August 1, 2002

Dockets Management Branch (HFA - 305) **Docket Number 00N-1652**

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20857

## Re: Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

Lilly appreciates the opportunity to comment on the proposal to require
that labeling content be submitted electronically in a form that the FDA
can process, review, and archive. We support FDA's desire to simplify
the drug labeling review process and speed up the approval of labeling
changes and, on the whole, agree with the proposal.

Lilly also commends FDA on the proposed rule\'s likelihood of improving
the review of \"Changes being effected\" supplements. With the current
process, a product sponsor is often left in the uncomfortable position
of waiting for an approval letter for a lengthy time (according to the
agency, an average of 28 months) without any estimate of when it is
likely to arrive. Ultimately, this means having labeling in use subject
to change at any time and makes it difficult to plan both production and
distribution. Because Lilly would like to have the most current approved
version of labeling available to the public, it appreciates any process
revisions that would speed up review times for these supplements.

Several who have read the proposed rule have expressed confusion about
the statement from I.B, "This proposal would be in addition to existing
requirements described in section I.A of this document that copies of
the label and labeling and specimens of enclosures be submitted."
Although a subsequent statement indicates that the submission of copies
of labeling may be made electronically or on paper, some of us are
confused about the requirements as stated in the proposed rule. Please
clarify in the regulations that the existing requirements as outlined in
section I.A of the proposed rule can be satisfied by the submission of
electronic copies of labeling.

We understand the rationale for the agency's decision to include
language in the proposed rule that will provide the "flexibility to
recommend file formats or software other than PDF in future guidance, to
make electronic submissions easier." With respect to this intent, Lilly
requests that FDA:

-   Accompany publication of the final rule with a guidance that
    specifies FDA's requirements for submission of labeling. (This is
    needed at the time of the implementation of this rule, not just in
    the future to implement changes.)

```{=html}
<!-- -->
```
-   Not make frequent changes in requirements for file formats or
    software, because these can require a complete re-work of IT support
    systems, an undertaking that often requires significant time and
    cost

-   Consistently implement requirements for labeling submissions. (In
    the past we have received requests from individual reviewers for
    "tailored" labeling submissions, e.g. labeling to be submitted on a
    floppy disc, or specific formats for side-by-side comparisons of
    labeling versions.These requests take us outside of our normal
    processes and procedures and can be problematic.)

Implementation of this proposed rule for the electronic submission of
labeling will enable the agency to move forward with other initiatives
to make labeling available more rapidly. As we make progress in this
"paperless labeling" environment we ask that the agency consider these
recommendations:

-   Use a standard database for labeling

-   Use standard display formats for viewing labels

-   Use a single database

    -   Reduces the number of sites to update and minimizes chance of
        outdated labeling

    -   Decreases redundant costs

-   Assure that dispensing sites have uninterrupted access at all times.

Finally, we think that there\'s a codified section identification
typographical error, where 314.50(l)(1)(i) is being referenced as
(1)(1)(i). The typo appears in both the preamble (on page 22370 about
2/3rds of the way down the first column), and in the corresponding
codified section on page 22375 (about a third of the way down the first
column).

Again, we appreciate the opportunity to comment on the details of the
proposal, and applaud FDA's initiative to speed up the approval process
for labeling.

Sincerely,

ELI LILLY AND COMPANY

Timothy R. Franson, M.D.

Vice President

Clinical Research and Regulatory Affairs -- U.S.

cc: Janet Woodcock, M.D.

Randy Levin, M.D.