Hope123
Senior Member
- Messages
- 1,266
The Food and Drug Administration (FDA) is the US federal agency that drug companies submit potential drugs to for assessment and approval before the drug can be placed on the market for a specific medical condition.
Currently, FDA has placed ME/CFS as one of 39 different medical conditions for special consideration BUT ONLY 20 WILL BE CHOSEN. If chosen, FDA will especially consider patient perspectives when evaluating drugs designated for that condition and possibly set up incentives for companies to look into that condition.
Tell FDA about how this disease has affected you (which symptoms? severity?), how most existing treatments either help symptoms (like sleep) or are inappropriate (uncautious exercise leading to disability), and the lack of well-established treatments that get at the root of this illness. If you want future studies to take into account objective measures (instead of only asking people "how do you feel?") like natural killer cell activity or exercise testing, write about that. If you are sick of studies only looking at "fatigue" improvements but not post-exertional malaise or cognitive function or pain, etc., write about that. Talk about how historically, patient perspectives have not been considered by the government/ medical/ scientific groups and how we welcome this chance to interact.
Deadline is NOVEMBER 1, link below for details, Green button on right to submit electronic comments. Note comments will be posted online publicly eventually so decide what you want to put down carefully.
https://www.federalregister.gov/art...ug-development-public-meeting-and-request-for
There is also an in-person meeting in DC October 25, the deadline for registration is Oct 18, also in above link.
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EXCERPTS from link:
A key part of regulatory decisionmaking is establishing the context in which the particular decision is made. In drug regulation, this context includes a thorough understanding of the severity of the treated condition and the adequacy of the existing treatment options. Patients who live with a disease have a direct stake in the outcome of the review process and are in a unique position to contribute to weighing benefit-risk considerations that can occur throughout the medical product development process. Though several programs exist to facilitate patient representation, there are currently few venues in which the patient perspective is discussed outside of a specific product's marketing application review. The human drug and biologic review process could benefit from a more systematic and expansive approach to obtaining input from patients who experience a particular disease or condition.
FDA is committed to obtaining input from patients and, as set out in the commitment letter, will conduct public meetings to consider 20 different disease areas over the 5-year authorization of the program. For each disease area, FDA will conduct a public meeting to discuss such topics as the impact of the disease on patients, the spectrum of severity for those who have the disease, the measures of benefit that matter most to patients, and the adequacy of the existing treatment options for patients.
FDA is nominating the following disease areas as potential candidates for the focus of one of the 20 future public meetings and invites public comment on this preliminary list. In your comments, please identify the disease areas that you consider to be of greatest priority and explain the rationale for your recommendation.
Currently, FDA has placed ME/CFS as one of 39 different medical conditions for special consideration BUT ONLY 20 WILL BE CHOSEN. If chosen, FDA will especially consider patient perspectives when evaluating drugs designated for that condition and possibly set up incentives for companies to look into that condition.
Tell FDA about how this disease has affected you (which symptoms? severity?), how most existing treatments either help symptoms (like sleep) or are inappropriate (uncautious exercise leading to disability), and the lack of well-established treatments that get at the root of this illness. If you want future studies to take into account objective measures (instead of only asking people "how do you feel?") like natural killer cell activity or exercise testing, write about that. If you are sick of studies only looking at "fatigue" improvements but not post-exertional malaise or cognitive function or pain, etc., write about that. Talk about how historically, patient perspectives have not been considered by the government/ medical/ scientific groups and how we welcome this chance to interact.
Deadline is NOVEMBER 1, link below for details, Green button on right to submit electronic comments. Note comments will be posted online publicly eventually so decide what you want to put down carefully.
https://www.federalregister.gov/art...ug-development-public-meeting-and-request-for
There is also an in-person meeting in DC October 25, the deadline for registration is Oct 18, also in above link.
***********************************************************************************************************
EXCERPTS from link:
A key part of regulatory decisionmaking is establishing the context in which the particular decision is made. In drug regulation, this context includes a thorough understanding of the severity of the treated condition and the adequacy of the existing treatment options. Patients who live with a disease have a direct stake in the outcome of the review process and are in a unique position to contribute to weighing benefit-risk considerations that can occur throughout the medical product development process. Though several programs exist to facilitate patient representation, there are currently few venues in which the patient perspective is discussed outside of a specific product's marketing application review. The human drug and biologic review process could benefit from a more systematic and expansive approach to obtaining input from patients who experience a particular disease or condition.
FDA is committed to obtaining input from patients and, as set out in the commitment letter, will conduct public meetings to consider 20 different disease areas over the 5-year authorization of the program. For each disease area, FDA will conduct a public meeting to discuss such topics as the impact of the disease on patients, the spectrum of severity for those who have the disease, the measures of benefit that matter most to patients, and the adequacy of the existing treatment options for patients.
FDA is nominating the following disease areas as potential candidates for the focus of one of the 20 future public meetings and invites public comment on this preliminary list. In your comments, please identify the disease areas that you consider to be of greatest priority and explain the rationale for your recommendation.