Monmouth Beach, NJ, February 10, 2013 --(PR.com
)-- The Food and Drug Administration (FDA) has recently created the Nonprescription Safe Use Regulatory Expansion (NSURE) task force and is working with the Brookings Institute and "invited experts" such as Francesco International consultants. Their goal is to explore and expand the number and kind of tools and strategies that could assist the conversion of prescription drugs to over-the-counter status (Rx-to-OTC switch). One meeting took place in December, the next is planned for May 9th and one more is planned during 2013 at the Brookings Institute, 1775 Massachusetts Ave., NW, Washington, DC 20036.
Francesco International recently released its second major pharmaceutical report on this increasingly important healthcare subject. The overall goals of both the FDA initiative and the Francesco report is to explore ways to safely expand the number of Rx-to-OTC switches in a way that improves health care outcomes as well as lowers costs. For example, combining a drug with new smartphone technology could create potentially valuable OTC opportunities in several therapeutic categories.
Major prescription therapy categories potentially impacted could be hypertension ($7B), lipid-lowering with statins ($17B), benign prostate hyperplasia ($3.6B), and chronic obstructive pulmonary disorder ($5.2B). For example, a drug such as Lipitor could be OTC by 2016 for lowering cholesterol to help prevent a second heart attack. Under these new conditions of safe OTC use, the quality of life for the consumer could be significantly enhanced and overall health care costs could be reduced without the need for constant physician involvement.
A New FDA-Driven Rx-to-OTC Switch Initiative: The Expansion of Conditions of Use©” is a 47 page report addressing the key building blocks under this potentially important new health care paradigm.
“This new report focuses on these exciting new switch opportunities and details the strategies and mechanisms that could likely emerge. These innovations could positively change the future dynamics of Rx-to-OTC switch. The report is intended for all in the healthcare industry, including pharmaceutical, technology, insurance and retail pharmacy companies." says Steven Francesco, the principal author of the report and CEO of Francesco International.
According to Francesco, “The U.S. healthcare system has been in an unsatisfactory gridlock for some years now with payers, providers, pharmaceutical companies, patients and consumers all somewhat frustrated. For example, Rx-to-OTC switch has dramatically declined in the last 10 years with some years (2012, 2008, 2004) having no new switched molecules. That's not good for healthcare in general.”
“Finally, there is the chance for change as the major stakeholders are now starting to re-think their business models and some of these new opportunities, especially those from the new health care legislation and the contribution of new technology, are becoming apparent and actionable. The FDA sees this as an opportunity. As experts on the subject, we can see some new conditions of safe use having a potentially huge positive impact on both public health as well as health care industry sales and profit."
About Francesco International
For nearly two decades Francesco International has been actively involved in pharmaceutical lifecycle management with a focus on Rx-to-OTC switch. I addition to consulting for numerous pharmaceutical companies worldwide, the firm published the newsletter, “SWITCH,” as well as SWITCH Market Impact studies. It also has its own proprietary planning model “Max the Molecule” for assessing pharmaceutical product lifecycle opportunities, especially Rx-to-OTC switch. CEO Steven Francesco is a prolific writer, having authored over fifty articles and essays on the pharmaceutical industry.
For more information on
“A New FDA-Driven Rx-to-OTC Switch Initiative: The Expansion of Conditions of Safe Use©”