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☆ How the Psychedelics Medicine Bubble Burst - The New York Times
▼ + stars: | 2024-08-23 | by ( Caty Enders | ) www.nytimes.com time to read: +2 min

The drug company Lykos Therapeutics had spent much of this year expecting to vault to meteoric heights. It had sent an application to the Food and Drug Administration seeking approval to use MDMA to treat post-traumatic stress disorder. It was the capstone to months of increasingly loud concerns being voiced over the quality of Lykos’s clinical trials. Lykos has spent years conducting clinical trials testing whether MDMA-assisted psychotherapy could alleviate the symptoms of PTSD. Its most recent drug trial showed that more than 86 percent of people treated had a measurable reduction in symptom severity.

Persons: ”, Lykos Organizations: Lykos Therapeutics, Food and Drug Administration, Lykos, Merck

☆ Three Studies of MDMA Treatment Retracted by Scientific Journal
▼ + stars: | 2024-08-12 | by ( Andrew Jacobs | More About Andrew Jacobs | ) www.nytimes.com time to read: +1 min

The journal Psychopharmacology has retracted three papers about MDMA-assisted therapy based on what the publication said was unethical conduct at one of the study sites where the research took place. Several of the papers’ authors are affiliated with Lykos Therapeutics, the drug company whose application for MDMA-assisted therapy to treat post-traumatic stress disorder was rejected last week by the Food and Drug Administration. The company said the research in the retracted papers was not part of its application to the F.D.A. has asked Lykos to conduct an additional clinical trial of its MDMA-assisted therapy, which would have been the first psychedelic medicine to win approval by federal regulators. Lykos has said it would appeal the decision.

Persons: Lykos Organizations: Lykos Therapeutics, Food and Drug Administration

☆ F.D.A. Declines to Approve MDMA Therapy, Seeking More Study
▼ + stars: | 2024-08-09 | by ( Andrew Jacobs | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Friday declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder, dealing a serious blow to the nascent field of psychedelic medicine and dashing the hopes of many Americans who are desperate for new treatments. An additional clinical trial could add years, and millions of dollars, to the approval process. If approved, MDMA would have become the first psychedelic compound to be regulated by federal health authorities. “This is an earthquake for those in the field who thought F.D.A. approval would be a cinch,” said Michael Pollan, the best-selling author and co-founder of the UC Berkeley Center for the Science of Psychedelics.

Persons: F.D.A, ”, Michael Pollan Organizations: Drug Administration, Lykos Therapeutics, UC Berkeley Center, Psychedelics

☆ F.D.A. Approves Blood Test for Colon Cancer Detection
▼ + stars: | 2024-07-29 | by ( Gina Kolata | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Monday approved a new screening test for colorectal cancer. For many people, a routine blood test is easier to get than a colonoscopy or a fecal sample test. But the blood test, made by Guardant Health of Palo Alto, Calif., comes with a limitation. It is approved for people aged 45 and over who are at average risk for colon cancer. As many as 53,000 Americans are expected to die from colorectal cancer this year.

Persons: Guardant, Matt Burns Organizations: Drug Administration, Guardant Health, Palo Locations: Palo Alto, Calif, United States

☆ Live Updates: Supreme Court Overrules Chevron Doctrine, Imperiling an Array of Federal Rules
▼ + stars: | 2024-06-28 | by ( Adam Liptak | ) www.nytimes.com time to read: +12 min

But that gave too much power to unelected government officials, according to conservatives, who ran a coordinated, multiyear campaign to end the Chevron doctrine. The Environmental Protection AgencyEnvironmentalists fear that the end of the Chevron doctrine will mean the elimination of hundreds of E.P.A. “I would expect the industry to attack the F.D.A.’s authority to do premarket review at all,” said Desmond Jenson, deputy director of the commercial tobacco control program at the Public Health Law Center. Others noted the Chevron decision could have a chilling effect, compelling the F.D.A. “The Supreme Court has not relied on Chevron in quite a few years,” she said.

