Research Catalyst does more than follow the rules; The legal and development teams work with the people who make the laws as to embody their intention. The regulatory environment concerning the use of social media for the promotion of pharmaceuticals is complex. A comprehensive understanding of not only the rules but also the intention of the law is imperative. Research Catalyst approaches the ethical considerations of patient education and marketing from a patient first perspective. All information provided must be accurate, truthful, complete, fair and balanced. The industry standard of fair balance for post FDA marketing generally includes an accurate representation of the indicated use, proven benefits, and potential side effects. Research Catalyst not only abides by the rules established to govern FDA approved marketing campaigns but also adhere to a stricter and more comprehensive set of guidelines designed for the medical research community. The set of principles most relevant to this discussion is generally known as the informed consent process. This ethical framework not only requires accurate and balanced information about a treatment option (indications, potential benefit and risks), but most notably incorporates education about other suitable opportunities the patient should consider that are not associated with the sponsored treatment. Broadly educating the patient about reasonable options such as support groups, exercise, physicians in their area, and other treatment opportunities not only protects clients but also gains the patients’ trust as their wellbeing is prioitized above financial incentive. Research Catalyst is not only doing what is compliant but also what is right.
This methodology goes well beyond what is required by law and actualizes the governing bodies vision as it relates to the incorporation of digital media to the patient education process. By placing the patient first and understanding both the laws and their intentions, Research Catalyst establishes the security to leverage internet technology with unprecedented results. Our clients are distanced in this way from the bleeding edge and stay firmly at the cutting edge. By educating patients broadly, trust is earned and the message is heard. Integrating the most ethical practices with the most sophisticated technology can produce the greatest reward for both the patient and the organizations that support them.
Research Catalyst has worked through the compliance issues with multiple Pharamcuetical companies and is able to share with your General Counsel, the legal support to develop an MSA and SOW that protects all parties.