Ex-Mela chief Gul­fo joins the list of would-be FDA com­mish can­di­dates, col­or-cod­ed drug ap­proval plan in hand

Joseph Gul­fo

A few weeks ago, Joseph Gul­fo spurred a con­sid­er­able round of chat­ter around a pro­pos­al for a col­or-cod­ed ap­proach to ap­prov­ing new drugs. Es­sen­tial­ly, he wants drug de­vel­op­ers to be able to gain an OK based on a range of fac­tors, in­clud­ing bio­mark­er ev­i­dence of ef­fi­ca­cy.

Now, Gul­fo’s name has been raised — by STAT — as an­oth­er pos­si­ble can­di­date for the top job at the FDA, as the bio­phar­ma in­dus­try anx­ious­ly awaits word on the next com­mis­sion­er and how Pres­i­dent Trump plans to de­liv­er on a promise to speed up new ap­provals even as he bat­ters the in­dus­try with crit­i­cism of its pric­ing strate­gies.

In a re­cent op-ed for The Hill, Gul­fo wrote:

Clin­i­cal util­i­ty and clin­i­cal ben­e­fit are high­ly sub­jec­tive and per­son­al ex­pe­ri­ences, best judged by pa­tients and their doc­tors.

Whether to use a drug (based on the po­ten­tial ben­e­fit and risk tol­er­ance of the pa­tient), or to con­tin­ue us­ing a drug giv­en the ben­e­fit-risk pro­file in the in­di­vid­ual pa­tient, is a per­son­al health de­ci­sion.

That ap­proach is more along the lines of the Lib­er­tar­i­an po­si­tions tak­en by two oth­er ru­mored can­di­dates for top jobs at the FDA. Both Jim O’Neill and Bal­a­ji Srini­vasan want to drop stan­dards that they be­lieve have kept drugs out of the mar­ket­place, which can best de­cide on their prop­er use. O’Neill fa­mous­ly said that drugs should be ap­proved based on safe­ty alone, an ap­proach that Gul­fo de­scribes as sell­ing “safe snake oil,” STAT re­ports.

“The FDA has in­creas­ing­ly added new hur­dles for pre-ap­proval re­quire­ments by de­mand­ing long-term out­comes and sur­vival,” Gul­fo main­tains. “A great ex­am­ple of this is in the ap­proval of Pralu­ent and Repatha, med­i­cines that low­er LDL cho­les­terol.”

Gul­fo had his own con­tro­ver­sial ex­pe­ri­ence with the FDA, pur­su­ing a lengthy cam­paign to gain an ap­proval for Mela Sci­ence’s MelaFind sys­tem, even as ex­perts warned of its pos­si­ble mis­use. In the words of Mass­De­vice:

Mela Sci­ences, and Gul­fo, be­came some­thing of a poster child for charges of un­pre­dictabil­i­ty at the FDA dur­ing the pri­or decade.

It’s hard to say how far Gul­fo’s can­di­da­cy can get. STAT’s re­port in­di­cat­ed that he had met with a cou­ple of mem­bers of Trump’s tran­si­tion team, which is a far cry from an ac­tu­al face-to-face with the pres­i­dent.

Scott Got­tlieb re­mains a wide­ly ru­mored can­di­date for Com­mis­sion­er as well. But he’s been able to keep a low pro­file re­cent­ly, un­like the oth­er ri­vals for this po­si­tion.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

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.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Vi­iV Health­care looks to make long-act­ing HIV pre­ven­tion shot ac­ces­si­ble in low- and mid­dle-in­come coun­tries

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.