Persons: ”, Lisa Heinzerling, Donald J, Trump, Mandy Gunasekara, President Trump, Jonathan Berry, doesn’t, ” Rather, Berry, ” Mr, Chevron, Biden, Garden, “, Desmond Jenson, Nicholas Bagley, Rachel Sachs, Louis, Abbe R, Gluck, Ms Organizations: Georgetown University, “, Congress, Labor, Act, Republican, Trump, Chevron, Labor Department, Mr, Environmental Protection Agency, Biden, University of Minnesota, The National Labor Relations Board, Food, Drug Administration, Public Health Law Center, Health, Affordable Care, University of Michigan, Washington University School of Law, Department of Health, Human Services, Centers, Medicare, Services, Yale Law School, Treasury, Internal Revenue, Treasury Department, Internal Revenue Service Locations: Chevron, St

☆ Contraception Is Free by Law. So Why Are a Quarter of Women Still Paying for It?
▼ + stars: | 2024-06-26 | by ( Alisha Haridasani Gupta | ) www.nytimes.com time to read: +1 min

Some experts estimate that those practices could affect access to birth control for millions of women. Since 2012, the Affordable Care Act has mandated that private insurance plans cover the “full range” of contraceptives for women approved by the Food and Drug Administration, including female sterilizations, emergency contraceptives and any new products cleared by the F.D.A. The mandate also covers services associated with contraceptives, like counseling, insertions or removals and follow-up care. That means that consumers shouldn’t have any associated co-payments with in-network providers, even if they haven’t met their deductibles. Medicaid plans have a similar provision; the only exception to the mandate are plans sponsored by employers or colleges that have religious or moral objections.

Persons: Bernie Sanders of, —, haven’t Organizations: Office, Affordable, Food and Drug Administration Locations: Bernie Sanders of Vermont

☆ F.D.A. Authorizes First Menthol-Flavored E-Cigarettes
▼ + stars: | 2024-06-21 | by ( Michael Levenson | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration said on Friday that it had approved the first menthol-flavored e-cigarettes in the United States, less than two months after the Biden administration delayed a fiercely contested decision on whether to ban traditional menthol cigarettes. said it had authorized four types of menthol-flavored e-cigarettes made by NJOY, part of the tobacco company Altria, making them the first flavored e-cigarettes that can be sold legally in the United States. said that evidence indicated that they could benefit adult smokers who want to transition to a “less harmful product.”Public health groups sharply criticized the decision, warning that e-cigarettes and flavored tobacco products were especially appealing to young people. The Campaign for Tobacco-Free Kids pointed out that, according to the 2023 National Youth Tobacco Survey, nearly a quarter of high school students who use e-cigarettes use illicit menthol-flavored varieties, which are often easy to find in gas stations and corner stores.

Persons: Biden, NJOY Organizations: Drug Administration, Tobacco, Tobacco Survey Locations: United States

☆ Live Updates: Supreme Court Upholds Broad Access to Abortion Pill
▼ + stars: | 2024-06-13 | by ( Abbie Vansickle | ) www.nytimes.com time to read: +2 min

ETThe Supreme Court on Thursday upheld access to a widely available abortion pill, rejecting a bid from a group of anti-abortion organizations and doctors to unravel the Food and Drug Administration’s approval of the pill. In a unanimous decision, written by Justice Brett M. Kavanaugh, the court held that the plaintiffs lacked standing to challenge the F.D.A.’s actions. The case involved easier access: The challenge before the court centered on changes the F.D.A. The safety of the pill: The groups — citing five studies, including two that were later retracted — questioned the safety of mifepristone, which was approved by the F.D.A. Their claim contradicted a large scientific record on the safety of mifepristone and another abortion medication, misoprostol.

Persons: Brett M, Kavanaugh, ”, Roe, Wade, ’, Matthew J, Kacsmaryk, —, Adam Liptak Locations: Texas, Amarillo , Texas, Panhandle

☆ F.D.A. Warns Against ‘Microdosing’ Mushroom Chocolate Bars
▼ + stars: | 2024-06-10 | by ( Dani Blum | ) www.nytimes.com time to read: +1 min

At least eight people in four states have fallen ill after eating Diamond Shruumz-brand Microdosing Chocolate Bars, including several who had seizures or lost consciousness and needed to be placed on ventilators. Diamond Shruumz has marketed the chocolates as “trippy little squares” and calls the chocolate a “microdose,” referring to a term for a small amount of a psychedelic. But the company has said the bars do not contain psychedelic substances, including psilocybin, the hallucinogenic drug found in so-called magic mushrooms. Instead, Diamond Shruumz says its products have “nootropic and functional mushrooms,” like Lion’s Mane, Reishi and Chaga mushrooms. The Food and Drug Administration and Centers for Disease Control and Prevention are working with poison control centers and state health agencies to investigate the cause of the illnesses.

