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

Famous organizer Marie Kondo says she is “gave up” on tidying up her house after having her third child. She says spending time with her family is now what sparks joy.

The FDA has moved to make blood donation more accessible to men who have sex with men, moving away from time-based deferrals and instead offering the use of individual risk-based questionnaires.

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Restrictions on blood donation will be relaxed

The Food and Drug Administration (FDA) has released draft guidelines to change its blood donation policies, moving away from time-based deferrals for men who have sex with men and instead proposing individual “risk-based questions” to reduce the potential spread of HIV through transfusion.

  • Under current FDA guidelines for blood donation, men who have sex with men are permitted to donate blood after a three-month deferment period during which they abstain from sex with men. men. This change was made in 2020, after previous guidelines imposed a 12-month deferral period.
  • The new question-based approach would instead ask potential donors about new or multiple sex partners they have had in the last three months.
  • Those who had a new sexual partner or more than one during this period would be deferred if they reported having had anal sex.

“Maintaining a safe and adequate supply of blood and blood products in the United States is paramount to the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will allow us to continue to use the best science to do so,” FDA Commissioner Robert Califf said in a statement.

Limits remain: The postponement policy would remain in place for those who have exchanged sex for money or drugs as well as those with a history of injecting over-the-counter drugs.

People taking oral medications to prevent HIV will be subject to a three-month debarment from their last dose, while those receiving injectable PrEP would be subject to a two-month debarment.

Learn more here.

FDA withdraws authorization for COVID antibody treatment

Evusheld, the preventive monoclonal antibody treatment for COVID-19, has lost emergency use authorization in the United States because it is unlikely to be effective against currently circulating strains of the coronavirus.

  • The Food and Drug Administration (FDA) announcement comes weeks after the agency issued a notice stating that did not expect Evusheld to be effective against the XBB.1.5 omicron subvariant, responsible for 61% of cases nationwide, according to the most recent federal data.
  • “Today’s action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when less than 10% of variants circulating in the United States causing infection are susceptible to the product,” the FDA said in a statement.

According to a press release from Evusheld producer AstraZeneca, lab data showed the treatment to be ineffective against many omicron subvariants, including the top three circulating in the US: XBB.1.5, BQ. 1.1 and BQ.1.

Descending options: The constant mutation of the coronavirus has rendered other similar treatments effectively obsolete. The FDA in November authorization suspended on monoclonal antibody therapy bebtelovimab, the latest such therapy to treat coronavirus infections.

In light of the unavailability of these treatments, the FDA has advised patients who develop symptomatic cases of COVID-19 to seek treatments such as Paxlovid, remdesivir, or molnupiravir, antivirals that should still be effective in treating infections. .

Learn more here.

DEMS PRESS J&J FOR MORE INFORMATION ON CHILDREN’S MEDICINE SHORTAGE

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

Dissatisfied lawmakers: Sen. Elizabeth Warren (D-Mass.) and Democratic Reps. Ayanna Pressley, Katherine Clark and Lori Trahan sent the second letter to Johnson & Johnson CEO and Chairman Joaquin Duato, saying the initial response from the company left key questions unanswered.

The group of legislators shipped their first letter on January 12 and the company replied on January 18.

“While your response of January 18 highlighted your public statements on the production increase, provided insight into the model-based production increase forecast as early as April 2022, and clarified the timeline for communicating with the FDA, key questions remain unanswered,” they said. wrote.

Lawmakers said the company has not provided them with any data or response when drug availability returns to normal. They urged Johnson & Johnson to provide answers by February 3.

Learn more here.

WHO UPDATE LIST OF DRUGS FOR NUCLEAR EMERGENCIES

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

The updated list, which advises nations on how to build up stockpiles for nuclear and radiological accidents and emergencies, is included in a new WHO report reflecting data and research on related medical treatments that have emerged over the past decade.

Maria Neira, director of the WHO’s Department of Public Health and Environment, said it was important for nations and governments to have “ready stocks of lifesaving medicines that will reduce risk and treat radiation injuries”.

“In the event of a radiological emergency, people can be exposed to doses ranging from negligible to life-threatening,” Neira said. said in a press release. “Governments must make treatments available to those who need them – quickly.”

The list shows several others that can treat infection, diarrhea, vomiting, or other causes of bodily injury and damage from radiation exposure. It also details the types of drugs and chemicals, how to store and manage them, and how to use the drugs for treatment in an emergency.

Learn more here.

Red State Americans See Abortion Access Disappear

In states where abortion is no longer protected by law, nearly half of residents report that access to abortion has narrowed since the Supreme Court struck down Roe v. Wade.

A small but significant number of Americans know someone who crossed state lines for an abortion, had a birth control procedure, or postponed pregnancy in the months following the landmark Dobbs v. Jackson decision. Women’s Health Organization, which denied a constitutional right to abortion. after nearly half a century.

The results, of a new NPR-Ipsos survey, reflect a new divisive reality. In about half of the states, a Republican majority does not want easy access to abortion. In the other half, a Democratic majority believes that abortion should be accessible to all.

Several abortion bans in red states remain stalled in court. The Guttmacher Institute, an abortion rights research group, predicts abortion will be bannedd in 24 states once the post-Dobbs dust has cleared.

The flurry of legislation and litigation would leave abortion mostly legal on the East and West Coasts and parts of the upper Midwest and lower Southwest, and mostly illegal everywhere else.

This patchwork reflects the strong national division of opinions on Roe and abortion.

Learn more here.

WHAT WE READ

  • FDA experts still don’t know who should get which COVID vaccines and when (Kaiser Health News)
  • When is it okay to make germs worse in a lab? This is a more relevant question than ever (NPR)
  • Deaths among pregnant and recently pregnant women have increased, particularly from unrelated causes such as drug poisoning and homicide (CNN)

STATE BY STATE

  • It’s easy to buy flavored vapes in California, even in cities with longstanding bans (Statistical)
  • Governor Greg Abbott says he won’t relinquish COVID-era power until Texas lawmakers ban vaccination mandates and toughen the border (The Texas Grandstand)
  • Don’t eat these enoki mushrooms: Maryland Department of Health (NBC4 Washington)

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