[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Notices]
[Pages 9928-9929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03198]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0124]
Food and Drug Administration Drug Shortages Task Force and
Strategic Plan; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: To assist the Food and Drug Administration (FDA or Agency) in
drafting a strategic plan on drug shortages as required by the Food and
Drug Administration Safety and Innovation Act, the Agency is seeking
public comment from interested persons on certain questions related to
drug and biological product shortages.
DATES: Submit either electronic or written comments by March 14, 2013.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0124, by any of the following methods:
Electronic Submissions:
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions:
Submit written submissions in the following way:
Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2013-N-0124. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kalah Auchincloss, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6208; Silver Spring, MD 20993, 301-796-
0659.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the President signed into law the Food and Drug
Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144).
Section 1003 of FDASIA adds section 506D to the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to require the formation of a task force to
develop and implement a strategic plan for enhancing the Agency's
response to preventing and mitigating drug shortages. Section 506D of
the FD&C Act (21 U.S.C. 356D) requires that the drug shortages
strategic plan include the following:
Plans for enhanced interagency and intra-agency
coordination, communication, and decisionmaking;
Plans for ensuring that drug shortages are considered when
the
[[Page 9929]]
Secretary initiates a regulatory action that could precipitate a drug
shortage or exacerbate an existing drug shortage;
Plans for effective communication with outside
stakeholders, including who the Secretary should alert about potential
or actual drug shortages, how the communication should occur, and what
types of information should be shared;
Plans for considering the impact of drug shortages on
research and clinical trials; and
An examination of whether to establish a ``qualified
manufacturing partner program'' as described in section 506D(a)(1)(C)
of the FD&C Act.
II. Scope of Public Input Requested
Per the directive in section 506D, FDA has formed an internal Drug
Shortages Task Force (Task Force) to develop and implement the drug
shortages strategic plan. The Task Force is seeking comments from the
public on issues related to the development of this strategic plan.
Importantly, although FDASIA refers only to a drug shortages strategic
plan, we anticipate that the strategic plan will consider prevention
and mitigation of both drug and biological product shortages.
Accordingly, we are interested in receiving comments on these questions
from all parties, including those with an interest in biological
products. The Task Force is specifically interested in seeking public
input on the following questions:
1. In an effort to address the major underlying causes of drug and
biological product shortages, FDA is seeking new ideas to encourage
high-quality manufacturing and to facilitate expansion of manufacturing
capacity.
a. To assist in the evaluation of product manufacturing quality,
FDA is exploring the broader use of manufacturing quality metrics. With
that in mind, FDA would like input on the following issues: What
metrics do manufacturers currently use to monitor production quality?
To what extent do purchasers and prescribers use information about
manufacturing quality when deciding how to purchase or utilize
products? What kinds of manufacturing quality metrics might be valuable
for purchasers and prescribers when determining which manufacturers to
purchase from or which manufacturers' products to prescribe? What kinds
of manufacturing quality metrics might be valuable for manufacturers
when choosing a contract manufacturer? How frequently would such
metrics need to be updated to be meaningful?
b. The use of a qualified manufacturing partner program similar to
one used under the Biomedical Advanced Research and Development
Authority (BARDA) has been suggested as a potentially useful approach
to expanding manufacturing capacity and preventing shortages. FDA
recognizes that there are important potential differences between the
BARDA program and the use of a parallel program to address shortages.
For example, the BARDA program covers a relatively stable and limited
number of products, but drugs at risk of shortage are many, may change
rapidly over time, and are difficult to predict in advance. In
addition, FDA does not have funding to pay manufacturers to participate
in a drug shortages qualified manufacturing partner program or to
guarantee purchase of the end product. With these differences in mind,
is it possible to design a qualified manufacturing partner program that
would have a positive impact on shortages?
c. Are there incentives that FDA can provide to encourage
manufacturers to establish and maintain high-quality manufacturing
practices, to develop redundancy in manufacturing operations, to expand
capacity, and/or to create other conditions to prevent or mitigate
shortages?
2. In our work to prevent shortages of drugs and biological
products, FDA regularly engages with other U.S. Government Agencies.
Are there incentives these Agencies can provide, separately or in
partnership with FDA, to prevent shortages?
3. When notified of a potential or actual drug or biological
product shortage, FDA may take certain actions to mitigate the impact
of the shortage, including expediting review of regulatory submissions,
expediting inspections, exercising enforcement discretion, identifying
alternative manufacturing sources, extending expiration dates based on
stability data, and working with the manufacturer to resolve the
underlying cause of the shortage. Are there changes to these existing
tools that FDA can make to improve their utility in managing shortages?
Are there other actions that FDA can take under its existing authority
to address impending shortages?
4. To manage communications to help alleviate potential or actual
shortages, FDA uses a variety of tools, including posting information
on our public shortages Web sites and sending targeted notifications to
specialty groups. Are there other communication tools that FDA should
use or additional information the Agency should share to help health
care professionals, manufacturers, distributors, patients, and others
manage shortages more effectively? Are there changes to our public
shortage Web sites that would help enhance their utility for patients,
prescribers, and others in managing shortages?
5. What impact do drug and biological product shortages have on
research and clinical trials? What actions can FDA take to mitigate any
negative impact of shortages on research and clinical trials?
6. What other actions or activities should FDA consider including
in the strategic plan to help prevent or mitigate shortages?
III. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
Dated: February 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03198 Filed 2-11-13; 8:45 am]
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