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☆ F.D.A. Approves Pfizer’s R.S.V. Vaccine for Older Adults
▼ + stars: | 2023-05-31 | by ( Christina Jewett | ) www.nytimes.com time to read: +3 min

Each year, about 60,000 adults 65 and older are hospitalized with R.S.V. The Centers for Disease Control and Prevention estimated that in one year, more than 21,000 people in that age group would need to take the GSK vaccine to prevent one R.S.V. Several treatments, including a maternal vaccine and a monoclonal antibody for infants against R.S.V., are under agency review. The GSK vaccine, called Arexvy, was nearly 83 percent effective against severe R.S.V. The final vote of the F.D.A.’s advisory panel in favor of the Pfizer vaccine’s safety and efficacy was 7 to 4.

Persons: Miller Fisher, Jerica Pitts Organizations: Disease Control, GSK, Pfizer, Infants, R.S.V

☆ Why The F.D.A. Should Move Birth Control Over the Counter - The New York Times
▼ + stars: | 2023-05-22 | by ( Eric Reinhart | ) www.nytimes.com time to read: +1 min

An advisory panel at the Food and Drug Administration this month unanimously recommended that a contraceptive pill, Opill, be made available over the counter. At a 1992 conference on birth control, an official on the F.D.A.’s fertility and maternal health drugs advisory committee, Philip Corfman, noted that the birth control pill is safer than aspirin, which is available over the counter. subsequently announced plans to convene a hearing to consider moving oral contraceptives over-the-counter. It was believed that this would greatly expand access to birth control by bypassing doctors, to whom millions of Americans then — as still now — had little access. Dr. Prescott reported that the program director of the National Women’s Health Network at the time, Cindy Pearson, said that a “birth control prescription is the poor woman’s ticket to health care.” Advocates for women’s health were concerned that if birth control were made available over the counter, then insurance might stop paying for it and impose new financial barriers to access.

☆ F.D.A. Panel Recommends R.S.V. Vaccine to Protect Young Infants
▼ + stars: | 2023-05-18 | by ( Christina Jewett | ) www.nytimes.com time to read: 1 min

An advisory panel to the Food and Drug Administration voted on Thursday in favor of approving a vaccine by Pfizer to prevent the severe respiratory virus that is a potentially deadly threat to infants. The vaccine would be the first to protect babies from respiratory syncytial virus, or R.S.V., which is the reason many infants are admitted to children’s hospitals each year and kills several hundred under 5 each year. Fourteen agency advisers unanimously agreed that the vaccine was effective, and the F.D.A. typically follows the recommendations of its advisory panels. Ten of the 14 agreed that the vaccine was safe, with some airing concerns about elevated rates — not all statistically significant — of preterm births among mothers who got the vaccine compared to those who received a placebo.

☆ Fifth Circuit Judges Are Hearing Arguments in Abortion Pill Case
▼ + stars: | 2023-05-17 | by ( Abbie Vansickle | Pam Belluck | ) www.nytimes.com time to read: +1 min

A federal appeals court is hearing arguments on Wednesday in a case that could determine the availability of a medication used in a majority of abortions in the country. As the hearing began in New Orleans, the three Republican-appointed judges on the U.S. Court of Appeals for the Fifth Circuit interjected questions and comments as lawyers from both sides presented their cases. Although the case is still in its early stages and any decision is likely to be appealed, it could ultimately have profound implications. If the initial judge’s ruling is upheld, access to medication abortion would be upended in states where abortion is legal, not just in states where bans and restrictions are in force. The F.D.A.’s regulatory authority over other drugs could be challenged with other lawsuits, and pharmaceutical companies say that uncertainty about the F.D.A.’s role could chill drug development in the United States.

