After Nearly 25 Years, Final OTC Monograph for Emergency Eye Products Sought
Posted 19 September 2013 | By
As Murphy's Law tells us, anything that can go wrong, will go wrong-a painfully obvious adage to anyone who has ever managed to expose their eyes to caustic or otherwise dangerous chemicals. Now the US Food and Drug Administration (FDA) is proposing a meeting to figure out how best to regulate the product needed to respond to such a calamity.
The products in question are known as emergency first aid eyewash drug products (EE products), and include a wide range of products used to treat ocular exposure to acids, alkalis, particulates or other hazards. The products are understood by FDA to be comprised of two component parts: the solution itself, and the delivery mechanism.
In an 18 September 2013 Federal Register notice, FDA explained that the solutions are currently on the market as both sterile and non-sterile formulations, and generally in two different forms. Ready-to-use products are pre-filled canisters or bags of solution which can be used rapidly, usually for small-volume purposes. Concentrated solutions and additives, meanwhile, are meant to be mixed with potable water for use in large-volume eyewash stations.
The products currently inhabit somewhat of a complicated place within FDA's regulatory framework, the agency explained.
FDA is currently considering the products for inclusion within an OTC drug monograph system, which would allow them to be manufactured and sold more easily so long as they adhered to the monograph and good manufacturing practices. The current monograph for OTC ophthalmic drug products was published in 1988, but notably calls for the products to be sterile.
However, the monograph never contained reference to EE products because safety and efficacy data had not been submitted to FDA at the time of its release. In 1989 FDA issued a call for such data, and in February 2003 proposed to amend the OTC monograph to include EE products through proposed rulemaking (PR) based on a positive assessment of the data it received.
However, the PR has never been finalized, and in the meantime FDA has been exercising what it calls "enforcement discretion"-in practical terms, meaning it won't go after manufacturers who act in good faith and in compliance with all other parts of the law-to permit EE products to be marketed as OTC products while the final monograph remains under development.
New Attempts to Finalize
Now, however, FDA says it believes additional data and information are required in order to finalize the OTC monograph, and has proposed holding a hearing on the subject. At issue: How should EE products be controlled with respect to formulation, manufacturing and labeling?
The 4 December 2013 meeting will reportedly focus on six core questions:
- What ingredients are necessary in EE formulations besides water? What are the functions of these other ingredients? What is the minimum and maximum quantity that should be allowed for these other ingredients?
- Are there any potential safety concerns or suitability issues with the use of ingredients other than water? What data are available to support the safety and suitability of EE ingredients other than water?
- What evidence supports the safety and effectiveness/suitability of antimicrobial preservatives when mixed with potable water to limit the presence of certain pathogenic microorganisms (such as Acanthamoeba, bacteria, or fungi)? For example, FDA is aware of published reports of Acanthamoeba having contaminated reservoir EE stations and been a source of infection in people who used these types of EE products (Refs. 1 and 2).
- Is there evidence that solutions made from EE products mixed with potable water are safer or more effective than potable water used alone? If not, what data would be needed to make that determination?
- What EE products or types of products are not currently manufactured and distributed as sterile? Are there EE products for which sterility is not necessary for safety? Why or why not?
- What directions for use are appropriate to ensure the safety and effectiveness of EE products for OTC use?
Federal Register Notice