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FDA Finds Violations and Unsanitary Conditions at Emergent J&J Plant as Lawmakers Open Investigations

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  • The Food and Drug Administration said Wednesday that it found numerous safety violations at Emergent Biosolutions, the Baltimore manufacturing plant responsible for ruining more than 15 million Johnson & Johnson Vaccines.
  • The FDA said it watched security footage of employees ignoring cross-contamination protocols and improperly handling medical waste. It also found brown and black residue on the floors and walls of the plant, respectively. 
  • Separately, top House Democrats launched an investigation into how Emergent won contracts to manufacture two COVID-19 vaccines and whether or not those contracts were the result of an improper relationship between the plant and a former Trump administration official.
  • Democrats are also investigating Emergent’s role as the country’s only provider of the anthrax vaccine in the Strategic National Stockpile.

The FDA’s Unforgiving Report

The U.S. Food and Drug Administration released a damning inspection report Wednesday on Emergent Biosolutions, the Baltimore manufacturing plant that ruined 15 million Johnson & Johnson COVID-19 vaccines.

Among a multitude of violations, inspectors workers hadn’t been properly trained. They also found that medical waste had been improperly handled, saying “such waste was transported through the warehouse before disposal and has the potential to contaminate the warehouse and adjacent areas.”

For example, it found that employees had used their gloved hands to put waste into bags, that they drug the waste through hallways, and that they even allowed it to touch walls.

Made worse was the fact that the FDA found peeling paint on the walls of several sensitive work areas, with inspectors noting that they found paint flecks all along the floors around the walls. As the agency reported, that peeling — as well as additional wall damage — “impacts the firms’ ability to adequately clean and disinfect the area.”

Moreover, inspectors said they found an unknown brown residue attached to the walls, as well as a black residue on the floor.

Through reviewing security footage, inspectors said workers repeatedly failed to follow procedures that were meant to prevent vaccine cross-contamination.

Notably, that backs up information that had been previously reported, particularly that those 15 million Johnson & Johnson vaccines were ruined because of cross-contamination with AstraZeneca’s vaccine. That said, it’s important to note that none of those vaccines were ever distributed to the public because the FDA never gave the plant approval to do so.

It’s possible that the report also describes the event that specifically led to the vaccine cross-contamination, as it mentions that through security footage, it watched an employee travel from one area of the plant where one vaccine was being made, to another area of the plant where the other vaccine was being made — all without that employee changing their protective gear. 

With that finding, the FDA said Emergent didn’t properly investigate its workers’ movements as a potential cause of contamination. More broadly, it also noted that even after the plant was made aware of the contamination, it only performed routine cleaning and didn’t take further decontamination steps.

Congress Investigates Emergent’s Role in Winning Vaccine Contracts

Alongside the FDA’s recent report, top House Democrats have now launched an investigation into how Emergent won several multi-million dollar contracts.

Those lawmakers are specifically looking into what role Dr. Robert Kadlec played in helping the company obtain the contract and if it was influenced by Kadlec’s previous role as a consultant for Emergent. 

Kadlec was the assistant secretary for preparedness and response under former President Donald Trump, and as this group of Democrats alleges, Kadlec “appears to have pushed for this award despite indications that Emergent did not have the ability to reliably fulfill the contract.”

Those Democrats went on to say that after Kadlec’s confirmation, Emergent obtained millions in contracts from his agency — including some that “were awarded without competitive bidding.” In fact, the Trump administration ultimately awarded $628 million to the plant, even though it had fallen short on federal investigations.

Emergent also reportedly tried to encourage oversight of the stockpile to be shifted from the CDC to an office under Kadlec’s control. 

“We are concerned by the costs to taxpayers and the potential impact on our nation’s vaccination efforts caused by Emergent’s failed attempts to manufacture these vaccines,” the Democrats said. 

Congress Investigates Emergent’s Role as Sole Anthrax Provider

It doesn’t end there. Those lawmakers are also looking into Emergent’s role as the country’s sole provider of the anthrax vaccine in the Strategic National Stockpile.

