A biostatistician, Michael Elashoff was a drug reviewer for the FDA from 1995 to 2000. Elashoff says he found himself marginalized at the FDA after he voiced his concerns about a new flu drug called Relenza. In this interview, Elashoff speaks out about the culture of the FDA's drug approval process and why he felt Relenza should not have been put on the market. This interview was conducted on Feb. 19, 2003.

It was pretty widespread. You know, many drugs really had pretty good safety and efficacy. So of the remainder, the ones where there are potential problems, I'd say in nearly all the cases I was familiar with -- both that I worked on, and other people in my division worked on -- there would be pressure to approve those drugs, or soften the language in the reviews and on the labels, so that they could have a more easy justification for why they're approving it. So I would say it was very common.

Also, when it would come time to write the official review, there would be times when the management -- it would review my drafts [and] would want to take out various sections where [I] commented on lack of efficacy or safety problems; or [management would] want [me] to tone down the language, so that they could more easily have a written justification for why they're approving the drug.

For the most part, when drug applications came in, there was the presumption that the drug was going to be safe and effective, and was going to be approved. So, when during the course of the review you find something that suggests some problems, typically the other reviewers and the FDA management would not want to really explore those problems, and would kind of view it as a hassle on the way to drug approval. That was a pretty much constant pressure for most reviews.

You worked at the FDA for five years. Can you describe the kind of pressure, day-in and day-out, to recommend approval of new drugs that would come your way for evaluation, versus having an objective opinion?