Role of Legal Counsel In US Rx-to-OTC Switching

The lawyer's role in a prescription to over-the-counter drug switch becomes more critical with the type of approval, consultant Russell Bantham, former associate general at Bristol-Myers, told the US Nonprescription Drug Manufacturers Association's legal affairs conference (Marketletter October 31). The difficulty level rises from a straight switch to a pseudo-switch to an active one.

Counsel has an important role on a multidisciplinary team dealing with a switch candidate, he said, and should: - ensure the team does not dispense with questions and move directly to answers; - become the most knowledgeable member of the team by talking early on to those outside as well as within the company, including the NDMA and the Food and Drug Administration; - be the plan's facilitator, to keep the project on target and moving; - take primary responsibility for risk management; - be the company's conscience; and - use lawyer's skills to help prepare presentations to the FDA Nonprescription Drug Advisory Committee.

Lawyers should not only ask questions internally about potential switch candidates, but look outside to learn what disciplines are represented on the NDAC, if other firms are trying to switch similar products and the opinions of relevant interest groups, said Johnson & Johnson associate general counsel Kathy Schroeher. Bring an outside expert (preferably an academic) to the NDAC meeting, plus favorable interest groups, she suggested; there are audiences other than the FDA in the room, including media and consumers.