The key issue is the fact that Big Pharma pays user fees to the FDA and the money is ear marked for the exclusive use of processing NDA's for approval. Over 50% of FDA annual budget is ear marked this way. The solution is to take most of the NAIAD budget and transfer it to the FDA and have the FDA manpower be redirected to doing what it's original mission was. Protect American Citizens from harm. From Food, Drugs, Vaccines and Cosmetics that HARM! Second, the revolving door between FDA and Big Pharma has to be locked. Most ex FDA commissioners have gone over to the dark side. Dr. Kessler is one that has not. Big Tobacco tried to black ball him because he and Dr. Koop believed nicotine cigarettes should be managed as a drug. In 2025, the fight to return Americans into healthy lifestyles will be enormous.
Yes, the resistance to such changes will be strong, especially since our present Health regime is aligned with the WHO/WEF's goal of global governance.
This draft makes me very excited to see started. You are in a unique position, with a wide range of understanding of these processes, as well as an ear to Kennedy and others who know and respect both of you. Full speed ahead!
Again, I am dumbfounded by the wealth of knowledge of Dr. Robert Malone, and his wife. While reading/listening to this substack, I had to do a little research to better understand what was written. To have such an indepth knowledge is truly a gift that is being shared with us. Thank you for all o your hard work.
This first draft covers a lot of territory, but is laser focus on the issues that need to be addressed and changed in the FDA. If the suggestions are implemented, this would be a major win for American citizens. Here are some of my takeaways:
1. Current Emergency Use Authorization terminated immediately.
2. Categorize the COVID shots as Gene Therapy.
3. Doctors should be able to administer “off label use” medications to their patients.
4. Any warnings and guidelines should be written on a 9th grade level. (I read all my inserts, and have to use a search engine to figure out what is being said. The inserts and warnings should not be complicated to users.)
5. Royalties received by employees need to be re-examined and changed due to conflict of interest—and I would say greed.
6. One Health putting animals on par with humans needs to cease.
7. FDA needs to stay in their assigned lane; otherwise known as Mission Statement, and go no further.
You are a man of moral courage who has stood firm in the face of opposition since 2020. Your moral values as proposed here will elevate this country to a level of health that was due many decades ago. I am certain RFK, jr will seek your advice and counsel on this important strategic shift in mission for the FDA.
Donald Trump is a patriot for our country as expressed in his tagline "Make America Great Again", but we will be a different country when RFK, jr (and you and Jill ) assist with Making America Healthy Again. It is one thing to feel secure economically, but it is life-changing to feel good because of great health and vitality.
If I was given a chance to make one wish it would be to restore professional equity to the many health professionals who lost careers from defending what was right and just during COVID. There are too many real heroes to name but a few include Dr. Peter McCullough, everyone in the FLCCC Alliance, and dozens of others who made bold statements and took decisive actions to defend our health during COVID. It was all to their professional detriment. May this change then also be a reckoning for their service and sacrifice too.
Personally, I'm not concerned with perfection. We need the right people in the right positions, and the improvements should take on a life of their own. I draw comfort in knowing that Drs. Malone, and Mr. Kennedy are involved; there is such potential here. I'll hold a grudge against any Republican senator who steps in to muck this up.
Just sent this to my two senators re: Matt Gaetz for AG. I've evolved into communicating in unadorned language:
"This constituent would very much like to see Matt Gaetz confirmed as Attorney General. I note that some consider him to be a controversial, even unacceptable pick. I also note that, in the US and the western world, potentially effective people who threaten the status quo have a way of finding themselves embroiled in dubious legal scrutiny and investigations.
AG Merrick Garland was approved by the Senate. And behold the wreckage done. Selective, partisan prosecutions; unchallengeable by congressional oversight, veiled behind the pretext of “an ongoing investigation,” free to do or not do as he chooses, without consequence or accountability. I have watched with great distress as executive branch bureaucracies have run amok, especially these last four years. I want to see effective new officials who will aggressively root out the corruption that permeates this federal government. Matt Gaetz is one of the few men to whom I’d attribute the guts, determination, and talent to do it.
America just voted for Trump’s version of the GOP. Not that of Senator McConnell, et al."
Republicans voted for Garland, so voting for Gaetz should be a no brainer. I’m seeing the necessity of putting in tough skinned Constitutionalists versus weak kneed, spineless, jelly fish, politicians—say what you want about Gaetz, but a person cannot deny his love for our nation and Constitution.
