**Butler, Jennie C**

**From:** Susan_Shellabarger@hill-top.com

**Sent:** Wednesday, May 24, 2000 12:04 PM

**To:** FDADockets@oc.fda.gov

**Subject:** Docket No. 00N-1256; OTC Drug Products Hearing

Please find in the attached word document, my request for 20 minutes of
time at

the OTC Drug Product Hearing on June 28-29, 2000.

Please feel free to call me with any questions at 317-706-9690

Thank you.

Susan Shellabarger

Sr. Director, Business Development, OTC Products

Hill Top Research

13571 Kensington Place

Carmel, IN 46032

317-706-9690

(See attached file: Written Notice for Participation and
Comments.doc)![](media/image1.wmf)

Written Notice for Participation and Comments

Docket No. 00N-1256

OTC Drug Products Hearing

Submitted by:

Susan Shellabarger

Sr. Director, Business Development, OTC Products

Hill Top Research

13571 Kensington Place

Carmel, IN 46032

317-706-9690

<susan_shellabarger@hill-top.com>

PLEASE NOTE: This request is being submitted [both]{.underline} by
e-mail and regular US Mail.

May 26, 2000

To whom it may concern:

I would like to request 20 minutes of time on the Docket for the FDA's
OTC Drug Products Hearing, Docket No. 00N-1256.

I am currently Senior Director Business Development for OTC Products for
Hill Top Research. Over the past eight years, I have specialized in the
development and implementation of Label Comprehension and Actual Use
Studies in support of several Rx-to-OTC switches. My request for
participation is voluntary and without compensation from any outside
parties. My interest in participating is because of my professional
knowledge and experience in this ever-changing Rx-to-OTC switch arena.

During these 20 minutes I will be addressing the following major points:

1.  The Rx-to-OTC switch research process should be considered on a
    case-by-case basis -- even within therapeutic categories. The
    research should be driven by:

-   open, interactive discussions between the sponsor and FDA leading to
    mutually agreed upon research objectives and study designs

-   pivotal knowledge and concerns known about the parent Rx product
    (e.g. adverse events, drug interactions, product use issues)

-   issues identified regarding the proposed OTC use of the product
    (e.g. product labeling, misuse, abuse)

2.  Label Comprehension and Actual Use studies have proven to be useful
    tools that meet the unique scientific/regulatory issues that
    characterize the Rx-to-OTC switch process.

> While often considered to be "Market Research" or "Consumer Research"
> studies, they are no less scientific in their design, implementation
> and management/interpretation of data than Phase II or Phase III
> studies for an Rx product. In fact, the "All comers" or "Naturalistic"
> approach for study enrollment probably is a better representation of
> the potential end-user of the product than what is routinely
> experienced in Rx Phase II/III trials which have extensive
> inclusion/exclusion criteria that can bias the study population.

3.  Decisions about labeling should be driven by data obtained through
    well designed and implemented studies - not through untested
    subjective views.

> Key points on consumer comprehension of efficacy data in four
> experimental OTC label conditions will be presented from an article
> published in the *Drug Information Journal,* Volume 31, No. 3, 1997.

Respectfully submitted,

Susan Shellabarger