FDA Expects OTC Switch Self-Selection Studies To Probe Consumer Thinking
This article was originally published in The Tan Sheet
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A draft guidance on designing self-selection studies in support of Rx-to-OTC switches reflects FDA’s interest in drilling down for greater insight into consumers’ thought processes. The guidance document issued Sept. 16 could provide a valuable resource for firms proceeding with challenging OTC switches. In addition to presenting a self-selection question requiring a yes/no response, study sponsors should follow up with medical history questions and additional open-ended queries, FDA’s Center for Drug Evaluation and Research says in the guidance. Non-leading, open-ended questions in response to a self-selection decision – such as “Why do you say that?” – can elicit additional information for the study analysis, FDA says. “Additional open-ended questions should be asked to assess reasons why subjects make incorrect self-selection decisions,” the agency adds. “It is important to determine why subjects make incorrect decisions to better understand what label revisions may need to be made to improve correct self-selection.” Though some firms elect to ask consumers whether they ultimately would purchase the OTC product, FDA warns that such a question “should not be used to mitigate a self-selection decision,” since a drug’s cost often influences purchase decisions independent of the self-selection process. Difficult Switches Face Self-Selection Challenge Some experts contend there are no more switches for conditions that are relatively easy to self-diagnose, meaning the bar to convince the agency that consumers can appropriately self-select for an Rx drug in an OTC setting has been raised. Merck attempted to detail self-selection decisions in its most recent attempt to switch the cholesterol drug Mevacor Daily (lovastatin) (Also see "Merck’s Mevacor Switch Bid Digs Deeper Into Consumers’ Self-Selection" - Pink Sheet, 10 Dec, 2007.). The company’s Self-Evaluation of Lovastatin to Enhance Cholesterol Treatment study, presented to FDA in December 2007, focused on motivations behind study subjects’ off-label usage decisions and informed Merck’s development of a proposed consumer education program to support nonprescription Mevacor. However, Merck’s enhanced visibility into consumer decision-making could not overcome the decisions themselves; the switch failed because too many subjects said they would take an OTC statin even if their cholesterol levels did not warrant it (Also see "The Future Of OTCs: Self-Selection Meets Diagnostics, Genetic Personalization" - Pink Sheet, 16 May, 2011.). CDER Director Janet Woodcock has come out as a proponent of behind-the-counter drugs, which would enable switch candidates with greater self-selection obstacles to be available without a prescription (Also see "CDER Director Sees Behind-The-Counter Switches As Best Bet" - Pink Sheet, 11 Apr, 2011.). Looking Beyond Medical Histories While the draft guidance recommends self-selection studies include medical history questions, Saul Shiffman of regulatory consulting firm Pinney Associates noted that it omits a mention of testing for current conditions.
Industry stakeholders say up-to-date diagnostics could play a role in upcoming switches. Specifically, a successful OTC switch of statins likely will depend on consumers testing their own cholesterol prior to electing to use the drug. “I think the more difficult switches of things like asymptomatic products do introduce new issues in self-selection, but they don’t alter the fundamental structure” of self-selection studies, said Shiffman, who also is a professor of psychology at the University of Pittsburgh. Although the guidance largely tracks self-selection study practices already used by industry, Shiffman said there may be some debate around the concept that, according to FDA, “a correct self-selection decision can be based on a single label element or a composite of several label elements depending on the drug product.” He explained that past practice typically involved researchers considering separate label elements – such as concurrent use warnings – separately when determining whether a subject self-selected to use the product. Shiffman participated at the September 2006 meeting of FDA’s Nonprescription Drugs Advisory Committee, which focused on issues of analysis and interpretation of consumer studies in support of OTC drug marketing (Also see "NDAC Panelists Look At Future Of Behavior Research For OTC Postmarket" - Pink Sheet, 9 Oct, 2006.). CDER incorporated advice from that NDAC meeting into the self-selection study draft guidance. By Dan Schiff |