Persons: Diamond, Diamond Shruumz Organizations: Drug Administration, Centers for Disease Control

☆ A Drug to Slow Alzheimer’s Is Finally Available. How Are Patients Faring?
▼ + stars: | 2024-06-10 | by ( Dana G. Smith | ) www.nytimes.com time to read: +1 min

Over the last three years, a new class of Alzheimer’s drug, the first to treat a root cause of the disease, has set off a roller coaster of hope and disappointment. Lecanemab (brand name Leqembi; pronounced le-KEM-bee) was given full approval by the Food and Drug Administration in July 2023 and is currently the only one of its class available to Alzheimer’s patients, outside clinical trials. The drug has been shown to slow the progression of the disease, but its benefits are fairly modest. With lecanemab having been approved for nearly a year — and with a similar drug, donanemab, being reviewed by an F.D.A. There are strict requirements for patients to be eligible for lecanemab; by one estimate, fewer than 20 percent met the qualifications for the medication.

Persons: Neurologists Organizations: Food and Drug Administration, New York Times, Mayo Clinic, Mayo Clinic , Massachusetts General Hospital, University of California Locations: Mayo Clinic , Massachusetts, San Francisco

☆ 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. Panel Weighs MDMA Therapy and Its Risks
▼ + stars: | 2024-06-04 | by ( Andrew Jacobs | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration is weighing whether to approve the use of MDMA, also known as Ecstasy, for treatment of post-traumatic stress disorder. An independent advisory panel of experts will review studies on Tuesday and is expected to vote on whether the treatment would be effective and whether its benefits outweigh the risks. The panel will hear from Lykos Therapeutics, which has submitted evidence from clinical trials in an effort to obtain agency approval to sell the drug legally to treat people with a combination of MDMA and talk therapy. Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive drug first developed by Merck in 1912. After being resynthesized in the mid-1970s by Alexander Shulgin, a psychedelic chemist in the Bay Area, MDMA gained popularity among therapists.

Persons: Alexander Shulgin Organizations: Drug Administration, Lykos Therapeutics, Merck Locations: Bay

☆ PTSD Treatments Are Falling Short for Many Patients
▼ + stars: | 2024-06-04 | by ( Dani Blum | ) www.nytimes.com time to read: +1 min

They withdraw — often reluctant to talk about what they’ve experienced and unable to trust others or themselves. The treatments for PTSD — including several forms of psychotherapy and medication — are effective for many patients, but they don’t work for everyone. Sometimes, they can be so distressing that patients stop the treatment before it’s complete. On Friday the Food and Drug Administration declined to approve what would have been the first new treatment for PTSD in decades, a therapy that combined the psychoactive drug MDMA with talk therapy. approve the treatment, citing concerns about safety and issues in clinical trials.

Persons: —, it’s Organizations: and Drug Administration, Lykos Therapeutics

☆ F.D.A. Panel Rejects MDMA-Aided Therapy for PTSD
▼ + stars: | 2024-06-04 | by ( Andrew Jacobs | ) www.nytimes.com time to read: +1 min

An independent advisory panel of the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday, highlighting the unparalleled regulatory challenges of a novel therapy using the drug commonly known as Ecstasy. Before the vote, members of the panel raised concerns about the designs of the two studies submitted by the drug’s sponsor, Lykos Therapeutics. The panel voted 9-2 on whether the MDMA-assisted therapy was effective, and voted 10-1 on whether the proposed treatment’s benefits outweighed its risks. Other panelists expressed concerns over the drug’s potential cardiovascular effects, and possible bias among the therapists and facilitators who guided the sessions and may have positively influenced patient outcomes. A case of misconduct involving a patient and therapist in the study also weighed on some panelists’ minds.

Organizations: Food and Drug Administration, Lykos Therapeutics

☆ 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

☆ F.D.A. Approves Drug for Persistently Deadly Form of Lung Cancer
▼ + stars: | 2024-05-16 | by ( Gina Kolata | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Thursday approved an innovative new treatment for patients with a form of lung cancer. It is to be used only by patients who have exhausted all other options to treat small cell lung cancer, and have a life expectancy of four to five months. The drug tarlatamab, or Imdelltra, made by the company Amgen, tripled patients’ life expectancy, giving them a median survival of 14 months after they took the drug. After decades with no real advances in treatments for small cell lung cancer, tarlatamab offers the first real hope, said Dr. Anish Thomas, a lung cancer specialist at the federal National Cancer Institute who was not involved in the trial. Dr. Timothy Burns, a lung cancer specialist at the University of Pittsburgh, said that the drug “will be practice-changing.”

