What is the first action a regulatory affairs professional should take upon discovering an off-label indication in promotional materials?

The appropriate first action for a regulatory affairs professional upon discovering off-label indications in promotional materials is to communicate with the sales department to stop using those materials. This step is crucial because it addresses the potential for regulatory violations and protects both the company and healthcare providers from the risks associated with off-label promotion.

When promotional materials include off-label indications, it raises significant concerns regarding compliance with regulatory guidelines set forth by authorities such as the FDA. Promoting a product for indications that are not approved can lead to legal ramifications, such as fines or damage to the company's reputation. By promptly informing the sales department to cease the use of these materials, the regulatory affairs professional can mitigate risks and ensure that the company adheres to ethical marketing practices.

This action prioritizes compliance and serves to realign the promotional strategy with approved labeling, which is essential in maintaining integrity in all communications with healthcare professionals. The other options may imply a misunderstanding of regulatory obligations—such as allowing off-label use or contacting doctors without addressing the promotional compliance issue first—thereby not effectively managing the immediate concern of unauthorized promotional practices.