FDA Chief Warns on Reimport of Drugs

Food and Drug Administration Commissioner Mark B. McClellan warned Thursday that innovation in the biotechnology industry would be harmed if states reimported cheap drugs from Canada.

McClellan made his remarks during a brief news conference after he met privately with industry leaders in Claremont to discuss the issue. Rep. David Dreier (R-San Dimas) also attended the meeting.

California, home to two of the biggest biotech concerns -- Amgen Inc. of Thousand Oaks and Genentech Inc. of South San Francisco -- has 2,500 biotech companies that employ 225,000, more than any other state.

McClellan said his visit was unrelated to legislation pending in Sacramento that would permit the cash-strapped Medi-Cal program to purchase drugs in Canada, where name-brand drugs are on average 40% cheaper than in the United States. McClellan said the bills “are illegal under the laws Congress has given us.”

“The challenge is to encourage innovation,” he said, while making sure drugs are available and affordable in the U.S.

McClellan said Medi-Cal could lower expenses by making greater use of generic drugs, which cost significantly less than name-brand products.

There are no generic biotech drugs now, but McClellan said the FDA was developing a framework for approving copy-cat versions of human growth hormone and insulin, which are no longer protected by patents. A generic version of growth hormone should be approved this year, he said.

Most drugs imported from Canada are pills produced by big pharmaceutical companies, not biotech firms. But industry leaders said they worried that reimportation would have a chilling effect on private investment in biotech start-ups.

After the news conference, McClellan sidestepped a question on industry rumors that he soon would be leaving the FDA to run Medicare. “Right now I am focused on the FDA,” he said.