Critical thinker especially when outdoors, good at zoomies, never keep a hairball close, able to climb trees in a single bound. Live by the rules of nature.
America, YOU MUST read to the end: First, when Pfizer caused medical providers to promote and administer Bextra and three other drugs for off-label uses, and those providers billed the United States for such use, the Department of Justice fined Pfizer more than $1 billion for fraud. Where does the CDC derive authority to engage in the same kind of off-label promotion of COVID-19 drugs for which DOJ has levied historic criminal and civil penalties on everyone else?
Second, Congress denies any person authority to introduce unapproved drugs into interstate commerce without FDA approval, which includes unlicensed uses of licensed drugs. Doctors can administer off-label uses, but just as the FDA cannot engage in medicine to promote such off-label use, it cannot be determined where the CDC is authorized to engage in such conduct. If the CDC can recommend the use of unlicensed drugs, then you are no longer required to issue an EUA for them; the CDC can partner with America's largest medical providers and pay them with federal funding to administer them on the CDC director's recommendation to bypass all such requirements relating to unlicensed uses under the Federal Food, Drug, and Cosmetic Act & the Public Health Service Act, facts I'm confident HHS legal counsel and the Office of Human Research Protection are concealing from you. In other words, you are no longer required to issue EUAs, CDC can recommend the use of any unlicensed drugs, including those approved under the World Health Organization, but not the FDA. Unlicensed is unlicensed, period.
Third, 26 USC § 4132(a)(2) states that a vaccine is one that is designed to "prevent" a disease. "Prevent" is a term the FDA must assign as a licensed fact. Can the federal government, under the Social Security Act, pay for unlicensed uses of drugs not licensed as a vaccine by the FDA? I think not. Under the first EUA for the Pfizer-BioNTech COVID-19 Vaccine, it was plainly stated that the drug was an "investigational vaccine," meaning it was under investigation to become licensed, according to 42 U.S.C. § 262(a), as a biological vaccine.
Fourth, if the federal government and/or Pfizer require the providers to monitor recipients for adverse effects and report on those effects, then that activity is subject to 42 U.S.C. § 289, requiring you to ensure the recipients' "legally effective informed consent" is obtained.
Finally, you should require the CDC Director to identify the statutory authority under which the agency issues recommendations that promote drugs for off-label uses—conduct pharmaceutical manufacturers themselves could not lawfully engage in — and the authority under which the federal government can fund such uses, since they are not licensed to "prevent" anything.
Moreover, why is the CDC not conspicuously requiring providers to inform the public that unlicensed use of the drugs means the FDA has not approved such use based on clinical trials proving the drug's safety for that age group? IMPORTANTLY: the CDC should remind healthcare providers that under misbranding laws, no provider can claim the unlicensed use WILL prevent the disease or promote the drug for an indication. They can only state that it is their opinion that the drug MIGHT have benefit, not that it WILL accomplish an end result.
Any other language that claims the same benefit of the licensed product is a misbranding violation—a felony under 21 USC § 331, punishable with incarceration and fines under § 333. The CDC should be clearer before its political fervor leads medical professionals to engage in criminal conduct.
You should know that Governor Pritzker enacted a law stating that Illinois will no longer consider it misbranding for a provider to promote a drug the FDA refuses to approve but the World Health Organization does. Now, future CDC directors can simply recommend WHO drugs, which rogue political actors will use as justification to mandate them for the public, and those drugs will be shielded from civil liability when injuring Americans. The CDC Director knows exactly what pathway is being laid for the next administration. That pathway violates federal law, and you should be informed of your exclusive authority to stop it. Congress authorizes you, not the CDC director, to determine when, where, and how unlicensed drugs will be used in commerce. When the CDC oversteps your authority, you possess the authority to correct it. Furthermore, you cannot trust HHS legal counsel to protect public safety or to inform you of your exclusive powers regarding this subject. I know this personally.
America needs you more than you can possibly understand at the moment because you're unaware of what the Democrat led Governors Public Health Alliance is doing in preparing America for the next pandemic. It is a level of horror few know is coming because no one knows the laws regulating unlicensed drugs, biologics, and devices. That lack of knowledge led to the past human rights atrocities under the Biden administration.
Texas A&M. You’re next. You may be a rivals with UT on the field, but this should unite you completely.
A&M spent $3.25 million since 2020 processing H-1B labor.
Abbott froze new petitions in January. They still filed 61 more and 57 were certified after the freeze order.
Meanwhile the main campus went from about 59% White to 49%. ‘Asian’ share doubled.
Same direction. Different school…
PRESIDENT TRUMP LIGHTS UP THE JUMBOTRON AT NEYLAND STADIUM
Trump appears on the big screen before a packed crowd at the Texas-Tennessee showdown in Knoxville, seated alongside Tennessee gubernatorial candidate Sen. Marsha Blackburn. 🇺🇸🏈
A home in Kibbutz Kfar Aza, shortly after the massacre. The medical teams had already removed the bodies.
Dozens of bullet holes cover the bedroom door. The terrorists had emptied entire magazines into it before entering. The last room in the video is a children's room inside the home's bomb shelter. The family dog is still lying on one of the children's beds, refusing to move.
The blood-stained beds and sheets speak for themselves. They are a reminder of the life that filled this home only hours before.
Major development in the Swedish election.
Authorities now have SIX ongoing investigations into suspected election fraud.
It's astonishing to see how little the media outside of Sweden is reporting on this.
Popular news station and dear friend @TexasSpectator account wrongfully suspended on @X! A neutral Texan spectating and informing fellow Texans about the truth, news, and current events in Texas was silenced. @elonmusk please restore the account as it did not violate any X rules.
The NGOs end up increasing the number of homeless people they manage, because that’s the only way to increase their revenue! Incentives drive outcomes.
“Homeless” is a propaganda word used to describe people on the street who are mentally ill or severely addicted to drugs. The word implies that this is someone who fell a little behind on their mortgage payment and they’re one job offer away from getting back on their feet, which is obviously false if you’ve ever tried talking to a “homeless” person in SF, LA, NY, Austin or anywhere else.
The honest reality is that we need to bring back asylums for extreme mental illness or drug addiction for those who are a serious danger to themselves or others.