm of the FDA pre­cise­ly be­cause his ex­pe­ri­ence had to make him aware of the re­al­i­ties in­volved in de­vel­op­ing ther­a­pies — a per­spec­tive that of­ten seems lack­ing in the White House. There’s no ques­tion his port­fo­lio took him on a glob­al jour­ney in bio­phar­ma that makes him a safe bet to run the agency.

But ex­pect to hear a lot more about this in the weeks to come.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

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Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

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As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

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Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.