Persons: tarlatamab, Anish Thomas, “, Timothy Burns, ” Organizations: Drug Administration, National Cancer Institute, University of Pittsburgh

The Major Supreme Court Cases of 2024No Supreme Court term in recent memory has featured so many cases with the potential to transform American society. In 2015, the Supreme Court limited the sweep of the statute at issue in the case, the Sarbanes-Oxley Act of 2002. In 2023, the Supreme Court temporarily blocked efforts to severely curb access to the pill, mifepristone, as an appeal moved forward. A series of Supreme Court decisions say that making race the predominant factor in drawing voting districts violates the Constitution. The difference matters because the Supreme Court has said that only racial gerrymandering may be challenged in federal court under the Constitution.

Persons: Donald J, Trump, Anderson, Sotomayor Jackson Kagan, Roberts Kavanaugh Barrett Gorsuch Alito Thomas, Salmon, “, ”, Mr, Nixon, Richard M, privilege.But, Fitzgerald, Vance, John G, Roberts, Fischer, Ruth Bader Ginsburg, Clarence Thomas, Samuel A, Alito Jr, Alito, ’, Moyle, Wade, Roe, Johnson, Robinson, Moody, Paxton, Robins, Media Murthy, Sullivan, Murthy, Biden, Harrington, Sackler, Alexander, Jan, Raimondo, ” Paul D, Clement, Dodd, Frank, Homer, Cargill Organizations: Harvard, Stanford, University of Texas, Trump, Liberal, Sotomayor Jackson Kagan Conservative, Colorado, Former, Trump v . United, United, Sarbanes, Oxley, U.S, Capitol, Drug Administration, Alliance, Hippocratic, Jackson, Health, Supreme, Labor, New York, Homeless, Miami Herald, Media, Biden, National Rifle Association, Rifle Association of America, New York State, Purdue Pharma, . South Carolina State Conference of, Federal, Loper Bright Enterprises, . Department of Commerce, Chevron, Natural Resources Defense, ”, SCOTUSPoll, Consumer Financial, Community Financial Services Association of America, Securities, Exchange Commission, Exchange, Occupational Safety, Commission, Lucia v . Securities, Federal Trade Commission, Internal Revenue Service, Environmental Protection Agency, Social Security Administration, National Labor Relations Board, Air Pollution Ohio, Environmental, Guns Garland, Alcohol, Tobacco, Firearms, Explosives, National Firearms, Gun Control Locations: Colorado, Trump v . United States, United States, Nixon, Florida, Gulf of Mexico, Dobbs v, Idaho, Roe, Texas, States, New, New York, Grants, Oregon, . California, Martin v, Boise, Boise , Idaho, Missouri, Parkland, Fla, Murthy v . Missouri, . Missouri, ., South Carolina, Alabama, SCOTUSPoll, Lucia v, Western

☆ Walnuts Recalled From Natural Food Stores After E. Coli Outbreak
▼ + stars: | 2024-05-01 | by ( Johnny Diaz | More About Johnny Diaz | ) www.nytimes.com time to read: +1 min

A California company is recalling organic walnuts that were sold at natural food stores and coop retailers in 19 states because of an E. coli outbreak that has sickened 12 people and hospitalized seven, federal officials said. The recall came after the Centers for Disease Control and Prevention notified the company of 12 recorded illnesses that were linked to the walnuts. They were distributed at more than 300 food retailers, including Whole Foods Market, New Seasons Market and Rosauers Supermarkets, the F.D.A. An investigation is underway to determine the potential source of the contamination, the F.D.A. The company did not immediately respond to inquiries on Wednesday.

Persons: Gibson Organizations: and Drug Administration, Centers for Disease Control, Foods, Rosauers Locations: California, Hollister , Calif

The same bacteria that commonly cause food-borne illnesses, like salmonella, E. coli and listeria, can fester in raw milk. Between 1998 and 2018, researchers linked over 200 outbreaks, which sickened 2,645 people and led to 228 hospitalizations, to raw milk. Can you catch bird flu from raw milk? Researchers and health officials are not sure whether bird flu can spread from raw milk to humans. “There’s not a tremendous amount of studies showing the infectivity related to this virus and raw milk products,” Dr. Prater said.

