Docket Management
Docket: 97N-0314 - Guidance for Industry on Levothyroxine Sodium Products-Enforcement of August 14, 2001
Comment Number: EC -10

Accepted - Volume 9

Comment Record
Commentor Mr. F. Bud Sweet, III Date/Time 2001-08-03 08:53:00
Organization Univera Healthcare
Category Health Professional

Comments for FDA General
1. General Comments Somebody get a back bone....Flint, Boots, Knoll and now Abbott have boonswaggled the American public for years about this product which has been superpotent or deficient, depending on the born on date. Has everyone forgotten the Dong study and cover up by the manufacturer ? This study showed the bio equivelancy between generics and Synthroid and hence was buried by the manufacturer. Synthroid has had continual manufacturing issues and recalls...these days it appears that PhRMA can get away with anything ! Next Schering will double the price on Claritin and everyone sits back while they have bad manufacturing practices. Hurt these companies financially ! Tell the truth ! It continues to appear that FDA is in PhRMA's back pocket. Another example is the pediatric patent extension...this should be an initial requirement of NDA submission, not a reward to extend and gouge the American public ! What's next a canine indication reward ? Show me that you can do the right thing ! Thanks.

EC -10