386
Breyer, J., dissenting
In fact, it could prevent compounded drugs from reaching out-of-state patients who genuinely need them.
Fifth, the Court says that the Government could "ca[p] the amount of any particular compounded drug, either by drug volume, number of prescriptions, gross revenue, or profit." Ibid. This alternative, like the others, ignores the patient-need problem, while simultaneously threatening to prevent compounded drugs from reaching those who genuinely need them, say, a patient whose prescription represents one beyond the arbitrarily imposed quantitative limit.
Sixth, the Court says that the Government could rely upon "non-speech-related provisions of the FDAMA, such as the requirement that compounding only be conducted in response to a prescription." Ibid. This alternative also ignores the patient-need problem and was specifically rejected by the Government in the Court of Appeals for the Ninth Circuit. See supra, at 380-381.
The Court adds that "[t]he Government has not offered any reason why these possibilities, alone or in combination, would be insufficient." Ante, at 373. The Government's failure to do so may reflect the fact that only the Court, not any of the respondents, has here suggested that these "alternatives," alone or in combination, would prove sufficient. In fact, the FDA's Compliance Policy Guide, from which the Court draws its first four alternatives, specifically warned that these alternatives alone were insufficient to successfully distinguish traditional compounding from unacceptable manufacturing. See Compliance Policy Guide 77a.
III
The Court responds to the claim that advertising compounded drugs causes people to obtain drugs that do not promote their health, by finding it implausible given the need for a prescription and by suggesting that it is not relevant. The First Amendment, it says, does not permit the Government to control the content of advertising, where
Page: Index Previous 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 NextLast modified: October 4, 2007