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."
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV