Robert Califf (L) shakes hands with Sen. Mitt Romney (R-UT) at Califf's confirmation hearing for FDA commissioner, Dec. 14, 2021 (Graeme Sloan/Sipa via AP Images)

Sen­ate health com­mit­tee again of­fers its sup­port for FDA com­mis­sion­er nom­i­nee Rob Califf

Rob Califf, the fa­mous car­di­ol­o­gist from Duke Uni­ver­si­ty, is like­ly to re­turn to the top of the FDA, this time un­der the Biden ad­min­is­tra­tion.

At his con­fir­ma­tion hear­ing Tues­day, De­moc­rats and Re­pub­li­cans on the Sen­ate health com­mit­tee of­fered their sup­port for Califf, with Chair Pat­ty Mur­ray (D-WA) stress­ing the need for an ex­pe­ri­enced leader, like Califf, who can en­sure that sci­ence comes first.

“I’m not sure you could write a re­sume for some­one who’s more qual­i­fied to be FDA com­mis­sion­er,” Sen. Richard Burr (R-NC) said while in­tro­duc­ing Califf and say­ing he thought there was enough Re­pub­li­can sup­port to get Califf across the fin­ish line.

While crit­i­ciz­ing Pres­i­dent Joe Biden for leav­ing this com­mis­sion­er po­si­tion open for al­most a year, Burr called on Califf to en­sure that FDA does “not go back to the ways be­fore Covid. We need a war time com­mis­sion­er.”

Califf, who re­cent­ly worked as a se­nior ad­vis­er to Google Health and Ver­i­ly, and is well-known for his clin­i­cal re­search knowl­edge, called the pan­dem­ic “dev­as­tat­ing,” and said he was ready to “hit the ground run­ning” while thank­ing act­ing FDA com­mis­sion­er Janet Wood­cock and the agency’s staffers for their “ex­em­plary ser­vice” over the past sev­er­al years.

“I’m go­ing to be very ag­gres­sive in this area of med­ical mis­in­for­ma­tion,” Califf said.

He stressed that all of the FDA’s ac­tions must fo­cus on pro­tect­ing con­sumers and pa­tients, call­ing for a more “sys­tem­at­ic ap­proach to im­prove pa­tient safe­ty and bet­ter un­der­stand ben­e­fits and risks” of med­ical prod­ucts.

Califf was al­so ques­tioned re­peat­ed­ly on re­al weal world ev­i­dence, one of his long­time pet projects. He said the FDA needs to get sys­tems in place to pro­duce re­al world da­ta more quick­ly, give peo­ple the con­fi­dence to share da­ta, and “get those rules right.”

When sev­er­al De­moc­rats raised con­cerns with the FDA’s han­dling of the con­tin­ued opi­oid epi­dem­ic, Califf com­mit­ted to con­duct­ing a re­view of opi­oid la­bels, adding, “We need to learn from the past sev­er­al decades and re­assess be­cause what­ev­er we’ve done un­til now is not enough.”

At­tract­ing and re­tain­ing the sci­en­tif­ic work­force at FDA, mean­while, “may be more im­por­tant than any oth­er pol­i­cy,” Califf said. Two se­nior vac­cine of­fi­cials re­cent­ly re­tired and CBER in par­tic­u­lar is strug­gling to re­tain and re­cruit tal­ent.

While Califf has his foes, most­ly for his web of fi­nan­cial ties to in­dus­try, in­clud­ing De­moc­rats like Joe Manchin (WV), Ed Markey (MA), Richard Blu­men­thal (CT), Bernie Sanders, and po­ten­tial­ly Ben Lu­ján (NM), Re­pub­li­cans who pre­vi­ous­ly sup­port­ed him in 2016 — Sens. Burr, Bill Cas­sidy (LA), Su­san Collins (ME), and Mitt Rom­ney (UT) — seemed to of­fer their sup­port again in Tues­day’s hear­ing.

