The FDA’s plan to standardize expression-based pre-clinical toxicology data “potentially has some positive implications,” said William Pennie, director of molecular and investigative toxicology at a Pfizer R&D outpost in Groton, Conn.
However, he cautioned that the standards should be as flexible as possible. “Now is not the time for [the FDA to be] be overly prescriptive in terms of guidelines,” said Pennie, who also chairs a committee sponsored by the International Life Sciences Institute that studies the application of genomics to mechanism-based risk assessment. (According to the FDA, ILSI will be one of several bodies asked to help the FDA review the new toxicology standards.) “This is a rapidly evolving area of technology and science, and I think we need to maintain significant flexibility, and be receptive to new approaches and methodologies, analytical methods, and ... new technical platforms.”
Asked whether the FDA dove into the project too soon, Pennie said the answer depends on how prescriptive the guidelines will be in the first place. “I think that general guidelines around the resolution of information that the agency would like to have submitted — the way that a sponsor reports the protocols of their experiments under analytical methods — those kinds of things are fine,” he explained. However, if the standards end up directing pharma experiments, “then I would argue that [the goal of a standard] is premature.”
Will this guidance spur Pfizer to change the way it performs gene expression-based pre-clinical toxicology studies, or embolden the company to begin submitting these kinds of data to the FDA? “We may or may not decide that it’s a better environment to be performing these experiments,” said Pennie. Pfizer’s R&D decisions are not driven “very much by fear of regulatory repercussions at the moment.”