May 01, 2006
Waxman alleges Troy blocked Plan B decision
Before he left the FDA 18 months ago, former chief counsel Dan Troy failed to complete a necessary legal review of Barr Laboratories' proposed under-16 sales restriction on over-the-counter Plan B, requested by FDA reviewers eight months earlier, according to a March 9 letter to the agency from Henry A. Waxman (D-CA).
Waxman's letter charges that the FDA set Barr up for Plan B's defeat by convincing it to amend its application to propose the under-16 restriction that it knew it would later call too “difficult and novel” to be approved without indefinite further consideration—“a regulatory Catch 22,” as Waxman called it.
His seven-page letter cited internal FDA e-mails suggesting Troy's office was repeatedly reminded of the need for the legal review and of its urgency due to a six-month statutory deadline on Barr's application, a deadline the FDA failed to meet. These documents “reveal that in addition to having created the situation it now protests as too complex to solve, FDA has seriously mischaracterized its consideration of the regulatory questions at stake,” Waxman wrote.