Dr. and Jill Malone, Thank you for initiating this monumental task! I am excited to see where this administration takes this! We've actually spoken before by zoom. My area of FDA interest would be in regulation the mRNA vaccines (um gene therapies) in our food. I believe we need to get it out of our swine production and keep it out of our beef/milk/cheese/chicken/lettuce etc. Best wishes to the two of you, I am a huge fan and supporter of yours!
Much as your blueprint brings out good ideas in general, when it comes down to staffing an organization it is the people and their make up that counts. They need to share the mission goal of the organization and bring character and intelligence to the mix. It starts at the top and all levels must work toward the mission. Since the 1990s the CDC has been staffing its ranks with YES men (and women). You want a $200k+ job then "you do what we tell you , not what is good for the citizens" was their approach. The negative influence was probably due to the Deep State or other organization attempting to cash in on pharma money.
The kind of people needed are those like Shirley Lindenbaum. Here is her story and how she figured out the source of Mad Cow Disease long before her peers.
Back around 1990’s scientists were feverishly trying to find the source of Mad Cow Disease (Prion Disease) for years and they couldn’t come up with the answer. One scientist finally got in touch with Shirley Lindenbaum, a medical anthropologist with the City University of New York who was studying a tribe in Papua New Guinea. The tribe were having a problem with people suddenly going mad from “Kuru” disease as they called it. After much work in the early 1960’s she found the source of the problem. The men on the island lived separate from the women and children. When a woman wanted children she went to the men’s side of the island. The men hunted small animals for food while the women grew grains and vegetables. The only time the women got meat was when one of them died. They boiled up grandma so to speak.
Shirley discovered that the boiling process did not destroy the “prion” that then carried over into the eater. This was the clue to what was causing mad cow disease. Despite her notifying mad cow researchers of the possible link they ignored her for some time.
She is relatively uncredited in the history of Mad Cow disease.
My point is there are smart, ethical scientists out there who are not doing high profile work but often have the answers. Unfortunately they are often ignored and the sloppy high profile money grubbing scientists with their shoddy work get the ear of the government and wrong decisions are made. We need more dedicated ethical scientists like Shirley Lindenbaum.
Thank you for sharing this very thoughtful and comprehensive list.
I would take things further and abolish EUAs. Emergency powers have almost always been abused at the cost of the public's well-being and our constitutional rights. If they won't abolish EUAs, then I think there needs to be a Founding-Fathers-type threshold to create one, such as all three branches of govt and 2/3 of the states ratifying each and every attempted EUA.
Repealing all legislation going back 100 years that transfers power from elected officials to bureaucrats - and particularly "public health" bureaucrats, is critical.
We must also make vaccine incentives illegal, for physicians, pharmacists, hospitals, corporations, and even for veterinarians. People are being way over vaccinated to the point of obtaining long term chronic disease and death. This is true of our pets too. Vaccine incentives are rampant in veterinarian clinics across the country. We must advocate for our pets.
We should consider creating or updating a medical bill of rights - one which innoculates us from unwanted innoculations. And ideally, add this into the First Amendment. (same for a digital bill to rights - the right to not be surveilled).
Finally, there need to be very severe consequences for those who harm others through the various means you so aptly have laid out.
For a draft this is very comprehensive. Are you submitting this to RFK Jr.? It is a very good blueprint to get started. The issues are so big and so important, but as you point out, you must be careful to follow the appropriate process to make this work efficiently. Wow, you and Jill are amazing!
Bravo! This draft is brilliant in all regards. Very thorough and comprehensive outline on how to fix the FDA and, hopefully, prevent future mission creep in this government agency.
If you don’t mind, I would like to provide additional input from a patient/citizen perspective.
There is a conflict of interest within the FDA that to this day continues by their burying promising therapeutics that compete with the medical industrial complex.
This was evident in the suppression of safe and widely used drugs (e.g., ivermectin and hydroxycholoroquine) so that dangerous and ineffective, but incredibly profitable, pharmaceutical products could monopolize the COVID-19 market.
Some other examples:
DMSO (dimethyl sulfoxide) for treating pain, autoimmune and other medical conditions
ultraviolet blood irradiation
GHB (gamma hydroxybutyrate) for insomnia and PTSD
I would like to see an information database that would list all treatment options available for a medical issue not just the options from a profit center focused pharma company.
