Docket Management
Docket: 00N-1256 - Over-the-Counter Products
Comment Number: EC -53

Accepted - Volume 6

Comment Record
Commentor Mr. Joel Heins Date/Time 2000-06-28 03:03:37
Organization Mr. Joel Heins
Category Individual

Comments for FDA General
Questions
1. General Comments I recall having severe intestinal pains in Germany. A kind person gave me some Tagamet although it was a prescription drug there (as it was here at that time). Upon entering Italy, I found I could buy it OTC. In my travels in Latin America I also noticed that I could buy many pharmaceuticals that required prescriptions in the U.S. This experience made me think about what I had to do in this country to get the same drugs. A visit to the primary care physician, then, often a referral to a specialist (with their $170 family history chat!), and then a prescription. Then the pharmacy charged me (or more appropriately my insurance company) far more for the drug then what I would pay for it in other countries OTC. The net result is unnecessary delay in alleviating a malady and also an expenditure that is as much as $500 more than it could be. Two thoughts occur to me. First that my intelligence in making a self care decision has been questioned and undervalued. And second that our litigation crazy culture costs more than we, as a society, can now afford. There are surely risks in taking any supplement or medication, but the fact that a rare individual could be harmed should not inhibit the availability of proven safe drugs to our citizens. A few can and perhaps will be harmed if the FDA loosens it's standards; concomitantly many can get relief more expeditiously and cheaply. I do believe what should guide the FDA is the fundamental tenets of our democratic form of government and the personal freedoms it supposeded promulgates. I fear that the few may determine what is best for the many and surely that does not meet the ideals that democracy purportly stands for. Have faith in your fellow citizen's good judgement, intelligence and common sense. For the sake of expediency and economics, do what is best for the vast majority of our populace. Make statins and antihistamines that are currently unavailable without the sanction of a doctor available. respectfully, joel j. heins




EC -53