QDIS Blog

According to a report out today from MSNBC, some officials at the FDA were left out of the decision regarding plan B.

MSNBC report: Top FDA staff left out of contraceptive ruling

Seems both Steve Glason director of CDER and Janet Woodcock deputy FDA commissioner were not involved in the decision and it seems to have come from Lester Crawford then FDA commissioner. Woodcock stated that she was informed of the decision rather then being involved in the process.

I find Steve Galson’s comments strange when he was the one who actually issued the written statement. He acknowledged at the time there was dissent but that it was made on scientific evidence. Here is a quote from the SF Chronicle:

In an internal memo, Galson acknowleged that “some staff have expressed the concern that this decision is based on nonmedical implications of teenage sexual behavior, or judgments about the propriety of this activity.” He called the staff’s concerns unfounded.

Now it seems he has a different story according to the MSNBC story:

Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, testified that around January 2005 he was leaning toward approving Barr’s plan to sell Plan B over the counter. But then-Acting FDA Commissioner Lester Crawford “told me that he was concerned about where we were heading because he knew that I was heading towards this recommendation, and he told me that he was going to make the decision on what to do with the application,” Galson said, according to deposition transcription.

Is it just me or does this seem to be contradictory? The story surrounding plan B gets stranger and stranger.

In a Washington Post article in May 2004, Steven Galson stated:

“The decision I made had to do with looking at all the data and reading all the transcripts,” said Galson, who was named deputy director of the FDA’s drug evaluation office in 2002 after more than 10 years with other federal agencies. He said he was especially concerned about the lack of information about “the younger age group between 11 and 14, where we know there is a substantial amount of sexual activity.”

But now in the MSNBC report he states:

Galson, a doctor and career scientist who has worked at the FDA since 2001, said he had never before had his authority to make a decision removed by a commissioner.

Did he make the decision himself as he states in the Washington Post in May 2004 or did Lester Crawford make the decision for him as he now states in this MSNBC article in May 2006?

Other resources:
• San Francisco Chronical: Experts not behind reversal on Plan B / FDA bowed to politics, critics say
• Washington Post article from May 2004: FDA: Plan B Sales Rejected Against Advice

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