By Lisa Seachrist

Washington Editor

WASHINGTON - The FDA has released its plan for implementing the fast-track drug development provisions of the FDA Modernization Act (FDAMA) of 1997.

The document, available on the FDA's website (, outlines the rules and provides a road map under which fast-track drugs will be designated and handled by the agency.

"It's largely procedural in nature, giving the FDA's perspective on fast-track [drugs]," said Allan Goldhammer, director of technical affairs for the Biotechnology Industry Organization (BIO). "It does provide useful information. It allows people to start planning whether something they are working on will fall under fast-track [provisions]."

The guidance document defines a drug with a potential for fast-track designation as a drug designed to treat a serious aspect of a serious or life-threatening condition and that meets an unmet medical need.

Even where there are approved therapies for the condition, a drug may still qualify for fast-track designation if it is being evaluated to show superiority to current therapies; provide benefit to patients who can't tolerate existing treatments; provide the same benefit with less toxicity; or work effectively against the serious outcomes of the condition not addressed by current therapies.

CBER Fast-Tracking Nine Of 14 Submissions

Even without the official guidance, the FDA has proceeded with fast-track plans. The Center for Biologics Evaluation and Research alone has designated as fast-track drugs nine of the 14 submitted to the center since the passage of FDAMA. South San Francisco-based Genentech Inc.'s Herceptin, for the treatment of breast cancer, and Seattle-based Immunex Inc.'s Enbrel, for the treatment of rheumatoid arthritis, already have been approved as fast-track drugs.

Goldhammer noted that the one thing not addressed by the guidance document is the requirement that the Department of Health and Human Services create a program to identify appropriate surrogate endpoints.

"We aren't sure how the department intends to deal with this," Goldhammer said. "[The National Institutes of Health (NIH)] does have a program that [NIH director Harold] Varmus has started, to look into this stuff."

Like all guidance documents, this one comes with a 90-day comment period, during which interested parties may offer their opinions.

Goldhammer said that, once BIO has had the opportunity to study the document, the organization will be submitting its comments to the agency. Media spokesperson Jeff Trewhitt said the Pharmaceutical Research and Manufacturers of America would also be making comments.

"[The guidance] looks fairly reasonable," Goldhammer said. "We do have to take some time with it, though." n