Docket Management
Docket: 00N-1256 - Over-the-Counter Products
Comment Number: EC -60

Accepted - Volume 6

Comment Record
Commentor Dr. Michelle Corrado Date/Time 2000-06-28 11:14:13
Organization Harvard Vanguard Medical Associates
Category Health Professional

Comments for FDA General
1. General Comments I feel that placing the statin drugs on OTC status is a mistake. How would we manage patients? How would we ascertain compliance? And how would we accurately track liver function? How would we monitor for side effects and drug interactions. Patients aren't always forthcoming about which OTC meds they take. Also, when drugs are OTC, people tend to take them more haphazardly. With drugs such as statins, continuous, daily doses are necessary to achieve the desired therapeutic effect. And who would decide who needs these medications? Patients?? I can see the DTC adds now: prevent a heart attack, take a statin. But, these agents are NOT necessary for EVERYONE. By using scare tactics, the drug companies do patients a disservice. Just look at Claritin and Allegra as examples. Look at how profits and usage have flown through the roof because of all the DTC adds and the consequence of having patients demand these medications. And, I feel that the cost of medications to the consumer INCREASES when they go OTC. Would you rather pay $10 for a 30-day supply of your cholesterol med as a co-pay through your insurer or the probable $30-40/month or more it will cost you OTC.

EC -60