FDA Announces Hearing to Explore Rx-to-OTC Switches, Francesco International to Participate

March 1, 2012 - PRLog -- The Food and Drug Administration (FDA) just announced a public hearing to discuss the role that technology could play in assisting the prescription to over-the-counter (Rx-to-OTC) switch of many drugs. The meeting is scheduled for March 22-23, 2012 from 9 a.m. to 4 p.m. and will be held at the FDA’s White Oak Campus in Silver Spring, Md.

Francesco International LLC, a cutting-edge pharmaceutical think-tank and healthcare consultancy based in New Jersey, predicted this change in the industry and recently published a breakthrough 100-page report regarding the issue, “The Major Global Expansion of Rx-to-OTC Switch by 2016©”. Francesco International CEO, Steven Francesco will be submitting a request to present at this historic meeting. Francesco has presented at similar FDA policy meetings in the past years.

The Francesco International report presents a strong case that selected prescription drugs will gain OTC status in the near future thanks to "enabling" modern technology, such as smart phones, kiosks, digitalized home-based healthcare hubs, private home healthcare networks, etc.

The combination of these drugs plus new enabling technology will create a group of nonprescription drugs that Francesco International refers to as “enabled” over-the- counter (OTC-E™) drugs. These OTC-E™ drugs have several distinct characteristics. Most important, this new group of drugs will be used primarily for chronic therapy treatment. Amongst others, therapy areas impacted will be hypertension, dermatology, lipid-lowering, osteoporosis, arthritis and incontinence. For example, drugs such as Lipitor will be used OTC by 2016 for lowering cholesterol to help prevent cardiovascular disease.

“This is a breakthrough report that focuses on the changing dynamics of Rx-to-OTC switch between now and 2016,” says Francesco, the principal author of the report.

The report is for companies interested in exploring the promising opportunities of Rx-to-OTC switch that will surface in the next five years. In addition, the report identifies key therapy and product areas for switches that can benefit from a combination of the drug plus the use of the exciting new technology.

According to Francesco, “The US healthcare system has been in an unsatisfactory gridlock for some years now with payers, providers, pharmaceutical companies, patients and consumers all somewhat frustrated. Finally, the major players are now starting to move and some of the new dynamics, especially the contribution of technology, are becoming apparent. This report captures what is happening now and what is likely to happen over the next few years, especially the Implications for Rx-to-OTC switch. This report is essential for those who want a guide for solid long-term growth coming from the global Rx-to-OTC space.”

For more information on “The Major Expansion of the Rx-to-OTC Switch by 2016©” or Francesco International visit www.franint.com.

About Francesco International LLC

Francesco International Inc. has been actively involved in pharmaceutical lifecycle management with a focus on Rx-to-OTC switch for nearly two decades, consulting for numerous pharmaceutical companies worldwide. The firm published the newsletter, “SWITCH,” as well as SWITCH Market Impact studies. It has its own proprietary planning model “Max the Molecule” for assessing opportunities.  CEO Steven Francesco has authored over fifty articles and essays on the pharmaceutical industry and is a recognized expert on product life cycle issues. He has been on the board of several companies and is also the CEO of MMDerm LLC.