Docket Management
Docket: 01N-0205 - Applications for FDA Approval to Market a New Drug
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Mr. John Dalton Date/Time 2001-06-04 21:59:43
Organization Georgetown Memorial Hospital on Disability
Category Health Professional

Comments for FDA General
Questions
1. Is the proposed collection of information necessary for the proper performance of FDA's functions? Will the information have practical utility? Yes under the Orphan Drug Clause the FDA in its wisdom should allow the drug 4-AP that is currently compounded at various pharmacies to be granted to patients with MS. I have tried this product and it works for me. I was the FDA contact at my Hospital until MS reared its ugly head.
2. What is the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used? 4-AP has been out there for a long time. Use the orphan drug clause to help these voters/people's quality of life. It is better to work than to end up on disability. I am a Professional Biomedical Engineer and all I know is that it works.
3. What are ways to enhance the quality, utility, and clarity of the information to be collected? Cut through the red tape and orphan it in! See if SSI applications goes down because of this. It might save tens of million od dollars not to mention the quality of life.
4. What are ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology? Try the JAMA for feedback
5. General Comments I as a citizen of the USA thinks it is a sorry nation that will allow untested OTC medicines to be marketed. It is criminal and very unethical to not allow a drug like 4-AP to be made available to the people who pays your salary. The FDA needs to be careful, yes, but don't overdo it please. John Dalton BSEM;CCE Former Director of Engineering.




EC -2