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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 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