DIRS.INFO The most relevant business & tech news

The Supreme Court’s decision on Friday to limit the broad regulatory authority of federal agencies could lead to the elimination or weakening of thousands of rules on the environment, health care, worker protection, food and drug safety, telecommunications, the financial sector and more. The decision is a major victory in a decades-long campaign by conservative activists to shrink the power of the federal government, limiting the reach and authority of what those activists call “the administrative state.”The court’s opinion could make it easier for opponents of federal regulations to challenge them in court, prompting a rush of new litigation, while also injecting uncertainty into businesses and industries. “If Americans are worried about their drinking water, their health, their retirement account, discrimination on the job, if they fly on a plane, drive a car, if they go outside and breathe the air — all of these day-to-day activities are run through a massive universe of federal agency regulations,” said Lisa Heinzerling, an expert in administrative law at Georgetown University. “And this decision now means that more of those regulations could be struck down by the courts.”

Persons: ”, Lisa Heinzerling Organizations: Georgetown University, “

☆ Law Enforcement Unit Is Formed to Crack Down on Illegal E-Cigarettes
▼ + stars: | 2024-06-10 | by ( Christina Jewett | ) www.nytimes.com time to read: +1 min

A multi-agency coalition of law enforcement agents will begin tackling the unruly market of illegal e-cigarettes, under pressure from antismoking groups, lawmakers and the tobacco industry urging federal authorities to stop the flood of vaping devices favored by adolescents. The Justice Department announced the new effort, which is expected to target fruit- and candy-flavored vapes containing high levels of addictive nicotine. The new coalition would include the Bureau of Alcohol, Tobacco, Firearms and Explosives; the U.S. Postal Service, tapping into federal laws that could include significant fines and jail terms. “Unauthorized e-cigarettes and vaping products continue to jeopardize the health of Americans — particularly children and adolescents — across the country,” Benjamin C. Mizer, the acting associate attorney general, said.

Persons: —, ” Benjamin C Organizations: Justice Department, Alcohol, Tobacco, Firearms, Explosives, U.S . Marshals Service, Federal Trade Commission, U.S . Postal Service, Food and Drug Administration

☆ F.D.A. Advisers Recommend a New Covid Vaccine Formula for the Fall
▼ + stars: | 2024-06-05 | by ( Noah Weiland | Christina Jewett | ) www.nytimes.com time to read: +1 min

The unanimous vote by the 16 advisers recommends a formula aimed at combating the variant JN.1, which dominated infections in the United States in February, or a version of it. In recent weeks, JN.1 has been overtaken by descendants known as KP.2 and KP.3. is expected to formally recommend a variant target for vaccine makers for the next round of shots in the late summer or early fall. Any decision involves some educated guesswork, given that any new vaccine formula won’t be available until months after a variant becomes dominant. “It’s becoming clear that the ideal timing for a vaccine composition decision remains elusive,” said Jerry Weir, an official with the F.D.A.’s vaccine division.

Persons: ”, Jerry Weir Organizations: Food and Drug Administration Locations: United States

☆ F.D.A.’s Review of MDMA Cites Health Risks and Study Flaws
▼ + stars: | 2024-05-31 | by ( Andrew Jacobs | Christina Jewett | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Friday raised concerns about the health effects of MDMA as a treatment for post-traumatic stress disorder, citing flaws in a company’s studies that could pose major obstacles to approval of a treatment anticipated to help people struggling with the condition. The agency said that bias had seeped into the studies because participants and therapists were readily able to figure out who got MDMA versus a placebo. It also flagged “significant increases” in blood pressure and pulse rates that could “trigger cardiovascular events.”The staff analysis was conducted for an independent advisory panel that will meet Tuesday to consider an application by Lykos Therapeutics for the use of MDMA-assisted therapy. The agency’s concerns highlight the unique and complex issues facing regulators as they weigh the therapeutic value of an illegal drug commonly known as Ecstasy that has long been associated with all-night raves and cuddle puddles. Approval would mark a seismic change in the nation’s tortuous relationship with psychedelic compounds, most of which the Drug Enforcement Administration classifies as illegal substances that have “no currently accepted medical use and a high potential for abuse.”

