FDA, EMA approval for patentable drugs only?

[Algr]

TL;DR Summary

FDA EMA approval for patentable drugs only? Flavonoids

A friend of mine is telling me that the FDA (and presumably the EMA in europe) never approves any drug unless a drug company can patent it. This means that the effectiveness of things like Flavonoids, Melatonin, or even special uses of Vitamins, will never be approved by them no matter how effective they may be. He doesn't know if this is an official rule, or something de-facto like the costs of approval being too high for a commodity drug that anyone could make.

I have found this:
https://www.fda.gov/drugs/development-approval-process-drugs

It seems to assume that a "drug company" is asking for approval after having done all the safety and efficacy studies themselves. This doesn't quite prove what my friend says, but I can't find anything to deny it either. Does anyone here know about this?

 

[shjacks45]

If you spend the money required to do the medical testing required, overpriced like most medically related tasks, often in the millions of dollars in debt then to market the drug to repay development costs become harder when a drug is generic and any low cost company can undercut you and sell more. A patent simply protects a financial investment in being able to ream the end user with exhorbitant patented drug prices.

 

[jim mcnamara]

There is - in the US - the FDA's GRAS list. Generally Regarded As Safe.
Drugs like aspirin are on there.

GRAS notices are how new food and food packaging items are added:
https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=GRASNotices

SCOGS GRAS database keeps track of items on the list.
https://www.fda.gov/food/generally-recognized-safe-gras/gras-substances-scogs-database

Trans fats (partially hydrogenated polyunstatured fats) were recently removed after being placed on the list many years ago.
Example removal:
https://www.fda.gov/food/food-additives-petitions/trans-fat

@shjacks45 - please do not speculate. If you do have a valid citation please cite it.

 

[Algr]

I presume that all the herbal medicines and such would be on the GRAS list. But that doesn't mean that they DO anything. (Or can be sold as such.) Would proving that something is effective really be harder than proving that it is safe? I would think it would be the other way around.

 

[rbelli1]

The FDA information packet for patients and consumers on drug approval has no mention of patents.

The FDA article on market exclusivity indicates that there can be a government granted monopoly on patent-expired drugs after approval.

"Some drugs have both patent and exclusivity protection while others have just one or none."

"And though FDA makes clear the distinctions between patents and exclusivity, Sherkow told us that he cannot recall there ever being a case where a generic company got to tell FDA, “there are literally no patents covering this reference listed drug.”

These quotes say that there have never been any un-patented drugs targeted for manufacture by generic drug companies. They also strongly imply that patents are not necessary for a drug to become approved.

BoB

 

[Astronuc]

Summary:: FDA EMA approval for patentable drugs only? Flavonoids

A friend of mine is telling me that the FDA (and presumably the EMA in europe) never approves any drug unless a drug company can patent it. This means that the effectiveness of things like Flavonoids, Melatonin, or even special uses of Vitamins, will never be approved by them no matter how effective they may be.

Flavonoids are various compounds found naturally in many fruits and vegetables. They're also in plant products like wine, tea, and chocolate.

There are some excellent sources of naturally occurring melatonin in foods:

• Fruits and vegetables (tart cherries, corn, asparagus, tomatoes, pomegranate, olives, grapes, broccoli, cucumber)
• Grains (rice, barley, rolled oats)
• Nuts and Seeds (walnuts, peanuts, sunflower seeds, mustard seeds, flax seed)

Vitamins occur naturally in many sources, e.g., fruit, nuts, vegetables, grains.

One cannot patent naturally occurring substances. One could patent a novel process to make certain compounds (vitamins, . . . ). FDA can still regulate supplements (vitamins, minerals, . . . ) provided Congress (legislature) grants such authority.

 

[Algr]

One cannot patent naturally occurring substances. One could patent a novel process to make certain compounds (vitamins, . . . ). FDA can still regulate supplements (vitamins, minerals, . . . ) provided Congress (legislature) grants such authority.

So the question is, could the FDA ever approve a drug that no one had a patent on? Is there any way that this could actually happen? Or is such a drug rendered unusable by being too inexpensive?

 

[rbelli1]

Or is such a drug rendered unusable by being too inexpensive?

What does cost have to do with efficacy?

BoB

 

[Algr]

It doesn't matter if a drug is effective if the FDA never approves it. And it looks like that process can't happen unless a company decides they can make enough money by getting it approved.

