Alex Azar, HHS Secretary (AP Images)

Trump's HHS con­tin­ues to as­sert au­thor­i­ty over FDA in twi­light of his pres­i­den­cy, im­ple­ment­ing new drug time­line rules

With less than 10 days to go be­fore a new ad­min­is­tra­tion comes in, Alex Azar’s HHS is im­ple­ment­ing key changes at the FDA that are re­port­ed­ly rais­ing alarms among cur­rent and for­mer staffers about the agency’s in­de­pen­dence.

Azar en­act­ed two new poli­cies aimed at dereg­u­lat­ing FDA re­view poli­cies for new drug ap­provals and med­ical de­vices, HHS an­nounced late Mon­day. The first re­quires the agency to pub­lish its time­line for every NDA and AN­DA re­view on its web­site, while the sec­ond ex­empts a range of de­vices from pre­mar­ket re­view en­tire­ly.

Al­so late Mon­day, af­ter the top lawyer for the FDA re­signed ahead of Pres­i­dent-elect Joe Biden’s in­au­gu­ra­tion — nor­mal pro­ce­dure for such ap­pointees dur­ing tran­si­tion pe­ri­ods — HHS over­ruled the agency’s re­place­ment pick, per STAT.

Xavier Be­cer­ra

The moves come as Azar is set to de­part HHS when Biden is in­au­gu­rat­ed on Jan 20. It re­mains to be seen whether Biden’s HHS nom­i­nee Xavier Be­cer­ra, cur­rent­ly Cal­i­for­nia’s at­tor­ney gen­er­al, will keep these changes in place once he is con­firmed by the Sen­ate.

Of­fi­cials at the FDA were tak­en aback by the ac­tions, ac­cord­ing to Politi­co Pro, say­ing that HHS did not give the agency any heads up about whether the moves were com­ing. And on top of that, FDA of­fi­cials were re­port­ed­ly not giv­en an op­por­tu­ni­ty to pro­vide in­put on the new poli­cies.

For­mer FDA com­mis­sion­er Scott Got­tlieb, a for­mer ap­pointee of out­go­ing Pres­i­dent Don­ald Trump, blast­ed the changes.

“I’ve been dis­ap­point­ed to see HHS in­fring­ing on FDA’s pub­lic health pre­rog­a­tives in the clos­ing days of the ad­min­is­tra­tion,” Got­tlieb wrote on Twit­ter. “The way they’re pur­su­ing these uni­lat­er­al ac­tions will have long term con­se­quences at a time when FDA’s stature is crit­i­cal to see­ing us through this cri­sis.”

Azar jus­ti­fied the drug time­line pol­i­cy say­ing that, in 2019, near­ly 80% of new ap­provals took longer than the fed­er­al­ly man­dat­ed 180-day re­view pe­ri­od. The drug time­line rules re­quire the FDA to post three fig­ures on­line: the date in which it re­ceives a new drug ap­pli­ca­tion, the date it ap­proves a new drug and the to­tal days elapsed be­tween the 180-day mark and ap­proval.

Mon­day’s moves are the lat­est in what crit­ics say is a se­ries of at­tempts through­out the Covid-19 pan­dem­ic to crip­ple the FDA’s in­de­pen­dence and bring its rule­mak­ing more un­der HHS con­trol. Ca­reer of­fi­cials told Politi­co Pro that they’re wor­ried about what else might be in store in the fi­nal week and a half of the Trump ad­min­is­tra­tion, and a se­nior HHS of­fi­cial said the de­part­ment will be “un­leashed.”

Last Sep­tem­ber, Azar stripped the FDA and oth­er health agen­cies un­der his purview of their rule­mak­ing abil­i­ty and as­sert­ed all such pow­er “is re­served to the Sec­re­tary.” And when the FDA re-wrote guide­lines to strength­en Covid-19 vac­cine EUAs, Azar backed Trump in the mat­ter, who called the new rules “ex­treme­ly po­lit­i­cal.”

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; Flood, dead­ly fire threat­en As­traZeneca vac­cine plants

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.