Cite as: 535 U. S. 357 (2002)
Breyer, J., dissenting
seriously undervalues the importance of the Government's interest in protecting the health and safety of the American public.
I
In my view, the advertising restriction "directly advances" the statute's important safety objective. That objective, as the Court concedes, is to confine the sale of untested, compounded, drugs to where they are medically needed. But to do so the statute must exclude from the area of permitted drug sales both (1) those drugs that traditional drug manufacturers might supply after testing—typically drugs capable of being produced in large amounts, and (2) those compounded drugs sought by patients who may not clearly need them—including compounded drugs produced in small amounts.
The majority's discussion focuses upon the first exclusionary need, but it virtually ignores the second. It describes the statute's objective simply as drawing a "line" that will "distinguish compounded drugs produced on such a small scale that they could not undergo safety and efficacy testing from drugs produced and sold on a large enough scale that they could undergo such testing and therefore must do so." Ante, at 370 (emphasis added). This description overlooks the need for a second line—a line that will distinguish (1) sales of compounded drugs to those who clearly need them from (2) sales of compounded drugs to those for whom a specially tailored but untested drug is a convenience but not a medical necessity. That is to say, the statute, in seeking to confine distribution of untested tailored drugs, must look both at the amount supplied (to help decide whether ordinary manufacturers might provide a tested alternative) and at the nature of demand (to help separate genuine need from simple convenience). Cf. 143 Cong. Rec. S9840 (Sept. 24, 1997) (remarks of Sen. Kennedy) (understanding that "some of the conditions are intended to ensure that the volume of compounding does not approach that ordinarily asso-
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