Persons: ” Organizations: Drug Administration, Lykos Therapeutics, Drug

☆ Despite Setback, Neuralink’s First Brain-Implant Patient Stays Upbeat
▼ + stars: | 2024-05-22 | by ( Christina Jewett | ) www.nytimes.com time to read: +1 min

Just four months ago, Noland Arbaugh had a circle of bone removed from his skull and hair-thin sensor tentacles slipped into his brain. A computer about the size of a small stack of quarters was placed on top and the hole was sealed. Paralyzed below the neck, Mr. Arbaugh is the first patient to take part in the clinical trial of humans testing Elon Musk’s Neuralink device, and his early progress was greeted with excitement. Neuralink’s staff had to retool the system to allow him to regain command of the cursor. Though he needed to learn a new method to click on something, he can still skate the cursor across the screen.

Persons: Noland Arbaugh, Arbaugh, Elon Organizations: Mario Kart

☆ Philips Settles CPAP Breathing Device Lawsuits for $1.1 Billion
▼ + stars: | 2024-04-29 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +1 min

Philips Respironics has reached a $1.1 billion settlement over claims that people who used their CPAP and other breathing devices were harmed by noxious gasses and flecks of foam that lodged in their airways, sometimes for years. Thousands of people contended in lawsuits that they had been injured by popular Philips DreamStation machines. Philips did not admit any fault in the settlement, including whether the devices caused the injuries, according to a financial report issued Monday. The personal injury settlement follows a $479 million settlement reached in September over economic losses to the patients and medical equipment sales companies that financed replacement devices. Philips also agreed to a consent decree earlier this year that forced the company to halt U.S. sales of new devices until certain conditions are met.

Persons: Philips Respironics, Philips Organizations: Philips

☆ Biden Delays Ban on Menthol Cigarettes
▼ + stars: | 2024-04-26 | by ( Christina Jewett | Noah Weiland | ) www.nytimes.com time to read: 1 min

The Biden administration said on Friday that it was delaying a decision on whether to ban menthol cigarettes as federal officials take more time to consider the move. The White House has faced considerable opposition from the big tobacco companies that could lose billions of dollars from the move. But the proposal has also posed risks for President Biden in an election year because of his weakening support among Black voters, some of whom view it as heavy-handed. “This rule has garnered historic attention, and the public comment period has yielded an immense amount of feedback, including from various elements of the civil rights and criminal justice movement,” Xavier Becerra, the health and human services secretary, said in a statement. “It’s clear that there are still more conversations to have, and that will take significantly more time.”

Persons: Biden, ” Xavier Becerra, ” Organizations: Black

☆ Chinese Company Under Congressional Scrutiny Makes Key U.S. Drugs
▼ + stars: | 2024-04-15 | by ( Christina Jewett | ) www.nytimes.com time to read: +1 min

A Chinese company targeted by members of Congress over potential ties to the Chinese government makes blockbuster drugs for the American market that have been hailed as advances in the treatment of cancers, obesity and debilitating illnesses like cystic fibrosis. WuXi AppTec is one of several companies that lawmakers have identified as potential threats to the security of individual Americans’ genetic information and U.S. intellectual property. A Senate committee approved a bill in March that aides say is intended to push U.S. companies away from doing business with them. The Congressional spotlight on the company has rattled the pharmaceutical industry, which is already struggling with widespread drug shortages now at a 20-year high. Some biotech executives have pushed back, trying to impress on Congress that a sudden decoupling could take some drugs out of the pipeline for years.

Organizations: New York Times Locations: WuXi, U.S

☆ National Sciences Academy Asks Court to Strip Sackler Name From Endowment
▼ + stars: | 2024-04-12 | by ( Christina Jewett | ) www.nytimes.com time to read: +1 min

The National Academy of Sciences is asking a court to allow it to repurpose about $30 million in donations from the wealthy Sackler family, who controlled the company at the center of the opioid epidemic, and to remove the family name from the endowment funds. The petition filed by the Academy in Superior Court in Washington, D.C., Thursday aims to modify the terms of the donations so the institution can use them for scientific studies, projects and educational activities. The move follows a report in The New York Times last year that examined donations from several Sackler members, including an executive of Purdue Pharma, which produced the painkiller OxyContin that has long been blamed for fueling the opioid crisis that has claimed thousands of lives. “The notoriety of the Sackler name has made it impossible for the Academy to carry out the purposes for which it originally accepted the funds,” Marcia McNutt, president of the National Academy of Sciences, said in a statement released on Thursday.

