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AbbVie’s big Rinvoq ambitionsand the larger JAK classface even more uncertainty with latest FDA delays – FiercePharma
Posted: June 28, 2021 at 10:00 pm
AbbVies big expansion for Rinvoq is still unable to move forward, thanks to FDA delays that spell trouble across the entire JAK inhibitor class. But at least one analyst isnt soundingthe alarm yet.
The FDA wont be able to reach decisions for Rinvoqs applications in psoriatic arthritis and ankylosing spondylitis in June as promised, AbbVie said Friday.
The company didnt say whether the agency has provided a new decision date. For the psoriatic arthritis indication, the news marks the second deferral.
The problem arises from the FDAs safety concerns after Pfizers fellow JAK inhibitor Xeljanz turned up additional risks for dangerous heart side effects and cancer in a post-marketing study in patients with rheumatoid arthritis.
RELATED:FDA weighs tighter restrictions for Pfizer's Xeljanz on the heels of safety red flags
In postponing Rinvoq, the FDA said its still reviewing those Pfizer data, according to AbbVie. In February, the agency alerted patients and doctors of Xeljanzs safety signal. At that time, it said it would dig into the results and consider what moves to take.
Existing JAK inhibitors, including Rinvoq, already bear warnings of increased risk of blood clots on their U.S. labels. Xeljanzs cardiovascular red flag obviously made the FDA nervous about it being a class-wide problem for all JAK drugs.
Still, as Piper Sandler analyst Christopher Raymond observedin a Friday note, its unlikely that Rinvoq would be painted with the same brush as Xeljanz, given the AbbVie drug selectively targets JAK1 and has shown a clean cardiovascular and cancer safety profile with rates of about 0.4 and 0.8 events per 100 patient-years, respectively. But Raymond also acknowledged that the new delays and the FDAs stated concern that got passed on from Xeljanz clearly cast more doubt on Rinvoqs label expansion hopes.
RELATED:AbbVie's big Rinvoq ambitions hit an FDA snag as JAK safety questions persist
The changed regulatory timeline does put into question AbbVies target of hitting $8 billion sales for Rinvoq in 2025. But Raymond said hes not hitting the panic button just yet. He also pointed tothe positive opinion from the European Medicines Agencys drug reviewers on approving Rinvoq in atopic dermatitis as a good sign that the drug will eventually pass muster at the FDA.
The FDA has so far delayed multiple decisions for the drug class. Besides psoriatic arthritis and ankylosing spondylitis, it has also pushed back a verdict for Rinvoq in atopic dermatitis to July. AbbVie didnt immediately respond to a request for clarification on the fate of that application.
Other drugs that have suffered similar fate include Xeljanz in ankylosing spondylitis, Eli Lillys Olumiant and Pfizers investigational abrocitinib in atopic dermatitisas well as Incytes Jakafi in chronic graft-versus-host disease and ruxolitinib cream for eczema.
AbbVie has a lot hanging on Rinvoq, which, alongside Skyrizi, is tasked with steadying the ship when megablockbuster immunology drug Humira loses U.S. patent protection in 2023.
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Elon Musk says Starlink will go public when its cash flow is more predictable – CNBC
Posted: at 9:58 pm
SpaceX founder and Tesla CEO Elon Musk visits the construction site of Tesla's gigafactory in Gruenheide, near Berlin, Germany, May 17, 2021.
Michele Tantussi | Reuters
Tesla and SpaceX CEO Elon Musk said he will only publicly list satellite broadband service Starlink when its cash flow is more predictable.
Starlink, which is currently operated by space exploration firm SpaceX, allows people to connect to the internet via a satellite dish that is placed on or near their property. The internet is beamed down to the dish via Starlink satellites that have been put into orbit by SpaceX.
"Going public sooner than that would be very painful," Musk said in a tweet late Wednesday. "Will do my best to give long-term Tesla shareholders preference."
The billionaire's tweet came after a Twitter user asked him: "Any thoughts on Starlink IPO we would love to invest in the future. Any thoughts on first dibs for Tesla retail investors?"
SpaceX President Gwynne Shotwell said last year that Starlink could be spun off from SpaceX for an initial public offering.
Starlink, which is based in Redmond, Washington, ultimately wants to provide the world with faster internet, starting by improving internet access in parts of the world that aren't currently served by broadband providers.
It plans to do this by putting thousands of small telecoms satellites into low-Earth orbit that can beam high-speed, low-latency internet to the ground.
