More trouble at the FDA. This time, it’s mice.

From: POLITICO Pulse - Tuesday Apr 12,2022 02:01 pm
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QUICK FIX

The FDA has a field mouse problem, long in the making and made worse by old food left in staffers' desks during the pandemic.

Philadelphia reinstates its indoor mask mandate, making it the first major U.S. city to tell residents to mask back up as BA.2 spreads.

Nursing homes are back in the federal government’s crosshairs, with CMS looking into improving facilities’ safety through better staffing and infection control.

WELCOME TO TUESDAY PULSE To belabor the space theme one more day, on the anniversary of the Apollo 13 launch, STAT offers a nice parallel between that mission and fight : doomed from the start, with some big wins along the way. Send your news and tips to kmahr@politico.com and sowermohle@politico.com.

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Across the Blue Cross and Blue Shield System, we are working to ensure all women – regardless of their race or where they live – can get necessary and appropriate care before, during and after birth. But we can't do it alone. Here are 10 ways we must come together to ensure safer, healthier care for all mothers.

 
Driving the Day

The Great room at the FDA

Field mice have infested parts of the FDA. | FDA

THE FDA’S OTHER PROBLEM: MICE The Food and Drug Administration has a field mouse infestation, POLITICO’s David Lim and Lauren Gardner report, exacerbated by the food left in desks at the mostly empty agency headquarters during the pandemic.

Like other government buildings, the FDA buildings at the White Oak campus had some mice problems before everyone went home in 2020, but things have gotten worse as many staffers continue to telecommute.

“It is accurate that food products left behind in offices when maximum telework was implemented is a contributing factor to offices with pest control issues,” FDA spokesperson Stephanie Caccomo told POLITICO.

Caccomo pointed out that the agency’s 662-acre campus sits among fields and woods that provide a natural habitat for field mice. She also said the mouse issue wouldn’t affect the agency’s plan to bring people back into the office.

But, as a former official said, it won’t boost anyone’s morale to open a desk after two years at home and find mice evidence. “That’s certainly not the kind of thing that’s going to excite people,” the official said.

MASKS BACK ON, PHILLY —  Philadelphia became the first major U.S. city to reinstate an indoor mask mandate on Monday as the Omicron BA.2 subvariant continues to spread, POLITICO’s Myah Ward reports.

The move corresponds with the city's data-driven guidelines. To remain in “Level 1: All Clear,” the city’s Covid metrics must meet two or more requirements: new average daily cases must stay below 100, hospitalizations must stay below 50 and cases must have “increased by less than 50% in the previous 10 days.”

On Monday, Philadelphia Health Commissioner Cheryl Bettigole said the city would move to the second level, which requires indoor masking, reporting an average of 142 new cases a day, roughly 50 percent higher than they were 10 days ago.

Nationally, Covid-19 case numbers are still flat, with cases increasing in some states and decreasing in others. Hospitalization numbers and deaths continue to decline.

This morning, White House Covid-19 response coordinator Ashish Jha told Today that it was “absolutely on the table” for the Centers for Disease Control and Prevention to consider extending the public transportation mask mandate.

SPOTLIGHT RETURNS TO NURSING HOMES — The Centers for Medicare and Medicaid Services is looking at how to improve safety at long-term care facilities by identifying optimal staffing levels and evaluating infection outbreaks, POLITICO’s Rachael Levy reports.

Nursing home residents have been among the hardest hit during the Covid-19 pandemic when shared, indoor settings facilitated the spread of the airborne virus.

CMS has said the problem was partly due to low staffing levels and on Monday said it’s seeking input to determine the best staffing levels at those facilities and on a potential measure that would evaluate facilities based on their staff turnover.

The agency also wants to monitor the occurrence of infections that residents acquire while in nursing homes and assess facilities based on their performance in infection prevention and control.

Infection-control lapses are among the most common faults of nursing homes during federal safety surveys and often include bad hand-hygiene practices among staffers “or improper use of protective equipment or procedures during an infectious disease outbreak,” CMS said.

 

SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today.

 
 
Coronavirus

VACCINES, INTERRUPTED A clear message came out of the meeting of the World Health Organization’s Strategic Advisory Group of Experts last week: Vaccinations around the world need to get back on track.

