For several weeks, the FIP community has been waiting for an announcement from Mutian that the company had made good on its promise to have FDA approval for its line of GS pills (called Mutian X), as an OTC drug under the FDA’s GRASE program.
Part Three of Anatomy of a Black Market looks at the legal risks and challenges faced by all those involved in the black market trade of GS-441524.
Part Two of the Anatomy of a black market drug takes a look at the methods to sell illegal substances.
It is a safe assumption that every single parent of a FIP cat wants the same thing: safe and effective drugs against Feline Infectious Peritonitis. In light of the recent developments in the FIP community regarding treatment with unregulated substances, I think it is only fair to find answers from those who are directly involved.
Can the use of GS-441524 fall under the umbrella of the Right to Try Act or GRASE? 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.
Who owns the chemical we know as GS-441524? Who is allowed to use it in a commercial product, and sell it on the market? The straightforward answer: Gilead Sciences and The Regents of the University of California.
Definition: “Black market is the illegal business of buying or selling currency or goods banned by a government or subject to governmental control. Also designates a place where such illegal business is carried on.”