How to Generate Excitement About Pipeline Products Without Legal Trouble — [Part 1 – Pre-Label Promo
Clinical-stage pharmaceutical, biotechnology and medical device companies need to generate “buzz” in order to attract investments to fund the costly clinical studies required for marketing approval.
But FDA regulations prohibit companies from promoting an investigational drug or device and securities regulations forbid them from making untrue statements or omitting material facts. Therefore, clinical-stage companies must excite investors while avoiding (i) express or implied claims of safety or efficacy, (ii) untrue statements or (iii) misleading omissions. Violations of FDA regulations and securities regulations can result in lawsuits, FDA response, fines, injunctions, consent decrees and criminal actions.
To help manage such risks, clinical-stage companies should have legal counsel review materials provided to investors as well as public statements (including companies’ websites), presentations and publications about pipeline products and clinical trial results. Additionally, companies should implement an appropriate compliance program, policies, trainings and monitoring (more on this in a later post). At the very least, all company personnel should be familiar with the laws and regulations discussed in this series of posts. Click here to read full article.