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Health Care – FDA chief admits agency lagged on formula shortage

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The internet is both bemused and seemingly unimpressed by an ad in which Kim Kardashian appears to eat a burger without leaving a bite mark. 

On Capitol Hill, angry lawmakers interrogated the commissioner of the Food and Drug Administration over the agency’s role in the baby formula shortage. 

Welcome to Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. For The Hill, we’re Peter Sullivan, Nathaniel Weixel and Joseph Choi. Someone forward you this newsletter? Subscribe here.

FDA admits slow response to formula shortage

The Food and Drug Administration’s (FDA) response to multiple reports of contamination at a baby formula manufacturing plant was delayed due to a COVID-19 outbreak and numerous logistical failures, the agency’s director told a House panel Wednesday. 

FDA Commissioner Robert Califf admitted the agency made a number of missteps that exacerbated a nationwide shortage of baby formula and pledged to reform the agency’s often criticized food safety division. 

The FDA’s response was “too slow, and some decisions in retrospect could have been more optimal,” Califf said. 

Early warnings: Califf said FDA first noticed strains in the formula supply chain in March 2020, but were confident the market would be able to handle it. 

“The system seemed to be keeping up with demand until fairly recently, although there were spot shortages that we were responding to,” Califf said. 

Lawmakers grilled Califf about the agency’s actions leading up to the subsequent shutdown of Abbott Nutrition’s Sturgis, Mich., manufacturing facility and the recall of the formula that was made there.  

They wanted to know why it took months to inspect the plant, even though agency officials knew about long-standing safety conditions. They also pressed Califf about why the agency did not appear to respond to the shortage until it gained national attention. 

“Babies and children are suffering,” said Rep. Diana DeGette (D-Colo), chairwoman of the Energy and Commerce Oversight subcommittee. 

FDA discovered a variety of safety issues at Abbott’s plant in September but didn’t conduct a follow-up inspection until January.  

Cronobacter sakazakii, which can be deadly to infants, was found in four babies who had consumed formula from the plant. Two died. Abbott maintains there is no conclusive evidence linking the contamination at its plant to the illnesses. 

Read more here. 

CVS halting some prescriptions from startups

CVS Pharmacy will no longer be accepting prescriptions for controlled substances issued by telehealth companies Cerebral and Done Health, citing ongoing concerns that were unable to be resolved. 

In a statement to The Hill, CVS said it was “important that medications are prescribed appropriately.” 

“We recently conducted a review of certain telehealth companies that prescribe controlled substance medications,” the pharmacy chain said. 

“As a result of our being unable to resolve concerns we have with Cerebral and Done Health, effective May 26, 2022 CVS Pharmacy will no longer accept prescriptions for controlled substances issued through these companies.” 

CVS’s decision was first reported by The Wall Street Journal

Cerebral called the timing of CVS’s decision “unfortunate” in a statement to The Hill. 

The telehealth company noted that it had stopped prescribing controlled substances earlier this month and was already in the process of transitioning its patients away from controlled substance use, by either finding alternative treatment plans of transfer their care to a local provider. 

“In light of CVS’s decision, Cerebral is doing everything possible to ensure these patients get access to medications that their health care providers have determined they need,” Cerebral said. 

Done did not immediately respond when reached for comment. 

Read more here. 

RHODE ISLAND GOV TO SIGN MEASURE LEGALIZING MARIJUANA

Rhode Island is poised to become the 19th state in the nation to legalize marijuana for recreational use after legislators on Tuesday passed the bill through both the state House and Senate by wide margins. 

Gov. Dan McKee (D) said he would sign the bill Wednesday when it reaches his desk. 

The bill will immediately legalize the possession of marijuana in Rhode Island, and it will start the clock ticking on sales of recreational cannabis by the end of the year. A newly created Cannabis Control Commission will oversee and regulate the industry. 

Rhode Island will eventually allow a maximum of 33 recreational pot dispensaries around the state. The three medical marijuana dispensaries that already operate in the state will be allowed to sell recreational marijuana as well. 

New marijuana products will be taxed at about 20 percent, about average among other states where recreational pot sales are legal. Rhode Island will levy a 7 percent sales tax, cities and towns will add a 3 percent sales tax, and products will be subject to an additional 10 percent tax that is likely to add millions of dollars to state coffers. 

The new bill will expunge tens of thousands of past charges for marijuana possession. But it allows towns and cities some flexibility in deciding to opt out of the legal regime. Those municipalities will be able to offer voters the chance to ban sales in voter referenda this fall. 

Read more here. 

WEST VIRGINIA ANNOUNCES OPIOID SETTLEMENT WITH DRUG COMPANIES 

West Virginia Attorney General Patrick Morrisey (R) on Wednesday announced a $161.5 million settlement with two drug companies over their role in the opioid epidemic, providing funds for a state hard-hit by the crisis.   

Morrisey’s office described the settlement with the companies Teva and Allergan as “record-breaking,” saying it was the highest per capita settlement in the country.   

