November 07, 2006
Duramed starts to pitch OTC Plan B
OTC Plan B is launching with detailing and professional ads, but the campaign will include a nod to consumers, too.
Duramed--a unit of generics firm Barr Labs that handles proprietary women’s health products--has started educating pharmacists, physicians and other healthcare providers on the contraceptive, which was approved for OTC use in August but only for women 18 and over. To enforce the age restriction, Duramed set up a pharmacist distribution program similar to how stores bar cigarette sales to minors.
Detailing by Duramed’s 250-person sales force has begun, and the product should be on store shelves by mid-November, the company said in a statement. Ads by Pace, a unit of Interpublic Group’s Lowe Healthcare, appear this month in the trade press, including in Clinical Advisor, which is aimed at nurse practitioners. (Clinical Advisor’s publisher, Haymarket Media, also publishes MM&M.) Medical journal advertising is planned as well.
Pace also has been assigned the DTC campaign. Print ads in women’s magazines and banner ads on high-traffic Web sites targeting women will roll out by the end of November, Carol Cox, Barr spokesperson, said by e-mail. PR, by CSI, will aim to reach colleges and universities with high female enrollment and encompass national and local media outreach.
The Duramed sales force distributes Plan B educational materials to healthcare practitioner offices and pharmacies in all 50 states, and a Web site for consumers and professionals, Go2PlanB.com, is available. IMC2 handles interactive.
Plan B, which has been marketed in the US since 1999, took a protracted route to the pharmacy counter. The FDA received the Rx-to-OTC switch application nearly three years ago but delayed a decision over concerns the pill would be available to young teens and, after Barr proposed limiting OTC access to those 16 and over, due to what former commissioner Lester Crawford described as uncertainty over how to enforce age restrictions.
Acting Commissioner Andrew von Eschenbach said in August that a review of public comments convinced the agency that new rules weren’t needed, leading to the approval for those 18 and over. That prompted Sens. Hillary Rodham Clinton (D-NY) and Patty Murray (D-WA), who had blocked von Eschenbach’s Senate confirmation until the agency made a decision on Plan B, to lift their hold. His nomination is still being blocked by two Republican senators, however, for unrelated reasons.
Based on the studies Barr conducted for Plan B’s OTC approval, the FDA gave Duramed a three-year exclusivity for the dual-label product valid until August 2009.