From: John W. Jayne, M.D. [j.jaynemd@worldnet.att.net]
Sent: Monday, April 30, 2001 3:52 AM
To: Titus, Sandra L
Subject: Changing Long-acting Antihistamines to OTC

Dear Madams/Sirs:

I have recently been informed that the FDA is considering changing the newer
long-acting antihistamines to OTC.  The great majority of patients do not
consider OTC "medications" to be medications at all!  This is a problem!
These newer antihistamines (Allegra, Zyrtec and Claritin) are very effective
medications with long half-lives.  They affect all forms of atopy, not only
seasonal allergies.  If these medications were to become available without a
prescription, then assessment of the patient would be much more difficult
because they do affect clinical evaluation, skin testing, and even bronchial
provocations!  Furthermore, follow-up assessments and treatment would also
be more difficult because there would not be any method to assess
compliance!

I would like to briefly discuss the differences between what might be
considered "fair" and "right."  Is it "fair" for the pharmaceutical industry
to loose money so that the insurance industry can save money?  Is it "fair"
to the patients for the pharmaceutical companies to decrease R & D
resources, particularly in those areas where there may be only a limited
group of patients who may benefit, because of those fears?  The
pharmaceutical industry has always supported patients, research for the
betterment of mankind, education for patients and their families,
physicians, education for physicians and even has supported the FDA!  The
FDA is one of the most respected (if not
the most respected) institutions in the U.S. today!  I personally have had
very limited exposure to the FDA, however, I must state that my experiences
have been unbelievably positive!  I will never forget that 17 years ago I
needed something that only the FDA could give for a young man who was dying!
Though I had a hard time reaching the correct department, once I did, I was
helped and a favorable decision was made within 10 minutes!

Now, if I may relay that which I believe is "right."  That is, that which is
in the best interest of the patient!  This is an issue, which I am sure is
in agreement with the desires of the FDA!  It is not in the best interest of
the patient to have more uncontrolled OTC medications that can (and will) be
taken incorrectly, abusively, or non-compliantly!  Who is to take
responsibility?  The patient?  The pharmaceutical industry who invented the
medication?  The physician?  Or the FDA?  Certainly not the Insurance
Company!

Remember, the pharmaceutical companies and the physicians are friends to the
FDA, just as the FDA is a friend to both the physicians and the
pharmaceutical industry!  Why?  Because we all three share a common goal and
bond:  the health and well-being of the patient!

I truly appreciate your time in this very important matter.

I am . . .
Very truly yours,

John W. Jayne, M.D.