Starlink is currently trialing its service with customers in 11 countries including the U.S. and the U.K.
Musk said in May that the company had received more than 500,000 preorders for its internet service and anticipates no technical problems meeting demand.
Starlink should be able to provide continuous global coverage by September, Shotwell said Tuesday.
"We've successfully deployed 1,800 or so satellites and once all those satellites reach their operational orbit, we will have continuous global coverage, so that should be like September timeframe," she told a Macquarie Group technology conference via webcast, according to Reuters.
"But then we have regulatory work to go into every country and get approved to provide telecoms services."
Starlink has said it plans to launch 12,000 satellites in total at a cost of approximately $10 billion.
Musk said in May that Starlink will be a crucial source of funding for some of his other plans, including sending paying customers to Mars and colonizing Mars.
In an interview in March last year, Musk said SpaceX could make up to $30 billion a year by providing broadband. He said that Starlink will be "helpful to telcos because Starlink will serve the hardest to serve customers" adding that 5G isn't great for the countryside because "you need range."
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In science we trust | CBC News – CBC.ca – CBC.ca
Posted: at 9:58 pm
This idea was not new. Plato believed society functioned best when it was run by experts. Technocracys focus on engineers was rooted in the conviction that there was a technological fix to almost all of societys problems.
Today, the idea that governments are too slow, too inefficient, too lacking in expertise to solve hard problems is widely shared among the engineers and entrepreneurs of Silicon Valley.
This libertarian impulse has always been part of the ethos of Silicon Valley. One of its first and most forceful expressions came in 1995, when tech pioneer John Perry Barlow delivered his Declaration of the Independence of Cyberspace to the World Economic Forum in Davos, Switzerland.
Governments of the Industrial World, you weary giants of flesh and steel, the Declaration began. I come from Cyberspace, the new home of Mind. On behalf of the future, I ask you of the past to leave us alone. You are not welcome among us. You have no sovereignty where we gather.
Silicon Valleys attitude towards government has become more accommodating since Barlow delivered his declaration, both out of choice and necessity. But there remains a conviction that, left to their own devices, tech companies are better able to solve problems in areas like transportation, education and health care, where decades of government regulation have put a break on innovation.
Theres a lack of focus on efficiency, lamented former Google executive chairman Eric Schmidt on a panel about government and technology in 2019. The reason there's no innovation in government is there's no bonuses for innovation. In fact, if you take a risk and it fails, your career is over.
This is the kind of overblown rhetoric weve come to expect from engineers and entrepreneurs in Silicon Valley, and their insistence that governments should step aside in favour of true problem-solvers is clearly self-serving. But the idea that we should be looking to experts rather than politicians for solutions to massively complex problems like a deadly pandemic or a climate emergency is gaining traction everywhere.
The idea of an apolitical world is appealing more and more to people, argues Eri Bertsou, a senior researcher at the University of Zurich and co-editor of a 2020 book called The Technocratic Challenge to Government.
People are tired, and they are put off by the commotion and the disagreement of representative politics, Bertsou said. So it's this appeal of an efficient machine-like system where problems can be identified through evidence, facts, reason, rather than ideological beliefs. I think that a lot of people find that appealing.
Bertsou has been studying the rise of technocratic governments around the world, especially in Europe. In February 2021, Mario Draghi, an economist and former president of the European Central Bank who had never held political office, was named Italian prime minister to help manage the countrys post-pandemic economic recovery.
Draghi is a technocrat, chosen for the specific experience he brings to the job. Italians are fond of technocrats, especially when times are tough, and Draghi is the fourth technocrat prime minister there since 1993. You can also find cabinet-level technocrats in Greece, France and Lebanon, among other countries. But none of them would be embraced by Technocracy, because they are still operating within the price system, still treating symptoms, not the disease.
While the number of technocrats in government is on the rise, so, too, is the number of populist politicians who wear their lack of expertise like a badge of honour.
During the 2020 U.S. presidential campaign, U.S. President Donald Trump mocked his opponent, Joe Biden, for saying he would listen to the scientists when it came to managing COVID-19. If I listened totally to the scientists, Trump proclaimed, wed have a country right now that would be in a massive depression.
But theres been a price for not listening to the experts. Countries run by populist leaders of various shades particularly the U.S., Brazil and the U.K. have recorded among the highest COVID-19 death rates.
For longtime Technocracy Incorporated supporters like Ed Blechschmidt, the idea that anyone would question the science around the pandemic, or anything else, is mystifying.
