[Federal Register: April 22, 2004 (Volume 69, Number 78)]
[Notices]
[Page 21839-21840]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ap04-68]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004-N-0181]
Critical Path Initiative; Establishment of Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket to obtain input on activities that could reduce existing
hurdles in medical product design and development. As described in a
recently released Report, ``Innovation/Stagnation: Challenge and
Opportunity on the Critical Path to New Medical Products,'' there is an
urgent need to modernize the product development toolkit, to make the
development process more predictable and less costly. FDA is seeking
input in identifying and prioritizing the most pressing medical product
development problems, and the areas that provide the greatest
opportunities for rapid improvement and public health benefits. To this
end, we are establishing this open docket to obtain input from
industry, patients, academics investors, and all interested parties.
DATES: Submit written or electronic comments through July 30, 2004.
ADDRESSES: Submit written comments concerning this document to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Lisa Rovin, Office of the Commissioner
(HFP-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857-0001, 301-827-1443.
SUPPLEMENTARY INFORMATION:
I. Background
On March 16, 2004, FDA released a report, ``Innovation/Stagnation:
Challenge and Opportunity on the Critical Path to New Medical
Products.'' (The full report is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf.
) The report notes the recent
slowdown in new medical products submitted for approval to FDA, and
describes ways in which the product development process, the ``critical
path,'' could be modernized to make product development more
predictable and less costly. According to Acting FDA Commissioner
Lester Crawford, ``A new focus on updating the tools currently used to
assess the safety and efficacy of new medical products will very likely
bring tremendous public health benefits.''
Recent investments in basic medical research and translational
research are intended to promote scientific discoveries and move some
of them into medical testing. At that point, however, a potential
medical product's journey from concept to commercialization is far from
complete. To produce a commercial medical product, developers must
successfully negotiate a ``critical path'' to ascertain whether the
potential drug, device, or biologic is effective and sufficiently safe
for use, and how it can be safely and reliably manufactured. Each of
the three dimensions of the critical path--assessment of safety
testing, proof of efficacy, and industrialization--presents its own set
of scientific and technologic challenges, often unrelated to the
science behind the mechanism of action of the product.
The ethics of human testing required that there
be a reasonable assurance of safety before people are exposed in
clinical trials. The tools used to predict preclinical safety (e.g.,
animal toxicology) are time consuming and cumbersome. In some cases,
particularly for assessment of products based on recent innovative
science, entirely new tools must be developed. There is an urgent need
for new biomarkers for evaluating safety during human trials.
Demonstrating the medical effectiveness of a
product is one of the most difficult challenges in product development.
Even identifying the best way to assess whether a product is effective
(what symptoms or physiologic indicators should be followed, and for
how long) can present significant unknowns.
Product development companies must figure out
how to manufacture large amounts of the product reliably. Turning a
laboratory prototype into a mass-produced medical product requires
solutions to problems in physical design, characterization,
manufacturing scaleup and quality control. These problems can be rate-
limiting for new technologies, which are frequently more complex than
traditional products.
Because of its unique vantage point, FDA can work with outside
experts in companies and the academic community to coordinate, develop,
and/or disseminate solutions to critical path problems, to improve the
efficiency of product development industrywide.
The first step is to identify and prioritize the most pressing
medical product development problems, and the areas that provide the
greatest opportunities for rapid improvement and public health
benefits. It is critical that we enlist all relevant stakeholders in
this effort. Such a national ``Critical Path Opportunities List'' is
intended to bring concrete focus to tasks (whether best undertaken by
industry, academia, FDA, by others, or jointly) that can modernize the
critical path.
For additional information, you may visit FDA's critical path home
page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/initiatives/criticalpath.
[[Page 21840]]
II. Request for Comments
We are seeking input on identification of the most pressing
scientific and/or technical hurdles causing major delays and other
problems in the drug, device, and/or biologic development process, as
well as proposed approaches to their solution. For each critical path
hurdle, we are particularly interested in receiving the following
information. Please note that all material submitted to this docket
will be publicly available.
1. Hurdle Identification. Please describe the product development
issue, the nature of the evaluation tool that is out-of-date or absent,
how this problem hinders product development, and how a solution would
improve the product development process. Please be as specific as
possible.
2. Please rank each hurdle identified in Question 1, above, in
priority order according to which hurdles create the most severe
product development problems. That is, which problems present the
greatest opportunity for improving product development processes? Our
goal is to identify those aspects of product development that would
most benefit from new evaluation tools.
3. For each problem identified, please indicate the type of drug,
biologic, or device to which the hurdle applies.
4. For each problem identified, if a solution would facilitate the
development of drugs, biologics, and/or devices for a particular
disease or categories of disease, please indicate which diseases would
be affected?
5. Nature of the Solution. For each problem identified, please
describe the evaluation tool that would solve the problem and the work
necessary to create and implement the tool/solution. For example, would
a solution come from scientific research to develop a new assay or
validate a new endpoint? If the solution involves biomedical research,
please specify the necessary research project or program. Would a tool
be developed through data mining or computer modeling? Would the right
tool be a new FDA guidance or industry standard? If work on a solution
is underway, what steps remain? Are there other innovative solutions
that could be explored?
6. For each solution identified, please indicate which could be
accomplished quickly, in less than 24 months, and which require a long-
term approach?
7. For each problem identified, what role should FDA play and what
role should be played by others? Should FDA play a convening role,
bringing the relevant parties together to discuss an approach or
solution? If so, who else should participate? Should FDA coordinate
scientific research, the results of which would be publicly available?
We are seeking input on ways to target FDA scientific and collaborative
activities to help industry bring more safe and effective medical
products to us for review.
8. What factors should guide FDA in setting priorities among the
hurdles and solutions identified?
III. Submission of Comments
Interested persons may submit written or electronic comments to the
Division of Dockets Management (see ADDRESSES). Submit a single copy of
electronic comments or two paper copies of any mailed comments, except
that individuals may submit one copy. Comments are to be identified
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. You can
also view received comments on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/dockets/dockets.htm
.
Dated: April 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-9147 Filed 4-21-04; 8:45 am]
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