Persons: Sackler, ” Marcia McNutt Organizations: National Academy of Sciences, Academy, Washington , D.C, The New York Times, Sackler, Purdue Pharma Locations: Superior Court, Washington ,, The

☆ Heart Pump Is Linked to 49 Deaths, the F.D.A. Warns
▼ + stars: | 2024-03-29 | by ( Christina Jewett | ) www.nytimes.com time to read: +1 min

A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration’s decision to issue an alert about the risk that it could puncture a wall of the heart. The tiny Impella pumps, about the width of a candy cane, are threaded through blood vessels to take over the work of the heart in patients who are undergoing complex procedures or have life-threatening conditions. added, would have led to a much broader official agency warning to hospitals and doctors. It is the third major F.D.A. action for an Impella device in a year.

Organizations: Food

☆ Alcohol-Related Deaths Surge to Nearly 500 a Day, C.D.C. Says
▼ + stars: | 2024-02-29 | by ( Christina Jewett | Jan Hoffman | ) www.nytimes.com time to read: 1 min

The Latest NewsAlcohol-related deaths surged in the United States by nearly 30 percent in recent years, with roughly 500 Americans dying each day in 2021, according to a new study published by the Centers for Disease Control and Prevention. The study chronicled a sustained spike in drinking during the Covid pandemic that continued to rise after the shock of the lockdowns of 2020. The incidence of alcohol-related deaths was higher in men, but among women the death rate shot up at a quicker pace. “I think the results of this research are really alarming,” said Dr. Michael Siegel, who is a professor of public health at Tufts University School of Medicine and was not involved in the study. “It shows that there’s been a truly substantial increase in alcohol-related deaths over the last six years.”

Persons: ”, Michael Siegel, there’s Organizations: Centers for Disease Control, Tufts University School of Medicine Locations: United States

Listen and follow The DailyApple Podcasts | Spotify | Amazon MusicA Times investigation has revealed how applesauce laced with high levels of lead sailed through a food safety system meant to protect American consumers, and poisoned hundreds of children across the U.S.Christina Jewett, who covers the Food and Drug Administration for The Times, talks about what she found.

Persons: Christina Jewett Organizations: Spotify, Times, and Drug Administration, The Times Locations: U.S

☆ Lead-Tainted Applesauce Sailed Through Gaps in Food-Safety System
▼ + stars: | 2024-02-27 | by ( Christina Jewett | Will Fitzgibbon | ) www.nytimes.com time to read: +1 min

Cinnamon-flavored applesauce pouches sold in grocery and dollar stores last year poisoned hundreds of American children with extremely high doses of lead, leaving anxious parents to watch for signs of brain damage, developmental delays and seizures. The Food and Drug Administration, citing Ecuadorean investigators, said a spice grinder was likely responsible for the contamination and said the quick recall of three million applesauce pouches protected the food supply. Children in 44 states ate the tainted applesauce, some of which contained lead at extraordinarily high levels. and a food-safety law that gives companies, at home and abroad, wide latitude on what toxins to look for and whether to test. “Largely, the food supply regulatory system is based on an honor system.”

Persons: ”, Neal Fortin Organizations: Drug Administration, The New York Times, Institute for Food Laws, Michigan State University, “

☆ A Quarter of Smokers Quit Under Menthol Bans, Study Finds
▼ + stars: | 2024-02-22 | by ( Christina Jewett | ) www.nytimes.com time to read: +1 min

Nearly a quarter of menthol cigarette smokers quit in the year or two after a ban on menthol went into effect, according to a study published on Wednesday. Researchers found that about half of the menthol smokers switched to other cigarettes and another quarter managed to keep smoking menthols. The rate of menthol smokers who quit was higher in nations that imposed bans, in contrast with cities or states, since it was harder for people to drive a few miles to keep buying menthol cigarettes, according to the study. The Food and Drug Administration has been urging the Biden administration to impose a ban on menthol cigarettes, a goal that has generated intense opposition from retailers and tobacco companies alongside concerns in a presidential election year that it could alienate Black voters. Black smokers, who heavily favor menthol cigarettes, also stand to gain the most from such a ban, public health researchers say, noting that premature deaths from cancer, heart and lung disease could be avoided after a sharp decline in smoking rates.

Persons: menthol, Biden Organizations: Drug Administration

☆ N.Y. Attorney General Urges Stricter Warnings for Asthma Drug
▼ + stars: | 2024-02-22 | by ( Christina Jewett | Benjamin Mueller | ) www.nytimes.com time to read: +1 min

The New York attorney general on Thursday urged the Food and Drug Administration to “take immediate action” and renew alerts to doctors and patients about the dangerous effects of Singulair for children, saying that the current warnings about the drug’s psychiatric side effects were not sufficient. In a letter, the attorney general, Letitia James, also called on the federal agency to consider discouraging the prescription of Singulair, an asthma and allergy drug, to children. Thousands of patients and parents have complained to the F.D.A. about symptoms of anxiety, rage, hallucinations and other psychiatric problems that they linked to the drug, which is also known in its generic form as montelukast. in 2020 to order its most stringent warning on instructions for the drug’s usage.

