On Friday evening, FDA presented a proposal that could create a major opportunity for pharmacists to improve public health, much as we’ve done with immunizations.

The title of this “Notice of public hearing; request for comments” is Using Innovative Technologies and Other Conditions of Safe Use To Expand Which Drug Products Can Be Considered Nonprescription. What this means is that FDA is considering ways to make the distinction between prescription drugs and OTC less rigid so that needed drugs are available to patients under “conditions of safe use” such as requiring an interaction with a pharmacist before the medicine can be purchased.

Based on our conversations with FDA, we know they are seriously interested in ways to improve public health and reduce harm from untreated disease, and they believe pharmacists have a key role to play. APhA will be reaching out to other organizations as we prepare comments. I encourage you to read the notice and open the link in the notice. What do YOU think?

Here’s the notice from FDA:

Dear Colleague,

The U.S. Food and Drug Administration (FDA) is announcing a public hearing to obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use. These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined healthcare settings, such as a pharmacy. This public hearing is being held to obtain information and comments from the public on the feasibility of this paradigm and its potential benefits and costs.

DATES: Public Hearing: The public hearing will be held on March 22 and 23, 2012, from 9 a.m. to 4 p.m. at FDA's White Oak Campus in Silver Spring, Maryland. The meeting may be extended or may end early depending on the level of public participation. Submit either electronic or written requests for oral presentations and comments by March 9, 2012. Additional meeting information is available at http://www.fda.gov/Drugs/NewsEvents/ucm289290.htm where an advance notice of the Federal Register Notice is displayed.

Thank you for your support of FDA and its mission. We look forward to your participation in this meeting.