Zyrtec OTC Switch: Pfizer Says Rx Status Necessary For “Best Use” Of Drug
This article was originally published in The Tan Sheet
Executive Summary
A forced OTC switch of Zyrtec would deprive consumers of the "health information component" doctors provide, which is needed for optimal care, Pfizer CEO Henry McKinnell said during the firm's April 24 annual meeting in Ann Arbor, Mich
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A forced OTC switch of Zyrtec would deprive consumers of the "health information component" doctors provide, which is needed for optimal care, Pfizer CEO Henry McKinnell said during the firm's April 24 annual meeting in Ann Arbor, Mich. "The health information component that a doctor provides is very important to achieve the compliance that is necessary for the best use of these drugs," McKinnell stated. "When people buy drugs over-the-counter, not under the supervision of a physician...quite frankly they don't take those drugs as directed," McKinnell said. "They tend to take them for three or four days, feel a little better, and then stop taking them." McKinnell discussed the potential forced switch of the antihistamine Zyrtec (cetirizine) in response to a shareholder question about recent lay media stories on the topic. The stories are picking up on FDA's oft-repeated statement that WellPoint Health Network's citizen petition to force the switch of Zyrtec and Aventis' Allegra (fexofenadine) remains under consideration. The switch was endorsed by FDA's Nonprescription and Pulmonary-Allergy Drugs Advisory Committees in 2001 (1 (Also see "Second-Generation Antihistamine OTC Labeling Could Resemble Monograph" - Pink Sheet, 14 May, 2001.), p. 3). Schering-Plough's Claritin (loratadine) also was covered by the WellPoint petition; Schering switched Claritin OTC of its own accord in December (2 (Also see "Schering OTC Claritin Post-Approval Filings To Include Hypospadia Reports" - Pink Sheet, 2 Dec, 2002.), p. 3). WellPoint followed its initial citizen petition, however, with a second petition urging FDA to switch Schering's follow-on drug Clarinex OTC (3 (Also see "Clarinex Clinical, Safety Characteristics Support OTC Use – WellPoint" - Pink Sheet, 22 Apr, 2002.), p. 9). McKinnell reaffirmed Pfizer's position on forced switches by declaring: "We are opposing this. We think the decision on when a drug should be switched to over-the-counter availability should be our decision, regulated by FDA." Nevertheless, "it is under active consideration right now by FDA. We are trying to intervene in that discussion to make sure that that decision is made on our recommendation, not on FDA's recommendation." Pfizer can be expected to sue the agency if it attempts to force a Zyrtec switch (as would Aventis to block a forced switch of Allegra and Schering to protect Clarinex). The property rights argument likely would be central to Pfizer's case. McKinnell's discussion of the value of physician counseling is perhaps best viewed as an argument intended to ensure Pfizer has a strong case to make in the public policy arena. The issue of compliance with OTC medications usually is not raised as an important commercial consideration in the switch process. Generally, the concern is that the consumer market is more price sensitive (given the absence of insurance coverage) and that marketing and packaging costs cut deeper into margins. However, by focusing on the value of the "health information component" of medicine, McKinnell is framing an argument that would appeal to physicians, a potentially valuable group of allies for the company. It also is a subtle reminder that the savings managed care expects to see from moving the category OTC are not limited to the cost of the drug; insurers presumably also will see a decline in claims for physician visits during allergy season. Another challenge for sponsors in combating forced switches is in finding arguments that do not contradict their overall business profile. McKinnell's position on the importance of physician intervention in allergy therapy, for example, is hard to reconcile with the company's marketing of the OTC Benadryl line - or with Pfizer's moves to expand its OTC business overall with the acquisitions of Warner-Lambert and Pharmacia. The Pfizer CEO, however, offered another argument against the Zyrtec switch. "I find it just a little annoying that in the original application of Zyrtec for prescription use, FDA took eight years...in deciding that the risk-benefit of Zyrtec justified it being available even as a prescription medicine [while] today they think the drug is safe enough to be switched [OTC]." Zyrtec's NDA initially was held up by carcinogenicity questions raised in the context of the Claritin review and then by safety questions related to the cardiac side effects of Aventis' Seldane (terfenadine). |