For companies with marketed medicinal products, it would be difficult to imagine a time when labeling changes or updates wouldn’t be occurring. Since labeling requirements extend to any and all written, printed or graphic material associated with a product, this necessitates a seemingly endless review cycle to ensure that appropriate changes are implemented whenever there is new safety information or new requirements are issued from Health Authorities (HAs). For any pharmaceutical company, these ongoing changes require constant vigilance and well-defined processes for coordinating all aspects of labeling.
But for generics companies there are additional complications because of the requirement to maintain consistency across the board with branded comparator drugs. Generics companies are required to update their labeling as soon as possible once a branded label has been revised and approved. This means that it is critical for generics companies to have procedures in place to regularly and consistently check labeling updates. Unfortunately, all too often this isn’t happening. Labeling changes are ubiquitous, making it a demanding, time-intensive and cost-intensive exercise, and many smaller companies just don’t have personnel resources to stay on top of labeling changes.
While the challenges are undeniable, there are processes generics companies can put in place to ensure they’re aware of labeling updates to the branded product and are remaining compliant with the requirements.
One simple step generics companies should be adopting is to regularly check the US Food and Drug Administration’s (FDA) website and the DailyMed website maintained by the U.S. National Library of Medicine to see when any new labeling or changes to the label have been approved. To simplify the process, companies can subscribe to receive email updates when labeling is approved for their products or when other updates occur.
Another simple step companies can take is to monitor the websites of companies who own branded comparator drugs and download the labeling to make sure they have the most current and relevant details from the prescribing information.
In addition to staying vigilant, generics companies should have robust procedures in place to ensure once they have identified changes that need to be made they go through the proper change control procedures – you can’t arbitrarily make changes to the content on your website or package.
After going through the change control process, the FDA needs to be notified when there are labeling changes. How quickly those changes can be made depends on whether it is a prior approval supplement or whether the product falls under the changes being effected (CBE) 0 or CBE 30 categories – meaning the changes can be implemented immediately (in 0 days) or the company needs to wait 30 days to hear from the FDA before implementing. If the changes are very minor (editorial changes, such as adding a distributor’s name) the company can send a summary of the changes in their annual report.
Removing the Stress
While all these processes are important, there remain challenges around lack of resources or know-how. Working with a partner experienced in all aspects of labeling can alleviate many of the complexities generics companies face. One example is the Structure Product Labeling (SPL) requirement for submitting drug listing information to the FDA to ensure consistency in format for labeling documents.
The problem for generics companies – particularly smaller and mid-sized companies – is that SPL software is expensive and requires regular updates. Purchasing the software and bringing in the personnel with the expertise to deal with the requirements is an additional burden.
Partnering can vastly simplify these processes for generics companies, removing the burden, ensuring consistency of processes, and lifting many of the costs associated with retaining the technology and experienced personnel in-house.
Learn more about labeling capabilities and requirements and what approach makes most sense for your company by listening to our recent webinar.
Diane Gross is Life Sciences Regulatory Consulting, CSC