 

[rbelli1]

And it looks like that process can't happen unless a company decides they can make enough money by getting it approved.

This is true for a pure capitalist approach.

What if Gates, Musk, Bezos, etc. funded an unpatentable drug out of altruism and then wanted it to go through the FDA approval process. They could even give it away to anyone that needs it.

Then your OP becomes relevant.

If the cure for all cancers was found to be some mundane compound that has been known for ever one would hope that someone would fund it for trials and the FDA would accept it for the approval process.

We don't yet have enough information in this thread for a definitive answer to that yet.

BoB

 

[jim mcnamara]

@rbelli1 - this is what GRAS and the homeopathic list is for. Example:

Ichthammol (brand name) is a drawing salve. It was originally a fermented horrible smelling gorp derived from rotting fish and some other ingredients. Works really well. Did I mention the smell? The active ingredients were found in a less noxious source. The modern version, after a simple FDA petition, is on the homeopathic list, meaning there is no testing or research available to support its use. Any pharmacy/drugstore in the US has the stuff.

I worked with several physicians who routinely used it for puncture wound therapy, especially for diabetic patients. - after a tetanus "booster shot" usually.

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9698b98c-bca1-4a7e-8a67-05d2a2b770a5

So -
@Algr -- please stop making up stuff. PF does not support unfounded speculation.
Fair warning: this is second speculation post problem. Any more and the thread will be closed.

 

[rbelli1]

this is what GRAS and the homeopathic list is for

GRAS does not appear to be available for new approval of existing (non approved) drugs.
https://camargopharma.com/resources/blog/the-gras-is-not-always-greener/

GRASE is for aproval of old drugs but requires similar testing as for new drug approval
https://www.accessdata.fda.gov/scripts/cder/training/otc/topic3/topic3/da_01_03_0040.htm

Homeopathic medication contains no or very nearly no portion of the "active" ingredient. Anything can be made safe if diluted enough.

What are the requirements for using a GRAS or GRASE drug in a substantially different method? For example a topical treatment to an oral treatment or for a totally different disease.

BoB

 

[Astronuc]

So the question is, could the FDA ever approve a drug that no one had a patent on? Is there any way that this could actually happen? Or is such a drug rendered unusable by being too inexpensive?

Yes, consider generic drugs. No patent. Just companies interested in mass producing drugs, many for which the patent has expired.

The FDA's Office of Generic Drugs (OGD) within the Center for Drug Evaluation in Research ensures that people have access to safe, affordable generic drugs by following a rigorous review process that includes:

The FDA still reviews and approves the drug. https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs

The Office of Generic Drugs follows a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic medications:

• Contain the same active/key ingredient;
• Have the same strength;
• Use the same dosage form (for instance, a tablet, capsule, or liquid); and
• Use the same route of administration (for instance, oral, topical, or injectable).

FDA's review process ensures that generic medications perform the same way in the human body and have the same intended use as the name brand medication. Health care professionals and consumers can be assured that FDA-approved generic drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity, and stability as brand-name drugs. In addition, FDA inspects facilities to make certain the generic manufacturing, packaging, and testing sites pass the same quality standards as those of brand-name drugs.

https://www.fda.gov/drugs/generic-drugs/overview-basics

Approved generic medicines are generally only sold after patents and exclusivities protecting the brand-name version end

Patents and exclusivities are forms of protection for drug makers that may affect how and when a generic drug is approved and can be sold. New brand-name drugs are usually protected by patents (issued by the U.S. Patent and Trademark Office) that prohibit others from selling generic versions of the same drug. Periods of marketing exclusivity for brand-name drugs can also impact the approval of generic drugs.

FDA must comply with the delays in approval that the patents and exclusivities impose. Once these patents and marketing exclusivities expire (or if the patents are successfully challenged by the generic drug company), the generic drug can receive full approval and can be sold.

https://www.fda.gov/drugs/generic-drugs/generic-drug-facts

So this answers the question about the FDA reviewing and approving non-patentable drugs.

A patent does not exclude the possibility of licensing the patented drug, but it means paying a higher price unless the patent holder agrees to a low royalty. If a generic drug manufacturer can produce the drug at a lower cost than the patent holder and still make a profit after royalty payments, then they may produce a generic equivalent and get FDA approval.