Aug. 18--Linda Alexander, chief executive and founder of Golden Valley-based Alquest Inc., has some definite opinions about the machinations at the Food and Drug Administration (FDA).

No surprise -- Alquest is a contract research organization that specializes in conducting medical-device clinical trials and other support processes that help medical technology companies negotiate the FDA's often confounding approval process.

The Star Tribune asked Alexander about the latest turn at the FDA last week -- the abrupt resignation of Dr. Daniel Schultz, who headed the agency's Center for Devices and Radiological Health for the past five years.

President Obama's pick to head the $2.7 billion agency, public health expert Dr. Margaret Hamburg, took over in May.

It's still too early to determine where Hamburg will take the embattled agency, which faced recent food recalls, the emergence of dangerous drugs and concerns that it is too cozy with industry, a charge that dogged Schultz in his job.

Q Was Dr. Schultz's resignation a surprise?

A The fact that he resigned so quickly was a surprise. I was hoping he'd stay longer under the new leadership. He was at the center of the controversy raised last fall (when a group of nine device division employees complained to the House Energy and Commerce Committee that the division's leaders approved devices despite concerns about safety and effectiveness).

It would have been good for him to stick it out and battle a little bit for the positions he had taken.

Q What will Schultz's legacy be?

A I think he was a person who understood the regulations very well. He was open to communication with companies and, ultimately, that's what's being held against him.

People interpret that if you're respectful of companies, if you listen to their opinions and negotiate, that that automatically means you're going to do something evil.

Q Where do you see the FDA going under Commissioner Hamburg?

A On the device side, we're seeing a much more cautious, rigorous approach that isn't necessarily interpreted as scientifically or medically sound. It's a fear of making any decision that could be questioned later on.

Q What does this mean for med-tech companies seeking FDA approval for a device?

A More and more delays. The FDA would much rather ask more questions, ask for more information, ask for more testing, more everything.

Q What do you suggest?

A Companies can take their product abroad first. Typically, companies get approvals in other countries first, and they would use that to influence the market and show that they were approvable somewhere else.

But they wouldn't go through the process of manufacturing and distributing products in those countries because it would be too expensive. Usually, U.S. approval would be fairly close on the heels of [foreign] approvals.

Today, what companies have to recognize is that U.S. approval will not be close on the heels, so they need to develop a strategy that involves selling their product over in Europe, in Canada and other places. Then, that revenue stream can help support and sustain them, and serve as additional proof to the venture market that they have a viable product.

Q What countries are best?

A Europe would probably be my first choice. It's fairly technically advanced there. The CE Mark (European regulatory approval) is a more easily defined process, it doesn't have all the political and legal nuances that FDA has.

Janet Moore --612-673-7752

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