BIOLOGICS FIRM DISPUTES NEED FOR LICENSE, DRUG APPLICATIONS

A company making cancer treatments is disputing a warning letter from the FDA that claims the firm's manufacturing process falls under its regulations, but a former FDA official says the company has little chance of prevailing.

At issue is Envita Natural Centers of America, which extracts cells from cancer patients in its own clinical setting and manipulates those cells to increase the T-cell count to produce "natural killer cell immunotherapy." In doing so, the firm uses the body's own ability to "kill tumor cells that have spread from the original diseased site," according to Envita's literature cited in the FDA's warning letter.

The letter, issued June 14 and posted on the agency's website July 12, is based on a March 1 inspection during which the FDA concluded that the company's processes rise above the FDA's threshold of "minimum manipulation" of cells. The FDA told Envita it does not have a valid biologics license or a new drug application and that it needs to file an investigational new drug application.

The company, however, disagrees. "This is an infringement on the practice of medicine; we're not manufacturing a drug at all," said Dino Prado, Envita's office administrator. "This is a discriminatory act, and we intend to counter every argument step by step. We've only seen the benefits to our patients in the time we've used these biologics.

"While the FDA believes they're just doing their jobs, they're restricting patients from receiving care that's necessary to get well," Prado said. "Everything we're doing is extremely well-published and well-rooted in research in using the body's own natural immunity system. It's not a drug, but using the body's natural killer cells to evoke an immunological response, which is beneficial to many cancers."

But a former FDA official said the agency's rules on biologics, first promulgated in 1993, but finally revised in their current form in May 2005, are clear about what constitutes "minimal manipulation" of cells and tissues.

"They're going to have a tough fight," said Joyce Frey, the FDA's deputy director of cell, tissues and gene therapies from 1993 to 2005, who helped draft the current rules.

The warning letter can be seen at www.fda.gov/foi/warning_letters/g5901d.pdf (http://www.fda.gov/foi/warning_letters/g5901d.pdf).