Claim: Half of FDA funding comes from pharma companies. Conflict of interest?

Kalil

New Member
I saw a post that half of FDA funding comes from pharma companies.

The Food and Drug Administration has moved from an entirely taxpayer-funded entity to one increasingly funded by user fees paid by manufacturers that are being regulated. Today, close to 45% of its budget comes from these user fees that companies pay when they apply for approval of a medical device or drug.

Source




FDA mission from their webpage:

FDA Mission​

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

https://www.fda.gov/about-fda/what-we-do

How can FDA be funded even with a 1 dollar from the parties they should regulate? Isn't that text book conflict of interest?



FDA mission from their webpage:

FDA Mission​

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

https://www.fda.gov/about-fda/what-we-do

How FDA can be funded even with a 1 dollar from the parties they should regulate. Isn't that text book conflict of interest?
 

Landru

Moderator
Staff member
I saw a post that half of FDA funding comes from pharma companies.

The Food and Drug Administration has moved from an entirely taxpayer-funded entity to one increasingly funded by user fees paid by manufacturers that are being regulated. Today, close to 45% of its budget comes from these user fees that companies pay when they apply for approval of a medical device or drug.

Source




FDA mission from their webpage:

FDA Mission​

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

https://www.fda.gov/about-fda/what-we-do

How can FDA be funded even with a 1 dollar from the parties they should regulate? Isn't that text book conflict of interest?



FDA mission from their webpage:

FDA Mission​

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

https://www.fda.gov/about-fda/what-we-do

How FDA can be funded even with a 1 dollar from the parties they should regulate. Isn't that text book conflict of interest?
How is it a conflict of interest? The funding is through mandatory fees from the drug companies plus general revenue funds. The drug companies cannot say, "do this or we will stop paying."
 

Mendel

Senior Member.
"User pays"??
compare: the California DMV (first example I found) is 95% funded by the drivers it is supposed to regulate:
Article:
SmartSelect_20220808-023034_Samsung Notes.jpg


Financial contributions tend to generate a conflict of interest when they're voluntary or negotiable, like campaign donations, bribes, or side job earnings; fees don't.

That's not to say agencies are always free of conflicts of interest: e.g. regulatory capture can happen when the industry that an agency is meant to regulate achieves control of the entity overseeing the agency.

Example:
Article:
Regulatory capture is defined as when a supposedly objective regulatory agency ends up promoting the ends of the industries they are regulating. The FDA has been captured for quite a while. In a 2016 study published in the British Medical Journal, the majority of the FDA’s hematology-oncology reviewers who left the agency ended up working or consulting for the biopharmaceutical industry. In another investigation by Science magazine, 11 of 16 FDA reviewers who worked on 28 drug approvals and subsequently left the agency are working or consulting for the companies they recently regulated.


Going at this via the funding doesn't really reflect what's going on. If anything, the FDA being underfunded exacerbates the danger of it getting "captured", and cutting the mandatory pharma fees because of alleged "conflicts of interest" would make the FDA more underfunded—things would get worse!
 

econ41

Senior Member
Financial contributions tend to generate a conflict of interest when they're voluntary or negotiable, like campaign donations, bribes, or side job earnings; fees don't.
Hence my terse comment: "user pays!" And an even more generic observation. "If some sectoral industry needs regulating they should meet the cost of regulation. Not impose it on the rest of the community." << Now stating it that loosely could attract some disagreement. ;)
 

Mendel

Senior Member.
Hence my terse comment: "user pays!" And an even more generic observation. "If some sectoral industry needs regulating they should meet the cost of regulation. Not impose it on the rest of the community." << Now stating it that loosely could attract some disagreement. ;)
yes, it's a political issue

say, you want a diverse market, or maybe just cheap pharmaceuticals, as your political goal, then having large fees create a barrier to entry that discourage smaller competitors or cheaper products, and you're going to want smaller fees. But if you still want these pharmaceuticals to be safe, somebody else has to pay for ensuring that safety. And that means a political process to balance those various opposite goals plays out and arrives at some compromise.
 

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