Case Analysis Pepcid Ac Racing to the Otc Market Essay example

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MBA 560 – Marketing Principles

Case Analysis
Pepcid AC Racing to the OTC Market

The managers at Johnson & Johnson/Merck Consumer Pharmaceuticals Co. (JJM) have two options regarding their newest over-the-counter (OTC) drug Pepcid AC. The first option would be to pursue both claims of treatment and prevention, which would help differentiate their drug from other competitors OTC drugs that are also pending FDA approval. The first option could require up to 9 months of additional studies and investments to provide further evidence to the advisory committee and FDA. Conversely, they could choose the second option, to bypass the recommendations of the advisory committee and take their case directly to the FDA with the goal of
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The importance of being first to enter the OTC ulcer/heartburn medication market and capitalization on the remaining six years of patent protection should not be overlooked by the managers of JJM. The drug market is highly competitive, for example; Tagamet’s US prescription sales dropped by over 37% in 1993 when generic manufacturers entered the market. The FDA’s historical record generally follows the recommendations of the advisory committee, but they had made exceptions in the past. JJM needs to attempt to persuade the FDA of the validity of their current research to gain approval without the advisory board’s recommendation. Prescription Pepcid’s safety had already been approved by the FDA so JJM needs to prove the efficacy with current research of the lower dosage and consumers’ willingness to use the product safely for their OTC version. Another reason to move forward with the treatment only claim is because the FDA has been critical of all prevention claims, choosing to rely more on education for prevention. The final reason is the prevention claim was more of a strategic consideration for differentiation from Tagamet when it originally appeared to have secured the first-to-market slot. The most important position in the OTC market is the first to enter. With Tagamet stalled, JJM could now secure the position and continue to get additional clinical support of their prevention claim to

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