Over-the-Counter Drug “New Paradigm” Coming–FDA Urges Patience

IMG_0148.JPG On May 11, FDA reportedly told attendees of the Consumer Healthcare Product Association’s Regulatory & Scientific Conference in Washington, D.C. to be patient while FDA implements its “new paradigm” for prescription to over-the-counter (“Rx-to-OTC”) switch applications (The Tan Sheet (May 21, 2012). Andrea Leonard-Segal, M.D., Director, Division of Nonprescription Clinical Evaluation, Office of Nonprescription Products, Center for Drug Evaluation and Research, said that FDA’s anticipated, revised Rx-to-OTC regulations will allow for expanded conditions of safe nonprescription use.

Leonard-Segal acknowledged, however, that the process will take time, warning “if you submit [a new drug application] where we don’t have the regulations to support the switch, if you’re ahead of your time compared to the regulations, then I think the project won’t go where you want it to go.” While waiting for FDA to final the regulations, Leonard-Segal suggested that firms make business decisions about initiating switch programs that employ new diagnostic technologies and other measures, according to their internal estimate project timelines. Leonard-Segal, however, sympathized with sponsors that had failed to meet FDA’s current, less flexible regulations that only permit OTC conversions where the Drug Facts label has full comprehension. An example of failed Rx-to-OTC switches cited was statins to lower cholesterol, but other categories of products that may benefit from the new regulations are sleep aids and triptans to treat migraines.

Commenting further, Leonard-Segal said at the Conference: “One of the frustrations of being in the switch business . . . has been watching the regulations interfere with, what in my perspective have been some very interesting and very innovative ideas, but that just can’t move forward because the regulations don’t allow us to go there.” Leonard-Segal further noted that a priority for the new regulations will be to consider how diagnostic devices could work together with OTC drugs, which is currently a complex approval process involving multiple centers and considerations.

As we previously reported here, FDA has been seeking input from industry and the public regarding how FDA should modify its Rx-to-OTC regulations to permit additional drugs become available OTC, including a public hearing on March 22-23, 2012, and comments to be filed to its Dockets Management by May 7. FDA has expressed concern that individuals may choose to not fill prescriptions or seek appropriate pharmaceuticals due to barriers filling prescriptions at pharmacies following physician visits. A companion concern, however, is whether individuals can self-diagnose or effectively participate with a kiosk or other non-physician interface for conditions such as hypertension, high cholesterol, asthma, or migraine headaches.

So how long with the OTC industry and consumers have to wait for FDA’s regulations? FDA will first have to consider all of the comments that it has received, then post draft regulations in The Federal Register, before finalizing them, again with an announcement in The Federal Register. Because FDA is under no mandate to finalize these regulations, the process could still take more time than many in the OTC industry or consumers would like to wait. For chronic medications, moreover, FDA should consider the companion impact on an individual’s health care plan co-pays for OTC drugs, which in many cases do not cover OTC drugs but do for Rx drugs. FDA’s new regulations could then run counter to what FDA has intended by creating financial barriers for individuals to choose other necessities over pharmaceuticals.