☆ How a 150-Year-Old Law Against Lewdness Became a Key to the Abortion Fight
▼ + stars: | 2023-05-16 | by ( Emily Bazelon | ) www.nytimes.com time to read: +1 min

The plaintiffs’ primary argument is that the courts should force the Food and Drug Administration to revoke its approval of mifepristone, the first pill in the two-drug regimen for medication abortion. At the same time, another potentially consequential part of the suit challenges an F.D.A. decision in 2021 allowing patients to receive the prescribed pills by mail. The plaintiffs in the Texas suit argue that the Comstock Act “explicitly forbids” mailing the drugs to any state, whether abortion is legal there or not. In defense of the agency’s actions, which were based on studies showing that the medication could be safely dispensed without an in-person medical visit, the Biden administration argues that Congress made the agency responsible for assessing a drug’s safety and effectiveness, not whether other laws might affect its use.

☆ F.D.A. Approves New Drug to Treat Hot Flashes
▼ + stars: | 2023-05-12 | by ( Christina Jewett | ) www.nytimes.com time to read: +3 min

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, an official with the F.D.A. Background: Symptoms have long been enduredHot flashes are the most common side effect of menopause for which women typically seek treatment, Astellas said. And the complaints of those who experience severe hot flashes and other symptoms of menopause are often dismissed in the workplace and elsewhere. Because signs of liver damage emerged in some patients during study of the drug, the F.D.A. What’s Next: The drug price may be prohibitiveAstellas said that the drug would cost $550 for a 30-day supply, not including rebates.

☆ A Birth Control Pill May Soon Be Available Over the Counter. Here’s What to Know.
▼ + stars: | 2023-05-10 | by ( Alisha Haridasani Gupta | ) www.nytimes.com time to read: +1 min

Food and Drug Administration advisers concluded that the benefits outweighed the risks of making a hormonal contraceptive pill — sold under the brand name Opill and produced by the French company HRA Pharma — available without a prescription. follows the nonbinding recommendation of its advisers — and there is a chance the agency might not — Opill would become the first and only birth control pill to be available over the counter since oral contraceptives were introduced in the U.S. in 1960. A 2022 survey found that 77 percent of more than 5,000 female participants favored the idea of getting the birth control pill over the counter, with many saying it would be more convenient and efficient to get it without a prescription. Progestin-only pills have been widely used in the United States since the first one was approved in 1973. Like other oral contraceptives, they require a prescription from a health care provider or, in some states, a pharmacist.

☆ F.D.A. Advisers Say Benefits of Over-the-Counter Birth Control Pill Outweigh Risks
▼ + stars: | 2023-05-10 | by ( Pam Belluck | ) www.nytimes.com time to read: +1 min

A panel of advisers to the Food and Drug Administration voted unanimously on Wednesday that the benefits of making a birth control pill available without a prescription outweigh the risks, a significant step in the decades-long push to make oral contraception obtainable over the counter in the United States. If the F.D.A. approves nonprescription sales of the medication, called Opill, this summer, it could significantly expand access to contraception, especially for young women and those who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor, reproductive health experts say. Approval is not a foregone conclusion, however. analysts also raised questions about whether younger adolescents and people with limited literacy could follow the directions.

☆ F.D.A. Advisers Weigh Allowing First U.S. Over-the-Counter Birth Control Pill
▼ + stars: | 2023-05-09 | by ( Pam Belluck | ) www.nytimes.com time to read: +1 min

It was like a tale of two birth control pills. At a hearing Tuesday to consider whether the Food and Drug Administration should authorize the country’s first over-the-counter birth control pill, a panel of independent medical experts advising the agency was left to reckon with two contradictory analyses of the medication called Opill. During the eight-hour session, the manufacturer of the pill, HRA Pharma, which is owned by Perrigo, and representatives of many medical organizations and reproductive health specialists said that data strongly supported approval. scientists questioned the reliability of company data that was intended to show that consumers would take the pill at roughly the same time every day and comply with directions to abstain from sex or temporarily use other birth control if they missed a dose. “I’m just really quite confused by the level of discrepancy,” one member of the advisory panel, Pamela Shaw, a senior investigator with Kaiser Permanente Washington, said after both sides had made presentations.

