"Searle had originally asked the FDA to consider simultaneously an application for three dosages of Enovid: 10, 5, and 2.5 milligrams. Searle was particularly interested in promoting the lower dosage forms of Enovid because one of the chief criticisms of the pill up to this point had not been a medical one, but rather an economic one. Partly developed in response to concerns about world hunger, it was feared that Enovid would prove far too expensive for woen in poorer countries. The cost of the hormone was directly proportionate to the cost of the drug and the dose. Lowering the dose significantly lowered the cost of Enovid. Searle, therefore, had great incentive to prove the safety and efficacy of its lower dosage pills. As far as Searle officials were concerned, the lower dose of Enovid should not have required a separate NDA because they considered it merely an alternative dose of the same drug. As one Searle representative wrote when seeking approval of the lower dosage: “[I find it] very difficult to understand how less of a drug can be more dangerous than a larger dose...a basic fact of any drug use is adjustment of the dosage to a particular individual’s requirement. That’s all we are trying to do with the lower dosage forms of Enovid....I find it impossible to understand how one increases danger by reducing the dose.” The FDA, however, viewed the dosage question as an issue of efficacy and possibly safety in 1959. The lower doses produced an increased incidence of breakthrough bleeding. It was not immediately clear whether this was an indication that ovulation had not been effectively suppressed. If so, it would have undermined Enovid’s effectiveness as a contraceptive, rendering it unapprovable. The FDA was therefore very cautious in considering any alteration in the original dose formulation of the pill."