“Emergent has raised the government purchasing price of the anthrax vaccine by 800% since acquiring the drug in 1998,” they said. “As a result, through most of the last decade, nearly half of the SNS’s budget has been spent purchasing Emergent’s anthrax vaccine.” 

When Emergent acquired that anthrax vaccine license in 1998, the vaccine was selling for about $3.35 a dose. Today, it’s over $30.

See what others are saying: (The Washington Post) (Wall Street Journal) (CNBC)

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Man Spent COVID Relief Loan on $58,000 Pokemon Card, Feds Say

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The man is facing a wire fraud charge, which carries a max sentence of up to 20 years in federal prison, along with a $250,000 fine.


COVID Relief Funds Used on Pokemon Card

Authorities have accused a man in Georgia of misusing COVID-19 relief funds, claiming that he spent $57,789 on a single Pokemon card.

Prosecutors said Vinath Oudomsine made false statements about the gross revenue his business earns and the number of workers he employs when he applied for aid authorized under the CARES Act.

On his July 2020 application, Oudomsine allegedly claimed he had 10 employees and 12-month gross revenues of $235,000.

The following month, he was given about $85,000 from the Small Business Administration (SBA), which means he spent nearly all of the money on the rare card.

Authorities have given few details about the specific card purchased, though they have said Oudomsine was charged with wire fraud and is expected to appear in court on Thursday.

The charge carries a max sentence of up to 20 years in federal prison, along with a $250,000 fine.

Misuse of COVID Relief Funds

Oudomsine is far from the first person to face charges for fraud related to small business loans issued amid the pandemic. Others who received relief funds have been accused of spending the money on Lamborghinis, nights at strip clubs, and even an alpaca farm, among other purchases.

In fact, the first person to be charged with fraudulently seeking a pandemic relief loan was recently sentenced to 56 months in prison following a nationwide search after the man faked his own death.

According to The Washington Post, a federal watchdog said this month that the SBA overpaid $4.5 billion in grants to self-employed people and that “no system of controls was in place to flag applications with flawed or illogical information.”

On top of that, the SBA inspector general determined earlier this year that the agency rushed to send out billions of dollars in loans through the Paycheck Protection Program (PPP) “at the expense of controls” that could have blocked inappropriate aid.

In a statement on Sunday, the agency said that under the Biden administration, it has worked with Congress and the inspector general to add antifraud measures. Meanwhile, defenders of pandemic relief programs have argued that flagged loans and grants represent only a small fraction of the distributed aid that has been critical to small businesses and their pandemic recovery.

See what others are saying: (NPR)(USA Today)(The Washington Post)

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FDA Authorizes Moderna and J&J COVID Vaccine Boosters, Approves Mix-and-Match Doses

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The approval will allow at-risk Americans who received Pfizer and Moderna vaccines to get any booster six months after their initial series and all Johnson & Johnson recipients 18 and older to do the same two months after their single-shot dose.


New FDA Authorization

The U.S. Food and Drug Administration (FDA) on Wednesday authorized boosters shots of Moderna and Johnson & Johnson COVID-19 vaccines and approved a mix-and-match strategy that will allow people who got one company’s shot to get a booster from a different maker.

The decision paves the way for millions of more at-risk Americans to get extra protection, and not just certain Pfizer recipients as previously approved by the FDA.

Under the authorization, people who received Moderna or Pfizer can get any one of the three booster shots six months after completing their initial series if they are 65 and older, at high risk of severe COVID, or face increased exposure because of their work.

Meanwhile, all J&J recipients 18 and older can get any of the approved vaccines two months after they received the one-shot jab.

Hazy Recommendations, For Now

Notably, the FDA did not recommend a certain combination of vaccines, nor did the agency say whether or not it would be more effective for people to stick with their original vaccine maker for their booster.

The new authorizations draw on a study from the National Institutes of Health (NIH), which found that there are no safety concerns with mixing boosters and that vaccine combinations were at least as effective in stimulating antibodies as matched vaccines.

In the case of J&J recipients, the NIH found that people actually had a higher boost from mixing either Moderna or Pfizer boosters.

However, some of the scientists who worked on the study said it should not be used to recommend one combination over another because the research was limited.

