Part 1: RFK Jr.'s Chopping Block to Make America Healthy Again (MAHA)
As many of the overstaffed FDA departments appear to be in place to do more harm than good, drastic cuts to the FDA will be a welcome drain on the agency’s power.
November 10, 2024: In an article entitled, “What Can Trump and RFK Jr. Actually Do on Health Care?”, STAT News reported that the Trump/RFK Jr. MAHA (Make America Healthy Again) dream team, along with the Republican majority House and Senate have a good probability of banning fluoride in water and BioPharma DTC (direct-to-consumer) advertising.
Content of this article is copyright of Karen Kingston, The Kingston Report.
Photos: ShutterStock
What Can Trump & RFK Jr. Actually Do on Healthcare?
Ban Direct-To-Consumer Advertising
Does Banning BioPharma DTC Advertising Violate the 1st Amendment?
(No.)
STAT News also reported that an assistant attorney-in-charge of opioid litigation at the Oregon Department of Justice opined that banning BioPharma DTC advertising is in violation of the 1st amendment. This is rich coming from a consumer-protection opioid prosecutor who seems to be oblivious to the fact that President Nixon and Congress banned cigarette ads on TV and radio in 1970 and Purdue Pharma continues to face civil and criminal litigation for false and misleading marketing of their opioid, OxyContin.
If I may further opine on this Oregon attorney’s legal opinion:
This past summer SCOTUS struck down a 50-State bankruptcy settlement against Purdue Pharma that would provide iron-clad civil and criminal immunity to the opioid manufacturer for engaging in willful injury by knowingly misrepresenting OxyContin as a ‘less-addictive’ opioid to doctors and consumers.
In other words, if a pharma company runs advertisements promoting their product as ‘safe and effective’ (or pays spokespeople to do so) when they knowingly have data showing that their product causes harm, they are engaging in acts of civil and criminal fraud, as well as willful injury.
This is why Pfizer is currently being sued by Texas and Kansas.
The FDA has been banning DTC campaigns since 1998 and direct-to-physician ads essentially since the agency was formed.
Everything is Zoloft
My earliest memory of the FDA banning a Pharma campaign was the FDA’s shut down of Zoloft’s “Everything is Zoloft” directed at physicians. In 1999, I recall the Zoloft team did something else to tick-off the FDA. I was working on the VIAGRA account that year and we got $millions injected into our budget last minute in Q1 or Q2. Per my recollection, I was told the money came because the Zoloft team had to cut all their ad spending and even had to pull printed educational materials due to crossing the line with the FDA….again.
It’s Not Magic, It’s Botox
I was a consultant for Allergan in 2003 when the FDA warned Allergan to stop the “It’s Not Magic, It’s Botox” campaign. (I quite liked that campaign).
The executive team tried fighting the FDA in court to no avail. Shortely thereafter, the DOJ went after Allergan. In 2010, Allergan agreed to pay $600 million for off-label promotions of Botox.
It’s great to know that the DOJ has their priorities straight by dragging Allergan into court in 2010 for educating doctors off-label on how to treat crow’s feet (and not just forehead elevens (111s)), while ignoring the millions of reported cases of disease, disabilities and deaths caused by the COVID-19 mRNA injections. (heavy sarcasm)
The FDA Has Always Had the Authority to Cancel DTC Campaigns
If Dr. Casey Means becomes FDA Commissioner, it is well within her authority to strike down and cancel BioPharma campaigns. The FDA has been doing this for decades.
Photo: X @CaseyMeansMD
When I worked on the Viagra account, the FDA was calling the regulatory and marketing team like a psycho-stalking ex-boyfriend for reasons like; showing handsome, fit, salt-n-pepper-haired men who looked “too young and too healthy,” showing slow-motion video footage of a football being thrown through a tire, or showing a man bite a peach in a commercial.
BTW, Cialis later got away with running similar ads ‘no problem.’ Many years later, Viagra was allowed to have their football back.
What’s the Difference Between a Sponsorship and a Bribe?
A significant portion of PFIZER’s DTC budget isn’t even for running ads on the mainstream media, but for “sponsorships.” Whether it’s the Super Bowl or an episode of The View, we’ve all seen the Pfizer logo at the beginning or end of media segments with the audio clip, “Brought to you by Pfizer.”
A savvy attorney, such as Calley Means, will effortlessly be able to argue how the purpose of BioPharma ‘sponsorships’ for sports or news programs is not about ‘health education,’ but rather to control the narrative of what can and can not be reported on by the network, i.e. hundreds to thousands of young professional athletes dropping dead since the COVID-19 rollouts.
Photo: X @calleymeans
This dynamic brother-sister duo could help launch a DOJ investigation into off-label and fraudulent claims made by product spokespeople (i.e. NFL star Travis Kelce) as well as news anchors (i.e. Rachael Maddow), reporters, and talk show hosts (i.e. members of The View.)