You cant argue with science and technology, he insisted. Science exists and scientific fact is fact. You cant have a political position about it. You have to recognize it and implement science.
But as weve discovered during the pandemic, science can sometimes speak with many voices, and by definition, representative democracy requires a constant balancing act among competing interests. Governments have to listen to the scientists but also to business people, parents and others.
Bertsou believes that by insisting on finding the one correct solution to every problem, Technocracy has presented a false dichotomy. There is not one type of scientific knowledge, and no one way of governing social problems.
Technocracy Incorporated began nearly a hundred years ago by seeking answers to two important questions: Why on a continent so rich in natural resources, energy and industrial capacity, were so many people suffering? And how could democracy, with all its obvious imperfections, continue to function effectively in a world where science and technology played an ever more dominant role?
Technocracys answers to both those questions were bold, radical, overly complicated and wildly impractical. Today, no one is talking about a North American Technate or a 16-hour work week or replacing money with energy certificates. But it would be wrong to dismiss Technocracy Incorporated as just another failed utopian scheme not while the answers to those two questions remains so elusive.
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At the Rate Things Are Going, American Rovers Might Find Chinese Cities on Mars – autoevolution
Posted: at 9:58 pm
To date, five rovers made in America, at least partially, have been sent to the Red Planet. They are the Sojourner, Spirit,Opportunity, Curiosity, and Perseverance. Of them, only two are presently still active, the Curiosity and the recently arrived Perseverance, and theyre accompanied by a tiny helicopter called Ingenuity.
Each of the five land-based pieces of hardware sent up there by the Americans is extraordinary in one way or another. A good chunk of them far exceeded their initial life expectancy, some have made discoveries no one expected, while others (or should we say pretty much all of them) have sent back precious data and images that kept keep scientists busy and the public in the loop.
Even if you personally are not all that interested in space exploration in general or the exploits of the human-made rover on Mars in particular, chances are you at least once saw a photo of the planet sent back by the said rovers or a selfie portraying one of them surrounded by the surreal Martian landscape.
Theyre extraordinary stills, revealing a world our race might eventually end up colonizing, a future home for the generations to come. They also reveal how, at times, the lack of an idea so simple it should seem obvious to all allows others to take the lead.
The American photos of Mars show just the desolate landscape, or the motionless rovers from awkward angles, at times weirdly distorted on account of a large number of shots being stitched together for a more panoramic look.
To date, despite decades of experience, American engineers didnt think of sending to the planet a wireless camera one of the rovers could plant in the soil and snap the first, proper photo of a human-made wheeled machine on Mars.
Also, despite decades of experience, the Americans didnt consider for one bit they could use that camera to snap an actual video of the rovers moving on the reddish surface of the neighboring piece of rock, making this entire Mars exploration thing much more real for us here on Earth.
The Chinese did both in the span of a single month.
As you might already know, back in May, the Asian nation became the second to land a rover on Mars. Zhurong is how its called, and while its not supposed to live for long, it has already made history.
Shortly after it came down from its lander, it planted a wireless camera in the Martian soil and moved away some 30 feet (10 meters) to take a photo of itself and the lander, Chinese flag includedthat reminds me, when's the last time you've seen the American flag on Mars?
That happened in mid-June, but now, as the month is drawing to a close, the Chinese released something even better: actual footage of the Zhurong moving away from the camera (check tweet attached below), which, if I am not mistaking, is the first time humans can experience a rover from this perspective.
China is a very propaganda-conscious nation and one that has ambitions of colonizing the solar system. It has these ambitions since about the same time as the Americans, but it is only in the past two decades or so that they have really taken off.
Thats because China is pumping huge amounts of resources into space exploration. In the span of a few short years, the country sent its people to space, landed on Mars, and sent a crew to a space station it just began building in orbit this month.
The scary (or encouraging, depending on which side of the fence you're on) part is that this whole space thing seems to come natural to the Chinese, who make it look all easy and simple.
It might be a big gamble, but if I were a betting man, Id put my money on China becoming the first to send people to Mars, and who knows, even set up a colony there.
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Elon Musk Said To Have Talked With Walter Issacson Over A Biography – Benzinga
Posted: at 9:58 pm
Biography author Walter Isaacson has been in touch with Tesla Inc(NASDAQ: TSLA) CEO Elon Musk to discuss the possibility of penning a biography of the billionaireentrepreneur, as per a Fox Business report.
