[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Pages 9928-9929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03198]



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.


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-


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 

[[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 
    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 
    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]