The common wisdom at U.S. biotech companies has been to retain the greatest possible degree of U.S. marketing rights, while partnering in other areas of the world. That has meant focusing initially on product development in the U.S. - starting clinical trials in the U.S., getting sufficient data to lure an overseas partner, and working secondarily overseas.

But time is money and it took the FDA an average of 24 months to review the 23 biological products approved in 1993. While the FDA has promised that expedited reviews and user fees will improve its performance, those kinds of numbers must discourage every CEO and CFO who is trying to manage finite amounts of cash while waiting to show investors that they have a product.

Additional surprises from the agency also wreak havoc with financial planning and investor ability to project returns. For example, Telios Pharmaceuticals Inc. waited in limbo for nine months before the FDA got around to raising questions it wanted answered before it would file TLIO's PMA for a wound-healing gel, setting back the company's product launch window by at least one if not two years (See Jan. 31 BioCentury).

Impact ignored

"One of the things I remember very clearly from my FDA days was the feeling at the agency that you really didn't care about the impact on the company," said Jere Goyan, president and COO of Alteon Inc. and a former FDA commissioner. "I feel very differently now. I'd be willing to bet you couldn't find more than 10 or 15 people at the FDA who've given that item more than 10 seconds of thought."

But while the size of the U.S. market means that no one can ignore it, there's nothing written in stone that says U.S. clinicians should get first crack at new drugs, or that U.S. consumers have to either.

European figures aren't easy to come by, but companies that have worked in Europe say it can be cheaper and faster to get through the clinic, as well as easier and faster to get through the regulatory process.