Being the “Responsible Person” (RP) is a big responsibility ( no pun intended). Whomever takes on that position needs to take it very seriously, because that person is responsible for interacting with and reporting to FDA adverse events (AE) and serious adverse events (SAE). This is not a “check box” type position, to be performed by anyone at the company with some free time.
Although FDA is not explicit about the professional qualifications of the RP, manufacturers are encouraged to “use trained health care professional to elicit information from reporters.” The RP may also use computer-assisted interview technology, targeting questionnaires and other methods. At the very minimum, the RP should document efforts to obtain the minimal elements, and seek the injured person’s permission to contact their health care practitioner (HCP).
The RP is a kind of medical detective, seeking to gain a clear understanding of what happened with the AE or SAE. This will involve asking questions of the person reporting the AE, and going beyond merely regurgitating what this person presented. The benefit of having a medical background is that there are many things that can cause an AE, such as medical conditions, medications or other supplements. In addition, in my opinion, people reporting an AE are more likely to give additional information if they are speaking with a qualified health care professional .
Aside from creating a high-quality narrative and mailing the MedWatch 3500 or 3500A form to FDA, realize that the RP may be required to talk or communicate in writing with FDA about a particular case or supplement. All correspondence for a particular case should be saved electronically or in hard-copy, and be accessible should the FDA auditor request it (they can and will!). Such a request to communicate with FDA may come completely out of the blue, so you need to be prepared.
As the RP, your first duty is to gather as much information as you can about the case and then write the narrative. At the core of your work is the safety of a supplement in a typical user. You need to communicate to the company that employs you that this is your primary responsibility. While you don’t want to communicate the AE in the worst possible light for a company, you must be factual and provide clear, concise information about the case, and not sugarcoat an AE. You will also communicate to your employer (the Supplement Company) that FDA expects to see AE, and if you consistently write high-quality narratives, FDA will have more confidence in the company. Over time, that will pay dividends.
So take your job as RP seriously – it’s an important one.
|Key Learning: Being the RP is an important position, one to be taken seriously. Do your job by carefully investigating and documenting cases, by going beyond the minimal elements approach, and by writing high-quality narratives that give the FDA reviewer a clear picture of the AE you are reporting.|