☆ Opinion | The Drug That Saves Lives Even if It’s Never Used
▼ + stars: | 2023-05-07 | by ( Elizabeth Spiers | ) www.nytimes.com time to read: +2 min

Although the drug has no major adverse effects, until later this year, New York State requires people to get some training before they can administer it. Dr. Avery, the vice chair for addiction psychiatry at Weill Cornell Medicine, had conducted many such trainings, and in his office that day he got right to it. Still, the drug has yet to become a standard part of the public’s tool kit. Dr. Avery, whose research is in negative attitudes toward addiction, says it’s because legal and regulatory issues were only part of the problem. It shapes the language we use to talk about addiction and the responses we think are appropriate.

In the face of an escalating opioid epidemic, the F.D.A. recently approved over-the-counter sales for Narcan — a lifesaving nasal spray that can reverse an opioid overdose. Jan Hoffman, who covers health law for The Times, explains why the new availability of Narcan could change the trajectory of the epidemic.

☆ R.S.V. Vaccine Approved for Older Adults
▼ + stars: | 2023-05-03 | by ( Christina Jewett | ) www.nytimes.com time to read: +3 min

advisory panel reviewed data from trials for two vaccines aimed at older adults, one from GSK and one from Pfizer. The virus can lead to pneumonia, which is far more worrisome for older adults and especially for those with underlying medical conditions like heart and lung disease or diabetes. vaccine for older adults is also expected to receive F.D.A. in older adults and said it expected authorization in the first half of this year. Last week, the European Medicines Agency did recommend approval of GSK’s vaccine for adults 60 and older.

☆ F.D.A. Approves Drug for Rare Form of A.L.S.
▼ + stars: | 2023-04-25 | by ( Rebecca Robbins | ) www.nytimes.com time to read: +1 min

Biogen will be required to provide confirmatory evidence, from ongoing clinical research, to keep the drug on the market. The decision is the first conditional approval granted for a medication for A.L.S., or amyotrophic lateral sclerosis, which generally causes paralysis and death within a few years. The approval is based on evidence that the drug can significantly reduce levels of a protein that has been linked to damage to nerve cells. Despite the uncertainty about its benefit, Qalsody’s approval is widely seen as more justifiable than that of Aduhelm, another drug from Biogen. unanimously recommended that the agency grant conditional approval of Qalsody, even though a majority of advisers concluded that there was not convincing evidence that it was effective.

☆ In Abortion Pill Ruling, the Supreme Court Trades Ambition for Prudence
▼ + stars: | 2023-04-22 | by ( Adam Liptak | ) www.nytimes.com time to read: +1 min

WASHINGTON — It was an interim ruling, and the majority gave no reasons. But the Supreme Court’s order on Friday night maintaining the availability of a commonly used abortion pill nonetheless sent a powerful message from a chastened court. Ten months ago, five conservative justices overturned Roe v. Wade, eliminating a constitutional right to abortion that had been in place for half a century. All three of the Trump justices were in the majority. Cynics might be forgiven for thinking that the decision last June, in Dobbs v. Jackson Women’s Health Organization, was a product of raw power.

☆ The decision brought vows to keep fighting from both sides of the abortion debate.
▼ + stars: | 2023-04-21 | by ( Ava Sasani | ) www.nytimes.com time to read: +1 min

A Supreme Court decision Friday to keep available — for now — the widely used abortion pill mifepristone was met with relief from one side of the debate, disappointment from the other and a vow from both to keep fighting. “This is good news, but the facts remain the same: Access to mifepristone should never have been in jeopardy in the first place,” Planned Parenthood tweeted after the court issued a stay on two lower court rulings that would have limited access to the pills. The court temporarily halted two separate rulings while an appeal is being considered: one from a Texas federal judge who suspended the F.D.A.’s approval of the drug, and another from an appeals court that said the pill could no longer be delivered by mail. Those rulings would have impacted the availability of the drug even in states where abortion is legal. Maura Healey of Massachusetts called the court’s decision a “victory” for abortion patients and providers.

