Dr. Gerard M. Nadal appropriately nails the non-functional FDA to the wall, noting it’s new Kelsey award, honoring a former FDA reviewer from back when the agency was worth something.
Frances O. Kelsey, now 96 years old, is the namesake and first recipient of the Kelsey award from the FDA for doing what she was supposed to do. She stopped distribution of Thalidomide, for morning sickness, in the USA, likely sparing countless kids the associated birth defect called phocomelia, severely shortened limbs.
Nadal notes that the present FDA commissioner, Margaret Hamburg has ushered in the new drug Ella, ulipristal acetate, without appropriate testing, and with next to zero study of its effects on the babies who survive its embryocidal effects. In addition, the FDA has misbranded this drug as a contraceptive, thus disrespecting female patients’ right of informed consent to treatment.