We have a public comments period. It seems like a crime not to use it. Individual voices make a difference.
The FDA is assembling a process to design more patient-focused drug development. They are using a set of disease areas to attack the project systematically. They realize risk and reward decisions should no longer be made without patients at the table.
Organizations and institutions can represent constituencies well, but people with ALS should be allowed to represent themselves first-hand, too. They are bright and full of ideas and deal with life in spite of that ticking clock. They are not of one mind. That's a good thing. If the FDA gets to work with some of them on an up-close and personal basis, perhaps they'll start hearing the clock tick, too.
It would be a classic win-win for the FDA and for people with ALS if ALS were one of those represented disease areas. Unfortunately ALS wasn't mentioned on their preliminary list. It's time for the public to speak up during the public comments period, folks!
What are they looking for in the disease areas that they will use to develop the patient-focused processes? Here's what it takes to make the cut --
- Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living
Disease areas that reflect a range of severity Disease areas for which aspects of the disease are not formally captured in clinical trials
- Disease areas that have a severe impact on identifiable
subpopulations (such as children or the elderly)
- Disease areas that represent a broad range in terms of
size of the affected population
- 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.
ALS fits these criteria like a glove. Please click here and read the materials and make some comments to the FDA on the importance of FDA patients in patient-focused drug development. It simply fits their criteria.
Thanks very much for exercising your free speech to help reform FDA processes to take advantage of what people with ALS have to offer. Those who follow them will benefit.