☆ Supreme Court Is Expected to Decide on Access to Abortion Pill as Appeal Moves Forward
▼ + stars: | 2023-04-21 | by ( Abbie Vansickle | Pam Belluck | ) www.nytimes.com time to read: +1 min

At issue is the availability of mifepristone, part of a two-drug regimen that now accounts for more than half of the abortions in the United States. More than five million women have used mifepristone to terminate their pregnancies in the United States, and dozens of other countries have approved the drug for use. added a series of guidelines that eased access to the pill. The restrictions would include blocking patients from receiving the drug by mail. The case could also pave the way for all sorts of challenges to the F.D.A.’s approval of medications.

It is the second time in a year that the Supreme Court has considered a major effort to sharply curtail access to abortion. Less than an hour later, a federal judge in Washington State, Thomas O. The competing rulings meant that the matter was almost certainly headed to the Supreme Court. But the panel imposed several barriers to access, siding in part with Judge Kacsmaryk, while the lawsuit moved through the courts. Seeking emergency relief, the Biden administration asked the Supreme Court to intervene while a fast-tracked appeal moved forward.

The Supreme Court temporarily halted court orders that would have impacted the availability of an abortion drug. A Supreme Court decision Friday to keep available — for now — the widely used abortion pill mifepristone was met with relief from one side of the debate, disappointment from the other and a vow from both to keep fighting. Maura Healey of Massachusetts called the court’s decision a “victory” for abortion patients and providers. While statements of muted celebration poured in from elected Democrats and groups supporting abortion rights, comment from Republicans and anti-abortion groups was noticeably sparser. Attorney General Andrew Bailey of Missouri, who opposes abortion, said through a spokesman that the decision was a disappointment.

☆ The Fight Over a Drug That Is Great for Horses but Horrific for Humans
▼ + stars: | 2023-04-20 | by ( Jan Hoffman | ) www.nytimes.com time to read: +2 min

Josh Shapiro of Pennsylvania, where the Philadelphia neighborhood of Kensington is ground zero for tranq dope, announced that his administration was doing so. Since then, it has been used for procedures on sheep, deer, elk and even cats and dogs, as well as on horses and cattle. Earlier trials in humans had been shut down because the drug led to respiratory depression, so manufacturers never sought approval for human use. And unlike the protocols for opioids, those for reversing tranq dope withdrawal or managing rehabilitation have not been standardized. Schedule III includes buprenorphine and the anticonvulsant drug gabapentin.

☆ Opinion | The Abortion Pill Case Could Throw Our Health Care System Into Chaos
▼ + stars: | 2023-04-20 | by ( Jack Resneck Jr. | ) www.nytimes.com time to read: +2 min

Against this backdrop, the Supreme Court faces a decision that lays bare the threat to facts, evidence and the health of America’s patients. — in which anti-abortion organizations and doctors who have never prescribed the pill mifepristone argue, absurdly, that 23 years ago the F.D.A. If the lower courts’ rulings on mifepristone are not reversed entirely, it could also upend the Food and Drug Administration’s drug regulatory process. This would throw our health care system into chaos in ways that extend far beyond the specific fight over mifepristone, a highly effective drug that has been used safely by millions of patients for medication abortions and for miscarriage care for more than two decades. In seeking to restrict access to abortion across the United States, the plaintiffs in this case have, intentionally or not, seriously jeopardized our nation’s 85-year-old drug regulatory system.