Thank you Drs Malone for this amazing detailed blueprint to overhaul the FDA. It will be incredibly helpful to those who are tasked with this huge undertaking. I realize this is a starting document and could be expanded as necessary. I like your idea of multiple groups working on the same thing to prevent groupthink. Thank you for being proactive and putting your thought to paper. It will be an important tool. Your voices will be important in the work to be done.
AGGRESSIVE WOULD BE TO ELIMINATE THE CITIZENS UNITED SUPREME COURT DECISION OR CREATE LEGISLATION TO BLOCK IT'S EFFECTS. CORPORATIONS ARE NOT PEOPLE. MAKE THE PEOPLE'S VOICE HEARD AGAIN.
RESEARCH GRANTS MOSTLY FROM NAIAD ARE USED AS INCENTIVES TO CONTROL THE BEHAVIOR OF RESEARCHERS INCLUDING UNIVERSITY. REVISE THAT.
Very impressive grasp of the scope of the problem! However, the corruption of the existing system does seem to be overwhelming. Where and how to find unsullied workers who have not been hardened "within the framework of the administrative state?" The "experts" are disqualified. A gargantuan task!
What we aren't considering here is the potential impact of DOGE cuts. VR seemed to be coming into restructuring with some preconceived ideas. If some groups are duplication, it could require further reflections. There might be consideration of inviting ee buy ins. Would/where would ee1 see themselves best suited to contribute/wirk?
I'm not clear who is charged with damages resulting from approved drugs ( in particular 'vaccines'). Should the FDA be spelling out potential harms caused by approved new or revised drugs?
The more important thing is an effective program to deal with needs of the harmed. If the EUA industry protection continues, what's in place is a farce. Likely a special access to SSDI or the uninsured version could be viable. It should be addressed.
The key issue is the fact that Big Pharma pays user fees to the FDA and the money is ear marked for the exclusive use of processing NDA's for approval. Over 50% of FDA annual budget is ear marked this way. The solution is to take most of the NAIAD budget and transfer it to the FDA and have the FDA manpower be redirected to doing what it's original mission was. Protect American Citizens from harm. From Food, Drugs, Vaccines and Cosmetics that HARM! Second, the revolving door between FDA and Big Pharma has to be locked. Most ex FDA commissioners have gone over to the dark side. Dr. Kessler is one that has not. Big Tobacco tried to black ball him because he and Dr. Koop believed nicotine cigarettes should be managed as a drug. In 2025, the fight to return Americans into healthy lifestyles will be enormous.
Yes, the resistance to such changes will be strong, especially since our present Health regime is aligned with the WHO/WEF's goal of global governance.
This draft makes me very excited to see started. You are in a unique position, with a wide range of understanding of these processes, as well as an ear to Kennedy and others who know and respect both of you. Full speed ahead!
This is so reasonable. So obviously needed. So revealing of what has been missing...
Organic standards for food need to be strengthened, and then enforced. Oregon Tilth is a very good source.
Again, I am dumbfounded by the wealth of knowledge of Dr. Robert Malone, and his wife. While reading/listening to this substack, I had to do a little research to better understand what was written. To have such an indepth knowledge is truly a gift that is being shared with us. Thank you for all o your hard work.
Wow, very comprehensive! Perhaps you should be the one implementing this :-)
This first draft covers a lot of territory, but is laser focus on the issues that need to be addressed and changed in the FDA. If the suggestions are implemented, this would be a major win for American citizens. Here are some of my takeaways:
1. Current Emergency Use Authorization terminated immediately.
2. Categorize the COVID shots as Gene Therapy.
3. Doctors should be able to administer “off label use” medications to their patients.
4. Any warnings and guidelines should be written on a 9th grade level. (I read all my inserts, and have to use a search engine to figure out what is being said. The inserts and warnings should not be complicated to users.)
5. Royalties received by employees need to be re-examined and changed due to conflict of interest—and I would say greed.
6. One Health putting animals on par with humans needs to cease.
7. FDA needs to stay in their assigned lane; otherwise known as Mission Statement, and go no further.
8. Emphasis on Wellness.
The subsequent drafts can only get better!
You are a man of moral courage who has stood firm in the face of opposition since 2020. Your moral values as proposed here will elevate this country to a level of health that was due many decades ago. I am certain RFK, jr will seek your advice and counsel on this important strategic shift in mission for the FDA.
