Best reportage anywhere on the recent Plan B decision. Not surprisingly, it’s by Steve Usdin of BioCentury. The article is titled, “Plan B’s Fallout.”
Two selected paragraphs to share:
Peter Pitts, who was associate FDA commissioner during the Bush administration when the Plan B storm first broke, also bemoaned the interference with a science-based decision. “Unfortunately, it’s on the prickly topic of reproduction rights,” he told BioCentury This Week. “But at the end of the day, the Secretary overruling the FDA on a scientific issue brings to bear many negative, unintended consequences.”
Ironically, according to Pitts, Korman’s ruling actually could undermine FDA’s ability to make decisions based on its scientific judgments. Sebelius’ intervention raised the specter of companies appealing FDA decisions to the HHS secretary, and Korman’s ruling suggests they might seek to overturn regulatory decisions in the courts, he said. “The court told the FDA to make a certain regulatory decision and that sets a dangerous precedent,” according to Pitts. “I agree with the decision, but I would feel better if he’d said it was based on FDA’s decision that was overturned by the secretary.”
The entire article can be found here – and it’s worth a read.
