Biotechs say FDA ranges from good to 'horrifying'

By Lisa Richwine

BOSTON (Reuters) - Biotechnology companies trying to get new drugs to the market have had experiences with U.S. regulators that range from productive to "horrifying" as they craft early development plans, senior executives told Reuters this week.

Interactions can vary vastly between Food and Drug Administration divisions that review products and provide guidance to companies long before they seek approval to sell a drug, company officials said.

"We have some very good experiences and we have had some horrifying experiences, where you wonder, 'Where did that come from?'" Genzyme (GENZ.O: Quote, Profile, Research, Stock Buzz) Chief Executive Henri Termeer said at the Reuters Biotechnology Summit in Boston.

"What is reasonable and what is not reasonable differs by individual. ... It's quite frustrating," he added.

FDA officials have acknowledged inconsistencies, or a lack of clarity, from some reviewers during early stages, when companies are seeking input on how to design clinical studies of experimental medicines. They have pledged improvements and launched major efforts to work with manufacturers earlier in the process to help more drugs make it to the market.

The agency holds more meetings than ever with drugmakers, more than 2,000 annually.

"We believe more and better interactions will lead to better outcomes and have invested a lot of resources in these efforts," Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, said via e-mail.

The FDA also is providing guidelines on how to develop better applications, he said. Officials will announce other measures to improve the review process soon.  Continued...