Market Support Studies

In addition to the Rx-to-OTC switch, a second type of study is very prominent in the OTC area. This is the market support study. These are clinical studies intended to demonstrate particular advantages of one company's drug over another's, or of one particular formulation of the same drug over other competitors. Opportunities for demonstrating such advantages depend on locating genuine differences that can be successfully studied. While anything can be tried in a clinical study, only authentic differences will emerge as successful claims at the end of the study process. Locating such possible advantages can be done through careful attention to feedback from actual users of the drug. Usage and attitudes (U and A studies) studies done by the marketing department and focus group sessions can be invaluable in discovering the possible existence of advantages for a particular formulation over its competitors. Careful review of the pharmacologic literature is another way in which differences can be detected. Even small differences may be quite meaningful to patients, even though they may appear minor to the pharmacologist, who is not actually using the drug him/herself. In the case of an anti-nausea drug, for example, a difference in onset of action of 10-15 min can be highly significant if you're the one suffering from the nausea. Therefore, a careful review of literature can often find pharmacokinetic and other differences that can be more meaningful than they at first appear. Any difference that is not meaningful to the patients will not produce much difference in sales. In selecting market support opportunities for study, it is important to manage expectations so that the marketing group can understand that only real differences that are meaningful to the patient and can be demonstrated with reasonable certainty in clinical trials are worth pursuing. If expectations are allowed to grow out-of-hand, one will find oneself designing studies for the most bizarre purposes and encountering a very high rate of failure, because you're chasing after advantages that never existed in the first place.

Once a probable new claim has been identified and the chances of its being scientifically valid have been assessed, you must carry out actual studies to support the claim. In most situations, two-good quality studies are necessary to support an advertising claim, even though these are not necessarily regulated by the FDA. In some special situations, a single study may be enough. Guidance on this issue may be taken from the company's legal department.

To understand what will be needed to support a claim, it is important to understand how the advertising and marketing of OTC drugs is regulated. Typically, after a brief initial period, the FDA does not take a primary role in such regulation. Rather, this duty passes to the Federal Trade Commission and, much more importantly, to the federal courts. The OTC industry's advertising claims tend to be self-enforcing. The companies maintain a close vigilance on each other's advertising and tend to be eager to sue their competitors in the federal courts if any unsupportable advertising claims are suspected. The possession of scientifically sound studies is of great value in preventing lawsuits and ensuring that if they do occur, they will be won.

Although the pharmaceutical physician rarely pictures him/herself as a person testifying in lawsuits, this is not an uncommon experience for the OTC medical director. This need not be viewed with any particular trepidation if you have been careful to prepare a satisfactory scientific basis for the advertising claims that you have approved.

In summary, the role of the OTC physician is significantly different from that of the pharmaceutical physician working in any other area of the industry. It requires a greater degree of creativity and independence. It features a different kind of responsibility, since there is no other physician between you and the patient to share that responsibility with. One is more completely on one's own and called upon to utilize an expertise which is broader than that required of the physician in virtually any other area of pharmaceutical development.

Section III

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