FDA Changing the Approach

[Devonmoonshire]

While everyone else is bashing the FDA and making derogatory posts about recent legislation, the wheels in my head are turning. I am thinking, clearly, concisely and with great concentration.

What I propose is a petition, NOT to the Whitehouse but rather to the President of the United States Himself. Requesting Him to sign a Presidential Mandate that requires the FDA to publicly disclose any and all sources of funds and financial contributions that it receives. Basically this is to request a mandatory audit of all sources of financial support that the FDA receives and to publicly disclose the Names of ALL of these sources of financial support.

The Legal justification for this request would be to Prove beyond the shadow of a doubt that there is NO bias in the decision making process that the FDA uses in regards to whether or not it "Approves" or "Disapproves" any and all products that it deems to be under "FDA Jurisdiction or Control". This financial subsidy disclosure would expose any imbalance that may exist that would in fact indicate "Financial Bias" towards the approval/disapproval process due to greater funds being contributed by any one entity be it corporate, government or individual contributions.

I believe this to be fully justified due to the increasing number of "FDA Approved" pharmaceuticals that are being pushed through into the public domain that are almost instantly labeled with warnings such as "May lead to death, heart attack, increased risk of infection or certain types of cancer."

If these products contain warning labels such as these then how can the FDA Justify the approval of such products since they are contradictory to the FDA Mandate of Public Safety and well being? They are clearly unsafe and therefore the only justification possible is financial gain which is an unlawful justification for approving a potentially deadly substance for use in human beings.

I am open to any and all comments on this issue but I do believe that it is necessary in order to discover the Real Truth behind the clearly questionable motives of the Food and Drug Administration.



I know there are people on this site with the legal knowledge to word this properly and most likely far better than I am able to as I am not a legal analyst or from any sort of legal background.

With regards;
Nate

 

[Talyon]

My hope is that this can be done.

A Transparent Government, what a novel idea.

 

[Devonmoonshire]

Thank you Talyon;

I believe wholeheartedly that as The Citizens and the People of the United States Of America we have the inalienable right to be informed of ALL aspects of what our Political Leaders, and the associated administrations thereof, base their decision making processes on. Especially when it comes to our health and well being. We must be assured that our health and well being is NOT being decided based primarily on financial gain for the Officials that are in Office.

I believe it is time that we hold them accountable to PROVE that the common assertions towards Government Corruption are false and unfounded. If they ARE IN FACT false and unfounded then let us see the proof. If they ARE IN FACT founded though then it is time to demand change to correct this.

Sincerely;
Nate

 

[CES]

Here's a good starting place

FDA Budgets

 

[Fitzie]

There's already a law on the books which covers lobbying disclosure. Whether it's lead to more transparency in government is another issue.

Lobbying Disclosure, Office of the Clerk

 

[Devonmoonshire]

Here's a good starting place

FDA Budgets

That is going to take a while to read Luckily I do have time to read through it quite thoroughly. Thank you very much for the link.

Thus far I have read many disclosures on the intended appropriation of the funds received and requested. It does not say WHERE these funds are coming from as far as I have read thus far. Many more documents to go over though so hopefully somewhere in there will be the answers I seek. Namely a Pie Chart showing the sources of funding and the percentages of the contributing entities. Which I doubt seriously that I will find.

Sincerely;
Nate

 

[Devonmoonshire]

There's already a law on the books which covers lobbying disclosure. Whether it's lead to more transparency in government is another issue.

Lobbying Disclosure, Office of the Clerk

This is a great law indeed, however it does pertain to "Lobbyists" and "Lobbying"

What I propose is a targeted audit directed at the disclosure of "Sources of funding which discloses publicly the entities, individuals and agencies that provide the funding to the FDA" It needs to be thorough, easily understood such as a pie chart showing exactly to the decimal what percentage the funding body contributes to the FDA.

Sincerely;
Nate

 

[CES]

FWIW, Wikipedia has a bit of a breakdown Food and Drug Administration - Wikipedia, the free encyclopedia . At a fast glance it looks like the budget comes from the federal budget and applications/fees. Good luck wending your way throught the budget documents.

 

[Fitzie]

I don't believe anyone, including BT, can donate money directly to the FDA. It's funded by the US Treasury, with the exception of user fees paid by big pharma. An interesting article on this:

The Fda - How Independent Is The Fda? | Dangerous Prescription | FRONTLINE | PBS

 

[Devonmoonshire]

FWIW, Wikipedia has a bit of a breakdown Food and Drug Administration - Wikipedia, the free encyclopedia . At a fast glance it looks like the budget comes from the federal budget and applications/fees. Good luck wending your way throught the budget documents.

I agree that it comes from both federal funding and fees. However HOW MUCH COMES from "Fees" as they call it, and are the fees different for different products as well as the biggest question of all, "Does Paying a Higher Fee equate to faster approval and does a higher "Fee" equate to automatic approval as opposed to a Lower fee"

 

[KODIAK (TM)]

Requesting Him to sign a Presidential Mandate that requires the FDA to publicly disclose any and all sources of funds and financial contributions that it receives. Basically this is to request a mandatory audit of all sources of financial support that the FDA receives and to publicly disclose the Names of ALL of these sources of financial support.

I don't think you understand. Like Fitzie says, the FDA is basically funded by you. (via your tax dollars).

Now... the "appropriations" for funding is approved by congress who get lobbied by special interests.

 

[Devonmoonshire]

I don't believe anyone, including BT, can donate money directly to the FDA. It's funded by the US Treasury, with the exception of user fees paid by big pharma. An interesting article on this:

The Fda - How Independent Is The Fda? | Dangerous Prescription | FRONTLINE | PBS

There is no question that the treasury department funds the FDA. However the word "Donate" never once is mentioned in my proposal. My Only question is WHERE does every single penny in the FDA's budget come from. Account for it, disclose that accounting and be Honest about where the funds come from.

It does not matter how money changes hand, whether it be by donation, allocation, federal funding or fees. Money changing hands is money changing hands and when more money comes from one entity than the others then there is a concern for Bias in that entities favor.

 

[Devonmoonshire]

I don't think you understand. Like Fitzie says, the FDA is basically funded by you. (via your tax dollars).

Now... the "appropriations" for funding is approved by congress who get lobbied by special interests.

I don't think either of you are understanding what I am asking here.

FDA: Account for every incoming cent. I promise you that every single cent provided to the FDA does not come from our taxes or the US Treasury, that is FACT due to the fees collected by the FDA from other entities for the research into their products. I want to know what percentage of the total collected by the FDA these "Fees" make up. Just to determine the posibility or exclude the possibility of Bias in either direction.

 

[CES]

Yeah, so...i'm pretty sure bigger guys pay more than little guys...and if you have the money you get to pay the fees, and if you have enough money you get to help write the regs. I don't think that makes me a conspiracy theorist, because i don't think it's hidden anywhere other than in plain sight.

(Feeling a teensy bit cynical on this rainy afternoon)

 

[KODIAK (TM)]

I promise you that every single cent provided to the FDA does not come from our taxes or the US Treasury, that is FACT due to the fees collected by the FDA from other entities for the research into their products. I want to know what percentage of the total collected by the FDA these "Fees" make up. Just to determine the posibility or exclude the possibility of Bias in either direction.

These "fees" are indeed enforced and collected by the U.S. Treasury. I highly doubt the FDA has its own Accounts Receivable department. .

Look, I know where you're trying to go with this but I really think with all the oversight most of these agencies are very careful about the sleeping arrangements they have with the outside world. At least on paper.

 

[Devonmoonshire]

Yeah, so...i'm pretty sure bigger guys pay more than little guys...and if you have the money you get to pay the fees, and if you have enough money you get to help write the regs. I don't think that makes me a conspiracy theorist, because i don't think it's hidden anywhere other than in plain sight.

(Feeling a teensy bit cynical on this rainy afternoon)

LOL You are allowed to be cynical anytime ya like CES

These "fees" are indeed enforced and collected by the U.S. Treasury. I highly doubt the FDA has its own Accounts Receivable department. .

Look, I know where you're trying to go with this but I really think with all the oversight most of these agencies are very careful about the sleeping arrangements they have with the outside world. At least on paper.

Kodiak, did you read any of the links provided. They clearly state that the FDA Fees are indeed payed Directly to the FDA not through the treasury anymore per the Prescription Drug User Fee Act.

That is why I ask for a pie chart showing what percentage these "Fees" make up of the FDA's budget. Very simple and very direct question. Intended to show through mathematics whether or not there exists the possibility of a bias in favor of the entities paying the fees.

 

[Fitzie]

Maybe this answers your question, Devonmoonshire, I dunno. It's pretty dense stuff. I'm not trying to pull your chain, believe me. Just trying to add some insight as someone who worked for the federal government for almost 33 years (and as an attorney as well).

http://www.gpo.gov/fdsys/pkg/FR-2013-08-02/pdf/2013-18624.pdf

P.S. I don't claim this makes me an expert on the FDA, the mysterious processes of the federal government or anything else for that matter, other than my arcane specialty of federal personnel law.

 

[Devonmoonshire]

Maybe this answers your question, Devonmoonshire, I dunno. It's pretty dense stuff. I'm not trying to pull your chain, believe me. Just trying to add some insight as someone who worked for the federal government for almost 33 years (and as an attorney as well).

http://www.gpo.gov/fdsys/pkg/FR-2013-08-02/pdf/2013-18624.pdf

Very very good information. So even in just skimming over it for numbers I see two things:

1: 56% of the revenue for clinical testing and evaluation comes from the fees of the applicant. Which in and of itself creates a conflict of interest or "Bias" in favor of the applicant.

and

2: There are literally Trillions of dollars paid to the FDA every year through the implementation and collection of these "Fees" which also creates a monetary conflict of interest and "Bias" in favor of the applicants paying the "Fees"

 

[Fitzie]

I guess that's why the FDA keeps approving all those crazy drugs whose side effects seem worse than the malady they're meant to address. I find those TV ads about drugs to be really, really scary myself.

 

[Devonmoonshire]

I guess that's why the FDA keeps approving all those crazy drugs whose side effects seem worse than the malady they're meant to address. I find those TV ads about drugs to be really, really scary myself.

Exactly why I bring this because, when there is a bias or conflict of interest that exists between the applicant and the testing authority it poses a clear and present danger to the end user of said products.