What Happened: As per the report, Isaacson, whose biography on late Apple Inc (NASDAQ: AAPL) co-founder Steve Jobs sold over 3 million copies, has spoken with Musk over the telephone in recent weeks; the two plan additional conversations before a final decision is made.
Musk is known to have shown interest in having someone of Isaacson's stature write his biography but a final decision is still pending, the report said citing sources.
Isaacson conducted more than 40 interviews and spent two years writing his most popular biography on the iconicAppleco-founder.
The author of "The Code Breaker," "Leonardo da Vinci," "Benjamin Franklin," and "Einstein" in an interview with Yahoo Financein Marchcalled Musk in some ways Steve Jobs of our time because hes crazy enough to think he can change the world.
See Also: Did Billionaire Elon Musk Sell All His Mansions To Live In A $50,000 House?
Why It Matters: In February, Musksaid on Twitter that he is writing a book on Tesla and SpaceX. The renowned entrepreneur and innovator who wants to colonize Mars, has created a unique legacy of his own with a mix of invention and entrepreneurial spirit.
Price Action: Tesla shares closed 1.17% lower at $671.87 on Friday.
For news coverage in French, Italian, or Spanish, check outBenzinga France,Benzinga Italia, orBenzinga Espaa.
Photo by Heisenberg Media on Flickr
2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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There is no life in the atmosphere of Venus – Tech News Inc
Posted: at 9:58 pm
With a temperature of about 500 degrees Celsius, the surface of Venus is hostile to life but the higher temperatures in the planets atmosphere are much lower. Could microorganisms colonize this area? My research team has now answered this question with a resounding refusal. According to scientists in the journal Nature Astronomy, there is not enough water for life. Mars offers better prospects. Lakes on the Red Planet have not only provided sparse conditions, but have also been life-friendly for millions of years, a second team also reports in Nature Astronomy.
Only recently has the supposed discovery of phosphine gas in the atmosphere of Venus sparked discussions about life on the planet. However, research on this matter has so far overlooked the role of aquatic activity in ecological livability, explain John Halsworth of Queens University Belfast and colleagues. Biologists use water activity to describe the proportion of unconstrained water, that is, water that is available for life processes. This value can range from 0 to 1, but life is only possible if the water activity is greater than 0.585.
Hallsworth and his team have now analyzed conditions in the highly volatile region of Venuss atmosphere. It turns out that the value of water activity in this area is less than 0.004 water is rarely available for life there. According to scientists, this is caused by large amounts of sulfuric acid droplets. This means that there are no microbes there.
The situation is different with Mars: Hallsworth and colleagues have determined a water activity of 0.537 for its thin atmosphere just below the limit allowed for a life-friendly environment. Since the climate on the Red Planet has changed dramatically during its history, the atmosphere may have been more favorable for life in the past.
This is also supported by the findings of a study by Elizabeth Lusa Adams and colleagues from the University of Vigo in Spain. The team analyzed X-ray measurements taken by the Curiosity rover on sediment deposits in Gale crater. Curiosity has been traveling in this Martian crater since 2012, where there was a lake in the early days of Mars. Until now, we did not know whether the sediments were formed by the slow process of deposition or by short-term selective floods, Losa-Adams and colleagues explain.
With the help of X-ray measurements, the researchers were able to examine the crystalline structure of the sediment and learn how it was deposited. Their finding: The sediment must have been deposited in calm waters over a long period of time. So the lake in Gale Crater was not a short-lived body of water, but rather provided life-friendly conditions for a much longer period of time perhaps up to ten million years. The temperatures should also have been suitable for the emergence of life during this epoch, because the water did not freeze into ice and did not evaporate very quickly. Unlike the atmosphere of Venus, it is possible that life may have arisen in the water-rich environment of the young planet Mars.
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Univ. of Washington and Sana researchers use gene editing to prep stem cells for heart repair – GeekWire
Posted: at 9:55 pm
Heart muscle regeneration researchers (left to right) Naoto Muraoka, Elaheh Karbassi, and Chuck Murry. (University of Washington Photo)
Human stem cell scientists have long dreamed of repairing damaged hearts, but have been stymied by researchshowing that the cells yield irregular heartbeats in laboratory animals. A new genetic engineering approach overcomes this barrier, according to a report at the annual meeting of the International Society for Stem Cell Research by scientists at the University of Washington and Sana Biotechnology, a Seattle-based company.
