The relevant statute is §505(d) of the Food, Drug and Cosmetic Act, which provides in pertinent part that the Secretary of Health and Human Services “shall” (that is, has a legal obligation to) approve a drug unless he finds that one or more specifically enumerated conditions obtains.snip
Assuming that none of these conditions were met, there was no legal basis for the secretary to deny approval of Plan B. That Plan B, when used as intended, causes the death of innocent human beings in utero, while of paramount concern morally, is not legally relevant. If the FDA continued to withhold approval of Plan B, the drug’s manufacturer could have sued the FDA in federal court and, in all human probability, obtained a ruling ordering the FDA to approve the drug for sale.
Bush: not a sell-out.
