In March 2018, the Federal government started accepting public commentary on the Food and Drug Administration’s (FDA) “proposed collection of certain information by the Agency”. This was specifically related to the information submitted to MedWatch, the FDA’s reporting program that collects the reports of side effects (or, adverse drug reactions) all around the country from healthcare providers, pharmaceutical manufacturers, consumers/patients and loved ones of consumers/patients (not just for prescription drugs but also for over-the-counter medications and medical devices…separate reporting processes should be followed for vaccines and investigational drug reporting).  These reports are sent to the FDA/MedWatch via their electronic system, via phone or via mail or fax.

Public comments were due by May 15, 2018 and, luckily, I was able to just meet the deadline (thanks to a reminder added to my iPhone calendar weeks ago!).

It’s a great thing to comment on things that can impact our country and I didn’t want to miss this opportunity because I care deeply about how well we are reporting and monitoring adverse drug reactions.

The public announcement made it clear that the FDA was accepting public comments per law and that the deadline was going to be strict (no public comments were going to be allowed post-May 15).

“Okay”, I told myself.  Got it. Let’s do this.

So, tonight when it was time for me to finally submit my comments (which I’m not sure if they will accept by the way…apparently they need to accept the comment before it appears publicly here), I took to my laptop and let it rip.

Here’s what I wrote:

“Thank you for the opportunity to comment. I’m a public health professional, researcher, social change advocate, entrepreneur and I host a podcast on medications in America. On behalf of the millions of patients and consumers in the U.S. who are exposed to FDA-approved pharmaceutical medications everyday, I’d like to suggest multiple changes or modifications to Form 3500B (Consumer Voluntary Reporting form). My comments are less related to changes in existing wording on the form and more geared towards strong recommendation to ask patients for more information on the form. Given the fact that a) all medications have potential side effects, b) we do not know in the majority of cases whether or not a medication will be genetically advantageous for an individual at the point of prescribing, and c) there is a severe under reporting of adverse drug reactions to Medwatch with slightly over 1 million reports being submitted in 2016 although there were over 4 billion prescriptions written, my concern is that gaining as much information as possible on the small amount of information that we are receiving is paramount and will be incredibly informative. So, let’s start by asking for prescriber information. There are many reasons to ask for this type of information but one reason for asking for prescriber information is to allow the FDA to receive information at the point of direct consumer reporting via Medwatch to determine any physician trends of prescribing and to also allow for a more immediate data access of information on the form of who prescribed the medication to the consumer/patient (maybe there will be certain doctors prescribing medications more often than others, or maybe there will be doctors prescribing who have had prior concerns reported with their medical or prescribing practice and this can be identified). So for example, this can be added to the form as: “Who was the prescribing healthcare provider of this medication (i.e. add your physician’s name if the physician prescribed the medication to you)?”. Furthermore, to evaluate the patient’s understanding of what the medication was prescribed to treat and to also trend off-label prescribing (which can increase a person’s likelihood for adverse drug reactions), I would also like to recommend the following question be added: “What was the reason you were prescribed this medication?”. Lastly, to determine whether or not the consumer/patient is also engaging with their healthcare provider and whether or not that healthcare provider has reciprocated that engagement and to what degree, I’d like to suggest the following is added to the form: “Did you already report your adverse drug reactions, or suspected side effects, to your healthcare provider?” “If yes, when did you report to your healthcare provider?” “Did your healthcare provider suspect the medication was causing your reported adverse drug reactions?” “Did your doctor prescribe another medication to you as a result of your reporting of the adverse drug reactions?”. I understand the FDA may have staff limitations when it comes to who can assess all reports that come into MedWatch if the incoming reports to Medwatch were to double or triple. However, we must meet the needs of the public health and if we have to increase staff presence, for the sake of public health, I think the U.S. government is poised to do that and the consumer population would support such agency support. Thank you for the opportunity to comment and I look forward to the upcoming changes to Form 3500B.”

Not sure if I covered everything and I literally wrote this on the fly while prepping my kids for bedtime but, again, I wanted to comment and contribute. However, let me also say that…I especially wanted to comment when I noticed there were only 12 comments displayed for public viewing (although only 6 were from this most recent round of comment that opened in March 2018).  Only 12 from a country of over 300 million people.

In the defense of this seemingly dismal public comment rate, maybe there are more comments in queue not yet public or submitted anonymously and I don’t expect the millions of children and teens in the U.S. to comment either (so that takes out millions of U.S. residents who would be likely to comment right there). I also don’t expect that people who think the MedWatch forms are fine “as is” would comment either. Additionally, I have to imagine that there is a large portion of our population that 1) knows nothing about the MedWatch form or reporting system’s existence and/or 2) had no idea that public comments were even being requested.

Personally, I just so happened to know about this because I am often on Twitter doing research for the show (trying to stay connected to the key players in our vast American healthcare system, keeping my eyes and ears as close to the ground on what consumers are saying or questioning about prescription drugs) and came across a tweet from the FDA about this invite for public comments.

Looking at the 12 public comments before I submitted mine, I found it interesting to see how some people submitted comments right in the text box for public comment (which is what I did), while others wrote a letter and submitted a pdf file to the comments page.  These pdf letters were accessible by the public.

Anyway, the point within my public comment was not to make consumers work harder in submitting their reports by adding so many more fields but to make sure as much information is available at that first point of reporting.  As someone who has worked in research I know how much data moves the needle when it comes to decision making in a timely fashion and I also know how hard it can be to try gaining more information on the follow up of an initial report, especially a safety report.

Furthermore, my suggested questions to add to Form 3500B were just that: suggestions. The FDA will need to make the tough decisions on what’s relevant and what’s not relevant in the final modifications to their MedWatch forms and, if my understanding is correct, that is their responsibility to make.  Where my questions purely address prescription pharmaceuticals, the form does serve multiple purposes since it addresses over-the-counter medications and medical devices too.  So, clearly the correct, blanket terminology will need to be used as appropriate.

I am not sure when the changes will be made to any of the MedWatch forms, but I am looking forward to what comes out and I am hopeful that the team over at the FDA will make the best decisions that will ultimately serve the public health of consumers first and foremost.

Let’s all stay tuned.

~Mika