The meeting underscored three ways Covid-19 has affected routine immunization outside the U.S.

— National immunization programs across the globe were thrown off course by the pandemic, seeing declining immunization coverage and surveillance due primarily to service delivery disruptions.

— Polio has emerged as a particular concern. While wild poliovirus cases remain at an all-time low, a case in Malawi, where the virus’ transmission had previously been disrupted, concerned experts. So did the 2021 outbreak of vaccine-derived polio in Ukraine, given that millions have fled the country and risk spreading the disease.

— Also of concern to Gavi, the global vaccine alliance, was a 13 percent drop in global HPV vaccine coverage in 2020 due to school closures and vaccine supply disruption. The disruption has thrown off global targets to reduce cervical cancer.

 

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

 
 
White House

ENVIRONMENTAL HEALTH IN BIDEN’S RURAL PLAYBOOK Biden’s plan to send billions of dollars into America’s rural communities ahead of this year’s midterms has some noteworthy health earmarks, assuming all goes according to plan.

Among the environmental health projects listed in the Bipartisan Infrastructure Law Rural Playbook:

— $44 billion would go toward improving the nation’s drinking- and wastewater systems, removing lead pipes and service lines and removing harmful contaminants.

— $11.3 billion would be used to “reclaim old mines, clean up polluted streams, and rebuild on sites contaminated by past coal mining.”

— $3.5 billion would be allocated toward improving sanitation across Indian Country through the Indian Health Services.

— $4.7 billion would be used to “plug, remediate, and restore polluted and dangerous orphan well sites across the country.”

 

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In Congress

Lawmakers are off to a busy start this week …

FIRST IN PULSE: PUSHING FOR GENERIC NALOXONE — On Tuesday, Sen. Tammy Baldwin (D-Wis.) is sending letters signed by more than two dozen lawmakers to seven drug companies that manufacture the opioid overdose reversal drug naloxone.

Baldwin and her colleagues are urging the drugmakers to apply for over-the-counter status for the lifesaving drug with the aim to expand its access as opioid deaths continue across the country. The Food and Drug Administration is supportive of the switch, but major manufacturers so far have “punted” on the move, Baldwin’s office said in a statement to POLITICO.

The letters went to the CEOs of Pfizer, Emergent BioSolutions, Teva , Akorn, Adamis, Amphastar and Hikma Pharmaceuticals USA.

DEMANDING ANSWERS FROM FDA Two committee chairs in the House and Senate that oversee the FDA are demanding answers in response to POLITICO’s investigation into the agency’s failure to act on a slew of pressing food-safety and nutrition issues, Helena Bottemiller Evich writes.

Sen. Patty Murray (D-Wash.), who leads the Senate Committee on Health, Education, Labor and Pensions, sent a letter to FDA Commissioner Robert Califf on Monday afternoon, seeking “immediate action to ensure the FDA is doing all it can to fulfill all aspects of its mission to protect the health and safety of the American people.”

URGING BIDEN NOT TO SHARE VACCINE IP Rep. Vern Buchanan (R-Fla.) and Rep. Buddy Carter (R-Ga.) are urging President Joe Biden not to finalize a potential deal to waive intellectual property protections for U.S.-developed Covid-19 vaccines, saying it poses a threat to national security.

“The reported agreement allows any government or company to copy state-of-the-art American technology, inevitably ensuring that it falls into the hands of Russia, China and other adversaries that threaten the United States and our allies,” said the members in the letter.

Backstory: In May, the U.S. announced it supported the waiver of IP protections for the Covid-19 vaccines to help end the pandemic. POLITICO Europe reported in March that a compromise had been reached in those negotiations, though no text was finalized.

What We're Reading

One former FDA deputy writes in POLITICO Magazine that the way to save the agency is to break it up.

America needs to develop a plan for its nuclear waste disposal — soon, writes Rebecca Tuhus-Dubrow for The Washington Post magazine.

A message from Blue Cross Blue Shield Association:

Across the Blue Cross and Blue Shield System, we are working to ensure all women – regardless of their race or where they live – can get necessary and appropriate care before, during and after birth. But we can't do it alone. To reverse racial health disparities in maternal health, we invite policymakers, insurers, hospitals, medical professionals, and private practices to come together for the safety and health of all mothers.

 
 

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