May 04, 2006
FDA Official Allegedly Contradicts Earlier Stance on Plan B
Two years ago the chief of the Food and Drug Administartion's new drug division said he alone made the decision to override an advisory committee's recommendation that Plan B, the morning after birth control pill, be made available over-the-counter. According to the May 8, 2004 Washington Post:
In a teleconference yesterday, Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said he made the decision in consultation with the FDA commissioner's office but without other outside input. "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."
Yesterday, the Center for Reproductive Rights, which has filed suit against the FDA and has access to depositions in the case, told FDA Webreview that Galson's sworn deposition contradicts his earlier statements. "From January 2005 on, the decision making regarding Plan B was solely within Crawford's office," a CRR spokeswoman said. "He withdrew authority from Galson and Woodcock and they were sort of cut out of that decision making, which is unusual and a major departure from the ways things are typically handled."
Galson and FDA deputy commissioner Janet Woodcock were deposed in the federal suit in late April. It would appear that the threat of perjury clarifies memory in a way that teleconferencing with journalists does not.
Next up to testify: Mark McClellan, the head of the Center for Medicare and Medicaid Services. Meanwhile, former FDA acting commissioner Lester Crawford is under criminal investigation, reportedly for hiding financial dealings while holding that office. This suit bears watching.