FDA Will Meet to Address Possible Behind-The-Counter Drug Availability

October 8, 2007

On October 4, 2007, FDA issued a Federal Register notice announcing that the Agency will hold a public meeting to address the possible creation of a third category of drugs for the U.S. market – so-called Behind-the-Counter (“BTC”) drugs.  Such drugs would be available without a prescription, but only after intervention by a pharmacist.  Currently, the law only recognizes two categories of drugs – prescription and Over-the-Counter (“OTC”).  FDA states in the notice that the Agency would like to “explor[e] the public health benefit of certain drugs being available BTC that were previously prescription medications,” and that “BTC [drugs] could be comprised of certain medications available behind the counter at the pharmacy without a prescription and require the intervention of a pharmacist before dispensing.”  FDA seeks written comments on the BTC category by November 28, 2007.  The public meeting is scheduled for November 14, 2007.  Because seating is limited, people wishing to attend the meeting must register with FDA by November 5, 2007.

Several other countries, including Australia, Canada, France, New Zealand, United Kingdom, Denmark, Germany, Italy, Netherlands, Sweden, and Switzerland, already recognize BTC drug status.  These countries generally use the following criteria to determine whether a drug’s switch from prescription to BTC class is warranted:  “(1) [i]ndications suitable for self-medication, including self-diagnosis, with the intervention of a pharmacist and (2) the medicine has a low potential for side effects or overdose, and intervention by a pharmacist could minimize these risks.” 

FDA’s notice lists several issues that the Agency would like feedback on, including: (1) which drugs should be made available BTC and why; (2) whether BTC status should be used as a temporary or transitional status for drugs that move from prescription to OTC; (3) whether BTC availability will be cost-effective to patients; and (4) what impact BTC drugs will have on the practice of pharmacy.  Given the complex issues that a new BTC drug category raises, FDA will likely receive significant public input with widely varying points of view.  Indeed, there was considerable discussion and differing points of view expressed about BTC status in 2005 and 2006 when FDA considered various issues related to the prescription-to-OTC switch of the contraceptive drug PLAN B (levonorgestrel) Tablets.

Moreover, FDA has previously considered and declined to create BTC drug status.  Specifically, in 2003, Pharmacists Planning Service, Inc., a non-profit organization that promotes consumer public health education and pharmaceutical information, submitted a citizen petition to FDA (that was later amended) requesting that the Agency “switch Nicotrol Inhaler (Nicotine Inhalation System) from prescription only to [OTC] status TO BE SOLD ONLY UNDER A PHARMACIST’S SUPERVISION as a third class of drugs.”  FDA denied the petition in April 2004 in a 3-page response without substantively discussing BTC status.

By Cassandra A. Soltis

Categories: Drug Development