Persons: Letitia James Organizations: New, Food and Drug Administration, New York Times Locations: New York

☆ U.S. Agencies Open Inquiry Into Generic Drug Shortages
▼ + stars: | 2024-02-14 | by ( Christina Jewett | ) www.nytimes.com time to read: +1 min

The Federal Trade Commission and the Department of Health and Human Services said on Wednesday that they would examine the causes of generic drug shortages and the practices of “powerful middlemen” that are involved in the supply chain. The federal agencies’ inquiry is aimed at the group purchasing organizations and drug distributors that have been in the spotlight in recent months as drug shortages reached a 10-year peak. During Congressional hearings in the last year, oncology experts have testified about the effects of the shortages, describing difficult decisions that forced them to ration key chemotherapy drugs. “For years Americans have faced acute shortages of critical drugs, from chemotherapy to antibiotics, endangering patients,” Lina Khan, the F.T.C. “Our inquiry requests information on the factors driving these shortages and scrutinizes the practices of opaque drug middlemen.”

Persons: ” Lina Khan Organizations: Federal Trade Commission, Department of Health, Human Services

☆ Philips Suspends U.S. Sales of Breathing Machines After Recall
▼ + stars: | 2024-01-29 | by ( Christina Jewett | ) www.nytimes.com time to read: +1 min

Philips Respironics announced on Monday that it would halt sales of all of its breathing machines in the United States after reaching a settlement with the Food and Drug Administration over continuing problems with the devices. Millions of the company’s ventilators and CPAP machines, used to ease breathing at night, were recalled after reports that they blew bits of foam and potentially toxic gases into consumers’ airways. Under the settlement, Philips said it would have to meet a list of standards in a “multiyear” plan before it could resume business in the United States. The company initially began the recall of millions of devices in June 2021 and paused sales of new sleep therapy machines to the United States, according to Steve Klink, a spokesman for Philips. cited the potential for serious injury or permanent impairment from the potentially cancer-causing chemicals emitted from the devices.

Persons: Philips Respironics, Philips, Steve Klink Organizations: Food and Drug Administration, Philips Locations: United States

Here are six reasons drugs in the United States cost so much:1. In the United States, negotiations with drug makers are split among tens of thousands of health plans, resulting in far less bargaining muscle for the buyers. Other nations also conduct careful analyses of how much additional benefit a new drug presents over drugs already on the market — and at what cost. If the cost is too high and the benefit too small, those countries are more willing to say no to a new drug. Health policy analysts say that is a start, but much broader negotiating authority is needed to make a dent in drug prices overall.

Persons: ”, Stacie Dusetzina Organizations: Vanderbilt University School of Medicine, Pharmaceutical, Industry Locations: United States

☆ Federal Scientists Recommend Easing Restrictions on Marijuana
▼ + stars: | 2024-01-12 | by ( Christina Jewett | Noah Weiland | ) www.nytimes.com time to read: +1 min

Marijuana is neither as risky nor as prone to abuse as other tightly controlled substances and has potential medical benefits, and therefore should be removed from the nation’s most restrictive category of drugs, federal scientists have concluded. The records shed light for the first time on the thinking of federal health officials who are pondering a momentous change. The agencies involved have not publicly commented on their debates over what amounts to a reconsideration of marijuana at the federal level. Since 1970, marijuana has been considered a so-called Schedule I drug, a category that also includes heroin. Schedule I drugs have no medical use and a high potential for abuse, and they carry severe criminal penalties under federal trafficking laws.

Persons: Matthew Zorn Organizations: Health, Human Services Locations: Texas

☆ Vaping Declines Among High School Students, Survey Shows
▼ + stars: | 2023-11-02 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +4 min

About 90 percent of the students who reported vaping said they used flavored products, citing favorites that tasted like fruit and candy. Public health experts also linked other state and local flavor bans and education campaigns to the falling high school vaping rate, which is the lowest in nearly a decade. In all, about 2.1 million middle and high school students reported using e-cigarettes, down from 2.5 million last year. While the agency has authorized about two dozen vaping products for sale, thousands of illicit candy-colored flavored vapes have flooded the country and are top sellers. Other researchers noted that the combined general use of tobacco products by middle and high school students barely fell, to 10 percent this year from 11 percent last year.

