The FDA quietly announced on Tuesday that just before New Year’s eve, the agency again paused all of its non-mission-critical inspections in the US, likely leading to an even larger backlog of inspections worldwide.
The pause, which will last at least two weeks, is meant to ensure the safety of FDA employees and the companies it regulates as the agency further adapts to the spread of Omicron.
‘Through Jan.19, the agency intends to continue mission-critical work but has temporarily postponed certain inspectional activities with the hopes of restarting these activities as soon as possible,’ the FDA said in a statement.
The agency had only just returned to relatively normal domestic inspections last July, after a long previous pause that began as the pandemic hit in early 2020. In a report from last November, the agency noted that 52 new drug applications were delayed as a result of the inspection backlog created by that long pause. On the foreign inspection side, where activities have still been mostly on pause since early 2020, FDA said it’s postponing the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in February 2022.
But the FDA said it will continue conducting mission-critical foreign and domestic inspections.
Between April and September 2021, the FDA said it completed just 37 foreign drug inspections, which compares with more than 1,200 in 2019.
And the FDA’s total tally for drug and biologic inspections in 2020 shows how the agency conducted 1,500 fewer inspections in 2020, when compared to 2019 (and over 2,600 fewer when compared to 2011). Only 74 inspections ended with an Official Action Indicated in 2020, which compared with 202 OAIs in 2019.
The agency has sought to shift to more remote assessments of facilities, but that hasn’t proven to be a major help as the backlog is filled mostly with surveillance inspections, and the legal definition of an inspection is one that is conducted on site.
Their Staying Power Lies in their Patient-Centricity
Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.
Patrick Collison, co-founder of Stripe, has become one of Silicon Valley’s biggest advocates for new forms of funding and conducting science (Matt Winkelmeyer/Getty Images for WIRED)
It’s big days for biology.
The pandemic has seen a series of very public scientific breakthroughs: mRNA vaccine, Covid antibodies, CRISPR as therapy. The minds behind these advancements have graced magazine covers and received prestigious awards.
But the last two years have also, far more quietly, seen a series of new experiments in how to fund the next generation of scientific breakthroughs.
Since March 2020, investors, academics, a significant number of Silicon Valley types, at least one Russian billionaire and two crypto billionaires and, most recently, a few West Coast universities have launched a series of grant programs, institutes, NGOs and companies hoping to change how life science research is done. Though unaffiliated and varying greatly in both size and form, they have broadly promised to evade bureaucracy and misaligned incentives and advance both basic and not-so-basic research in ways they say can’t be done in either conventional academia or profit-focused biotech.
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BioNTech CEO Ugur Sahin (Photo by ddp images/Sipa USA)
One of the biggest storylines of biotech’s next half-decade will be where Moderna, BioNTech and their growing list of rivals push the mRNA technology that’s already changed the world.
BioNTech and Pfizer gave part of the answer Wednesday, announcing a new partnership to co-develop an mRNA-based shingles vaccine. The candidate will be ready for early-stage trials in the second half of 2022, the companies said.
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For anyone who’s been following how the US government has been allocating and shipping supplies of its Covid-19 treatments over the past year, the news has shifted so many times that it can be difficult to keep track of what’s still being shipped and where.
More change is coming this week too, as HHS has now decided to re-start shipments of both Eli Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products after a short pause because neither product works against the new variant Omicron. Lilly’s combo also was halted last June due to the presence of other variants.
Kicking off 2022, hundreds of pharmaceuticals, including some blockbusters, saw their list prices rise by about 5% on average. But overall, net drug prices (cost after rebates) declined for the fourth year in a row, potentially complicating already stalled drug price reform efforts.
Among the drugs seeing new increases as of Jan. 1 are Gilead’s bevy of blockbuster HIV drugs.
Biktarvy, which pulled in more than $7 billion in worldwide sales in 2020, saw a 4.8% price increase in 2021, and now, another 5.6% increase in 2022, according to a new report from the nonprofit 46brooklyn Research.
Ray Tabibiazar, SalioGen CEO
Roughly 10 months ago, a fledgling biotech emerged from stealth with a modest Series A and a big promise looking to develop gene therapy 3.0. The promise inched closer to reality Wednesday as investors have now hopped on board thanks to a new, nine-figure round.
SalioGen Therapeutics closed its $115 million Series B, the company announced Wednesday morning, aiming to push forward its ‘gene coding’ platform and growing preclinical pipeline. The biotech, which focuses on activating dormant mammalian enzymes to edit genes in vivo, secured the new raise after fleshing out some of the technologies’ applications, CEO Ray Tabibiazar told Endpoints News.
Michael Heffernan, Avenge Bio CEO
Michael Heffernan was already the head of a biotech company focused on chronic pain, called Collegium Pharmaceutical, which he successfully brought public in 2015. But when his wife was diagnosed with ovarian cancer, he knew that was his next mission.
Heffernan’s wife is doing well — but unfortunately, that isn’t the case for most patients, he said. In 2018, he stepped down from Collegium to look for a better option for women with recurrent refractory ovarian cancer. That’s when he met Rice University’s Omid Veiseh, who was working on an immunotherapy platform with a physician over at The University of Texas MD Anderson Cancer Center.
All the big R&D trends are on display in this new list of drug approvals for 2021. Plus one.
Add up everything OK’d from CDER and CBER, and you have 60 new drug approvals for last year, topping the 59 in 2020. That’s a close second to the 64 OKs that came out of the FDA in 2018. The dark days of the early 2000s are a distant memory now, with a host of hungry upstarts promising to make their own entries one day as Big Pharmas double down on innovation.
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Shoshana Shendelman, Applied Therapeutics CEO/founder
When the FDA lifted a clinical hold on Applied Therapeutics’ lead program in galactosemia last February, the New York biotech signaled that they were then on a smooth road toward an accelerated approval, with plans to file an NDA in the third quarter of 2021.
Regulators, though, apparently changed their mind.
Applied has decided to hold on submitting an NDA for AT-007 as a treatment for galactosemia, the company disclosed, following discussions with the FDA in which the agency indicated that ‘clinical outcomes data will likely be required for approval.’
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