Generex Creates Own Regulatory Reality

The FDA formally instituted an expanded-access drug program in the late 1980s under pressure from AIDS activists who felt that regulators were taking too long to approve promising HIV/AIDS drugs such as AZT. In the program's early years, most of the experimental drugs to which patients gained early access were already in late-stage clinical trials for cancer and HIV. The FDA later granted full marketing approval for most, if not all, of those experimental drugs.

The granting of a Treatment IND, however, is not an FDA endorsement that an experimental drug is effective and safe, nor does it guarantee that the drug will be later granted full marketing approval by FDA.

"A Treatment IND and full marketing approval are not the same things," says FDA spokeswoman Riley.

In 2004, FDA granted Treatment IND status for Maxim Pharmaceutical's skin cancer drug Ceplene, despite the fact that the same drug, then called Maximine, had failed a phase III study in skin cancer patients in 2000. Maxim Pharmaceuticals conducted a second phase III study of Ceplene in skin cancer later in 2004, and it also failed. The drug was never approved as a treatment for skin cancer.

In December 2009, FDA rejected Ampligen, a drug for chronic fatigue syndrome developed by Hemispherx Biopharma (HEB), despite the agency allowing the company to treat patients with the drug under a Treatment IND program in the late 1990s.

And more recently, the FDA rejected the approval application for Cell Therapeutics' (CTIC) lymphoma drug pixantrone, even though at the same time, the FDA said it was amenable to granting severely ill lymphoma patients access to the drug through an expanded access program.

FDA rules do not allow companies with drugs available under a Treatment IND to market unapproved drugs to doctors and patients.

This is a line that Generex CEO Gluskin appears to have crossed. In one of the videos from the January health care conference Gluskin says, "One of the reasons why we are talking about being on the market with Generex Oral-lyn, we have been granted three months ago by U.S. FDA, a Treatment IND."

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