The Centers for Disease Control and Prevention (CDC), which determines vaccine recommendations, could issue more guidance on when and whether people should switch vaccine makers for their booster shots.

An advisory panel for the agency is meeting Thursday to discuss the new FDA authorizations and recommendations.

Once the panel makes its decision, the CDC director has the final say on the guidelines. If the agency agrees with the FDA’s decisions, the booster shots could be rolled out as soon as this weekend.

See what others are saying: (The New York Times) (NPR) (The Washington Post)

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Paris Hilton Urges Lawmakers To Crack Down on Abusive Teen Treatment Facilities

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The heiress alleges that she was a victim of abuse in these types of centers for two years and wants to ensure that no child suffers through the same experience.


Paris Hilton Details Abuse Within “Troubled Teen Industry”

Socialite and entrepreneur Paris Hilton spoke outside of the U.S. Capitol on Wednesday to support the Accountability for Congregate Care Act, which is set to be introduced in the near future.

Hilton joined Rep. Ro Khanna (D-CA), Rep. Adam Schiff (D-CA), Rep. Rosa DeLauro (D-Conn.), and Sen. Jeff Merkley (D-Ore.) to advocate for the legislation, which aims to create a “bill of rights” for children in treatment and behavioral centers.

The heiress has alleged that she spent two of her teenage years in these types of facilities and was subject to rampant abuse. She is far from alone. 

During a press conference, Hilton said that one night when she was 16, she woke up to two large men in her bedroom forcing her out of her house. She said she screamed for help because she thought she was being kidnapped, but her parents watched as she was taken away to a “troubled teen” program. 

“Like countless other parents of teens, my parents had searched for solutions to my rebellious behavior,” she explained in an op-ed for The Washington Post this week. “Unfortunately, they fell for the misleading marketing of the ‘troubled teen industry’ — therapeutic boarding schools, military-style boot camps, juvenile justice facilities, behavior modification programs and other facilities that generate roughly $50 billion annually in part by pitching ‘tough love’ as the answer to problematic behavior.”

Hilton said she was sent to four different facilities where she was “physically and psychologically abused.” 

“I was strangled, slapped across the face, watched in the shower by male staff, called vulgar names, forced to take medication without a diagnosis, not given a proper education, thrown into solitary confinement in a room covered in scratch marks and smeared in blood and so much more,” she explained during the press conference. 

“At Provo Canyon School in Utah, I was given clothes with a number on the tag. I was no longer me, I was only number 127,” she continued. “I was forced to stay indoors for 11 months straight, no sunlight, no fresh air. These were considered privileges.”

Goals of the  Accountability for Congregate Care Act

Hilton claims that a lack of transparency and accountability has allowed this structure of abuse to thrive for decades. In some cases, she said it has taken children’s lives. Now, she wants Congress and President Joe Biden to act. 

“This bill creates an urgently needed bill of rights to ensure that every child placed into congregate care facilities is provided a safe and humane environment,” Hilton said of the Accountability for Congregate Care Act.

“This bill of rights provides protections that I wasn’t afforded, like access to education, to the outdoors, freedom from abusive treatment, and even the basic right to move and speak freely. If I had these rights and could have exercised them, I would have been saved from over 20 years of trauma and severe PTSD.” 

Foster children, children being treated for mental disorders, and other children in youth programs would be impacted by the bill.

Hilton was one of several survivors and advocates who fought for the legislation on Wednesday. Rep. Khanna thanked them for using their stories to fight for change. 

“No child should be subjected to solitary confinement, forced labor, or any form of institutional abuse,” he wrote. “Thanks to Paris Hilton, my colleagues & the survivors & advocates who joined us today to discuss how we can hold the congregate care industry accountable.”

While only Democratic legislators are currently sponsoring the bill, Hilton called for a bipartisan effort to fight for the rights of children. 

Ensuring that children are safe from institutional abuse isn’t a Republican or Democratic issue,” Hilton said. “It’s a basic human rights issue that requires immediate attention.”

See what others are saying: (The Washington Post) (The Hill) (NBC News)

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