FDA Drug Labeling Requirements & Regulations: What’s in Your Label?

Why Does Pharmaceutical Product Labeling Matter?

Do you know what’s in your product’s labeling and what it is saying about your product? More importantly, do you know why that matters?

A drug’s label is the product’s calling card and story, the face of your product not only to a regulatory agency but the world. The label is also the driver for your promotional claims and reimbursement activities. This includes both the physician prescribing information and the patient labeling.

Having the most amazing clinical trial data, being first to market or first type of therapy only goes so far. The next critical step is having a label that adequately and appropriately provides the prescribing physician and patient/caregivers with this information.

Your product’s story shouldn’t be the last thing you work on – it’s far too important. It should be front and center as part of any drug development plan and submission activities.

Your product has a story to tell. Do you know what it’s saying?

Prioritizing Drug Labeling – Why the Afterthought Approach Doesn’t End Well

Ask anyone working on a product’s development what the process entails, and you will get a variety of answers -everything from disease state to clinical trial development and manufacturing processes. Rarely is the product’s labeling ever mentioned.

Too many times the drug label is the last thing thought of in the continuum of product development. This afterthought approach usually doesn’t end well as the outcome results in a rushed and hurried timeline to crank out a label to meet submission deadlines.

This results in your story being incomplete and key messaging lost. The longer-term consequences are a negative impact to your promotional messaging and reimbursement options – both crucial elements to any product’s post approval success.

You only get one shot at making a great label, and if you fall short of excellence you will forever live with a sub-par label. Once a label is approved by FDA, it’s very difficult, if not impossible, to make any substantive changes to improve the content.

These are all key reasons as to why drug labeling should always be part of the equation early and often in product and submission development.

What Can a Great Label Do For You?

An adequate or acceptable label meets all of FDA’s drug labeling requirements regarding content. But your label is so much more than that. Your label says everything about your product and is the face of your product not only to regulatory agency but to healthcare providers, patients, and caregivers. It is your product’s calling card – telling everyone what they need to know about the product and, when applicable, what separates your product from your competitors.  

A great label goes beyond the basics of just providing the required information, it becomes the storyteller for your product. It owns the narrative not only through the way the data is organized and articulated but also how key messaging is incorporated within the label. This empowers the marketing team to create promotional pieces that are unique, compelling, and compliant.

The narrative also includes the appropriate and necessary wording to support reimbursement, thereby helping patients who need your product have access to it.

Great labeling doesn’t happen by chance, and it certainly doesn’t happen when labeling is an afterthought. Great labeling is thoughtful, intentional and is woven throughout the product development process, starting with your trial design. Assuming trial success, key labeling sections can be drafted based on your proposed primary and secondary endpoints, giving your team early insights into what your labeling may look like. If this is done prior to the finalization of the trial design, your team may make subtle but important changes to the design that may positively impact the label once the product is approved.

Own your label – don’t let it own you.

Living with Your Label – The Long-Term Commitment of Product Labels

Congratulations – you wrapped up the submission review process and received FDA approval for your labeling. But now that you have your approved label, is it the label you want, but more importantly, need?

Your product label is a long-term commitment as the label is viable for the lifetime of your product. Once approved, it’s very difficult, if not impossible, to have FDA accept any substantive changes that would potentially improve the content of your label.

ProPharma: Expert Drug Product Labeling Consultants

Labels are an integral part of any product submission. They are the one place where everything about your product comes together. It’s how prescribers and patients learn about your product. 
How you tell your story is critical to specific post-approval activities such as advertising and promotional products and reimbursement. Labels should never be an afterthought to a submission as they are a long-term commitment spanning the entire life of your product. Remember, good labels can only get better, but bad labels will forever be just that. Bad.

Wherever your label is in the process, we can assist you in the labeling journey. From not yet written, still being worked on, or approved and being supported by lifecycle management activities, we can assist with all of your labeling needs. Using our proprietary Prodigy Labeling solution, ProPharma’s team of regulatory consultants is able to provide prior precedent and competitor insights.

Our global team of expert regulatory consultants brings unique and unparalleled expertise to the table and can assist with all of your global regulatory affairs needs. Interested in learning more? Contact us today.