[Federal Register Volume 72, Number 203 (Monday, October 22, 2007)]
[Notices]
[Pages 59536-59537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20759]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0114]


Electronic Distribution of Prescribing Information for 
Prescription Drug Products; Reopening of Comment Period

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; reopening of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reopening to 
December 6, 2007 the comment period for the notice that published in 
the Federal Register of April 2, 2007 (72 FR 15701); this notice was 
related to the public hearing of April 27, 2007, concerning the 
electronic distribution of FDA-approved prescribing information 
currently contained in the package insert (PI) for prescription drug 
and biological products. FDA is reopening the comment period for the 
sole purpose of inviting interested persons to submit comments on the 
concept of electronic distribution of FDA-approved prescribing 
information currently contained in the PI for prescription animal drug 
products.

DATES: Submit written or electronic comments by December 6, 2007.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to either 
http://www.fda.gov/dockets/ecomments or http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3360, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register notice of April 2, 2007 (72 FR 15701), FDA 
published a notice of public hearing concerning the concept of the 
electronic distribution of PIs for human prescription drugs and 
biological products and solicited relevant information and comments on 
this concept. The purpose was to garner views and information on the 
feasibility of establishing an efficient process for industry to 
electronically distribute prescribing information to dispensers. The 
PIs with prescribing information accompany prescription human drugs to 
meet the requirement that ``labeling on or within the package from 
which the drug is to be dispensed bears adequate information for its 
use * * *'' (21 CFR 201.100(c)(1)). For additional information, see the 
April 2, 2007, notice ( 72 FR 15701).
    Currently, the PI contains the prescribing information for the safe 
and effective use of the product in the form of a paper leaflet. 
Although the information in the PI is a valuable resource, it is often 
not readily accessible when a healthcare provider who has not 
physically received the drug makes a treatment decision or discusses 
treatments with a patient. Additionally, the PI may not contain the 
most current information, because the PI accompanying the drug's 
distribution may have been printed and distributed prior to more recent 
labeling changes. Accordingly, with technological advances in the 
electronic transmission of information, we are considering how 
prescribing information could be more effectively disseminated.
    FDA is reopening the comment period for the sole purpose of 
inviting interested persons to submit comments addressing a number of 
questions regarding the current use of package inserts for animal drug 
products and those logistical issues associated with electronic 
distribution of such prescribing information for animal drug products. 
The previous request for comments was limited to human drugs and 
biologics. As with prescription human drugs, the PIs with prescribing 
information accompany prescription animal drugs to meet the requirement 
that ``labeling on or within the package from which the drug is to be 
dispensed bears adequate information for its use * * *'' (21 CFR 
201.105(c)(1)). FDA approves the prescribing information as part of 
both human and animal drug labeling in the drug application. The 
request for comment is to gain a better understanding of how PIs for 
animal drugs are currently used by healthcare entities as we consider 
new approaches for the dissemination of labeling information.

II. Issues for Discussion

     FDA is specifically interested in receiving comments on the 
following questions and any other pertinent

[[Page 59537]]

information related to the electronic distribution of the prescribing 
information for animals.

A. General

    (1) Currently, who uses and benefits from the prescribing 
information?
    (2) How can electronic distribution and access of the prescribing 
information be accomplished?
    (3) Would electronic distribution and access of the prescribing 
information improve the public health?
    (4) Would electronic distribution and access of prescribing 
information improve prescribing habits? If so, how?
    (5) How might we ensure that changes in the distribution and access 
of the prescribing information will not negatively affect the current 
users?
    (6) Would an increase in electronic access to prescribing 
information affect prescribers, pharmacists, clients and patients? If 
so, how?
    (7) Are there any issues particular to the prescribing information 
for animal drugs that are dissimilar or distinct from those associated 
with human drugs and that might affect the feasibility of electronic 
distribution of labeling?

B. Logistics

    (1) Generally and without focusing on vendor-specific methods, how 
can electronic distribution of prescribing information be accomplished?
    (2) What are the costs associated with the successful 
implementation of electronic distribution and access to prescribing 
information, including startup and maintenance expenses? Please 
breakdown costs per healthcare sector.
    (3) Is the technology and infrastructure currently available to 
accomplish electronic distribution and access? If so, what is 
available? If not, what is needed?
    (4) What are other potential barriers to accomplishing the 
electronic prescribing information?
    (5) How can we ensure that electronic prescribing information is 
accessible to those who need the information?
    (6) How do we meet the needs of those who do not have electronic 
capability?
    (7) In case of emergency or when a computer system is down, what 
might be the backup?
    (8) How should electronically disseminated prescribing information 
be regularly updated and remain current?
    (9) What are the roles for the involved parties (manufacturers, 
third-parties, health professionals, FDA, and consumers)?
    (10) Should all products have electronic prescribing information or 
are there some products or classes of products that should continue to 
have paper prescribing information accompany the product?
    (11) If electronic prescribing information were to be used instead 
of paper inserts, then how should electronic prescribing information be 
implemented? Should electronic prescribing information be phased in? If 
so, over what time period? Which products should use electronic 
prescribing information first?

III. How to Submit Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two paper copies of any mailed comments, except 
that individuals may submit one paper copy. Comments are to be 
identified with the docket number at the heading of this document. 
Received comments may be seen in the office above between 9 a.m. and 4 
p .m., Monday through Friday.

    Dated: October 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20759 Filed 10-19-07; 8:45 am]
BILLING CODE 4160-01-S