Given the heightened scrutiny that pharmaceutical companies face in today’s marketplace, all communication is discoverable and could lead to increased regulatory penalties and negative publicity. Companies need to be proactive in providing training and guidance to ensure all interactions with healthcare professionals adhere to compliance requirements.
There is ample guidance in place that formalizes the process for documentation and the expectations associated with drug discovery, development, manufacturing, and approval. The issue is that the majority of pharmaceutical compliance related problems resulting in penalties, fines, and damaged company reputations are related to post-approval promotional activity(ies).
It is important for commercial leaders and compliance departments to always provide clear guidance, as well as to ensure regular enforcement of company expectations with regard to communication practices. This will determine the appropriateness and prevent missteps along the way. To jump start your compliant communications campaign, please see the “five” (5) tips listed below.
Five (5) tips for Compliant Communications:
- Be clear and specific: Clear writing ensures that your intended message cannot be misconstrued by others
- Show attention to detail: Watch out for phrasing that mischaracterizes conduct that is appropriate and compliant
- Be factual and formal: State facts, not opinions or emotions
- Think before you write: Remember that every document you create at your organization may become public
- Be simple and concise: Ensure final outcomes that close the loop are always documented
WLH Consulting, Inc. (“WLH”) has developed the Compliant Communications® Workshop and the W.R.I.T.E. It Right® Framework to reinforce communication skills that improve the quality of information shared, both internally and externally. Our solution will provide your organization with written communications and documentation training related to the following activities:
- Basic Communications (emails, texts, and generic documents)
- Call Plans and Post-Call Notes
- Business Plans
- Patient Information and Adverse Events
- Field Coaching Reports
- Requests for Medical Information