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Tuesday, July 4, 2023

Biden’s regulations costing Americans $10K per household

 A raft of regulations enacted by the Biden administration is pinching Americans’ wallets to the tune of nearly $10,000 per household as of the end of last year, according to a budget watchdog group.

Should Biden’s regulatory trajectory keep pace with that of his former boss, Barack Obama, the cost will skyrocket to roughly $60,000 per household by the end of Biden’s possible second term in office, the Committee to Unleash Prosperity estimated in a recent report that measured “current and expected future costs.”

“This is an across-the-board human capital crisis like we haven’t seen for decades,” Casey Mulligan, the University of Chicago professor who authored the report, told “Fox & Friends” Friday.

Many of the new rules include policies on the environment, energy, healthcare, telecommunications, and transportation.

President Biden speaks in Chicago June 28, 2023.
President Biden has begun touting so-called ‘Bidenomics.’
AP
President Biden
President Biden has crowed about the low unemployment rate and initiatives aimed at lowering costs for middle class families.
AFP via Getty Images

The most notable cost highlighted by the report was Biden’s executive action to grant mass forgiveness of student loans, which the Congressional Budget Office estimated would cost $316 billion, but which other sources said could go as high as $430 billion.

The Supreme Court nixed the giveaway on June 30, but Biden has already sought to revive the initiative. The White House announced Friday it will forgive “financially vulnerable” borrowers any missed payments for the first 12 months after collection resumes Oct. 1.

In addition, the Biden administration said it had finalized rules reducing the amount of discretionary income that borrowers have to pay each month from 10% to 5% for undergraduate loans and forgiving outstanding debts of $12,000 or fewer after 10 years of payments instead of 20 years.

Former President Barack Obama.
The Obama administration moved quicker than President Biden to impose environmental regulations during his first two years, according to the report.
AP

The Committee to Unleash Prosperity report also zinged Biden for implementing a COVID vaccine-or-test rule for large businesses, which was also smacked down by the high court; price controls for prescription drugs outlined in the Inflation Reduction Act; and higher standards for automobile emissions.

“While the automobile fuel economy and emissions standards contribute the greatest single cost, they still account for only a third of the total regulatory costs. Collectively, health, labor, telecommunications, and consumer finance regulations impose costs that exceed those of automobile regulations,” the report said.

The report found that Biden had implemented fewer new regulations in his first two years in office than either of his two immediate predecessors.

New rules from the Biden, Trump, and Obama administrations according to the Committee to Unleash Prosperity.
New rules from the Biden, Trump, and Obama administrations according to the Committee to Unleash Prosperity.
Committee To Unleash Prosperity

However, Biden topped both Trump and Obama in terms of the financial impact of those rules.

Costs for the president’s red tape in 2021 and 2022 clocked in at around $173.4 billion, according to government agencies. However, the watchdog pegged the costs at $616.7 billion, with Mulligan citing the feds’ “systematic and proven propensity to understate costs.”

Trump’s regulatory impact was measured at a cost of $8.6 billion by the government agencies, while the watchdog estimated savings of $323.9 billion. Obama’s rules added a cost of $147.9 billion, per the agencies’ estimations and $534.8 billion, per the watchdog.

New rules from the Biden, Trump, and Obama administrations according to the Committee to Unleash Prosperity.
The financial cost of rulemaking from the Biden, Trump, and Obama administrations according to the Committee to Unleash Prosperity.
Committee To Unleash Prosperity

In sharp contrast to Biden, Trump’s deregulatory push led to roughly $11,000 in savings per household and eight years of Trump would’ve delivered nearly $21,000 in savings, the report estimated.

“President Trump did something, first thing that had ever happened in American history: he had a budget for the regulators,” Mulligan told Fox.

“We saw amazing results from that. They were cutting out old regulations, cutting out unneeded regulations, and they were putting in some new ones that they felt were needed.”

Former President Donald Trump speaks in Bedminster, NJ on June 13, 2023.
Former President Donald Trump has made gutting federal regulations a core tenet of his platform.
James Keivom
Biden began aggressively promoting so-called “Bidenomics” last week as he seeks to counter fierce GOP criticism and dismal public opinion on the economy.

https://nypost.com/2023/07/04/bidens-regulations-cost-households-10k-watchdog/

Federal judge limits Biden administration contact with social media platforms

 A federal judge on Tuesday blocked Biden administration officials from communicating with social media companies, as two Republican state attorneys general challenge the legality of the administration’s efforts to curb disinformation.