A heart attack typically kills about one billion cells, said Charles Murry, director of the Institute for Stem Cell and Regenerative Medicine at the UW, who presented the data Monday. Such massive cell death can lead to downstream effects such as heart failure, an often-debilitating condition that affects about 6.2 million people in the U.S. Using stem cells to repair the damage after a heart attack has long been a goal in his lab.
One major challenge in the field is that implanting cells into the hearts of laboratory animals can nudge the whole heart into beating rapidly, a condition called engraftment arrhythmia, said Murry, who is also a senior vice president and head of cardiometabolic cell therapy at Sana, which went public earlier this year.
This engraftment arrhythmia, where the heart races too quickly, has been one of the major hurdles weve been trying to overcome en route to clinical trials, said Murry in a press release.
In their study, Murry and his colleagues quelled engraftment arrhythmia using a genetic engineering strategy in cells implanted into pig hearts. Their next step is to see if the cells can repair heart damage in macaques if those studies work, the researchers will initiate clinical trials in people, he said.
To quell the arrhythmia, Murry and his colleagues turned to CRISPR, the Nobel Prize-winning technique to knock out genes. They knocked out three genes in stem cells encoding different ion channels, molecules embedded in the cell membrane that mediate impulses that propagate heart beats. They also added DNA for another ion channel, KCNJ2, which mediates the movement of potassium across the membrane, Its a chill out channel, Murry told GeekWire, It tells the heart cell not to be so excitable.
The engineered stem cells, derived from human embryonic stem cells, were coaxed in a petri dish to produce heart muscle cells, which were then implanted into pigs via open heart surgery or a catheter. The result was an even heartbeat the genetically altered cells did not cause engraftment arrhythmia.
The researchers landed on this strategy after years of effort, assessing which channels were present in the cells during arrhythmia, and knocking out multiple types of channels until they hit the right combination.
In their next set of experiments in macaques, We want to make sure these cells are still effective, said Murry, They look good beating in culture, so I think they are going to be OK. Moving forward, the researchers will also use induced human pluripotent stem cells, obtainable from adults and more amenable longer-term for clinical use.
In another recent study, published in Cell Systems, scientists at the Allen Institute for Cell Science took a close look at cardiac muscle cells derived from stem cells. They found that they could classify the state of the cells, such as how mature they were, by assessing both cell structure and which genes were turned on.
This paints a broader picture of our cells. If someone wants to really understand and characterize a cells state, we found that having both of these types of information can be complementary, said Kaytlyn Gerbin, a scientist at the Allen Institute for Cell Science in a statement. The findings provide a fine-tooth analysis of cell state, which may guide future experiments on cardiac muscle and other cell types.
Murrys research was conducted primarily at the UW, with financial support from Sana. In addition to its cardiac program, Sana has cell and gene therapy programs in diabetes, blood disorders, immunotherapy and other areas.
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Genetic Engineering for Food Security to Have Strong Impact on Oilseed and Grain Farming Businesses | Discover Company Insights on BizVibe -…
Posted: at 9:55 pm
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UC San Diego Scientists Develop the First CRISPR/Cas9-based Gene Drive in Plants – UC San Diego Health
Posted: at 9:55 pm
Arabidopsis plants were used to develop the first CRISPR-Cas9-based gene drive in plants.
With a goal of breeding resilient crops that are better able to withstand drought and disease, University of California San Diego scientists have developed the first CRISPR-Cas9-based gene drive in plants.
While gene drive technology has been developed in insects to help stop the spread of vector-borne diseases such as malaria, researchers in Professor Yunde Zhaos lab, along with colleagues at the Salk Institute for Biological Studies, demonstrated the successful design of a CRISPR-Cas9-based gene drive that cuts and copies genetic elements in Arabidopsis plants.
Breaking from the traditional inheritance rules that dictate that offspring acquire genetic materials equally from each parent (Mendelian genetics), the new research uses CRISPR-Cas9 editing to transmit specific, targeted traits from a single parent in subsequent generations. Such genetic engineering could be used in agriculture to help plants defend against diseases to grow more productive crops. The technology also could help fortify plants against the impacts of climate change such as increased drought conditions in a warming world.
The research, led by postdoctoral scholar Tao Zhang and graduate student Michael Mudgett in Zhaos lab, is published in the journal Nature Communications.
This work defies the genetic constraints of sexual reproduction that an offspring inherits 50% of their genetic materials from each parent, said Zhao, a member of the Division of Biological Sciences Section of Cell and Developmental Biology. This work enables inheritance of both copies of the desired genes from only a single parent.The findings can greatly reduce the generations needed for plant breeding.