And should more De­moc­rats de­fect from vot­ing for Biden’s se­lec­tion for FDA, a to­tal of 34 Re­pub­li­cans who pre­vi­ous­ly vot­ed to con­firm Califf on his first time around are still in the Sen­ate.

“The Covid-19 pan­dem­ic has made clear­er than ever the choice be­tween phar­ma­ceu­ti­cal prof­its and the health of our peo­ple. In this crit­i­cal mo­ment, Dr. Califf is not the leader Amer­i­cans need at the FDA,” Sanders said in a state­ment on Tues­day.

In ques­tions from Burr and oth­ers on the ac­cel­er­at­ed ap­proval path­way, which is un­der scruti­ny in­side the agency and with­in HHS, Califf said that he’s “a fan of ac­cel­er­at­ed ap­proval un­der the right con­di­tions,” such as for peo­ple with rare ge­net­ic dis­eases or life-threat­en­ing can­cer. But he con­ced­ed the US needs a bet­ter sys­tem to eval­u­ate ac­cel­er­at­ed ap­proval prod­ucts as they’re used on the mar­ket.

Six for­mer FDA com­mis­sion­ers, as well as more than 90 oth­er or­ga­ni­za­tions of­fered their sup­port for Califf late Mon­day, in­clud­ing a let­ter of sup­port from the Na­tion­al Health Coun­cil, which has PhRMA and BIO ex­ec­u­tives on its board.

Oth­er Re­pub­li­cans ques­tioned Califf over what the FDA might do with the birth con­trol drug mifepri­s­tone, as the Biden ad­min­is­tra­tion pre­vi­ous­ly sig­naled that the FDA may re­move a decades-old pro­hi­bi­tion on dis­pens­ing such pills via mail. But Califf said he would lis­ten to the ca­reer ex­perts and the lat­est da­ta.

And while the FDA doesn’t usu­al­ly dip its toes in­to ar­eas like drug pric­ing, Califf said that he’s on record sup­port­ing Medicare’s abil­i­ty to ne­go­ti­ate prices. Sanders al­so ques­tioned Califf on how to make drugs more af­ford­able and Califf men­tioned the need for a more ro­bust gener­ics in­dus­try. The biosim­i­lars pro­gram needs to do bet­ter too, he said.

“Wealthy coun­tries need to pay their fair share,” Califf said. But he not­ed the US has not a hit a sweet spot, as fi­nan­cial tox­i­c­i­ty re­mains a se­ri­ous is­sue for can­cer pa­tients. Al­most one-quar­ter of those pa­tients skip their chemo treat­ments be­cause of the cost, he said.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Sen. Bill Cassidy (R-LA) (J. Scott Applewhite/AP Images)

Sen­ate un­veils its ver­sion of ac­cel­er­at­ed ap­proval re­forms as bi­par­ti­san duo calls on FDA and PTO to work to­geth­er

The Senate is joining its House counterparts and advancing accelerated approval pathway reforms to the FDA user fee legislation that must be signed by President Joe Biden before the end of September or else the FDA will have to start laying off its staff.

While Sen. Richard Burr (R-NC) warned yesterday that the user fee deals could be delayed by the infant formula crisis, the newly introduced bill on Friday shows how the Senate is aligning with its House counterparts on similar accelerated approval reforms.

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Co-CEOs Chintu and Chirag Patel (Amneal)

Look out, Neu­las­ta: A 5th biosim­i­lar is com­ing

As Neulasta sales slip, Amgen has yet another biosimilar to look out for: Amneal Pharmaceuticals and Kashiv Biosciences’ Flynetra.

Flynetra became the fifth approved biosimilar to Neulasta on Friday, snagging a win in neutropenia, a condition common among chemotherapy patients where neutrophils, a type of white blood cell that fights infection, are too low.

As of last summer, the list price of Neulasta was more than $6,400 per dose. It’s designed to be taken in a single dose per chemotherapy cycle. Amneal declined to reveal how much it intends to charge for Flynetra in an email to Endpoints News. 

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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