From: Donald Reitberg [donreitberg@opt-e-scrip.com]
Sent: Saturday, March 08, 2003 5:01 PM
To: fdadockets@oc.fda.gov
Subject: Comment to docket number 02N-0528 re: Concept Paper: Risk Management Programs

This comment is submitted with regard to docket number 02N-0528 re: Concept Paper: Risk Management Programs.

On page 6 of 12 of the pdf version of the document, I suggest adding at line 204 an additional bullet point for 2. Systems that guide the circumstances of individual prescribing, dispensing, and/or use, as follows:

*  Community-based monitoring systems that limit drug exposure only to individuals who have objective evidence of  benefit without undue additional risk from treatment, such as via randomized, controlled, blinded, pre-validated, single-patient trials.

In support of this addition, reference is made to a scientific seminar presented to CDER in November of 2002: 
Advances in the Use of Single-Patient Trials (N-of-1 studies) for Drug Treatment Optimization and Risk Management.  This was presented on invitation of the Committee for Advanced Scientific Education (CASE) of the Center for Drug Evaluation and Research (CDER) of the United States Food and Drug Administration (FDA).  The slides and a videotape are available in the CDER website and archives.

Attached also is a "Pink Sheet" article regarding the presentation.

The ability to restrict drug use to those in need based on controlled, individual data can importantly limit the overall exposure of the population to drugs that incur higher- than-usual risk. Those who continue to be exposed will be screened from those who experience a placebo-like effect or who would do as well or better using lower-risk treatments. These individualization technologies have only recently become commercially available, although there are many examples in the academic literature on single-patient (n-of-1) trials.

Thank you for the opportunity to comment on this important concept paper.

Respectfully,

Donald P. Reitberg, Pharm.D.

Opt-e-scrip, Inc.

101 Timberbrooke Drive

Bedminster, NJ  07921

973 699 3849