Cite as: 535 U. S. 357 (2002)
Breyer, J., dissenting
at a faster rate. And the risks associated with the untested combination of ingredients or the quicker absorption rate or the working conditions necessary to change an old drug into its new form can, for some patients, mean infection, serious side effects, or even death. See, e. g., J. Thompson, A Practical Guide to Contemporary Pharmacy Practice 11.5 (1998) (hereinafter Contemporary Pharmacy Practice). Cf. 21 CFR § 310.3(h)(1) (2002) (considering a drug to be "new" and subject to the approval process if the "substance which composes such drug" is new); § 310.3(h)(3) (considering a drug to be "new" and subject to the approval process if approved ingredients are combined in new proportions).
There is considerable evidence that consumer oriented advertising will create strong consumer-driven demand for a particular drug. See, e. g., National Institute for Health Care Management, Factors Affecting the Growth of Prescription Drug Expenditures iii (July 9, 1999) (three anti-histamine manufacturers spent $313 million on advertising in 1998 and accounted for 90% of prescription drug anti-histamine market); Kritz, Ask Your Doctor About . . . Which of the Many Advertised Allergy Drugs Are Right for You? Washington Post, June 6, 2000, Health, p. 9 (The manufacturer of the world's top selling allergy drug, the eighth best-selling drug in the United States, spent almost $140 million in 1999 on advertising); 1999 Prevention Magazine 10 (spending on direct-to-consumer advertising of prescription medicine increased from $965.2 million in 1997 to $1.33 billion in 1998).
And there is strong evidence that doctors will often respond affirmatively to a patient's request for a specific drug that the patient has seen advertised. See id., at 32 (84% of consumers polled report that doctors accommodate their request for a specific drug); Henry J. Kaiser Family Foundation, Understanding the Effects of Direct-to-Consumer Prescription Drug Advertising 3 (Nov. 2001) (A foundation survey found that more than one in eight Americans had asked
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