U.S. District Judge Terry Doughty, who was appointed by former President Trump, granted a preliminary injunction barring a wide swath of officials from the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), the Department of Justice (DOJ), the State Department and the FBI from communicating with the companies.

The Republican attorneys general of Louisiana and Missouri are suing the administration over what they describe as a “campaign of censorship,” in which the Biden administration allegedly “coordinated and colluded with social-media platforms to identify disfavored speakers, viewpoints, and content.”

They argued that administration officials’ public and private communications with social media companies about removing content related to COVID-19 vaccines and public health measures, election integrity and other topics violated the First Amendment.

The attorneys general pointed to various calls by the 2020 Biden campaign and later the Biden administration, as well other Democratic lawmakers, to reform Section 230 over the spread of disinformation, which the lawsuit characterized as “threats” and a “campaign of pressure.”

Section 230 waives social media companies’ liability for content posted on its platforms by third parties.

They also cited efforts by the Biden administration to work with social media companies to rein in COVID-19 and election disinformation, which the suit described as “collusion.”

Under the injunction Biden administration officials cannot email, call, send letters, text or meet with social media companies “for the purpose of urging, encouraging, pressuring, or inducing in any manner the removal, deletion, suppression, or reduction of content containing protected free speech posted on social-media platforms,” Doughty ruled.

However, Biden administration officials are still permitted to communicate with the platforms about criminal activity, national security threats, threats to public safety and posts “intending to mislead voters about voting requirements and procedures.”

https://thehill.com/regulation/court-battles/4080671-federal-judge-limits-biden-administration-contact-social-media/

US FDA approval and panel tracker: June 2023

 June was gene therapy month, with FDA approvals for both Sarepta’s Elevidys and Biomarin’s Roctavian. Both have challenges ahead, however. Elevidys was given only accelerated approval in Duchenne muscular dystrophy patients aged 4-5 years old; expanding the label to other ages depends upon the confirmatory Embark trial, data from which are due later in the year. For Roctavian, a haemophilia A gene therapy, durability remains a concern, and many expect a sluggish US launch, mirroring the slow roll out seen in Europe. Several setbacks also occurred in June, with three delays and seven complete response letters. Intercept’s tortuous Nash journey finally ended with another knockback for Ocaliva, while the rejection of Regeneron’s high dose Eylea will allow Roche’s Vabysmo to gain more ground on Eylea’s original formulation. Lastly, all the panels had positive outcomes last month, including one for Eisai and Biogen’s Leqembi, setting the Alzheimer’s therapy up for full approval by 6 July.

Notable first-time US approval decisions in June 2023
ProjectCompanyIndication(s)2028e WW SBI ($m)Outcome
Elevidys (SRP-9001, delandistrogene moxeparvovec)Sarepta/RocheAmbulatory patients with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene

3,357

Approved in patients aged 4-5 years old (accelerated)
Roctavian (valoctocogene roxaparvovec, gene therapy)BiomarinAdults with severe haemophilia A 1,430Approved (previous CRL)
BimzelxUCBPlaque psoriasis937Delayed to Q3
Glofitamab (Columvi)RocheRelapsed/refractory large B-cell lymphoma after ≥2 lines lines of systemic therapy763Approved (accelerated, ~ 2 weeks early)
Litfulo (ritlecitinib)Pfizer12 yrs+ with alopecia502Approved
MomelotinibGSKMyelofibrosis with anaemia465Delayed to 16 September
Rystiggo (rozanolixizumab)UCBGeneralised myasthenia gravis323Approved
OlorofimF2G (private)/ShionogiInvasive fungal infections in patients who have limited or no treatment options21CRL (additional data and analyses)
ADX-2191 (methotrexate injection)AldeyraPrimary vitreoretinal lymphoma9CRL (lack of substantial evidence of effectiveness)
Vyvgart Hytrulo (subcutaneous efgartigimod)ArgenxGeneralised myasthenia gravis- (IV forecasts 2,598**)Approved
Epinephrine nasal spray (Neffy)ARS PharmaceuticalsEmergency treatment of allergic reactions (type I) including anaphylaxis in adults and children ≥ 30 kg-Delayed to 19 September
Vevye (CyclASol/ cyclosporine ophthalmic solution)Novaliq (subsidiary of Geuder Group)Dry eye disease-Approved
Ocaliva (obeticholic acid)InterceptPre-cirrhotic liver fibrosis due to Nash-Second CRL (long-term outcomes needed, Intercept discontinuing all-Nash related investment)
Travivo (Exxua)Fabre-Kramer Pharmaceuticals/BristolMajor depressive disorder-Not yet disclosed
Dehydrated alcohol injection (DS-100)EtonMethanol poisoning-CRL (Chemistry Manufacturing and Controls)
IPX203AmnealParkinson's disease-CRL (additional PK data)
Lantidra (donislecel, allogeneic pancreatic islet cellular therapy)Celltrans (private)Adults with type 1 diabetes who are unable to approach target glycated haemoglobin because of current repeated episodes of severe hypoglycemia-Approved
NgenlaPfizer/OpkoPaediatric growth hormone deficiency-Approved (previous CRL)
*Forecast prior to adcoms, **MG indication assigned to IV version. SBI: sales by indication. Sources: Evaluate Pharma & company releases.

 

Advisory committee meetings in June 2023
ProjectCompanyIndication2028e SBI ($m)Outcome
LeqembiEisai/BiogenAlzheimer's disease (confirmatory study)4,4096-0 in favour (Pdufa 6 July)
Beyfortus (nirsevimab)Astrazeneca/ Sanofi/SobiPrevent RSV lower respiratory tract disease in neonates and infants1,72721-0 in favour (newborns or infants born/entering 1st RSV season)
19-2 in favour (up to 24 months of age who remain vulnerable through their 2nd RSV season)
(Pdufa Q3)
Sohonos (palovarotene capsules)IpsenPrevention of heterotopic ossification in adults and children (females aged ≥8 years and males ≥10 years) with fibrodysplasia ossificans progressiva-10-4 in favour of effectiveness
11-3 in favour benefits outweigh the risks
(Pdufa 16 August)
--Covid-19 (vaccine composition)-21-0 in favour of updating the current vaccine composition to a monovalent XBB-lineage
RSV: respiratory syncytial virus. Sources: FDA ad com calendar, Evaluate Pharma & company releases.
 
 
Supplementary and other notable approval decisions in June 2023
ProductCompanyIndication (clinical trial)Outcome
PrevymisMerckProphylaxis of CMV disease in adult kidney transplant recipients at high risk (NCT03443869)Approved
LinzessIronwoodPatients 6-17 years old with functional constipation (NCT04026113)Approved
Bylvay (odevixibat)Ipsen (Albireo)Alagille syndrome (Assert)Approved
Camzyos (mavacamten)Bristol Myers SquibbReduce the need for septal reduction therapy in adults with symptomatic obstructive hypertrophic cardiomyopathy (Valor-HCM)Approved
Talzenna + XtandiPfizerAdult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (Talapro-2)Approved
Jardiance, SynjardyBoehringerAdditions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes (Dinamo)Approved
BlincytoAmgenMinimal residual disease-positive B-cell precursor ALL (ECOG-E1910AALL1331)Conversion to full approval
Eylea 8mgRegeneron/BayerWet age-related macular degeneration and diabetic macular oedema (PulsarPhoton)CRL (ongoing review of inspection findings)
AVT02 (biosimilar)Alvotech/TevaHumira interchangeabilityCRL (deficiencies following facilities reinspection, previously received two CRLs for biosimilarity BLA)
GavretoRoche/BlueprintAdvanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer who require systemic therapyWithdrawn (not feasible to conduct confirmatory study, AcceleRET-MTC)
Janssen Covid-19 vaccine (Ad26.COV2-S)J&JPrevention of Covid-19EUA withdrawn
Source: Evaluate Pharma & company releases.

https://www.evaluate.com/vantage/articles/insights/nme-approvals-snippets/us-fda-approval-and-panel-tracker-june-2023

'Secret Service Investigating How Cocaine Got In The White House'

 The Secret Service on Tuesday confirmed rumors from the day earlier that it was investigating an "unknown item" found inside the White House library on Sunday, which was described in radio traffic as a cocaine-like substance.