☆ A Beauty Treatment Promised to Zap Fat. For Some, It Brought Disfigurement.
▼ + stars: | 2023-04-16 | by ( Anna Kodé | ) www.nytimes.com time to read: +1 min

A Supermodel SuesIn 2021, Ms. Evangelista, one of the most recognizable supermodels of the 1980s and ’90s, said she had gone into a long seclusion after developing P.A.H. Ms. Evangelista declined to comment for this article. received over 1,100 reports of adverse events from CoolSculpting treatments — more than in the entire previous decade. was, she would work out constantly, trying to lose the fat that had emerged after CoolSculpting. Research was contributed by Sheelagh McNeill , Kitty Bennett , Alain Delaquérière , Kirsten Noyes and Jack Begg .

☆ Virtual Clinics Have Been a Fast-Growing Method of Abortion. That Could Change.
▼ + stars: | 2023-04-14 | by ( Claire Cain Miller | Margot Sanger-Katz | ) www.nytimes.com time to read: +1 min

A nascent but rapidly growing industry of abortion providers administers abortions only through telemedicine, with no physical clinics. A federal court ruling Wednesday that aims to ban the mailing of abortion pills could make it much harder for them to operate. Honeybee, which fills the prescriptions for most of them and is the largest mail-order pharmacy for abortion pills in the United States, said it would continue to mail the pills to the 24 states where it’s allowed. “As a licensed pharmacy, we abide by the F.D.A.’s policies and regulations,” said Jessica Nouhavandi, co-founder and president of Honeybee. Rulings in the lower courts, if they go into effect, could severely limit the availability of the drug, including allowing it to be administered only to patients in a doctor’s office.

☆ Court Says Abortion Pill Can Remain Available but Imposes Temporary Restrictions
▼ + stars: | 2023-04-13 | by ( Pam Belluck | ) www.nytimes.com time to read: +1 min

Last week’s ruling by Judge Matthew J. Kacsmaryk, of the U.S. District Court for the Northern District of Texas, was a preliminary injunction saying that the F.D.A. Judge Kacsmaryk, a Trump appointee who has written critically of the Roe v. Wade decision, had stayed his order for seven days to give the F.D.A. The F.D.A had asked the appeals court to extend the stay beyond that seven days. In the decision, two Trump-appointed judges voted to reimpose some of the restrictions that the F.D.A. The third judge, appointed by President George W. Bush, said she would essentially have granted the full request.

☆ Inside the Online Market for Overseas Abortion Pills
▼ + stars: | 2023-04-13 | by ( Allison Mccann | ) www.nytimes.com time to read: +17 min

A selection of abortion pill kits available online from overseas sellers. A chart of the estimated number of abortion pills provided outside the U.S. health care system from July through December 2022. For most patients, the cost of the service remains the most important factor in deciding where to get pills online. A chart showing the minimum, average and maximum cost of abortion pills from overseas providers: Aid Access, Las Libres and for-profit online sellers. A chart showing the minimum, average and maximum delivery speeds of abortion pills from overseas providers: Aid Access, Las Libres and for-profit online sellers.

☆ Drug Company Leaders Condemn Ruling Invalidating F.D.A. Approval of Abortion Pill
▼ + stars: | 2023-04-10 | by ( Christina Jewett | ) www.nytimes.com time to read: +1 min

Senior executives of more than 250 pharmaceutical and biotech companies on Monday issued a scorching condemnation of a ruling by a federal judge that invalidated the Food and Drug Administration’s 23-year-old approval of the abortion pill mifepristone, and they called for the decision to be reversed. “The decision ignores decades of scientific evidence and legal precedent,” said the letter, which was signed by leaders of some of the industry’s most prominent companies, including Albert Bourla, chief executive of Pfizer, and Alisha Alaimo, president of Biogen. The ruling, by Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, “has set a precedent for diminishing F.D.A.’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry,” the letter argues. The letter also said that pharmaceutical companies rely on the F.D.A.’s autonomy to bring products to market under a “reliable regulatory process for drug evaluation and approval.”

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