September 20, 2012

Get your FDA Pre-Sub. Docket Comments here!

Will you please consider commenting on an open FDA docket? I would love the FDA to see the FDA everywhere they look, particularly when they reach out for public comment.

The FDA currently has a docket open on “Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre-Submission Program and Meetings with FDA Staff; Availability.”
http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO...

So far there are just a few public comments. This docket is an opportunity to for the DOC to be seen by the FDA. It is a fairly dull issue and at first glance not specifically about T1D. However the FDA did bring pre-submission up in an email exchange about LGS. See this YDMV post.

In simple terms, pre-submission is a formal process of industry working with the FDA to help define issues the FDA will want to see addressed in an actual application. Think of pre-submission as meeting with a teacher to understand the rubric and go over an outline before writing a paper. This guidance is 35 pages of how that will work where the FDA is the teacher and industry is writing the term paper.

My hope is for the FDA to know the DOC is looking at everything they do. So much so that they anticipate they will get our comments. Open dockets are an official way to do that.

In addition to posting a comment to the docket consider copying your Congressmember and Senators and noting that in what you post to the FDA. YDMV, so may FDA comments. Below are a few general form letters that you could used for this particular docket. Please feel free to use them, modify them and post them to the docket. In that modification please fill out and change the the opening paragraph so it  states who you are, what your relationship to diabetes is and how long you have been living with it. 


Comment here:
http://www.regulations.gov/#!submitComment;D=FDA-2012-D-0530-0001


If you do post I would love a comment here just to know who has sent one in.

Thanks
 


General Support

Dear Sir or Madam:

First, let me begin by extending my sincere gratitude to the U.S. Food and Drug Administration (“FDA”) for this opportunity to share my perspective as an individual whose life will be directly impacted by the draft guidance document: "Draft Guidance for Industry and FDA Staff; Medical Devices: The Pre-Submission Program and Meetings with FDA Staff; Availability".

I hope FDA will give the same consideration to my perspective as it does to comments from companies that stand to profit from the FDA’s final guidance documents, and that the FDA will remember to give the patient perspective appropriate consideration when preparing the final guidance document(s).

Perhaps I should take a moment to introduce myself.  My name is {your name here}. I live in {town/state}. I have been living with {Type 1 / Type 2 / LADA} diabetes -or- I am the parent of a child with {Type 1 / Type 2 / LADA} diabetes. {I/he/she} was diagnosed {X} years ago. Living with diabetes is a daily balancing act that requires multiple devices to measure blood sugar and administer insulin. It is never easy and while the tools available are acceptable, there is little doubt they can be better.  Innovative diabetes devices are not an abstraction in my life, they are the means of staying alive, and better tools will help {me/my child} live a longer and more productive life while also helping to reduce the amount of time that must be spent on routine management of blood glucose levels that {my/my child’s} body can no longer do on its own.

As the Federal Register announcement dated July 13, 2012 notes:

"The purpose of this guidance is to describe the Pre-Submission program (formerly the pre-Investigational Device Exemption [IDE] program) for medical devices reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER)."  The draft guidance document also notes that the original process was “designed to provide applicants a mechanism to obtain FDA feedback on future Investigational Device Exemption (IDE) applications prior to their submission. Over time, the pre-IDE program evolved to include feedback on other device submission program areas, such as Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, and Premarket Notification (510(k)) Submissions, as well as to address questions related to whether a clinical study requires submission of an IDE.”

As I interpret these statements as a layperson, these seem to suggest that the draft guidance is describing the FDA's thinking about how this Federal agency will be handling early conversations with drug, biotechnology medicines and medical devices BEFORE the actual submission of an application.

As I noted previously, I live with Type 1 diabetes, and have done so for {specify duration of time lived with diabetes}. I know that there are a number of devices and tools available in almost every other developed nation that are not currently available here. While I’d like to believe Americans are safer as a result of this, there are valid reasons to question such a presumption.  While I support the FDA initiative to use the pre-submission process to help industry more quickly make applications for devices that the FDA can approve, as a patient {or caregiver} the specifics addressed in such premarket discussions are largely undisclosed to the public, hence the process as it has operated so far lacks transparency, which is one area I’d like to see some more specificity in the final guidance document(s).

Innovation in diabetes care is accelerating. Today, there are more options for Continuous Glucose Monitors (“CGM”) enabled insulin pumps (also known as Continuous Subcutaneous Insulin Infusion or "CSII", although I will refer to this as “insulin pump” throughout the remainder of my comments) overseas, there are more accurate CGMs, there are insulin pumps that shut of insulin delivery to hypoglycemic patients, there are mealtime insulin dosage calculating guidance wizards in meters for people who manage their diabetes with multiple daily injections (not insulin pumps) and more. Innovations are slow in coming and the options available in U.S. are falling behind.

The FDA and industry really must find ways to keep pace with other regulatory bodies around the world, such as the European Medicines Agency or Health Canada.  While I’ve seen signs of progress in this direction from the FDA, today, many companies apply for regulatory approval in Europe first because companies operating view the EMA’s approval process as more transparent, consistent and predictable than the FDA’s processes are.  My life depends on working with my healthcare team to use the best devices to help me manage my diabetes. If the best devices are not available in the USA, my care team cannot prescribe them.

