Pharmaceutical Research and Mfrs. of America v. Walsh, 538 U.S. 644, 14 (2003)

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Cite as: 538 U. S. 644 (2003)

Opinion of the Court

mentin, a drug used to treat bacterial infections, declined from 49% to 18% in the six months after the program was imposed.22 In the third affidavit, Dr. Howell of SmithKline Beecham Corporation expressed the opinion that prior authorization had never been required in one program "for the purpose of influencing the manufacturer's pricing behavior in another program," and that such use, "without regard to safety or efficacy, will lead to drugs being prescribed that are less safe and efficacious." 23

Respondents' opposition to the motion was supported by Concannon's own affidavit and the affidavits of two doctors. They do not dispute the factual assertions concerning the impact of prior authorization on the drug companies' market shares, but instead comment on the benefits of prior authorization for patients. The State's Medicaid Medical Director, Dr. Clifford, explained that "[p]hysicians in Maine are already well acquainted with the extensive prior authorization programs of the four HMO/Insurance programs which collectively cover nearly half the state's residents" and that the State had taken steps to "ensure that physicians will always be able to prescribe the safest and most efficacious drugs for their Medicaid patients." 24 The second doctor, Dr. Richardson, stated that he prescribed Augmentin as a second line drug, that the drug amoxicillin was effective in treating ear infections 80%-85% of the time, and that Augmentin was

22 Id., at 112 (affidavit of David Moules of SmithKline Beecham Corp.).

23 Id., at 103-104. Dr. Howell further stated: "Prior authorization is often employed by managed care organizations ('MCOs') to enforce a drug formulary and is usually intended to limit the drugs to be prescribed by health care professionals. MCOs typically require health care professionals to obtain prior authorization from the MCO before prescribing a drug (1) to ensure proper use of prescription drugs with a high potential for inappropriate use, (2) to limit the use of prescription drugs with severe or life threatening side effects and/or drug interactions; and (3) to encourage the use of cost-effective medications without diminishing safety or efficacy." Id., at 102-103.

24 Id., at 149-150.

657

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