Persuade The FDA To Pay More Attention To Neuropathy

Today's post from neuropathy.org (see link below) the site of the US Neuropathy Association, is a call to arms. It asks people to contact the FDA and advocate in other areas, to give neuropathy more visibility in the field of debilitating diseases. Despite upwards of 20 million Americans alone suffering from neuropathy, if you ask the average man on the street if they have ever heard of it, you may well be met with blank stares. It's time that neuropathy gained a greater voice and became better known by the public at large. This article asks people to make the FDA more aware of neuropathy as a major and growing problem, thus inspiring more research and better treatment strategies. If you don't live in the USA, doing exactly the same with your own national health authority, will eventually bring improvements in your own area. Letting them consign neuropathy to the backwaters of public health is not an option. Try to take action now.

ADVOCACY ACTION ALERT! Your Chance to Urge the FDA to Give Neuropathy More Attention
By Natacha T. Pires, MBBS, Director, Medical and Public Affairs October 9, 2014

We have a time-sensitive opportunity to tell the FDA to give neuropathy more attention.

On April 11, 2013, the Food and Drug Administration (FDA) published a Federal Register notice (78 FR 21613) announcing the disease areas for meetings in FYs 2013-2015, the first 3 years of PDUFA V. In selecting the set of disease areas, FDA carefully considered the public comments received and the perspectives of review divisions at FDA. While neuropathy was on the FDA’s preliminary list of nominated disease states, it did not make the final list of diseases areas for meetings in FYs 2013-2015.
 
Click here to submit your comments online
to the FDA by December 5th, 2014…

Now, the FDA is initiating a second public process for determining the disease areas for FYs 2016-2017. The FDA will consider the public comments received through the public docket and publish the set of disease areas for FYs 2016-2017 in a Federal Register notice. Neuropathy is not included in the preliminary list of nominated disease areas for consideration in the patient-focused drug development meetings scheduled for fiscal years (FYs) 2016-2017. However, neurological and autoimmune diseases treated with IVIG -- such as CIDP and MMN, among others -- are included in the preliminary list. But this represents only a segment of our neuropathy community...

WHAT YOU CAN DO TO GET THE FDA TO FOCUS ON NEUROPATHY?

Even though neuropathy is not included in the preliminary list of nominated disease areas for consideration in the patient-focused drug development meetings scheduled for fiscal years (FYs) 2016-2017, the FDA is interested in public comment on disease areas that are not represented on the preliminary list. The FDA needs to hear about the impact of all forms of neuropathy on patients, the range of severity, what matters most to you in getting benefits from treatments, and the adequacy of existing treatments you are using for your neuropathy.

When proposing additional disease areas for consideration, the FDA asks to describe how you applied the following criteria in making recommendations for additional disease areas to consider:

- Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;

- Disease areas for which aspects of the disease are not formally captured in clinical trials;

- Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives; and

- Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly).

All of us – patients, caregivers, health care professionals, researchers… -- must commit to submitting public comments to ensure neuropathy has a better chance of making the FDA’s list in 2016-2017.

Click here to submit your comments online to the FDA by December 5th, 2014…



Alternatively, you may submit written comments (be sure to include the following identifier “ID: FDA-2012-N-0967-0595” with your comments) to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Don't miss this chance to advocate for your needs and for the needs of our community!

http://www.neuropathy.org/site/News2?page=NewsArticle&id=8787&news_iv_ctrl=1101