Docket Management
Docket: 00N-1256 - Over-the-Counter Products
Comment Number: EC -81

Accepted - Volume 6

Comment Record
Commentor Mr. Michael Watson Date/Time 2000-06-30 00:02:11
Organization Mr. Michael Watson
Category Individual

Comments for FDA General
1. General Comments I am writing in hopes that the FDA will consider loosening rules for approval of OTC medications making them more available to consumers. In this day and age the average person is very busy, visiting a doctor is expensive, and people are not as comfortable with the traditional doctor/patient relationship. In addition consumers have access to much more information about drugs than in the past. These days the average doctor visit essentially consists of a consumer requesting a specific prescription drug. I myself have had this experience. For a long time I’ve suffered from allergies, this past year symptoms were more severe than normal. I spent an hour online researching the three major prescription antihistamines: Clariton, Allegra, and Zyrtec. After careful consideration I chose Zyrtec before I ever saw my doctor because it was the fastest acting of the three drugs so that I could take it only periodically instead of continuously. (Allegra for example takes up to three hours to work so you must take it even if you are currently having no symptoms.) For me, not having to take a drug continuously was a big plus. In addition Zyrtec has few side effects. My doctor was surprised by my choice because this drug is not heavily advertised like the others but agreed completely with my decision. For years I have known of the existence of non-sedating antihistamines but I never had enough time to go to the doctor for the relatively minor annoyance of hay fever until I had a sustained bad experience. I could have had relief for years if Zyrtec were available over the counter. Another example from personal experience: I have, for a long time, suffered from social shyness. Probably not quite to the point of a clinical diagnosis but serious enough and it does affect my life. I am aware that Paxil is a potential treatment for this condition and I would like to try it. But I will not see a Psychiatrist for this… I am too concerned about any potential impact of having a problem diagnosed on my medical record. I have even considered purchasing this drug over the internet without a prescription but so far have refrained. Yet another example and one I know will be more problematic for the FDA. I have gout… its well controlled by prescription medication however I do occasionally have flare-ups. Gout is INTENSLY painful… sometimes so bad you can’t even walk without crutches. During an attack I need serious pain relief immediately. Sometimes flare-ups occur on the weekends or my doctor is busy and I can not get a prescription for moderate, opiate based, pain killers like Tylenol-3. I strongly support selling Tylenol-3 over the counter and frankly would like to see stronger ones. I understand these particular drugs are addictive and there could be abuse issues but there are ways of handling that. First of all, the commonly available opiate painkillers are deliberately poisoned with Tylenol. This is not commonly known but the codeine is mixed with high doses of Tylenol to the extent that you can not abuse these drugs to any significant extent without dying of liver failure. That is outrageous to me (although obviously off topic, I think this must be changed). Second, perhaps a system that would limit purchases of opiate painkillers to a reasonable amount would be acceptable. Other parts of the world sell Tylenol-3 OTC without significant problems. The FDA needs to step up and serve the American people. The huge increase in non-prescription alternative supplements is a direct result of and direct proof of the fact that Americans are no longer comfortable with our prescription drug system. Americans want to treat themselves and will buy untested herbal supplements instead of going to a doctor to get an effective prescription. I understand that some prescription drugs are dangerous and that not every person has the resources to read the PDR thoroughly before they buy an OTC medication but there has to be a middle ground. Clearly many drugs that are currently prescription are completely safe and effective as OTC drugs and are not dangerous and are not suitable for abuse. There is no reason these drugs should not be available to consumers at their local drug store. Thank you, Mike Watson

EC -81