"On Sunday evening, the White House complex went into a precautionary closure as officers from the Secret Service uniformed division investigated an unknown item found inside a work area," Secret Service spokesperson Anthony Guglielmi said in a statement, adding that the D.C. fire department determined the substance did not present a threat... although it certainly could present Hunter Biden with hours of brand new video material for his infamous notebook.

In a dispatch with an 8:49 p.m. timestamp, a firefighter with the D.C. department’s hazardous materials team radioed the results of a test: “We have a yellow bar saying cocaine hydrochloride.”

The brief broadcast was logged on a website called openmhz.com, which allows people to listen to live and archived radio transmission from police and fire departments. One of the officials familiar with the investigation, speaking on the condition of anonymity to discuss an open case, said the 8:49 transmission was from the White House call Sunday night. The official described the amount of the substance as small, which likely means that most of it had already been consumed.

The discovery came two days after recovering crack cocaine addict Hunter Biden was last seen at the White House; yet even so there appears to be some "mystery" as to how the cocaine got there.

The Biden family arrived back at the White House for Independence Day celebrations as the Secret Service continues to investigate the finding.

Secret Service spokesman Gulielmi said that President Joe Biden was not in the executive mansion when the substance was discovered.

"The DC fire department was called to evaluate and quickly determined the item to be non-hazardous. The item was sent for further evaluation and an investigation into the cause and manner of how it entered the White House is pending," he said, laughably hinting that there was some "confusion" as to how crack got inside the Blowden Biden family's DC estate as it is in the process of being auctioned off to Beijing. Here's a thought: since Hunter has a habit of recording his every close encounter with crack cocaine, just check his cell phone's latest video recordings.

In its report, ABC notes that "Cocaine hydrochloride can be used as an anesthetic or to control bleeding, but it is also considered to have effects similar to crack cocaine, according to the study National Library of Medicine National Center for Biotechnology Information", which suggests that the type of cocaine found was of a particular variety especially near and dear to Hunter's heart.

"The physiological and psychoactive effects of cocaine are similar regardless of whether it is in the form of cocaine hydrochloride or crack cocaine (cocaine base)," the study says. You do learn something new every day.

The "item" was sent to a Secret Service lab for further testing, the sources said.

The White House on Tuesday referred reporter questions about the matter to the Secret Service, because what else could they say: "to pay for Hunter's crack addition, Joe had to sell even the Resolute Desk to Beijing." Of course, that's a silly joke: after all, just imagine what America's international allies - and enemies - would think if any of this Jerry Springer Special, live from the White House, turned out to be even remotely true...

The Biden's cocaine antics take place just days after the younger Biden reached a plea deal with Justice Department prosecutors to avoid jail time after lying on a federal form to purchase a firearm. He checked a box claiming that he did not use and was not addicted to illegal substances – a fact that would disqualify him from buying the gun. The form contradicting the timelines and claims made in Hunter Biden's own memoir.

Biden critics and conservative decried Hunter's plea deal, claiming that anyone other than the president's son would receive jail time for the same offense. The deal also saw Hunter plead guilty to two tax misdemeanors which would have been a felony - and meant prison time - for anyone else but the president's crack and whore-addicted son.

Come to think of it, there was plenty of reasons for Hunter to be celebrating in the aptly named China White house.

https://www.zerohedge.com/markets/secret-service-investigating-how-cocaine-got-white-house

Lehigh Valley Health Network confirms it was attacked by ransomware gang BlackCat

 Allentown, Pa.-based Lehigh Valley Health Network has confirmed that its Jan. 8 cyberattack was conducted by Russian ransomware gang BlackCat.

On June 29, the health system notified patients that the breach from BlackCat occurred on Jan. 8, with the health system detecting the ransomware on its IT system on Feb. 6. 

BlackCat was able to obtain some patients' protected health information including email addresses, banking information, medical information, Social Security numbers and more. 

The hospital is offering affected patients 24 months of free identity theft protection and is working to strengthen its cybersecurity defenses. 

https://www.beckershospitalreview.com/cybersecurity/lehigh-valley-health-network-confirms-it-was-attacked-by-ransomware-gang-blackcat.html