Donald Trump is a patriot for our country as expressed in his tagline "Make America Great Again", but we will be a different country when RFK, jr (and you and Jill ) assist with Making America Healthy Again. It is one thing to feel secure economically, but it is life-changing to feel good because of great health and vitality.
If I was given a chance to make one wish it would be to restore professional equity to the many health professionals who lost careers from defending what was right and just during COVID. There are too many real heroes to name but a few include Dr. Peter McCullough, everyone in the FLCCC Alliance, and dozens of others who made bold statements and took decisive actions to defend our health during COVID. It was all to their professional detriment. May this change then also be a reckoning for their service and sacrifice too.
Personally, I'm not concerned with perfection. We need the right people in the right positions, and the improvements should take on a life of their own. I draw comfort in knowing that Drs. Malone, and Mr. Kennedy are involved; there is such potential here. I'll hold a grudge against any Republican senator who steps in to muck this up.
Just sent this to my two senators re: Matt Gaetz for AG. I've evolved into communicating in unadorned language:
"This constituent would very much like to see Matt Gaetz confirmed as Attorney General. I note that some consider him to be a controversial, even unacceptable pick. I also note that, in the US and the western world, potentially effective people who threaten the status quo have a way of finding themselves embroiled in dubious legal scrutiny and investigations.
AG Merrick Garland was approved by the Senate. And behold the wreckage done. Selective, partisan prosecutions; unchallengeable by congressional oversight, veiled behind the pretext of “an ongoing investigation,” free to do or not do as he chooses, without consequence or accountability. I have watched with great distress as executive branch bureaucracies have run amok, especially these last four years. I want to see effective new officials who will aggressively root out the corruption that permeates this federal government. Matt Gaetz is one of the few men to whom I’d attribute the guts, determination, and talent to do it.
America just voted for Trump’s version of the GOP. Not that of Senator McConnell, et al."
Republicans voted for Garland, so voting for Gaetz should be a no brainer. I’m seeing the necessity of putting in tough skinned Constitutionalists versus weak kneed, spineless, jelly fish, politicians—say what you want about Gaetz, but a person cannot deny his love for our nation and Constitution.
Well done, sir.
Dr. and Jill Malone, Thank you for initiating this monumental task! I am excited to see where this administration takes this! We've actually spoken before by zoom. My area of FDA interest would be in regulation the mRNA vaccines (um gene therapies) in our food. I believe we need to get it out of our swine production and keep it out of our beef/milk/cheese/chicken/lettuce etc. Best wishes to the two of you, I am a huge fan and supporter of yours!
Much as your blueprint brings out good ideas in general, when it comes down to staffing an organization it is the people and their make up that counts. They need to share the mission goal of the organization and bring character and intelligence to the mix. It starts at the top and all levels must work toward the mission. Since the 1990s the CDC has been staffing its ranks with YES men (and women). You want a $200k+ job then "you do what we tell you , not what is good for the citizens" was their approach. The negative influence was probably due to the Deep State or other organization attempting to cash in on pharma money.
The kind of people needed are those like Shirley Lindenbaum. Here is her story and how she figured out the source of Mad Cow Disease long before her peers.
Back around 1990’s scientists were feverishly trying to find the source of Mad Cow Disease (Prion Disease) for years and they couldn’t come up with the answer. One scientist finally got in touch with Shirley Lindenbaum, a medical anthropologist with the City University of New York who was studying a tribe in Papua New Guinea. The tribe were having a problem with people suddenly going mad from “Kuru” disease as they called it. After much work in the early 1960’s she found the source of the problem. The men on the island lived separate from the women and children. When a woman wanted children she went to the men’s side of the island. The men hunted small animals for food while the women grew grains and vegetables. The only time the women got meat was when one of them died. They boiled up grandma so to speak.
Shirley discovered that the boiling process did not destroy the “prion” that then carried over into the eater. This was the clue to what was causing mad cow disease. Despite her notifying mad cow researchers of the possible link they ignored her for some time.
She is relatively uncredited in the history of Mad Cow disease.
My point is there are smart, ethical scientists out there who are not doing high profile work but often have the answers. Unfortunately they are often ignored and the sloppy high profile money grubbing scientists with their shoddy work get the ear of the government and wrong decisions are made. We need more dedicated ethical scientists like Shirley Lindenbaum.
