Docket Management
Docket: 00N-1256 - Over-the-Counter Products
Comment Number: EC -92

Accepted - Volume 6

Comment Record
Commentor Ms. Sally Laubach Date/Time 2000-07-04 05:53:37
Organization Ms. Sally Laubach
Category Individual

Comments for FDA General
Questions
1. General Comments As a consumer, I believe that it is NOT in the best interest of the consumer to change most of the suggested types of drugs being considered for OTC status. (These suggestions have included antihypertensive agents, cholesterol-lowering drugs, antidiabetic drugs, treatments for osteoporosis, topical agents for the treatment of herpes lesions, problems of the stomach and intestines, asthma treatments, and oral contraceptives.) I do not believe that consumer can determine the accurate dosage or which drug to use I feel it could be life-threatening to have antihypertensive agents, cholesterol-lowering drugs, antidiabetic drugs, treatments for osteoporosis, problems of the stomach and intestines, asthma treatments, and oral contraceptives. I currently take eight or more prescription drugs (antihypertensive agents, cholesterol-lowering drugs, treatments for osteoporosis, stomach medications, oral contraceptives, and immunosuppresives). I can see the temptation as a consumer to save money by buying lower doses; or trying different drugs within the same type with slight formulation differences, but that can make a difference in how the treatment works (for example: various antihypertensives). Consumer will also be tempted to self-diagnose and then buying an OTC for a condition without medical advice. Taking more than one type of cholesterol-lowering medication at the same time can have serious effects such as taking Mevacor with Lopid. Also, consumers do not have the have the background to understand drug interaction. Some of the OTC medication now on the market, such as stomach medications, often come in lower doses and you have to buy twice as many (or more) than what you would have had to buy as a prescription. This can make the OTC cost higher than if it had been prescribed drug at its required dosage. I do understand that the cost of prescriptions is very high. Fortunately I have a insurance with a co-pay for prescription drugs. I pay between $1200 to $2400 in copays each year. I imagine that could get up to $10,000 a year easily if I were to have to buy them OTC. I do understand that for many people medications can be unaffordable. That needs to be fixed. But I do not think that conversion of the suggested prescription drugs to OTC drugs is the solution for the affordablility problem. Thank you for reading my comments.




EC -92