Ad Technology

Putting A Label On It: Editing Drug Labels On All Fronts

Amanda HeadshotThe pharmaceutical drug industry is one of the most highly regulated markets to exist and this is no surprise to marketers and consumers alike. The US Food and Drug Administration (FDA) regulates pharmaceutical manufacturers to ensure the safety and efficacy of drugs, from the initial stages of conception to post FDA approval. Pharma companies must be extremely compliant to the FDA, especially in the midst of change.

All pharmaceutical drugs are given a label, which guides the safety and effectiveness of an FDA approved drug. Drug labels contain the generic name of the drug, the year of its first FDA approval, black box warnings (if applicable), approved indications, dosage details, side effects and so on. Drug labels are developed by the drug’s manufacturer, but of course, final approvals come from the FDA (often as a result of multiple rounds of revisions). Being one of the most regulated markets, pharma companies must ensure that their drug labels reflect the most up-to-date and accurate information. So, if a prescription drug experiences any change, including but not limited to new side effects, new ways of dosing, or new uses for the drug, the label must be updated to reflect that.

But as you may have guessed, this is more than just a quick edit slapping it onto the bottles. There is a process that pharma companies must abide by. First the pharmaceutical company must send the proposed label changes to the FDA for their review. These changes are often rooted in recent studies and data. Secondly, the FDA reviews and scrutinizes every phrase within the proposed label to ensure all statements are accurate and informative. The FDA will then send the necessary edits back to the manufacture to implement. From there, the pharma company must make the required revisions and send the updated label back to FDA for their final approval. Once approval has been granted by the FDA, the drug manufacturer is responsible for printing and distributing the new label.

More than a thousand drugs have had their labels changed or have been taken off the market completely, in an effort to keep prescription drugs safe and effective. However, these label changes have rippling effects on how the drug can be marketed and advertised.

Once a new drug label has been final approved by the FDA, the updated language must then be integrated into any promotional and advertisement materials to remain compliant with the law. But again, this requires nearly seamless coordination between multiple parties: regulatory team, brand team, creative agency, media agency, and media partners.

The updated label language that will live within each advertisement must also be reviewed by the pharma company’s regulatory team before being pushed live. However, advertisements aren’t the only pieces that need to be revised to incorporate the new label language. It is the brand team’s responsibility to prioritize which elements should be reviewed in regulatory first, second, third, and so forth. While the pharma company is waiting for the green light from the FDA, the creative agency must be working in tandem to update the necessary creative pieces to reflect the revised language, whether it be updated dosing or side effect information.

As soon as the FDA gives their final blessing, the creative agency must be ready to hit the trigger to submit the prioritized elements to regulatory to avoid wasting time. Assuming some creative is already running, the new assets will need to be swapped in as soon as possible so that the most accurate label information is in market. The media agency must be in constant communication with the individual media partners to understand when the updated creative can be swapped into the plan. Depending on the existing media programs, creative can be incorporated instantly or partners may ask for a few weeks’ time. It is up to the media partners to coordinate the timing required by partners and the hand off of materials by the creative agency in a timely manner. Typically, there is a “grace period” for new materials with the up-to-date label to enter the market. But if a pharma company does not comply with the grace period, taking longer than the FDA deems necessary, there will be consequences.

Pharma ads can violate the law in a variety of ways. From stating that a drug can treat a condition that the FDA has not approved the drug for to making claims not backed by evidence to overstating the drug’s benefits, advertisers must be extremely careful in how the drug is marketed. Ads must be transparent regarding the drug’s risk information; therefore all prescribing information must be 100% clear and accurate. If outdated information is found within an advertisement outside of time determined as the grace period, the ad violates the law.

The FDA has a few ways to enforce laws related to pharmaceutical drug advertising. The most common is that the FDA will send a letter to the pharma company explaining how the ad has violated the law and asking the company to remove the ad. If the violation is extreme, the FDA will require the drug company to fix the misimpression made by the ad, which would be to create and run a corrective ad. Worst case scenario is that the FDA will take the drug company to court or taking supplies of the drug from the manufacturer.

As the pharma industry continues to advance, drugs will continue to change and adapt. This means that label changes will naturally be a part of this cycle. To avoid receiving a letter from the FDA, label changes must be acted on in a timely fashion with the coordination of all those involved.