- The U.S. Food and Drug Administration (FDA) will hold a public hearing Monday, Feb. 25, 2013, at 9 a.m. Eastern time, to discuss the development of drugs aimed at treating and managing amyotrophic lateral sclerosis (ALS).
- The public may view proceedings at the hearing via a live webcast, and may submit comments online or by mail until March 25, 2013.
- The public hearing will help the FDA assess and address the needs of people with ALS, and will inform the work of FDA offices that review ALS drug applications.
- Input in the form of verbal and written remarks will be given by people with ALS, caregivers, advocates, health care providers, academia, industry and others, including MDA President and CEO Steven M. Derks and Stan Appel, MDA Board member and director of the MDA/ALS Center at Methodist Neurological Institute in Houston.
The U.S. Food and Drug Administration (FDA) will host a public hearing Monday, Feb. 25, 2013, from 9 a.m. to 5 p.m. Eastern time, in Silver Spring, Md., to discuss the development of drugs for amyotrophic lateral sclerosis (ALS).
The hearing, "Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis," will gather input on the FDA’s regulation of drugs for ALS. It's expected to help the FDA assess and address the needs and preferences of people with the disease, and to inform the work of FDA offices that review ALS drug applications.
Input in the form of verbal and written remarks will be given by people with ALS, caregivers, advocates, health care providers, academia, industry and others — including MDA President and CEO Steven M. Derks, and longtime MDA grantee and Board member Stan Appel, who is chairman of the Department of Neurology at the Methodist Neurological Institute in Houston and who directs the MDA\ALS center at that institution.
Remarks in the hearing will cover such topics as:
- the numerous unmet medical needs within MDA's ALS community;
- benefit/risk decisions when participating in clinical trials and undergoing therapies;
- accelerated approval of new drugs for ALS and compassionate-use programs; and
- the so-called “disease burden” of daily life with ALS.
For those unable to attend in person, the hearing will be webcast live at collaboration.fda.gov/als.
Written comments about the hearing may be submitted online, through March 25, 2013, at Docket No. FDA-2013-N-0035 (click on the "Comment Now!" button), or via the United States Postal Service:
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Visit MDA's advocacy page to read the official FDA hearing notice, and for more details about submitting comments or attending the meeting.
The hearing is a result of efforts by MDA and the ALS Association to promote more fluid communication between the ALS community and the FDA as it works to enhance decision-making on ALS-related priorities.
To learn more, read the comment submitted to the FDA by MDA and ALSA in November 2012 regarding these issues.