The announcement comes as a trial over a lawsuit alleging the companies helped fuel the opioid epidemic was ending.   

Morrisey’s office said the companies “helped fuel the opioid epidemic in West Virginia by engaging in strategic campaigns to deceive prescribers and misrepresent the risks and benefits of opioid painkillers.”  

“It’s been a long trial and, as we have said from the very beginning, we are looking for accountability,”  Morrisey said in a statement. “This settlement, along with other settlements we will receive from other cases, will provide significant help to those affected the most by the opioid crisis in West Virginia.”  

The settlement money will be distributed to localities in the state to help fight the opioid epidemic. The terms include $27 million worth of Narcan, an opioid overdose treatment, from Teva.   

Read more here. 

Vaccines may offer ‘partial protection’ against long COVID

COVID-19 vaccinations may only offer limited protection against long COVID symptoms, according to a study published this week in the peer-reviewed Nature science journal. 

Researchers for the VA St. Louis Healthcare System reviewed data from the Department of Veterans Affairs national health care databases to compare people with breakthrough cases of COVID-19 to individuals with no documented history of testing positive for coronavirus. 

Compared to people who appeared to have never had COVID-19, individuals with breakthrough cases were found to have a higher risk of death and a higher risk of developing long COVID symptoms including issues with their heart, their digestive system, kidneys and mental health. 

Researchers made these comparisons based on follow-ups six months after initial infection. 

However, individuals with breakthrough cases were still observed to be at a lower risk of these effects when compared to unvaccinated COVID-19 survivors. 

“Altogether, the findings suggest that vaccination before infection confers only partial protection in the post-acute phase of the disease; hence, reliance on it as a sole mitigation strategy may not optimally reduce long-term health consequences of SARS-CoV-2 infection,” the researchers wrote. 

Read more here. 

WHAT WE’RE READING

  • Pfizer will sell its patent-protected medicines and vaccines to poor countries at low prices (Stat
  • Nation’s latest COVID-19 wave largely hidden from view, health experts say (ABC News
  • People who rebound with COVID-19 after Paxlovid may be highly contagious, new studies suggest (The Boston Globe

STATE BY STATE

  • Is the current COVID surge peaking? New wastewater data shows a turnaround (Boston.com)  
  • Police suspect arson in fire at Wyoming abortion clinic site (Associated Press
  • Bay Area COVID cases surpass 2021 winter surge, but far fewer hospitalized (San Francisco Chronicle

STATE BY STATE

There’s no reason one plant closure should spark a baby formula crisis 

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

VIEW FULL VERSION HERE


The internet is both bemused and seemingly unimpressed by an ad in which Kim Kardashian appears to eat a burger without leaving a bite mark. 

On Capitol Hill, angry lawmakers interrogated the commissioner of the Food and Drug Administration over the agency’s role in the baby formula shortage. 

Welcome to Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. For The Hill, we’re Peter Sullivan, Nathaniel Weixel and Joseph Choi. Someone forward you this newsletter? Subscribe here.

FDA admits slow response to formula shortage

The Food and Drug Administration’s (FDA) response to multiple reports of contamination at a baby formula manufacturing plant was delayed due to a COVID-19 outbreak and numerous logistical failures, the agency’s director told a House panel Wednesday. 

FDA Commissioner Robert Califf admitted the agency made a number of missteps that exacerbated a nationwide shortage of baby formula and pledged to reform the agency’s often criticized food safety division. 

The FDA’s response was “too slow, and some decisions in retrospect could have been more optimal,” Califf said. 

Early warnings: Califf said FDA first noticed strains in the formula supply chain in March 2020, but were confident the market would be able to handle it. 

“The system seemed to be keeping up with demand until fairly recently, although there were spot shortages that we were responding to,” Califf said. 

Lawmakers grilled Califf about the agency’s actions leading up to the subsequent shutdown of Abbott Nutrition’s Sturgis, Mich., manufacturing facility and the recall of the formula that was made there.  

They wanted to know why it took months to inspect the plant, even though agency officials knew about long-standing safety conditions. They also pressed Califf about why the agency did not appear to respond to the shortage until it gained national attention. 

“Babies and children are suffering,” said Rep. Diana DeGette (D-Colo), chairwoman of the Energy and Commerce Oversight subcommittee. 

FDA discovered a variety of safety issues at Abbott’s plant in September but didn’t conduct a follow-up inspection until January.  

Cronobacter sakazakii, which can be deadly to infants, was found in four babies who had consumed formula from the plant. Two died. Abbott maintains there is no conclusive evidence linking the contamination at its plant to the illnesses. 

Read more here. 

CVS halting some prescriptions from startups

CVS Pharmacy will no longer be accepting prescriptions for controlled substances issued by telehealth companies Cerebral and Done Health, citing ongoing concerns that were unable to be resolved. 

In a statement to The Hill, CVS said it was “important that medications are prescribed appropriately.” 

“We recently conducted a review of certain telehealth companies that prescribe controlled substance medications,” the pharmacy chain said. 