Persons: I’m, ”, Dean Blumberg, isn’t, Darin Detwiler, Rosemary Sifford, “ There’s, Dr, Prater Organizations: UC Davis Health, Food and Drug Administration, College of Professional Studies, Northeastern University, Department of Agriculture

☆ Federal Officials Find No Live Bird Flu Virus in Initial Milk Tests
▼ + stars: | 2024-04-26 | by ( Noah Weiland | Benjamin Mueller | ) www.nytimes.com time to read: 1 min

Federal regulators on Friday said that they had not yet discovered live bird flu virus in the first batch of retail milk samples they tested, a reassuring indication that the milk on store shelves remains safe despite an outbreak of the virus among diary cows. In an online update, the Food and Drug Administration said an initial set of tests looking for live virus, not just genetic fragments, suggested that the pasteurization process was effectively neutralizing the pathogen. “These results reaffirm our assessment that the commercial milk supply is safe,” the F.D.A. wrote in the update, adding that the testing efforts were ongoing. Officials also tested infant and toddler formula, which incorporate powdered dairy, and did not find the virus, the agency wrote.

Organizations: Food and Drug Administration, Officials

☆ F.D.A. Approves Antibiotic for Increasingly Hard-to-Treat Urinary Tract Infections
▼ + stars: | 2024-04-24 | by ( Andrew Jacobs | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Wednesday approved the sale of an antibiotic for the treatment of urinary tract infections in women, giving U.S. health providers a powerful new tool to combat a common infection that is increasingly unresponsive to the existing suite of antimicrobial drugs. The drug will be marketed in the U.S. as Pivya and will be made available by prescription to women 18 and older. It is the first time in two decades that the F.D.A. has approved a new antibiotic for U.T.I.s, which annually affect 30 million Americans. is committed to fostering new antibiotic availability when they prove to be safe and effective.”

Persons: U.T.I.s, Dr, Peter Kim Organizations: Drug Administration, Drug, Research Locations: Europe, U.S

☆ 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

☆ Supreme Court Poised to Hear Arguments About Abortion Pill Access
▼ + stars: | 2024-03-26 | by ( Abbie Vansickle | ) www.nytimes.com time to read: +1 min

The Supreme Court is expected on Tuesday to weigh the availability of a commonly used abortion pill, raising the possibility that it could sharply curtail access to the drug — even in states where abortion access remains legal. It could also have implications for the regulatory authority of the Food and Drug Administration, potentially calling into question the agency’s ability to approve and distribute other drugs. The current challenge involves mifepristone, a drug approved by the F.D.A. more than two decades ago that is used in nearly two-thirds of abortions in the country. At issue is whether the agency acted appropriately in expanding access to the drug in 2016 and again in 2021.

Persons: ” Organizations: Food and Drug Administration

☆ Why Abortion Is Back at the Supreme Court - The New York Times
▼ + stars: | 2024-03-26 | by ( Melissa Murray | Kate Shaw | ) www.nytimes.com time to read: +2 min

In his majority opinion in the case overturning Roe v. Wade, Justice Samuel Alito insisted that the high court was finally settling the vexed abortion debate by returning the “authority to regulate abortion” to the “people and their elected representatives.”Despite these assurances, less than two years after Dobbs v. Jackson Women’s Health Organization, abortion is back at the Supreme Court. In the next month, the justices will hear arguments in two high-stakes cases that may shape the future of access to medication abortion and to lifesaving care for pregnancy emergencies. These cases make clear that Dobbs did not settle the question of abortion in America — instead, it generated a new slate of questions. The first case, scheduled for argument on Tuesday, F.D.A. At issue is the law’s interaction with state laws that severely restrict abortion, like an Idaho law that bans abortion except in cases of rape or incest and circumstances where abortion is “necessary to prevent the death of the pregnant woman.”

Persons: Roe, Wade, Samuel Alito, Dobbs, America —, ” Organizations: Jackson, Health Organization, Supreme, Alliance, Hippocratic, Food, Labor Locations: America, Idaho

☆ Live Updates: Supreme Court to Hear Arguments on Abortion Pill Access
▼ + stars: | 2024-03-26 | by ( Abbie Vansickle | Linda Qiu | ) www.nytimes.com time to read: +4 min

If the Supreme Court sides with the plaintiffs and decides to roll back or invalidate Food and Drug Administration regulations on mifepristone, it would be the first time the court undercut the federal agency’s authority. The abortion pill case before the Supreme Court could have implications far beyond abortion, potentially undermining the regulatory system for all medicines in the United States. If the Supreme Court sides with the plaintiffs and decides to roll back or invalidate F.D.A. They would have to pick up mifepristone in person from a doctor and would have to visit the doctor three times during the medication abortion process. and not to abortion providers, some medication abortion services have been stockpiling mifepristone and may continue prescribing and mailing their supply.

Persons: ”, Matthew J, mifepristone Organizations: Drug, Food and Drug Administration, Northern, Northern District of, Trump, U.S ., Appeals, Fifth Circuit Locations: United States, Northern District, Northern District of Texas

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