Persons: vaping, Juul, Brian King, There’s, Dr, Neff, “, ” Dr, ”, Karen Knudsen Organizations: Public, ., Food and Drug Administration, Federal, University of Southern, American Cancer Society Locations: California, University of Southern California

☆ Doctors Wrestle With A.I. in Patient Care, Citing Lax Oversight
▼ + stars: | 2023-10-30 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +1 min

spokesman, said the agency’s staff members review thousands of pages before clearing A.I. oversight right in medicine, a task that involves several agencies, is critical, said Dr. Ehrenfeld, the A.M.A. in deadly plane crashes to warn about the perils of automated safety systems overriding a pilot’s — or a doctor’s — judgment. He is concerned that doctors might encounter a similar use of A.I. is there should be an obvious place to start,” Dr. Ehrenfeld said.

Persons: James McKinney, ”, Ehrenfeld, weren’t

☆ Why the F.D.A. Took So Long to Tackle a Disputed Cold Remedy
▼ + stars: | 2023-09-15 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +1 min

Dr. Leslie Hendeles began prodding the Food and Drug Administration to reject a decongestant in cold medicines when he had a mop of curly red hair and Bill Clinton had just become president. By the time opposition to the drug had coalesced, Dr. Hendeles was appearing, at age 80, as an expert to testify before the agency’s advisers, his hair white and his overview of the ingredient spanning 50 years. His advocacy culminated in the advisory panel’s unanimous vote on Tuesday, when it concluded that the decongestant, a common ingredient in cold and flu remedies, is ineffective. Prompted by the news, consumers threw open their medicine cabinets upon learning that the decongestant, phenylephrine, was listed in more than 250 of their go-to drugs for congestion like some versions of DayQuil, Sudafed, Tylenol and Theraflu. And the decision has caused some confusion — experts say the ingredient still works in nasal sprays, just not when taken orally in pill or liquid form.

Persons: Leslie Hendeles, Bill Clinton, Hendeles Organizations: and Drug Administration

☆ A Decongestant in Cold Medicines Doesn’t Work at All, an F.D.A. Panel Says
▼ + stars: | 2023-09-12 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +3 min

Every cold and flu season, millions of Americans reach for these products, some over decades. The decongestant is in at least 250 products that were worth nearly $1.8 billion in sales last year, according to an agency presentation. Among the products: Sudafed Sinus Congestion, Tylenol Cold & Flu Severe, NyQuil Severe Cold & Flu, Theraflu Severe Cold Relief, Mucinex Sinus Max and others. The ingredient has long been considered safe and effective under an old, outdated agency standard, and the F.D.A. The agency also may give the drug companies a grace period to swap ingredients in products, if required.

Persons: Leslie Hendeles, Hendeles, ”, Marcia D, Howard Organizations: Staples, Medicine Cabinet, University of Florida, Consumer Healthcare Products Association, White

☆ Covid Vaccines May Roll Out Within Days
▼ + stars: | 2023-09-11 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +1 min

The latest Covid boosters are expected to be approved by the Food and Drug Administration as early as Monday, arriving alongside the seasonal flu vaccine and shots to protect infants and older adults from R.S.V., a potentially lethal respiratory virus. After a final decision by the C.D.C.’s director, millions of doses will be shipped to pharmacies, clinics and health systems nationwide within days. As Covid cases creep up, the prevention measures could portend the first winter of the decade without a crush of patients pushing hospitals beyond capacity. But a healthy winter is far from a lock: Last year, the updated Covid vaccine made it into the arms of only 20 percent of adults in the United States. Others see this year as an opportunity to protect more vulnerable people from severe illness or death.

Persons: ’ Organizations: Food and Drug Administration, Disease Control, Pfizer, BioNTech Locations: R.S.V, Moderna, United States

☆ CPAP Maker Reaches $479 Million Settlement on Breathing Device Defects
▼ + stars: | 2023-09-07 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +1 min

The economic claims amount is uncapped, which will permit other device users to apply for compensation. This tentative settlement, which is subject to federal court approval, does not address other significant claims in the plaintiffs’ cases involving personal injury or the cost of medical care related to use of the breathing machines. The company has faced a multiyear setback, after beginning recalls in the United States of about five million of its breathing machines, which are intended for people with sleep apnea and other maladies. The lawsuits have claimed that flaking foam and gasses emitted from the machines were linked to health issues including respiratory illnesses, lung cancer and death. The foam was used in the machines to reduce noise and vibration.

Persons: Philips Respironics, Philips Locations: United States

Search resuls for: "Christina Jewett"

25 mentions found