Behind-the-Counter Availability of Certain Drugs – A Report from the Public Meeting at the FDA

Maria Marzella Sulli, PharmD

On November 14, 2007, the FDA held a public meeting to collect opinions on whether there should be "behind-the-counter" availability of certain drugs. If you are interested in self-care and nonprescription medicines, you know that this is an issue that has been debated for many years, and has resurfaced recently following the approval of Plan B as a "pharmacist-only" nonprescription product.

I had the opportunity to attend the public meeting, and wanted to share my experience with colleagues who may be interested. I have gained tremendous insight into the processes that govern our practice as pharmacists and learned just how important it is to be aware and be involved. In over 10 years as a pharmacist actively involved in the profession through organizations and academia, I had no prior knowledge of the inner workings of the FDA and how the decisions that shape our everyday work life are made. Many pharmacists I have spoken to since the meeting have shared with me that they were unaware of how to have their voices heard on certain issues. Not knowing what to expect when we signed on to present at the Public Meeting, I am hoping the reader will be able to gain some insight into what happens and how they can become more involved in the process.

The meeting opened at 8 a.m. with brief introductions to the topic by the Deputy Commissioner for Policy of the FDA and the Deputy Director of CDER for the FDA. With the background information presented, the meeting moved on to the public forum portion. The first round of speakers represented various professional organizations. The pharmacy organizations included APhA, ASHP, NCPA, and ACCP and all spoke of the value of the pharmacist and the need for this important class of medications that could improve patient's access to needed medications in a timely manner. The American Medical Association also sent a representative, and their position on the issue was not as favorable, citing that the FDA would not have the authority to create a third class of medications, and that the meeting was unnecessary.

The second panel of presenters, of which I was included, represented various academic institutions, as well as the Consumer Healthcare Products Association (CHPA) and the National Association of Boards of Pharmacy (NABP). Speaking for the Institute of Public Health and Pharmacy, Dr. Stuart Capper extolled the value this third class of medications would have on public health. Our presentation from St. John's focused on the training and education of pharmacists, highlighting the ACPE Standards requirements for knowledge and skills relating to assisting self-treating patients and the tremendous amount of preparation pharmacy students get during their education that would prepare them to handle the demands of overseeing this class of medications. Closing that session, the CHPA, who represent nonprescription medicine manufacturers, voiced their opinion that the current regulations allow flexibility for the FDA and companies to provide different approaches in moving prescription to nonprescription status.

The rest of the day was full of various presenters from different organizations presenting viewpoints on whether they agreed or disagreed with the possible formation of the "behind-the-counter" class of medications. Most informative in my opinion, was the presentation from Ms. Brigitte Zirger of Health Canada who was invited to present the classification system Canada uses for their medications. In Canada, three "Schedules" of medication exist. Schedule I drugs require a prescription, Schedule II requires professional intervention from the pharmacist but do not require prescriptions, and Schedule III drugs are sold only in an area of the pharmacy that is under direct supervision of the pharmacist. For Schedule III drugs, the pharmacist is available, accessible, and approachable, but intervention is not required. Lastly, Canada also has an unscheduled category which would be equivalent to our over-the-counter products. No supervision or intervention is required, and patients are free to self-select. Adopting such a system in the US, would require the development of two new categories of medications, but in my eyes, would be ideal for both protection of the patient and freedom to choose.

Many questions remain on this issue. First and foremost is whether the FDA has the authority to develop a new class of medications or whether this will require Congressional action. Once this debate is settled, how medications will be allocated into the classes remains to be solved. From the presentations witnessed, it appears that a manufacturer would "apply" for the status they prefer, as was the case with Plan B. Once rejected from one class, they may consider reapplying for a different class. Now that the Plan B precedent has been set however, we may see other medications apply for similar classification regardless of any regulatory changes.

A third class of "pharmacist-only" medications is well overdue. In the end, what this class will be called or how the interactions between the pharmacist and patient will be handled, remain to be defined. It would serve our profession well to be actively involved in the process, and to voice our ability and willingness to talk with patients, evaluate need for therapy, and play an active role in the care of patients by documenting our interventions. Without this necessary element, I feel the third-class would be "wasted" and relegate pharmacists to simply checking patient identifications.

What the future holds for us remains uncertain. I truly believe we will see this happen in upcoming years, and hope pharmacists see this as an opportunity rather than a burden.