NDMA Discusses Switch Changes At Legal Seminar

Switching medicines from prescription to over-the-counter status changes the bilateral role between companies and the Food and Drug Administration, according to Nancy Bue of Bue, Levitt & Beardsley, since it also involves the media and interest groups.

While Rx and straight OTC approvals stand on their own merits, switches are in the history of all other switch products, she noted, reminding those attending a legal seminar of the US Non-Prescription Drug Manufacturers Association that they may be dealing with a whole new set of people at the agency when they move from Rx to OTC approvals.

At the Non-Prescription Drug Advisory Committee meeting, non-scientific issues such as cost, reimbursement and doctors' opinion play key roles, she said, adding the companies have to use socio-economic issues and the like to deal with some of these questions. Lawyers should prepare for the presentation as if it were a trial, with company officials mastering the details, said Ms Bue.