Docket Management
Docket: 00N-1256 - Over-the-Counter Products
Comment Number: EC -8

Accepted - Volume 6

Comment Record
Commentor Mr. George Starr Date/Time 2000-06-27 01:22:29
Organization Mr. George Starr
Category Individual

Comments for FDA General
1. General Comments I was in the PREDICT Pravachol 10 OTC study. My view is that many more tests should be OTC including Liver Function Lab tests as Lipid profiles now are when sold for screening. I would not have participated without the blood tests to check Liver function. If Pravachol 10 is sold OTC -- then I want to be able to get Liver function Lab Tests without a Doctors Order. I took OTC Tagemet 200 until, I read a Drug Guide and found how many things Tagemet interacts with -- including possible Impotence as a side effect. Remember all an OTC buyer has to do is take 4 times the Tagement 200 recommended dossage to be at the prescription level. However, whatever your decision on Pravachol is -- A higher priority is FDA regulation of Alternative Medication Products i.e. double blind studies of Ginko Biloba, etc. George H. Starr 503-617-4693

EC -8