More drugs in development are failing to make it to market, according to Acting FDA Commissioner Lester M. Crawford. Historically, 14% of drugs entering Phase I have won approval, Crawford said in a speech to the Banc of America Securities Healthcare Institutional Conference on July 7, but now only 8% reach the marketplace. One-half fail in Phase III, he added, compared to one in five in the past. This has pushed the cost of developing a drug from $1.1 billion in 1995 to $1.7 billion in 2002, he says.
The reason why more drugs are falling by the wayside isn't clear, according to Sandra Kweder, deputy director of the FDA's Office of New Drugs. "It might be a business decision," she says. "The drug may work, but the company decides that it might not work well enough or in just the right way to give them the market share that they're interested in."
In March, the FDA launched an effort to investigate and address factors involved in drug attrition. The Pharmaceutical Research and Manufacturers of America has hired Boston Consulting Group (BCG) to study the issue. Some say the FDA's own practices are at fault, notes Peter Tollman, who is heading the effort for BCG. "Enough people are asking those questions that it's probably worth trying to understand," says Tollman. Other factors at play could include changes in industry strategy or the fact that drug companies are much larger and more complex than they were previously, he adds.
- Anne Harding