Healthcare – FDA to relax blood donation rules for gay and bisexual men

Celebrity organizer Marie Kondo says it is She “gave up” on tidying up her house After having her third child. Now, she says, spending time with family is what sparks joy.

The FDA has moved to make blood donation more accessible to MSM, moving away from time-based postponements and instead suggesting the use of risk-based, individualized questionnaires.

Welcome to The Hill’s Health Care news roundupWhere we keep up with the latest moves related to politics and news affecting your health. For The Hill, we are Nathaniel Wicksell And Joseph Choi. Subscribe here.

Restrictions on blood donation should be eased

The Food and Drug Administration (FDA) has issued draft guidance to change its policies on blood donations, moving away from a time delay for men who have sex with men, and instead suggesting “individualized, risk-based questions” to reduce the potential spread of HIV through transfusions. the blood.

  • Under current FDA guidelines for blood donation, men who have sex with men are allowed to donate blood after a three-month deferral period during which they abstain from sexual relations with men. This change was made in 2020, after previous guidance mandated a 12-month deferral period.
  • Instead, the new question-based approach will ask potential donors about new or multiple sexual partners they have had in the past three months.
  • Those who have a new sexual partner or more than one in that time frame will be put off if they report having anal sex.

“Maintaining a safe and adequate supply of blood and blood products in the United States is critical to the Food and Drug Administration, and this proposal to assess individual risks, regardless of gender or sexual orientation, will enable us to continue to use the best science to do so,” said FDA Commissioner Robert. Calif in a statement.

Borders remain: The deferral policy will remain in place for those who have exchanged sex for money or drugs as well as those with a history of injecting nonprescription drugs.

Individuals taking oral medications for HIV prevention will be subject to a three-month deferral period starting from the last dose, while those receiving injectable PrEP will be subject to a two-month deferral period.

Read more here.

The Food and Drug Administration (FDA) withdraws authorization to treat COVID with antibodies

Evusheld, the monoclonal antibody prophylaxis for COVID-19, has lost its emergency use authorization in the United States because it is likely not effective against strains of the coronavirus currently circulating.

  • The announcement from the Food and Drug Administration (FDA) comes weeks after the agency issued a notice saying it Didn’t expect Evusheld to be effective against the XBB.1.5 omicron subvariant, which is responsible for 61 percent of cases in the country, according to the latest federal data.
  • “Today’s action to limit use of Evusheld prevents exposing patients to potential side effects of Evusheld such as allergic reactions, which can be serious, at a time when less than 10% of the infection-causing variants circulating in the United States are susceptible to the product,” the FDA said in a statement. .

According to a press release from the Evusheld product AstraZeneca, in vitro data showed the treatment to be ineffective against several sub-omicron variants, including the top three circulating in the United States: XBB.1.5, BQ.1.1, and BQ.1.

Diminished options: The ongoing surge in the coronavirus has effectively rendered other similar treatments obsolete. FDA in November Paused permission On bebtelovimab monoclonal antibody therapy, the latest such treatment is intended to treat coronavirus infection.

In light of the unavailability of these treatments, the Food and Drug Administration (FDA) has advised patients with symptomatic cases of COVID-19 to seek treatments such as Paxlovid, remdesivir or molnupiravir, antivirals that are still expected to be effective in treating infections.

Read more here.

DEMS Press J&J for more information on pediatric shortages

Massachusetts Democrats sent a second letter to the CEO of Johnson & Johnson on Thursday again demanding more information about shortages in children’s Tylenol and Motrin.

Lawmakers are dissatisfied: Sen. Elizabeth Warren (D-Massachusetts) and Democratic Representatives Ayanna Pressley, Kathryn Clark and Lori Trahan sent the second letter to Johnson & Johnson CEO and Chairman Joaquin Duato, claiming that the company’s initial response left key questions unanswered.

group of legislators I sent Their first letter on January 12th, the company replied on January 18th.

While your January 18 response confirmed your public statements about increased production, provided insight into increased production based on forecast models as early as April 2022, and clarified the timeline for communication with the FDA, key questions remain. without an answer.” books.

The lawmakers said the company has not provided them with any data or an answer as to when the drug’s availability will return to normal. They urged Johnson & Johnson to provide answers by February 3.

Read more here.

Who updates the drug stock list for nuclear emergencies

The World Health Organization on Friday updated the list of drugs it recommends for the treatment of exposure to radiological and nuclear emergencies for the first time since 2007.

The updated list, which advises states on how to stock up for nuclear and radiological accidents and emergencies, is included in the New WHO report It reflects data and research on related medical treatment that has emerged in the past decade.

It’s important for countries and governments to have “ready supplies of life-saving medicines that will reduce risks and treat radiation-related injuries,” said Maria Neira, director of the WHO’s Department of Public Health and Environment.

“In a radiological emergency, people may be exposed to radiation at doses ranging from minimal to life-threatening,” Nira he said in a statement. “Governments need to make treatments available to those in need – fast.”

The list indicates many other people who can treat infections, diarrhea, vomiting, or other causes of physical injury and damage from radiation exposure. It also details the types of drugs and chemicals, explains how to store and manage them and how to use the drugs for emergency treatment.

Read more here.

Americans in the red state see abortion access slipping away

In states where abortion is no longer protected by law, nearly half of the population has reported that access to abortion has diminished since the Supreme Court ruled Roe v. Wade.

A small but significant number of Americans know someone who crossed state lines to get an abortion, take birth control or delay pregnancy in the months after the landmark Dobbs v. ruling. Jackson Women’s Health Organization, which rescinded a constitutional right to abortion after nearly half a century.

the findings, From a new NPR-Ipsos surveyIt reflects a divisive new reality. In about half of the states, Republican majorities don’t want abortion to be easy. In the other half, a Democratic majority believes abortion should be available to everyone.

Many red states’ abortion bans are still stalled in the courts. The Guttmacher Institute, a research group on abortion rights, predicts miscarriages It will be forbiddenD in 24 states Once I wiped the dust off after Dobbs.

A flurry of legislation and litigation would make abortion mostly legal on the East and West coasts and in parts of the upper Midwest and lower Southwest, and often illegal elsewhere.

This patchwork reflects the sharp national divide in opinions about Rowe and abortion.

Read more here.

what we read

  • FDA experts are still stumped over who should get COVID shots and when (Kaiser Health News)
  • When is it a good idea to make germs worse in the lab? It’s a more relevant question than ever (NPR)
  • Mortality among pregnant or newly pregnant women has risen, especially from unrelated causes such as drug poisoning and homicide (CNN)

State by state

  • It’s easy to buy flavored e-cigarettes in California, even in cities where they were banned long ago (stat)
  • Greg Abbott says he won’t give up COVID-era power until Texas lawmakers ban vaccine mandates, strengthen limits (Texas Tribune)
  • Don’t Eat These Enoki Mushrooms: Maryland Department of Health (NBC4 Washington)

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