Docket Management
Docket: 00N-1256 - Over-the-Counter Products
Comment Number: EC -16

Accepted - Volume 6

Comment Record
Commentor Dr. Ruth P. Ginzberg Date/Time 2000-06-27 07:37:31
Organization Dr. Ruth P. Ginzberg
Category Individual

Comments for FDA General
1. General Comments All medications have possible unwanted side effects and some degree of abuse or mis-use potential. A person could be attempting to self-medicate a brain tumor with Tylenol. Or stomach cancer with Maalox. Or congestive heart failure with Robitussin. And many individuals have given themselves ulcers from self-medication with aspirin. But is that a case against making Tylenol or Maalox or Robitussin or aspirin available OTC? No. Its a case in favor of public education. Similarly with many potential OTC drugs. We need as a society to determine whether it is worth the enormous inflation of health care costs for everybody just to keep relatively safe medications available by prescription only in order to force mostly healthy people to visit a doctor for relatively safe medications so we can screen for the extremely rare exception in every single case. In practical terms, this doesn't happen anyway. A patient who needs a Claritin refill is rarely actually seen by an MD; often the prescription is just called in by an office assistant after the patient is seen by a nurse practitioner. But the need for an office visit and the price of the prescription medication do prevent many Americans from receiving this useful allergy medication. Instead they self-medicate with Benedryl OTC. And how many of them wind up falling asleep at the wheel and causing accidents that contribute even more to the rising health care costs?

EC -16