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.

“The SUN­SET fi­nal rule, if im­ple­ment­ed, would have sig­nif­i­cant­ly al­tered the op­er­a­tions of HHS with con­sid­er­able neg­a­tive reper­cus­sions for a di­verse ar­ray of stake­hold­ers,” the fi­nal with­draw­al post­ing on Thurs­day said. “We now con­clude that these sig­nif­i­cant reper­cus­sions were not ad­e­quate­ly con­sid­ered in is­su­ing the SUN­SET fi­nal rule in part be­cause the process to pro­mul­gate the rule was ex­treme­ly un­usu­al, if not un­prece­dent­ed.”

As far as the on­go­ing lit­i­ga­tion, HHS added, “At the par­ties’ joint re­quest, the San­ta Clara lit­i­ga­tion has thus far been stayed.”

Had this with­draw­al of the SUN­SET rule not gone through, the FDA, ac­cord­ing to HHS, would have faced the mas­sive task of re­view­ing over 7,000 sec­tions of the CFR that were pro­mul­gat­ed by the agency and which are more than 10 years old or would be­come more than 10 years old dur­ing the first five years the rule would be in ef­fect, rep­re­sent­ing over 95% of the FDA’s cur­rent reg­u­la­tions.

And the fi­nal rule pro­vides no ex­cep­tions to avert the ex­pi­ra­tion of a reg­u­la­tion if it’s not re­viewed, even in the event of a pan­dem­ic, a pub­lic health emer­gency, or an­oth­er de­clared na­tion­al emer­gency.

FDA and HHS al­so ex­plain how they reg­u­lar­ly re­view their reg­u­la­tions, par­tic­u­lar­ly for FDA in re­sponse to cer­tain cit­i­zen pe­ti­tions.

“It should be not­ed at the out­set that HHS rec­og­nizes the im­por­tance of ret­ro­spec­tive re­view, al­ready con­ducts ret­ro­spec­tive re­views, and in­tends to con­tin­ue to con­sid­er how to im­prove these ex­ist­ing process­es,” the de­part­ment said in the Fed­er­al Reg­is­ter on Thurs­day.

The FDA al­so main­tains a web­site con­tain­ing its eco­nom­ic im­pact analy­ses of FDA reg­u­la­tions, with links to at least 170 reg­u­la­to­ry im­pact analy­ses the agency has de­vel­oped since 2012.

And the SUN­SET rule would’ve been tough on the en­ti­ties cov­ered by the reg­u­la­tions too, the with­draw­al no­tice from HHS says.

“For ex­am­ple, one com­menter ex­pressed con­cern that if the SUN­SET fi­nal rule is not with­drawn, their ad­vo­ca­cy or­ga­ni­za­tion would need to redi­rect re­sources to mon­i­tor the sta­tus of the ap­prox­i­mate­ly 2,000 FDA reg­u­la­tions and then, if need­ed, in­vest at least 40 to 100 hours per rule to pro­vide com­ments,” HHS said. “The ac­tu­al ex­pi­ra­tion of reg­u­la­tions could lead to con­fu­sion among stake­hold­ers and un­der­mine pre­dictabil­i­ty and con­fi­dence in many sec­tors reg­u­lat­ed by the De­part­ment.”

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Oncologists on Twitter are talking up ASCO studies, health equity and burnout, according to new deep dive research from Harris Poll (via Shutterstock)

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll re­search

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.

Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.