From: Richard Mabry [Richard.Mabry@UTSouthwestern.edu]
Sent: Monday, April 30, 2001 10:43 AM
To: Titus, Sandra L
Subject: Non-sedating antihistamines OTC

Dear Ms Titus,
Please allow me to strongly urge the FDA not to place the newer second- and third-generation antihistamines on over-the-counter status.  I realize that your decision will not be made on economic grounds (although it is patently obvious that the application to do this was made purely on that basis), but it is impossible not to consider the burden on patients on Medicaid and those depending on insurance to meet drug costs which would be imposed by this change.
On a scientific basis, let me strongly caution you that one of the problems I frequently encounter as a specialist in allergy and nasal and sinus disorders is the inability of patients to differentiate allergy from other disorders, such as sinus infections, polyps, and even tumors.  Putting these newer medications in the hands of patients without physician supervision will severely aggravate this problem.
As a matter of fact, I can make a very strong case that the FDA erred terribly in making first-generation antihistamines OTC.

I would be happy to discuss any aspect of this matter if you wish.  I've appended by address below.  Thanks for your consideration.

Richard L Mabry, MD
Professor of Otolaryngology (Rhinology and Allergy)
University of Texas Southwestern Medical Center
Dallas, TX  75390-9035
214 648 2243
FAX 214 648 2246