Guidelines for Adverse Event Reporting: The Pharmaceutical Market Research Context
Pharmaceutical marketing research and data analytics companies should not be required to assume responsibility for formal reporting of adverse events (AEs) uncovered during routine pharmaceutical marketing research and data analytics in the U.S. because:
- it is not a methodologically sound or practical approach to post-marketing surveillance;
- there is no pharma industry consensus on the proper interpretation of the federal regulations; and
- such reporting has the potential to jeopardize marketing research (and thus compromise the marketing research and data analytics function) in the pharmaceutical industry.
Given that some pharmaceutical and medical device companies have interpreted the regulations to require AE reporting of their research and analytics providers, a marketing research and data analytics company that accepts this responsibility for reporting AEs should, at a minimum, obtain contractual terms that:
- Fully specify all the conditions and procedures associated with those adverse reporting requirements, including procedures to be taken if the respondents/participants refuse permission to cooperate in the reporting process;
- Endorse a policy that affirms the obligation to protect respondent confidentiality and expressly avoid pressing respondents/participants to disclose any information they do not freely choose to disclose;
- Fully waive and indemnify the research and analytics company against any and all legal liabilities arising from its AE reporting responsibilities; and
- Compensate the research company fully for any and all additional expenses associated with accepting and executing the AE reporting requirements.
Such contract terms extend some measure of legal protection to marketing research and data analytics companies and help to safeguard the ethical integrity of the research process, but they do not overcome the Insights Association’s overriding concerns about the potential risks of requiring routine pharmaceutical marketing research and data analytics studies to serve as a direct instrument of the “pharmacovigilence” process.
The market research and data analytics industry is best-equipped to advance pharmacovigilence by encouraging voluntary reporting by physicians and patients. Recognizing that the industry’s extensive contact with patients and physicians puts us in a unique position to encourage and facilitate AE reporting by those who experience them and the medical professionals who observe them, the Insights Association recommends that research and analytics companies play an indirect role, by reminding respondents of the importance of AE reporting and providing them with information to help them do so.
This information is not intended and should not be construed as or substituted for legal advice. It is provided for informational purposes only. It is advisable to consult with your attorney on the precise scope and interpretation of any laws/regulation/legislation and their impact on your particular business.
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