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BEVERLY WINIKOFF, MD:  The drug started out in the laboratory of a pharmaceutical company in France and it was originally developed as a hormone blocking drug and it was soon realized that this meant that it could be used to block early pregnancy from continuing.  So the French developed this drug as a medical abortifacient, in other words, a drug women could take to end pregnancies, and after a certain number of years they discovered that it worked even better if it was used in combination with another kind of drug, a prostaglandin, which is a drug that makes smooth muscles contract, which meant that the effectiveness of this drug was increased from about 70% to well over 90%.

At that point, the French company felt they could market it as a drug for this purpose.  It was approved in France and in the same year also approved in China, and that was 1988.  It went on the market and became a successful drug in France for abortion.  Not too long after that, in the early 90's, it was also approved in the United Kingdom and in Sweden.  And there it stayed, in France, the United Kingdom, and Sweden, for almost a decade without going anywhere else.

MICHELLE LA MOTHE, MD:  You are with the Population Council and the Population Council has been involved, I believe, in bringing this drug to the United States.  Can you talk to us a little bit more about how the Population Council became involved?

BEVERLY WINIKOFF, MD:  Sure.  The Population Council is a research organization that had been working on this drug and its uses since the early 80's under a contract from the French manufacturer and never, frankly, envisaged being an introducer of this drug in the United States or anywhere else.  But the drug became a political symbol and the company became unwilling to introduce it into the United States for political reasons.

MICHELLE LA MOTHE, MD:  You mean the French company.

BEVERLY WINIKOFF, MD:  Roussel.  And that company then was under enormous pressure to do something with the drug, to make it available elsewhere, and didn't want to do it itself.  So it looked around for someone else to take over the drug and there wasn't any other commercial entity willing to do this.  So it decided to donate the drug to a nonprofit entity who could take on the responsibility.  The Population Council had had experience with registration of other drugs, for example in this case Norplant contraceptive device and also the IUD, so they knew how to do regulatory work and were willing to take on the responsibility, and that's how it started.

MICHELLE LA MOTHE, MD:  The regulatory work, specifically in the United States, has to do with the FDA, the entire approval process.  So the Population Council was fairly well-versed in having brought other drugs through?

BEVERLY WINIKOFF, MD:  Relative to any other noncommercial entity, I would say it was an organization that had a large amount of experience.  Relative to pharmaceutical companies, no.  It was a big, big new challenge.

RICHARD HAUSKNECHT, MD:  Once they had the patent rights in the United States to mifepristone, they then had to find somebody who would produce it, manufacture it and distribute it, and that was an equally daunting task because there was no particular company that had the capability to produce it that was interested in any way.  They didn't want to get anywhere near this drug.  So what was necessary was the formulation of a brand new company, and that's exactly what happened.  Danco Laboratories was formed with tremendous help from the Packard Foundation.  They gave a significant amount of money to get the process started.  And then there was a group of investors who came on board and a small company was formed, Danco Labs, which I joined a little over a year ago.

We, and I say Beverly and I and our gang, went and visited the FDA repeatedly throughout the summer and, with great help from a wonderful attorney, we were delighted on the 28th of September to have approval of Mifeprex for the termination of early pregnancies up through 49 days.  It's been a long, arduous process and a great deal of credit goes to the Population Council for having stuck with it.