How to Successfully Launch a Rx Product in the US Spotlight on: Packaging Graphics and Labeling
Launching your Rx product into the US market can be a lot like trying to land a fighter jet on the pitching deck of an aircraft carrier in the middle of a raging storm. You need to know and trust that there is a team of experienced people on that carrier that will support you in your approach and keep you from ending up in the sea.
I’ve led many successful Rx product launches for leading pharmaceutical companies and I want to share with you some of the packaging knowledge and experience I’ve gained to help ensure that this part of your launch goes well. Although it’s a small part of the launch, every other part depends on the packaging and it’s vital that you get this right.
Looking at our development timeline, we identify two targets for major deliverables:
1. Regulatory Submission
- Despite the fact that approval and launch are our ultimate goal, every activity through Phase 3 drug development, including packaging development, is focused on submission
- Although actual Regulatory Submission occurs 12 months prior to approval, graphics and labeling development should start 24-28 months prior to submission to ensure enough time for discussion with FDA and regulatory procedures and related artwork draft changes
If you can’t begin development this early in the process, when should you panic? If you’ve followed our advice and worked with the team, you’ll never need to panic: late arrival of artwork content and concepts stresses the process and strains resources but it can be overcome.
2. FDA Approval
- There are 12 months between submission and approval and that time will be packed with activities: FDA will review the filing and provide comments which will necessitate artwork updates and sending the changes back to FDA which will generate more comments resulting in artwork changes…you get the picture! Artwork amendments need to be managed quickly to ensure FDA timeline remains intact…you need to be able trust your artwork team to get it done right first time.
- If accelerated review and approval is identified by FDA it will effectively halve the time for review condensing the duration of this activity from 12 months to about 6 months. Be prepared for this likelihood!
- FDA comments always seem to come on Friday afternoons or the afternoon just before holidays. Be prepared for some night, weekend and holiday work to turn around artwork changes!
Often design firms will be engaged to create a comprehensive design portfolio for a new product, including packaging graphics designs. These artworks are created to look good for presentations on screen but will frequently be a nightmare for packaging component production. If you have a competent artwork team at you disposal, engage them with the designer to ensure the designs meet spec. Better yet, engage a firm with pharma packaging production experience to deliver packaging graphics built to technical specification from the start.
As Pharmaceutical professionals, Patient Safety is always uppermost in our minds. When working up logo and package designs that you want FDA to accept easily, make Patient Safety your primary goal. Build a design that contributes to identification of the product and differentiation of dosage strength. Create clean, easy-to-read product and generic names without useless and promotional icons; use color judiciously, to make key information stand out, particularly dosage strength. Keep company branding to a minimum or place it on a side panel. Following this simple advice will not only provide a design that will avoid comments and rejection by FDA but will provide dispensers and end users with a safe and effective label.
Consider cost of goods and quality of materials when selecting graphic designs. When color is used on the packaging components, use solid colors with color reference numbers (think Pantone) and avoid the use of CMYK process match colors and vignettes or fades…these have caused quality rejections for me and they will for you, too. The fewer the colors the better…less colors usually equals less cost and a cleaner design.
As we consider the label content structure or the “anatomy of the label”, again and always consider patient safety: design to identify and differentiate the product and dosage. Clean and uncluttered designs using easy-to-read fonts that are not lightweight or condensed and sans serif (think HELVETICA) with a 12-point minimum size for primary and secondary labeling. For the primary panel make sure that the product name, the generic name and the dosage are prominent and that the company branding is not. Use color blocks or geometrics to draw attention to dosage strength and other very important information. Leave as much space as possible between blocks of text. For inserts, follow the formatting of the Physician’s Labeling Rule and minimum point sizes it prescribes: 6 point minimum for inserts going to patients and physicians, 8 point minimum for patient-only leaflets and 10 point minimum for medication guides. Again, preference is for the use of a sans serif font.
Because pharmaceutical packagers have encountered difficulty with implementing the requirements related to the US Drug Supply Chain Safety Act (USDSCSA) or “serialization,” a one-year extension was given taking implementation to November 26, 2018. Although it appears the troubles with implementation continue, consider November 2018 a hard date and be prepared…do not hope for another extension and be caught short! Aside from the paperwork and date reporting requirements, ensure that the salable unit of any product carries in the same field of view human readable representations of the NDC number or GTIN, the Lot Number, the Expiration Date and a 12- or 14-digit unique serial number. Also, in this same field of view, include a 2D data matrix code encoded with the exact same data showing in the human readable representations as mentioned before. Do this and your package will be USDSCSA-ready!
When you do receive approval for your new product you can accelerate launch and speed-to-market by purchasing some or all packaging components at risk. Rely on your regulatory affairs professionals to help you measure risk of comments coming with approval, and, even if you do receive some comments, it’s possible to negotiate implementation of those changes post approval so long as the comments are not related directly to patient safety.
In the end, there are three things to keep in mind that is the best new product introduction advice that I can give:
1. Keep PATIENT SAFETY uppermost in all you do
2. Know the NPI PROCESS and the STAKEHOLDERS
3. Trust the Expertise of your TEAM
Thanks and best of luck!
Article written by Lenny Figorski
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