2001 | Case No. P38
In an unprecedented move in mid-1998, Blue Cross of California, a unit of WeilPoint Health Networks, Inc., filed a Citizen Petition with the FDA to switch Claritin, manufactured by Schering Plough, and two other secondgeneration antihistamines from prescription-only to over-the-counter (OTC) status. Prescription pharmaceuticals like Claritin were covered by insurance programs, whereas OTC drugs were not. In the late 1990s, U.S. spending on prescription pharmaceuticals had increased significantly, in part as a result of direct-to-consumer advertising of prescription drugs, and imposed a substantial burden on insurance companies. Blue Cross argued that the switch would make the drugs more widely available to consumers and would benefit consumers because the second generation antihistamines were non-sedating, unlike the 100 antihistamines sold on the OTC market. Manufacturers opposed the switch because it would put the second-generation antihistamines under considerable price pressure and would disrupt their product planning. Moreover, a switch initiated by an insurance company could lead to future petitions for switches of other prescription drugs. Just under three years later, on May 11, 2001 an FDA advisory committee voted overwhelmingly that the three second-generation antihistamines could safely be marketed over the counter. Although the vote was not binding, the FDA usually acted in accord with the judgments of its advisory committees. The pharmaceutical companies strongly objected to the committee’s vote and faced the challenge of developing a strategy for dealing with the threat.
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