Pros And Cons Of NSURE Initiative

Chapter 5 - NSURE Initiative
The healthcare industry has been plagued by the problem of under treatment of many common diseases and ailments for years. A major part of the US population still lacks access to medical care due to this problem. This emphasizes the need for improved access to non-prescription treatment options. The FDA has started exploring methods by which the under treatment of public health can be minimized. This has led to the convention of the NSURE (Nonprescription Safe Use Regulatory Expansion) initiative, which aims to expand the regulatory constraints associated with the non-prescription drug category, in hopes of providing increased access to adequate medical care for the public.
The NSURE initiative was conceptualized to aid the process of Rx-to-OTC switches by expanding the ‘Conditions of Safe Use’. According to the presentation of Theresa M. Michele, MD, Director, Division of Nonprescription Clinical Evaluation of the FDA, at a conference on OTC drugs held in October 2014, the existing switch process has a few limitations, mentioned below.
• The purchase decision for the OTC drugs is based only on the information conveyed through the Drug Facts label and the principal display panel
• The switch process is restricted in its communication with the consumer and doesn’t take
The initiative is defined by the FDA as a step towards alleviating the under treatment of common conditions or diseases by using innovative technologies or other conditions of safe use to expand which drug products can be considered nonprescription. Under this initiative, FDA plans to expand the nonprescription drug market by coming up with a different regulatory approach and approve a prescription drug to be used as OTC if certain conditions of safe use are