Health Care — FDA to ease blood donation rules for gay, bisexual men

Celebrity organizer Marie Kondo says she’s “given up” on tidying her home after having her third child. She says spending time with family is now what sparks joy.

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

Welcome to The Hill’s Health Care roundup, where we’re following the latest moves on policy and news affecting your health. For The Hill, we’re Nathaniel Weixel and Joseph Choi. Subscribe here.

Blood donation restrictions to be relaxed

The Food and Drug Administration (FDA) has issued draft guidance to change its policies on donating blood, moving away from time-based deferrals for men who have sex with men and instead proposing “individual risk-based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 transfusions.

• Under current FDA guidelines for donating blood, men who have sex with men are permitted to donate blood after a three-month deferral period in which they abstain from sexual encounters with men. This change was made in 2020, after the previous guidance had mandated 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 past three months.
  
• Those who have had a new sexual partner or more than one in that time frame would be deferred if they reported having anal sex. 

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

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

Individuals taking oral medications to prevent HIV will be subjected to a three-month deferral period starting from their last dose, while those receiving injectable PrEP would be subject to a two-month deferral period. 

Read more here. 

FDA pulls authorization for COVID antibody treatment

Evusheld, the preventative monoclonal antibody treatment for COVID-19, has lost its emergency use authorization in the U.S. as it is most likely not effective against the 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 did not expect Evusheld to be effective against the XBB.1.5 omicron subvariant, responsible for 61 percent of cases in the country, 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 fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product,” the FDA said in a statement. 

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

Dwindling options: The constant mutation of the coronavirus has rendered other similar treatments effectively obsolete. The FDA in November paused authorization on the monoclonal antibody treatment bebtelovimab, the last such treatment meant to treat coronavirus infections. 

In light of these treatment becoming unavailable, the FDA advised that patients who develop symptomatic cases of COVID-19 seek out 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 INFO ON CHILDREN’S MEDICINE SHORTAGE

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

Lawmakers unsatisfied: Sen. Elizabeth Warren (D-Mass.) and Democrat Reps. Ayanna Pressley, Katherine Clark and Lori Trahan sent the second letter to Johnson & Johnson CEO and Chairman of the Board Joaquin Duato, claiming the company’s initial response left key questions unanswered. 

The group of lawmakers sent their first letter on Jan. 12, and the company responded on Jan. 18. 

“While your January 18th reply underscored your public statements about increased production, provided insight into the scale up of production based on forecasting models as early as April 2022, and clarified the timeline of communication with the FDA, key questions remain unanswered,” they wrote. 

The lawmakers said the company did not provide them any data or answer when the medicine availability would return to normal. They urged Johnson & Johnson to provide answers by Feb. 3. 

Read more here. 

WHO UPDATES MEDICINE STOCKPILE LIST 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 stockpile for nuclear and radiological accidents and emergencies, is included in a new WHO report reflecting data and research for related medical treatment that emerged in the last decade. 

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

“In radiation emergencies, people may be exposed to radiation at doses ranging from negligible to life-threatening,” Neira said in a statement. “Governments need to make treatments available for those in need — fast.” 

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

Read more here. 

Red-state Americans see abortion access slipping away

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

A small but significant number of Americans know someone who has crossed state lines for an abortion, undergone a birth-control procedure or postponed getting pregnant in the months since the landmark ruling Dobbs v. Jackson Women’s Health Organization, which negated a constitutional right to abortion after nearly half a century.  

The findings, from a new NPR-Ipsos poll, reflect a divisive new reality. In roughly half of the states, a Republican majority doesn’t want abortion access to be easy. In the other half, a Democratic majority believes abortion should be available to all.  

Several red-state abortion bans remain stalled in the courts. The Guttmacher Institute, an abortion-rights research group, predicts abortion will be banned in 24 states once the post-Dobbs dust clears.  

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

That patchwork mirrors the sharp national divide in opinions about Roe and abortion.   

Read more here. 

WHAT WE’RE READING

• FDA experts are still puzzled over who should get which COVID shots and when (Kaiser Health News) 
• When is it OK to make germs worse in a lab? It’s a more relevant question than ever (NPR) 
• Deaths in pregnant or recently pregnant women have risen, especially for 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 longtime bans (Stat) 
• Gov. Greg Abbott says he won’t give up COVID-era power until Texas lawmakers ban vaccine mandates, strengthen border (The Texas Tribune) 
• Don’t eat these enoki mushrooms: Maryland Department of Health (NBC4 Washington) 
  
  

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That’s it for today, thanks for reading. Check out The Hill’s Health Care page for the latest news and coverage. See you next week!