Pharma Paid FDA Fees Are on the Chopping Block
Prescription Drug User Fee Act (PDUFA) Fees
PDUFA (pronounced: puh-doo-fah) fees came about because BioPharma companies were waiting a year or longer to get on the FDA’s calendar for a meeting after submitting their Biological License Application (BLA) and final Phase-3 data in order to receive FDA approval, feedback, or denial from the FDA.
PDUFA fees are paid by BioPharma companies when they submit their Biological License Approval (BLA) in order to get calendared on the FDA’s schedule for a review meeting to receive or deny FDA-approval within 6 business months of completing Phase-3 data submission.
Pfizer COVID-19 mRNA Vaccines PDUFA & FDA Approval Example
Pfizer paid an approximate $3 million in PDUFA fees when the BioPharma giant filed their Biological License Application (BLA) for FDA approval of their COVID-19 mRNA injections on May 18, 2021. The FDA meeting to review Phase-3 data and approve Pfizer’s BLA (mRNA vaccines) was scheduled 6 business months out on January 16, 2022.
Note: Many of the weeks between the end of November through the 1st week of January are blocked out due to the holidays (Thanksgiving, Christmas, New Year’s).
Due to political pressure, the FDA unlawfully approved Pfizer’s COVID-19 mRNA injections on August 23, 2021, five (5) calendar months before the PDUFA data and without holding an FDA review committee meeting.
‘Innovation’ is Why BioPharma Doesn’t Care if MAHA Kills PDUFA
In early 2022, the FDA put into full gear several new “Innovation Pathways” to accelerate the FDA approval of innovative products (such as cell and gene-based technologies) while lowering the standards for safety and efficacy.
A prime example of the FDA lowering the standards for safety and efficacy, is the FDA’s Director of Center for Biologics Evaluation and Research (CBER) Peter Marks single-handedly expanding the accelerated approval of Sarepta Therapeutics’ gene therapy for the Duchenne muscular dystrophy, Elevidys.
Peter Marks expanded the accelerated approval of Elevidys despite the following facts;
Three (3) FDA review committee TEAMS ruled against the Elevidys’ expanded approval, but Peter Marks overruled his peers in the name of ‘innovation.’
A biomarker (protein production) was used as the outcome datapoint for Peter Marks’ single-handed FDA approval of Elevidys, despite the fact that there is no statistically significant correlation or scientifically proven causation between the biomarker and clinical outcomes.
In April of 2024, the FDA announced the CDER’s Center for Clinical Trial Innovation (C3TI) to accelerate the approval of new therapies. A cornerstone of these innovative trial designs will likely entail changing meaningful clinical outcomes (reduction in disease symptoms) to biomarkers (i.e. production of proteins or antibodies) that may or may not contribute to reducing disease symptoms or increasing life expectancy.
The FDA Announced the Agency Will Approve Bird Flu Vaccines Without Receiving
Human or Animal Data
Lastly, PDUFA dates no longer matter because on October 10, 2024, the FDA held a 6.5 hour meeting on the upcoming FDA-approval of the H5N1 Pandemic of Virus Vaccines. During the meeting, Dr. Jerry Weir announced that the FDA will grant full FDA-approval to the pandemic vaccines without receiving any safety, efficacy or biomarker data in humans or animals.
So…..if anything, PDUFA is just slowing down BioPharma’s out-of-control innovation speed-train and the agency’s ability to enable BioPharma’s criminal human experimentation on American adults and children.
The Benefits of Getting Rid of PDUFA Fees and an Overstaffed FDA
PDUFA fees account for about 50% of the FDA’s budget. By cutting the FDA’s budget in half, MAHA will be able to quickly layoff 50% of the FDA staff (many of which are unnecessary).
As many of the overstaffed FDA departments appear to be in place to do more harm than good, including the FDA’s recently expanded Unified Human Foods Program targeted at controlling and reducing the US food supply, drastic cuts to the FDA will be a welcome drain on the agency’s power, as will replacing their BioPharma kowtowing bureaucrats with qualified experts that are actually committed to Making America Healthy Again (MAHA).
1 Corinthians 12: 24-26
God has put together all the parts of the body. And he has given more honor to the parts that didn’t have any. In that way, the parts of the body will not take sides. All of them will take care of one another. If one part suffers, every part suffers with it. If one part is honored, every part shares in its joy.
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Proverbs 21:20
The wise store up choice food and olive oil, but fools gulp theirs down.
I remember a relatives wife used Botox. She was slim and drop dead gorgeous before taking it and after was puffy faced. It added 10 years to her appearance age. Not a great choice.
I think there's a lot that can be done to improve these agencies. Thanks for this.