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Generex Creates Own Regulatory Reality

Later in the same video, Gluskin, speaking about Oral-lyn, states, "We would like to gain obviously a full label but in the meantime we're also going to be marketing through a Treatment IND."

In the second video, when Gluskin is interviewed about Generex and Oral-lyn by organizers of the OneMedForum conference, she says the company is "starting to commercialize Oral-lyn through the doctors as we speak."

FDA law governing the Treatment IND program states: "A sponsor or investigator shall not commercially distribute or test market an investigational new drug." It is not clear whether Gluskin intended to suggest that Generex will commercially test market Oral-lyn.

The law goes on to explain that "this provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution."

In both videos, Gluskin says Generex will be able to charge patients for Oral-lyn or get "paid for the drug" as part of the Treatment IND program. While Gluskin's statements are not necessarily inconsistent with FDA rules, regulators allow companies only to recoup costs and not earn a profit.

"The sponsor may not commercialize an investigational drug by charging a price larger than that necessary to recover costs of manufacture, research, development, and handling of the investigational drug," the FDA regulations state.

FDA established the expanded access program to help patients who are seriously ill or near death gain access to unapproved drugs. How many diabetics fit into this category and would therefore be eligible to receive Oral-lyn is not clear.

On the two Web videos, Gluskin suggests that many diabetics, including those who simply don't want to inject insulin, will be able to request Oral-lyn under the Treatment IND program.

"The exciting news is a lot of patients are eligible," said Gluskin in the first video. "This is not a compassionate use. In case of compassionate use, you don't charge for the product. In case of compassionate use only people that can't use anything else are qualified. In our situation, if the patient says, 'I know I need insulin, but because it's injectable, I'm not going to take it,' they qualify for our program, and we know that with 25 million diabetics in this country, there is a lot of people who are going to be able to qualify under that."

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