176
Breyer, J., dissenting
a device in light of its regulatory alternatives, and where the FDA has chosen the least dangerous path, i. e., the safest path, then it can—and does—provide a "reasonable assurance" of "safety" within the meaning of the statute. A good football helmet provides a reasonable assurance of safety for the player even if the sport itself is still dangerous. And the safest regulatory choice by definition offers a "reasonable" assurance of safety in a world where the other alternatives are yet more dangerous.
In any event, it is not entirely clear from the statute's text that a Class III categorization would require the FDA affirmatively to withdraw from the market dangerous devices, such as cigarettes, which are already widely distributed. See, e. g., § 360f(a) (when a device presents an "unreasonable and substantial risk of illness or injury," the Secretary "may" make it "a banned device"); § 360h(a) (when a device "presents an unreasonable risk of substantial harm to the public health," the Secretary "may" require "notification"); § 360h(b) (when a defective device creates an "unreasonable risk" of harm, the Secretary "may" order "[r]epair, replacement, or refund"); cf. 2 O'Reilly § 18.08, at 18-29 (point of Class III "premarket approval" is to allow "careful scientific review" of each "truly new" device "before it is exposed" to users (emphasis added)).
Noting that the FDCA requires banning a "misbranded" drug, the majority also points to 21 U. S. C. § 352( j), which deems a drug or device "misbranded" if "it is dangerous to health when used" as "prescribed, recommended, or suggested in the labeling." See ante, at 135. In addition, the majority mentions § 352(f)(1), which calls a drug or device "misbranded" unless "its labeling bears . . . adequate directions for use" as "are necessary for the protection of users." Ibid. But this "misbranding" language is not determinative, for it permits the FDA to conclude that a drug or device is not "dangerous to health" and that it does have "adequate"
Page: Index Previous 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 NextLast modified: October 4, 2007