By Joe Keenan, director of business development for MWV's Healthcare Div.
This fall, the U.S. Consumer Product Safety Commission (CPSC) will vote on a proposed new regulation to require child-resistant packaging for over-the-counter (OTC) or prescription (Rx) drug products containing the equivalent of 0.08 milligrams or more of imidazoline class active ingredients in a single package. The CPSC has initiated this change in response to more than 5,000 adverse events reported between January 2007 and December 2009 that relate to the ingestion of imidazoline products by children under the age of five years1.
This ruling will affect products currently on the market, as well as many pending market launch.
On Jan. 25, 2012, the CPSC proposed a rule to require CR packaging for any OTC or Rx products containing the equivalent of 0.08 milligrams or more of an imidazoline, a class of drugs that includes Tetrahydrozoline, Naphazoline, Oxymetazoline and Xylometazoline, in a single package2. Imidazolines are a family of drugs that are vasoconstrictors indicated for nasal congestion and/or ophthalmic irritation. Products containing imidazolines can cause serious adverse reactions, such as central nervous system depression, decreased heart rate, and depressed ventilation in children who accidentally ingest them.
Responses from industry have been received and it is anticipated that the CPSC will issue its final ruling no later than Dec. 31, 2012. Based upon industry comments filed and CPSC indicated considerations, it is expected that the compliance date will be 12 months from the ruling posting. It is also likely that CPSC will grant an additional 12 month extension in recognition of compliance challenges.
Implications for manufacturers
This new regulatory extension will likely impact the sale of circa 60 million units of product currently sold in the U.S. on an annual basis. Unless they have already taken the initiative in anticipation of the final ruling, manufacturers of these products may be under a tight timeline to meet the expected deadlines imposed by the CPSC.
The challenge to meet this regulation is not trivial. Manufacturers will need to embark on a formal development program, in partnership with their packaging suppliers, to identify, develop, verify and validate the best CR solution for their product before they can industrialize and bring to market an appropriate solution.
The ideal CR solution should:
• Balance an effective child-resistant solution with senior-friendly ease of opening.
• Encourage or make unnecessary the reengagement of the CR feature when product not in use.
• Improve the customer experience with the product rather than degrading it, taking into consideration ergonomics and additional features to improve patient experience
• Have a minimal impact on cost of goods.
• Have a minimal impact on the existing packaging assembly line.
• Provide opportunity to rebrand product with exclusive design to capture market share.
Manufacturers will need to work closely with their packaging suppliers to determine a CR solution concept that best suits their marketed product.
Once a concept or multiple concepts are chosen for progression, a multi-loop process of design optimization will need to be performed. This process will incorporate a series of prototyping and design review iterations, finishing with the manufacture of single tool injection molds (in the scenario where the CR is plastic components) to generate production-worthy devices for consumer insight and CR testing.
Once satisfactory results have been achieved and the cross-functional project team has frozen the design, the project will enter the industrialization stage.
The manufacturer may need to invest in additions and/or changes to filling and final packaging lines to accommodate the new design. They will also need to make changes to their labeling to incorporate how to operate the CR function. All this has to occur in a well-coordinated manner to ensure no stoppage in the supply of product to the marketplace.
As the newly CR-packaged product makes its way into market distribution, manufacturers will likely need to embark on a marketing campaign. Change, even if for the better, is typically hard on consumers—especially with products that haven't significantly changed in years. Therefore, manufacturers will need to interface with consumers, pharmacists, advocacy groups and other parties to bring awareness to the new packaging to mitigate negative market reaction.
The Yin and the Yang
Most agree that the new regulation, once imposed, will be a good thing in that it will help mitigate risk to our children.
Without a doubt, it will also pose a significant financial burden on manufacturers. Investment in the change required to comply with the new regulation will be considerable.
However, as the saying goes, "the rising tide raises all ships." The regulation is not biased; therefore, all manufacturers will need to comply, giving no unfair advantage to one manufacturer. Since the CPSC does not choose or designate favorite CR solutions, manufacturers may see this regulatory development as an opportunity to invest in their product; not just a change to comply with regulations, but a change to differentiate their product in order to capture more market share.
Joe Keenan has more than 20 years of experience in R&D and project management. He has been awarded six U.S. patents and brought 40+ medical devices to market. He holds a Masters in Biomedical Engineering from Worcester Polytechnic Institute and an MBA from Babson College.
1 Statement of Commissioner Robert S. Adler Regarding the Notice of Proposed Rulemaking Requiring Child-Resistant Packaging for Imidazolines, CPSC, Jan. 19, 2012
2 CPSC Docket No. CPSC-2012-0005
Source: MeadWestvaco Corp. (MWV)