Submitting FDA Comments That Will Make A Difference
Earlier this spring the Food and Drug Administration (FDA) issued a call for scientific information and public comments regarding cannabis and cannabis products. This is an opportunity for us to impress the FDA with the quality of information available and hopefully prompt them to pay attention to what the science says about cannabis.
Unlike many kinds of advocacy however, FDA comments aren’t looking for passion, popularity or a depth of support. They only care about being presented rigorous research and relevant policy. The FDA has outlined specific questions that it wants answers and we need to do our best to answer them as accurately as possible without a lot of extraneous information. An example would be:
a) How should consumers be informed about the risks associated with such products (e.g., directions for use, warnings)? What specific risks should consumers be informed about? Are there any subpopulations for which additional warnings or restrictions are appropriate? Please explain your reasoning.
With that in mind here are some guidelines for writing an FDA comment that will be convincing to FDA regulators:
What to do
- DO read the submission guidelines carefully before submitting.
- DO include the docket number [FDA-2019-N-1482-0001] in the beginning of your comments either on a title page or in your introduction, especially if you mail them or submit them as an attached PDF.
- DO support your comments with scientific research. For example, instead of just describing how cannabis or cannabis-derived products helped your condition, look to see if there is research for other people with your condition to strengthen your anecdote.
- DO include your contact information if you want the FDA to be able to follow up with you on your comments. Providing your contact information is not required.
- DO read the comments Americans for Safe Access is submitting before writing your own to get inspiration and ideas.
What not to do
- DO NOT try to answer all of the FDA’s questions. Pick one (or a few) and make sure your answers stay on topic.
- DO NOT make up data. If there is limited research on an area you are addressing in your comments, indicate that more research is needed and that the FDA should allow this research to proceed unimpeded.
- DO NOT limit your comment to a personal story. Though well-intentioned, that does not provide the FDA with enough specifics to create regulations or policy.
- DO NOT use threatening, profane, or rude language.
Your comments do not need to be completed before the FDA hearing on May 31, 2019. In fact, you may hear information at the public hearing that you would like to incorporate into your comments. The FDA is accepting comments through July 2, 2019, and we will send periodic reminders about comment submission. So take your time and visit our website to read some examples and sign up for my webinar this Thursday (5/23) where I will be guiding you through the commenting process. This is a great opportunity for advocates and we want to help you make the most of it!