FDASM: Report Out: Best Practices for Docket Comments (Melissa Levine)


Continuing our reporting out from the FDASM Forum on Tuesday, I hope to talk through my muddled memories of the high points from individual speakers. My memory doesn’t work so good these days, and I had no way to take notes since I was moderating the event, my computer was wired to the podium, and I was jumping up and down a lot (not like jumping jacks, but sometimes it felt like it). I’m not going in presentation order because some of the speakers are more vivid in my mind, or have given me their notes, making it easier to talk about what they said.

Today, I want to talk about Melissa Levine’s presentation, because we are really hoping people will file comments in the docket, and she gave some really helpful information on how to do that.

FDASM Forum: Melissa Levine

I very much liked what Melissa said about how to approach filing comment for a docket. She is a lawyer, she worked in DC in positions that dealt with this all the time, she is familiar and comfortable with this and communicated that comfort to the audience. Basically she said, read their questions, say who you are, answer their questions, tell stories and give examples to illustrate the issues. Don’t be afraid – think of it as a marketing survey for the government.🙂 That last bit really fits in some ironic ways. We have probably all encountered a marketing survey of some sort at sometime, from the “fill this in for a free prize” flyers in our magazines to the dinnertime phone call. It is common practice to loathe telemarketers and marketing surveys because they want our info so badly they are in our face ALL the TIME, driving us nuts, encroaching on our personal space. Somehow, it seems both backwards and illogically unsurprising that our government wants our opinion and information, but hasn’t figured out a better way to get it than the Regulation Docket.

That said, let’s rough out a simple outline for folks to use based on those points and process. This is me talking now, folks, not Melissa – I am just sharing thoughts inspired by her presentation.

STEP ONE
Take a look at the FDASM site and their guidelines for submission. Since you are reading this blog, I am assuming that you are electronic savvy and willing to submit electronically. If that is not the case, definitely look at the FDASM site, since they give full instructions. Key thing you need to know right now is the docket number, which probably should be at the head of the document for any comments you submit: DOCKET no: FDA-2009-N-0441, although a lot of the comments there now lack this it probably wouldn’t hurt to include it.

STEP TWO
This is a maybe step. I recommend taking a look at some of the comments already in the docket. Not very many of them, but just to get an idea of formatting, layout, things like that. Choose one of the PDF comments because my computer suggested that some of the Word files in the docket may have viruses in them. Ahem. I worry that if you read them, the whole thing someone else said, that it could influence your own words and voice too much, or that you don’t say something because someone else already said it. Think about it this way – the more people say the same thing, the more important it is for the FDA to hear and the more likely they WILL hear it. You are voting with your words! If it is really important, say it again and again, even if someone else said it already.

I am worried about the numbers. I’ve been watching the docket for a while now. In December there were 22 comments filed, in January 29, today there are 31. This is from the ENTIRE COUNTRY. Almost all of them are from companies, and some companies have filed more than one. There is maybe a handful of ones from individuals, and none from academia and I didn’t see any listed as being from patient advocacy organizations either. Most of the the comments from individuals are from individuals who work in companies that filed comments also commenting privately. That is great, but WHERE ARE THE REST OF US???

Be aware that with most of the comments coming currently from industry, that they will be worded in very formal and structured ways, and were probably looked over by lawyers before they were submitted. Real people don’t talk like that. This doesn’t mean you don’t have valuable contributions to the conversation. It doesn’t mean you need to talk like a lawyer to send in comments. Be yourself, tell the stories that are important to you, begin with what you know, what you hope for, what worries you.

STEP THREE

Answer the FDA’s questions, in your own words, in your own way, telling your stories, giving examples to illustrate the ideas and issues. Say what would be the best way to handle an issue, and what would be the worst. Some people do this in a hundred words, some take pages. It is up to you what you say, just say what is most important. Better something short and sweet than nothing. Just to review, the main concepts for the FDA question are these (full test is on slides 9-12 here and at the original full file here):

1. Accountability
2. Regulatory requirements best practices
3. Corrective information
4. Links
5. Adverse event reporting

STEP FOUR

Tell them also if they missed an important question and what the answers to those are also. What are examples of good and bad uses of social media use for healthcare?

STEP FIVE

GO FORWARD and submit your comments to the docket!!

Image #1:
Click on the image to enlarge it. At the docket, click on the bottom line shown in the image to move to the form for registering comments.
FDASM Comments Submission to Docket

Image #2:
What the comment submission form looks like.
FDASM Comments Submission to Docket

2 responses to “FDASM: Report Out: Best Practices for Docket Comments (Melissa Levine)

  1. To be honest, the BEST way to submit comments to the FDASM docket is using my questionnaire: http://bit.ly/6zP3I0

    This questionnaire makes it EASY for you to submit your comments to the FDA. Many questions are pre-programmed with answers that you can select. Also, you can include your comments.

    Results of this survey WILL be formally submitted to the FDA before the 28 February 2010 deadline. It will include your comments BUT will not include name or any other information that identifies who you are.

    Jean-Ah Kang said: “Thanks for the heads-up about your survey! I do believe your submission will be helpful, and if you are able to provide us with access to the online version, that sounds great too (if not, no worries – your summary spreadsheet together with the Excel sheet of raw data should be fine). We would count your survey itself as one submission; however, we will take each separate response within your survey into consideration given that they relate to all five questions we posed in the FR notice.”

    Like

  2. Hi, John! That is a nice way to submit anonymously, and I like for folks to have the option to do so. Personally, I’d rather see more individuals putting their stories into the docket rather than seeing an aggregate synthesis, but whatever gets people to comment at all is what is best! Thanks!

    Like

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