Advertising and Promotion: Time for an Update?

By Nathan Downing

A New Year Invites a Fresh Start

The advertising and promotion process creates many headaches for medtech companies. The start of a new year is a natural time to assess whether your current process is working as intended or creating unnecessary friction. Companies should assess whether the right experts are at the table, whether the process enables efficiency, and whether their process for creating and vetting claims is disciplined and defensible. Addressing these areas can improve both compliance and the quality of promotional output for your medical products.

Experts at the Table

Creating compliant and compelling messaging requires experts who understand the product, FDA labeling, and available evidence to substantiate claims consistent with the labeling. At a minimum, review teams should include the content creator and experts from legal, regulatory, and medical affairs. Depending on the information in the piece, additional subject-matter experts, such as engineering or reimbursement specialists, may also be necessary additions.

Just as important as expertise is time. Many companies have knowledgeable reviewers, but fail to afford enough time to properly review material. When approvers have a dedicated role on the review team, the process typically is smoother and results in more impactful pieces. Getting the right people at the table, including creators and reviewers, with the proper resourcing, is the first step to a quality advertising and promotion process.

Smart Procedures

Any company marketing a medical product should have proper procedures in place to consistently create compliant materials. Those procedures should be detailed enough to prove that following them will result in compliant material and will withstand audit scrutiny. Overly rigid procedures can also create risk. For example, including the exact temporal path each piece will follow can leave a procedure open to unnecessary noncompliance considerations. Procedures should align with the type of medical product being promoted as well as the applicable geographies, while allowing reasonable flexibility.

Additionally, procedures should be clear on the roles of reviewers. A well-written procedure can limit work by clearly identifying what material requires which reviewers instead of defaulting to universal review for all pieces. Procedures should also accommodate time-sensitive marketing needs as necessary while documenting adherence to that prescribed process.

Claims: The Battle Between Creators and Approvers

The ultimate goal of any marketing team is to provide balanced claims that fully convey the benefits of the product so the proper patients can receive treatment. These claims should be balanced using disclaimers and risk information while including substantiation to support the truthfulness of the claim. While that sounds easy, individuals on review committees know the effort it takes to finalize marketing language.

Quality claims development requires pre-planning and partnership. Before drafting claims, teams should align on FDA labeling and available substantiation. Tools like claims matrices detailing the exact language, use cases, substantiation, and any required context can help companies work through claims and assess their acceptability. All members of the team must be responsible for the claim and its compliance. The ultimate goal is to help healthcare providers treat the right patients, and the content creators and reviewers all play a role in this effort.

How Gardner Law Can Help

If your advertising and promotion process is creating inefficiencies or compliance concerns, contact Gardner Law. Our team of regulatory and compliance experts work with companies to streamline review processes, clarify procedures, and strengthen claims development. Promotional material is your company’s interface with the world, and the process behind them must be equal to the challenge.