The study is the latest development by researchers in the Tata Institute for Genetics and Society (TIGS) at UC San Diego, which was built upon the foundation of a new technology called active genetics with potential to influence population inheritance in a variety of applications.
A schematic representation of a new gene drive using CRISPR/Cas9 technology.
Developing superior crops through traditional genetic inheritance can be expensive and time consuming as genes are passed through multiple generations. Using the new active genetics technology based on CRISPR-Cas9, such genetic bias can be achieved much more quickly, the researchers say.
I am delighted that this gene drive success, now achieved by scientists affiliated with TIGS in plants, extends the generality of this work previously demonstrated at UC San Diego, to be applicable in insects and mammals, said TIGS Global Director Suresh Subramani. This advance will revolutionize plant and crop breeding and help address the global food security problem.
Coauthors of the paper include: Tao Zhang, Michael Mudgett, Ratnala Rambabu, Bradley Abramson, Xinhua Dai, Todd Michael and Yunde Zhao.
The research was funded by TIGS-UC San Diego and a training grant from the National Institutes of Health.
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UC San Diego Scientists Develop the First CRISPR/Cas9-based Gene Drive in Plants - UC San Diego Health
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USDAs Proposal to Take Back Regulatory Oversight of GM Animals from FDA Remains Viable Despite Change in Administration – JD Supra
Posted: at 9:55 pm
On December 14, 2020, the US Food and Drug Administration (FDA) approved GalSafe pigs, which are genetically modified (GM) for use in food production and medical products. At the time, the agency noted in its Consumer Q&A that intentional genomic alterations (IGAs) in animals would be regulated by FDA to ensure that it is safe for the animal, safe for anyone that consumes food from the animal, and that it is effective, i.e., it does what the developer claims it will do. The agency also explained that IGAs would be subject to premarket oversight whether they are intended to be used for food or to produce pharmaceuticals or other useful products (emphasis added), with the US Department of Agriculture (USDA) being responsible for the labeling of food from GM animals.
However, on yet another show of intra-agency conflict during the Trump administration, just several weeks later the USDA moved to wrest the oversight of GM animals intended for food production from FDA by issuing an Advanced Notice of Proposed Rulemaking (ANPRM), titled Regulation of the Movement of Animals Modified or Developed by Genetic Engineering. Under the ANPRM, the USDA would be responsible for:
Notably, FDA would continue to regulate GM seafood. This proposed regulatory framework is intended to operate under a Memorandum of Understanding (MOU) between the USDA and the US Department of Health and Human Services (HHS).
The MOU was signed by the two agencies on January 13, 2021, just mere days before the change in administration. The MOU transfers the oversight of GM animals intended for agricultural purposes (i.e., human food, fiber, and labor) from FDA to the USDA under authorities granted to the USDA by the Animal Health Protection Act, the Federal Meat Inspection Act, and the Poultry Products Inspection Act. Under the MOU, FDA will continue to have authority over IGAs intended for any purpose other than agricultural use, including biopharma, xenotransplantation, and gene therapies. Importantly, if a specific GM animal species is intended for human food supply, FDA must consult with the USDA on the food safety review to promote consistent food safety reviews and monitoring for all amenable species intended for human food as part of USDA's new program.
Considering the strong interest in the proposed change in agency oversight by both industry and consumers alikeas well as the Biden-Harris administrations likely desire to gauge the support and opposition for the plan before making a decisionUSDA reopened the comment period for the ANPRM in early March, which was extended to May 7, 2021. Despite strong support from industry, however, animal welfare, public health, and environmental advocates have signed letters urging both Tom Vilsack, Agriculture Secretary, and Xavier Becerra, HHS Secretary, to allow FDA to retain its oversight over GM animals intended for food production, claiming the MOU weakens FDAs authority to protect public health.
In the meantime, FDA continues to regulate GM animals for both agricultural and medical purposes. Whether USDAs effort to retain jurisdiction over GM meat intended for the food supply will be successful is unclear. However, it seems there would be some amount of duplication in determining whether a genetic modification to an animal is safe for purposes of producing food, drugs, new cells, or tissue structures for use in humans. Presumably the agencies will share their relevant scientific expertise in assessing the use of this novel technology and its possible effects on humans. Because state agencies are also heavily involved in the regulation of livestock, it is likely that states will have a view on which federal agency they believe is more capable to set appropriate standards and police activity. It remains unclear when a decision on the ANPRM will be issued and whether the Biden-Harris administration will support the proposed rule.
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