Thank you for sharing this very thoughtful and comprehensive list.
I would take things further and abolish EUAs. Emergency powers have almost always been abused at the cost of the public's well-being and our constitutional rights. If they won't abolish EUAs, then I think there needs to be a Founding-Fathers-type threshold to create one, such as all three branches of govt and 2/3 of the states ratifying each and every attempted EUA.
Repealing all legislation going back 100 years that transfers power from elected officials to bureaucrats - and particularly "public health" bureaucrats, is critical.
We must also make vaccine incentives illegal, for physicians, pharmacists, hospitals, corporations, and even for veterinarians. People are being way over vaccinated to the point of obtaining long term chronic disease and death. This is true of our pets too. Vaccine incentives are rampant in veterinarian clinics across the country. We must advocate for our pets.
We should consider creating or updating a medical bill of rights - one which innoculates us from unwanted innoculations. And ideally, add this into the First Amendment. (same for a digital bill to rights - the right to not be surveilled).
Finally, there need to be very severe consequences for those who harm others through the various means you so aptly have laid out.
Excellent work, Dr. and Dr. Malone!
Spot on. Great suggestions. Thx!
For a draft this is very comprehensive. Are you submitting this to RFK Jr.? It is a very good blueprint to get started. The issues are so big and so important, but as you point out, you must be careful to follow the appropriate process to make this work efficiently. Wow, you and Jill are amazing!
I think the expulsion of all the pharma lobbyists might help the cause as well.
I firmly believe All lobbyist must be removed from government!!!!
Dear Dr. Robert and Jill Malone,
Bravo! This draft is brilliant in all regards. Very thorough and comprehensive outline on how to fix the FDA and, hopefully, prevent future mission creep in this government agency.
If you don’t mind, I would like to provide additional input from a patient/citizen perspective.
There is a conflict of interest within the FDA that to this day continues by their burying promising therapeutics that compete with the medical industrial complex.
This was evident in the suppression of safe and widely used drugs (e.g., ivermectin and hydroxycholoroquine) so that dangerous and ineffective, but incredibly profitable, pharmaceutical products could monopolize the COVID-19 market.
Some other examples:
DMSO (dimethyl sulfoxide) for treating pain, autoimmune and other medical conditions
ultraviolet blood irradiation
GHB (gamma hydroxybutyrate) for insomnia and PTSD
I would like to see an information database that would list all treatment options available for a medical issue not just the options from a profit center focused pharma company.
Thank you for your time.
Regards,
Jeff
Thank you Drs Malone for this amazing detailed blueprint to overhaul the FDA. It will be incredibly helpful to those who are tasked with this huge undertaking. I realize this is a starting document and could be expanded as necessary. I like your idea of multiple groups working on the same thing to prevent groupthink. Thank you for being proactive and putting your thought to paper. It will be an important tool. Your voices will be important in the work to be done.
AGGRESSIVE WOULD BE TO ELIMINATE THE CITIZENS UNITED SUPREME COURT DECISION OR CREATE LEGISLATION TO BLOCK IT'S EFFECTS. CORPORATIONS ARE NOT PEOPLE. MAKE THE PEOPLE'S VOICE HEARD AGAIN.
RESEARCH GRANTS MOSTLY FROM NAIAD ARE USED AS INCENTIVES TO CONTROL THE BEHAVIOR OF RESEARCHERS INCLUDING UNIVERSITY. REVISE THAT.
Very impressive grasp of the scope of the problem! However, the corruption of the existing system does seem to be overwhelming. Where and how to find unsullied workers who have not been hardened "within the framework of the administrative state?" The "experts" are disqualified. A gargantuan task!
Scum rises to the top. So skim the surface and replace.
And keep skimming. And keep replacing.
As needed
Ask Elon. He’s the absolute master at this!!
What we aren't considering here is the potential impact of DOGE cuts. VR seemed to be coming into restructuring with some preconceived ideas. If some groups are duplication, it could require further reflections. There might be consideration of inviting ee buy ins. Would/where would ee1 see themselves best suited to contribute/wirk?
I'm not clear who is charged with damages resulting from approved drugs ( in particular 'vaccines'). Should the FDA be spelling out potential harms caused by approved new or revised drugs?
The more important thing is an effective program to deal with needs of the harmed. If the EUA industry protection continues, what's in place is a farce. Likely a special access to SSDI or the uninsured version could be viable. It should be addressed.