Tuesday, September 4, 2012

FDA Encouraging OTC Drug Switches


Ultimately, it's in everyone's interest to reduce healthcare costs.  This includes the Federal Government.  Thus, the FDA though an independent agency, has been encouraging OTC treatments where possible and safe in order to provide more treatments to patients at a lower cost.  They are accomplishing this through regulatory changes.  As commented on in Kalorama's recent report on OTC drugs, the FDA is continuing to review prescription drugs for potential switches...leading to a boost in the OTC market.  Several products are in discussions including those for pain, overactive bladder, an emergency kit for bacterial infections, cholesterol, high blood pressure and migraines.  

The FDA has outlined several methods of improving the flow of switches to the market including new ways of dosing existing Rx products, new indications for Rx products that may be suitable for OTC, and Rx-to-OTC switches for products reaching patent expirations and are OTC compatible.  

A meeting in November 2012 with the FDA will evaluate oxybutynin transdermal system for OTC use as a treatment for overactive bladder in women.

Kalorama Information’s report Over the Counter (OTC) Drug Markets includes incidence of conditions which are often treated with OTC medicines, health statistics related to the industry, birth rates, world population, populations by region and issues affecting the market as a whole. Information is presented as a worldwide overview, with special emphasis on the U.S., Japan, Germany, and other key markets. The market segments provide an overview of demographics, overview of products available in each region, market estimates and forecasts. Additionally, a competitive analysis of leading providers and profiles of providers is covered. Information on the report can be found at:http://www.kaloramainformation.com/Counter-OTC-Drugs-6923618/