Thanks you for the opportunity to comment.

{your name}

cc: {your Congressperson & Senators}

*****
LGS comment for adolescent parents

Hi my name is {your name here}. I live in {town state}. I have been living with {Type 1 / Type 2 / LADA} diabetes -or- I am the parent of a child with {Type 1 / Type 2 / LADA} diabetes. {I/he/she} was diagnosed {X} years ago. Living with diabetes is a daily balancing act that requires multiple devices to measure blood sugar and administer insulin. It is never easy and while the tools available are good they certainly can be better. Innovative diabetes devices are not an abstraction in my life, they are the means of staying alive and better tools will help {me/my child} live a longer and more productive life.  

Care options that physicians and patients can consider for type 1 Diabetes patients in the US lag behind the rest of the world. Uncertainty over regulatory processes here is a significant issue. Northwestern University reports that 76% of device manufacturers who replied to a survey on the FDA said the 510(k) process was unclear.

While the FDA, academicians and industry seek to find clarity on regulatory verbiage the lack of innovations in diabetes devices is costing American lives. One example in diabetes care is that Low Glucose Suspend devices are available in every developed nation other than the United States. A lack of clarity on how industry can apply to the FDA is part of the reason we do not have those devices.

Nocturnal hypoglycemia is killing Americans with Type 1 diabetes. The risk is particularly acute for adolescents facing hormonal changes that can significantly have an impact on glucose management. Unclear FDA process are costing the lives of American youth.

As the parent of an adolescent Type 1 child I find this delay and associated risk of life threatening  nocturnal hypoglycemia unacceptable.

The FDA must bring clarity and certainty to the US regulatory process. Robust pre-submission processes can facilitate approvals for innovative devices. The FDA must bring the clarity and transparency to the process that Northwestern demonstrated is lacking.

Thanks you for the opportunity to comment.

{your name}

cc: {your Congressperson & Senators}

****
Short and sweet AP based comment.

Hi my name is {your name here}. I live in {town state}. I have been living with {Type 1 / Type 2 / LADA} diabetes -or- I am the parent of a child with {Type 1 / Type 2 / LADA} diabetes. {I/he/she} was diagnosed {X} years ago. Living with diabetes is a daily balancing act that requires multiple devices to measure blood sugar and administer insulin. It is never easy and while the tools available are good they certainly can be better. Innovative diabetes devices are not an abstraction in my life, they are the means of staying alive and better tools will help {me/my child} live a longer and more productive life. .


The state of diabetes innovation is accelerating, as we move to more useful devices such as artificial pancreas and mobile devices that allow people with diabetes to integrate and manage their health with information from multiple diabetes tools the FDA will need facilitate bringing these innovations to physicians   and patients.

The status quo that devices are in use two to three years in other markets is unacceptable. The FDA should plan to use the pre-submission to bring the USA back to a position of leadership in seeing safe and effective devices come to market.

Thanks you for the opportunity to comment.

{your name}

cc: {your Congressperson & Senators}


*****
Sharper T1 comment with specific guidance language

Hi my name is {your name here}. I live in {town state}. I have been living with {Type 1 / Type 2 / LADA} diabetes -or- I am the parent of a child with {Type 1 / Type 2 / LADA} diabetes. {I/he/she} was diagnosed {X} years ago. Living with diabetes is a daily balancing act that requires multiple devices to measure blood sugar and administer insulin. It is never easy and while the tools available are good they certainly can be better. Innovative diabetes devices are not an abstraction in my life, they are the means of staying alive and better tools will help {me/my child} live a longer and more productive life.  

As a diabetes patient in the United States, I am disappointed that innovations that could help my care team prescribe better self-care tools are available in other nations but not here. This is particularly concerning when these devices are designed in the USA. I fear that that gap between the introduction of innovative tools elsewhere and in the US is increasing not decreasing.

The FDA should proactively use the pre-submission process to close the gap between better care everywhere else and less innovative care in the U.S.  To do that the FDA needs to bring consistent regulatory practice to the pre-submission process and the process requires sufficient transparency so that it does not appear to work as a “black box”. Yet this draft guidance document itself is not completely clear. In one case it says the FDA does not view pre-submission responses to “decisional or binding on the agency.” Later the document says {specify page/line numbers in the draft guidance document, please}, “Modifications to FDA’s feedback will be limited to situations in which FDA concludes that the feedback given previously does not adequately address important new issues materially relevant to a determination of safety or effectiveness.”

Industry needs regulatory clarity to safely speed effective life saving devices to market. Pre-submissions should be a tool to facilitate that end.

Thanks you for the opportunity to comment.

{your name}

cc: {your Congressperson & Senators}

5 comments:

  1. My Comment Tracking Number: 811202db

    ReplyDelete
  2. This comment has been removed by a blog administrator.

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  3. Tamara Ragon-Gamble RNSeptember 20, 2012 at 9:17 PM

    Thank you for taking the time to assist us in providing some letters that we can use. I have left a comment on the page as requested.

    ReplyDelete
  4. Tamara Ragon-Gamble RNSeptember 20, 2012 at 9:19 PM

    811210a4 My tracking number

    ReplyDelete
  5. Bennet,

    Thanks for these e-mails and this information. I have submitted my comment.

    ReplyDelete