“We were confident at that point that oral phenylephrine did not work.”
Randy Hatton and Leslie Hendeles pulled the FDA’s own evidence through FOIA. Seven of the unpublished studies showed oral phenylephrine no better than placebo, and the one lab with glowing results had nearly a quarter of its measurements ending in five. They petitioned the FDA in 2007 and the advisory panel only agreed last September. The FDA shrugged because the drug harmed nobody, and Sudafed PE kept selling.