“As a result of our being unable to resolve concerns we have with Cerebral and Done Health, effective May 26, 2022 CVS Pharmacy will no longer accept prescriptions for controlled substances issued through these companies.” 

CVS’s decision was first reported by The Wall Street Journal

Cerebral called the timing of CVS’s decision “unfortunate” in a statement to The Hill. 

The telehealth company noted that it had stopped prescribing controlled substances earlier this month and was already in the process of transitioning its patients away from controlled substance use, by either finding alternative treatment plans of transfer their care to a local provider. 

“In light of CVS’s decision, Cerebral is doing everything possible to ensure these patients get access to medications that their health care providers have determined they need,” Cerebral said. 

Done did not immediately respond when reached for comment. 

Read more here. 

RHODE ISLAND GOV TO SIGN MEASURE LEGALIZING MARIJUANA

Rhode Island is poised to become the 19th state in the nation to legalize marijuana for recreational use after legislators on Tuesday passed the bill through both the state House and Senate by wide margins. 

Gov. Dan McKee (D) said he would sign the bill Wednesday when it reaches his desk. 

The bill will immediately legalize the possession of marijuana in Rhode Island, and it will start the clock ticking on sales of recreational cannabis by the end of the year. A newly created Cannabis Control Commission will oversee and regulate the industry. 

Rhode Island will eventually allow a maximum of 33 recreational pot dispensaries around the state. The three medical marijuana dispensaries that already operate in the state will be allowed to sell recreational marijuana as well. 

New marijuana products will be taxed at about 20 percent, about average among other states where recreational pot sales are legal. Rhode Island will levy a 7 percent sales tax, cities and towns will add a 3 percent sales tax, and products will be subject to an additional 10 percent tax that is likely to add millions of dollars to state coffers. 

The new bill will expunge tens of thousands of past charges for marijuana possession. But it allows towns and cities some flexibility in deciding to opt out of the legal regime. Those municipalities will be able to offer voters the chance to ban sales in voter referenda this fall. 

Read more here. 

WEST VIRGINIA ANNOUNCES OPIOID SETTLEMENT WITH DRUG COMPANIES 

West Virginia Attorney General Patrick Morrisey (R) on Wednesday announced a $161.5 million settlement with two drug companies over their role in the opioid epidemic, providing funds for a state hard-hit by the crisis.   

Morrisey’s office described the settlement with the companies Teva and Allergan as “record-breaking,” saying it was the highest per capita settlement in the country.   

The announcement comes as a trial over a lawsuit alleging the companies helped fuel the opioid epidemic was ending.   

Morrisey’s office said the companies “helped fuel the opioid epidemic in West Virginia by engaging in strategic campaigns to deceive prescribers and misrepresent the risks and benefits of opioid painkillers.”  

“It’s been a long trial and, as we have said from the very beginning, we are looking for accountability,”  Morrisey said in a statement. “This settlement, along with other settlements we will receive from other cases, will provide significant help to those affected the most by the opioid crisis in West Virginia.”  

The settlement money will be distributed to localities in the state to help fight the opioid epidemic. The terms include $27 million worth of Narcan, an opioid overdose treatment, from Teva.   

Read more here. 

Vaccines may offer ‘partial protection’ against long COVID

COVID-19 vaccinations may only offer limited protection against long COVID symptoms, according to a study published this week in the peer-reviewed Nature science journal. 

Researchers for the VA St. Louis Healthcare System reviewed data from the Department of Veterans Affairs national health care databases to compare people with breakthrough cases of COVID-19 to individuals with no documented history of testing positive for coronavirus. 

Compared to people who appeared to have never had COVID-19, individuals with breakthrough cases were found to have a higher risk of death and a higher risk of developing long COVID symptoms including issues with their heart, their digestive system, kidneys and mental health. 

Researchers made these comparisons based on follow-ups six months after initial infection. 

However, individuals with breakthrough cases were still observed to be at a lower risk of these effects when compared to unvaccinated COVID-19 survivors. 

“Altogether, the findings suggest that vaccination before infection confers only partial protection in the post-acute phase of the disease; hence, reliance on it as a sole mitigation strategy may not optimally reduce long-term health consequences of SARS-CoV-2 infection,” the researchers wrote. 

Read more here. 

WHAT WE’RE READING

  • Pfizer will sell its patent-protected medicines and vaccines to poor countries at low prices (Stat
  • Nation’s latest COVID-19 wave largely hidden from view, health experts say (ABC News
  • People who rebound with COVID-19 after Paxlovid may be highly contagious, new studies suggest (The Boston Globe

STATE BY STATE

  • Is the current COVID surge peaking? New wastewater data shows a turnaround (Boston.com)  
  • Police suspect arson in fire at Wyoming abortion clinic site (Associated Press
  • Bay Area COVID cases surpass 2021 winter surge, but far fewer hospitalized (San Francisco Chronicle

STATE BY STATE

There’s no reason one plant closure should spark a baby formula crisis 

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

VIEW FULL VERSION HERE

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