Switching Pharmaceutical Products from Prescription to Over-the-Counter: The Debate in the US
1 December 2012
By Dr. Richard Rozek
The US Food and Drug Administration (FDA) recently held a hearing on whether to expand the types of pharmaceutical products that could be switched from prescription (Rx) to over-the-counter (OTC) status. In this article from the European Journal of Risk Regulation, NERA Special Consultant Dr. Richard Rozek discusses how switching pharmaceutical products from Rx to OTC will increasingly become an important public policy issue in the US and elsewhere, and how changing the regulatory environment in the US to accommodate switching broader classes of pharmaceutical products must balance the benefits and risks. The theme of the FDA hearing, as well as published studies on issues surrounding switching pharmaceutical products to OTC status, have focused on the benefits to the US health care system, such as improved access to health care and the potential for greater price competition. In terms of risks, the out-of-pocket costs to patients may increase, misdiagnosis of health problems may occur, adverse events may be unreported, and abuse may increase. Dr. Rozek urges regulators to seek to quantify these risks when revising or modifying the process for switching products from Rx to OTC status to avoid adopting policies that may increase overall health care costs.
