Right to try, GRASE, and the FDA.
Can the use of GS-441524 fall under the umbrella of the Right to Try Act or GRASE? This is an interesting question, and the answer is NO – in both cases.
The reason is simple: To be covered under ANY FDA program, the manufacturer or sponsor MUST be established with the FDA. That, in a nutshell, says it all.
Any claim that the black-market version of Gilead’s GS-441524 is covered by either or both programs is therefore invalidated. Unless black-market manufacturers have applied and secured an accreditation from the US Food and Drugs Administration, neither the Right to Try Act, GRASE program or any other FDA program applies to them. No lawyer or expert familiar with FDA procedures would ever argue that black-market substances can somehow be legitimized in such a way.
But, for the sake of being thorough, let’s take a closer look at both the Right to Try Act and GRASE. The definition (and explanation) of what is allowed (or disallowed) under the Right to Try Act and GRASE is publicly available, and well explained on the FDA’s site.
The Right to Try Act.
The Right to Try Act permits/allows eligible patients to have access to eligible investigational drugs.
An eligible investigational drug is a drug:
- For which a clinical trial has been completed.
- That has not been approved or licensed by the FDA for any use.
- For which an application has been filed with the FDA or is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of FDA approval and is the subject of an active investigational new drug application submitted to the FDA.
There you have it: an NDA (New Drug Application) must have been filed with the FDA. Since ONLY an FDA-established (accredited) company or sponsor can submit a NDA, black market outfits are excluded. With regards to GS-441524, only the patent holder and rightful owner, Gilead Science (or its authorized agent), can submit the NDA to the FDA.
Remdesivir, by Gilead, is an investigational drug. Phase one of clinical trials is complete (as well as Phase two). But there are two caveats here:
- One, the NDA is for treatment of Ebola in humans, not FIP in cats;
- Two, making the experimental drug available for compassionate use (Right to Try) is at the discretion of the manufacturer – Gilead. Unaccredited Chinese manufacturers of unregulated substances do not qualify for FDA programs.
GRASE (Generally Recognized As Safe and Effective).
The acronym stands for Generally Recognized As Safe and Effective and does not apply to new drugs (Remdesivir is a new drug).
The Food and Drug Administration has an easy to understand presentation that explains to the public what GRASE is – and isn’t. The presentation can be accessed by clicking here or you can read on.
A drug is not considered a new drug only when it is generally recognized as safe and effective (GRASE). This is a very important concept to grasp, as much hinges on the GRASE determination. In order to conclude a GRASE determination, a drug must satisfy three criteria:
- First, the particular drug product must have been subjected to adequate and well-controlled clinical investigations that establish the product as safe and effective.
- Second, those investigations must have been published in the scientific literature available to qualified experts.
- Third, experts must generally agree, based on those published studies, that the product is safe and effective for its intended uses. At a minimum, the general acceptance of a product as GRASE must be supported by the same quality and quantity of scientific and/or clinical data necessary to support the approval of a New Drug Application.
You might be thinking, “Why does it matter that my drug is considered a new drug?” Good question, so let’s explain the answer.
The Federal mandate says: “No person shall introduce or deliver for introduction into interstate commerce any new drug” unless the drug is the subject of an approved application. [21 U.S.C. § 355(a)]
So what does that mean? In other words, any drug, including an OTC drug that is a “new drug,” requires a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) in order to be legally marketed.
What is a New Drug Application?
The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States. The documentation required in an NDA is supposed to tell the drug’s whole story, including:
- Results of clinical tests.
- Drug ingredients.
- Animal studies’ results.
- Documentation of drug behavior in the body.
- Drug manufacturing, processing, labeling and packaging information.
The key operative words in GRASE are “Safe” and “Effective.” Regarding Remdesivir’s safety and efficacy, Gilead’s website states the following:
The safety and efficacy of the following investigational compounds or investigational uses of marketed products have not been established. These uses have not been approved by the U.S. Food and Drug Administration or other regulatory authorities.
Remdesivir (GS-5734, Nuc inhibitor) – Potential Indication: Ebola Virus Infection**
Any attempt to dress up the use of the Chinese-made version of GS-441524 as legal or somewhat not completely illegal is pointless. There is no room for interpretation. The line is clearly drawn. You’re either on one side, or the other, but you can’t straddle it. Gilead Science owns the patent to GS-441524. Anyone supporting in any way, shape or form, the use of black-market versions of GS-441524 is on the wrong side of the line.
Not so long ago, a well-known researcher wrote this to an owner inquiring about the availability of experimental compounds: “we are actually using science to identify drugs that we know will work and can ultimately be approved by the vigorous standards of the FDA, rather than publishing phony studies claiming efficacy and then having veterinarians and owners buy them under the table.” That researcher? UC Davis’ own Dr. Niels Pedersen, May 25, 2016 –the same one now openly assisting “under the table” users. What a difference three years make!
** On August 12, 2019 Anthony Fauci, Director of the NIH’s National Institute of Allergy and Infectious Diseases announced that Remdesivir had been removed from the current Ebola clinical trials, citing a mortality rate of 53%.