HHS Xavier Becerra (AP Images)

Rule­mak­ing au­thor­i­ty re­stored at FDA as a show of sup­port in a tu­mul­tuous time

Just a day af­ter two top ca­reer vac­cine lead­ers at FDA re­tired at a key mo­ment of the pan­dem­ic, HHS has now for­mal­ly re­versed a ques­tion­able Trump-era memo that had abol­ished FDA’s abil­i­ty to write new rules.

That memo from then-HHS Sec­re­tary Alex Azar, is­sued Sept. 15, 2020, re­scind­ed “any pri­or del­e­ga­tion of rule­mak­ing au­thor­i­ty” at the FDA. On Wednes­day, how­ev­er, HHS Sec­re­tary Xavier Be­cer­ra is­sued a del­e­ga­tion that re­voked the 2020 memo as it ap­plies to FDA, and re­in­stat­ed any del­e­ga­tions to FDA re­scind­ed by the memo.

Ef­fec­tive­ly, the move is a show of sup­port from HHS’ top po­lit­i­cal ap­pointee, restor­ing FDA’s au­ton­o­my to the pre-Trump days, and paving the way for FDA to con­tin­ue its rule­mak­ing agen­da, which typ­i­cal­ly in­volves rule­mak­ings to en­sure the safe­ty of med­ical prod­ucts and im­prov­ing pub­lic health.

“Good to see HHS re­vers­ing pol­i­cy de­ci­sion by their pre­de­ces­sors that would have great­ly lim­it­ed FDA’s dis­cre­tion to is­sue pub­lic health reg­u­la­tions,” for­mer FDA com­mis­sion­er and Pfiz­er board mem­ber Scott Got­tlieb, wrote on Twit­ter. “This de­ci­sion by cur­rent HHS will re­store an es­sen­tial el­e­ment of FDA’s in­de­pen­dent judge­ment and al­low the agency to act faster.”

The fig leaf from HHS comes as FDA con­tin­ues to reel from the de­par­ture of two key vac­cine lead­ers while grap­pling with a press­ing time­line on Covid-19 vac­cine boost­ers and chil­dren’s vac­cines lat­er this fall and win­ter.

Azar’s HHS claimed in 2020 that the memo was nec­es­sary be­cause while in some cas­es rules were signed by the HHS sec­re­tary and by the head of the agency in­volved, in oth­er cas­es, oth­er of­fi­cials to whom au­thor­i­ty had been del­e­gat­ed signed the rules.

Got­tlieb told CBS’ Face the Na­tion on Sept. 20, 2020 that the memo was a “a ma­jor dis­trac­tion” from Covid-19 re­lief ef­forts, and it could call in­to ques­tion all of the rules that were signed by low­er-lev­el peo­ple who were del­e­gat­ed to sign the rules. He said when he was com­mis­sion­er at FDA, he re-cod­i­fied the to­bac­co deem­ing rule be­cause the agency feared some­thing like this might oc­cur.

Mark Mc­Clel­lan, for­mer FDA com­mis­sion­er and now head of Duke Uni­ver­si­ty’s health pol­i­cy cen­ter, told the New York Times at the time, “We’re in the midst of a pan­dem­ic, when trust in the pub­lic health agency is need­ed more than ever. So, I’m not sure what is to be gained with a man­age­ment change with re­spect to FDA when they are do­ing such crit­i­cal work.”

In ad­di­tion to this re­ver­sal, Biden’s HHS has re­versed a few oth­er FDA-re­lat­ed Trump-era ini­tia­tives, in­clud­ing de­ci­sion to pull the FDA’s con­tro­ver­sial Un­ap­proved Drugs Ini­tia­tive, an­oth­er no­tice that would’ve re­quired the FDA to pub­lish re­dun­dant in­for­ma­tion on the time­lines for re­view­ing drug ap­pli­ca­tions, and two re­quests for pro­pos­als on the reim­por­ta­tion of in­sulin and the per­son­al im­por­ta­tion of pre­scrip­tion drugs.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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