[Federal Register: October 22, 2007 (Volume 72, Number 203)]
[Notices]
[Page 59536-59537]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22oc07-66]
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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.
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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, Erik.Mettler@fda.hhs.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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