[Federal Register: May 24, 2004 (Volume 69, Number 100)]
[Notices]
[Page 29544-29545]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24my04-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 2004S-0233]
Solicitation of Comments on Stimulating Innovation in Medical
Technologies
AGENCY: Department of Health and Human Services.
ACTION: Notice.
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SUMMARY: The Department of Health and Human Services (HHS) is seeking
public comment on how HHS and its agencies can work together to
facilitate the development and approval of new medical technologies.
DATES: Submit written or electronic comments by August 23, 2004.
ADDRESSES: Submit written comments concerning this document to the
Division of Dockets Management, 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:
For general questions about this document: Lisa Rovin, Office of
the Commissioner (HFP-1), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-1443.
For information about the seven specific questions listed in the
SUPPLEMENTARY INFORMATION section of this document: Tom Kuchenberg,
Office of the Secretary, Department of Health and Human Services, 200
Independence Ave. SW., Washington, DC 20201, 202-205-8644.
SUPPLEMENTARY INFORMATION:
I. Background
HHS is seeking comment on how to stimulate innovation in medical
technologies, such as drug and biological products and medical devices.
We are interested in hearing about ways HHS and its agencies (e.g.,
National Institutes of Health (NIH), Food and Drug Administration
(FDA), Centers for Medicare and Medicaid Services (CMS), and Centers
for Disease Control and Prevention (CDC), can work together to
facilitate the development and approval of new medical technologies.
Recent advances in basic sciences, such as genomics, proteomics,
and bioinformatics, have created the potential for the development of
innovative medical technologies that can provide new hope and better
quality of life for many Americans. At the same time, more funds are
being invested in biomedical science in America than ever before. NIH,
which is just completing a 5-year doubling of its budget to $27 billion
(Ref. 1), has launched its Roadmap initiative (Ref. 2). The Roadmap
initiative aims to transform the nation's medical research enterprise
and help speed the movement of research discoveries from the laboratory
to the patient.
During the past decade, pharmaceutical firms have increased their
research and development investments to more than $30 billion (Ref. 3).
Considering the many other organizations involved in medical research
in this country (e.g., Department of Defense, Department of Energy,
Department of Veteran's Affairs, academic organizations, and
foundations), the total amount spent each year in the development of
medical technology in the United States could conceivably approach $100
billion.
With an aging population it is worth noting that in 2002 Medicare
expenditures for new drugs and devices were approximately $4 to 6
billion. To help speed access to these new technologies, CMS is working
on novel ways to better coordinate coverage, payment, and coding for a
more timely reimbursement process.
Nonetheless, there is concern that new discoveries in basic
sciences are not rapidly translating into new medical products for
patients. In a recent report announcing its Critical Path initiative\1\
(Ref. 4), FDA noted that the numbers of new drug and biologic
applications being submitted to FDA are decreasing despite the dramatic
increase in research and development spending over the past decade.\2\
Current estimates suggest that it takes 10 to 15 years and $800 million
in investment for a new drug to make it from the laboratory bench to a
patient's bedside (Ref. 5). On April 22, 2004, FDA published a notice
in the Federal Register (69 FR 21839) asking for input on the
scientific and technical hurdles that cause delays and other problems
during the product development process. That notice focused exclusively
on FDA. In this notice we are requesting that all constituents comment
on what HHS agencies can do together to stimulate innovation in medical
technologies.
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\1\ The report lays out FDA plans to help make the critical path
more predictable and efficient. If products that are likely to fail
can be identified earlier in the development process, more research
and development resources can be devoted to developing those
products that are likely to succeed.
\2\ Only one in five products that reach the clinical testing
stage ever makes it to marketing.
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HHS, through its operating agencies (e.g., NIH, FDA, CMS, and CDC),
is an important part of the nation's medical technology infrastructure.
To help HHS understand what it can do to facilitate the development of
innovative medical technologies, we are asking the following questions:
1. What strategies and approaches could HHS implement to accelerate
the development and application of new medical technologies?
2. How can HHS help its agencies (e.g., NIH (and its grantees),
FDA, CDC, and CMS) to work together more effectively to eliminate
obstacles to development of medical technologies?
3. How can the HHS scientific and regulatory agencies work more
effectively with CMS to eliminate obstacles to development?
4. What forums should HHS use to survey constituents about
obstacles to innovation (e.g., public meetings, contract research,
focus groups)?
5. How can the portability of information between HHS agencies be
optimized?
6. Which HHS policies and programs effectively spur innovation?
Which policies and programs at NIH (and its grantees), CMS, FDA, and
CDC should be expanded to help spur innovation? Do any policies and
programs pose obstacles to innovation?
7. What role should be played by nongovernmental partners in
assisting the Federal Government in this process?
II. 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 mailed comments, except that
individuals may submit one paper copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments are available for public examination in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
[[Page 29545]]
III. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Elias A. Zerhouni, ``Statement of the Director to the House
Subcommittee on Labor-HHS-Education Appropriations on the FY 2004
President's Budget Request,'' April 2, 2003.
2. National Institutes of Health, Roadmap Overview, September
2003.
3. Tufts Center for the Study of Drug Development, U.S.
Pharmaceutical Industry Inflation-Adjusted R&R Expenditures and NCE
Approvals, 1963-2002.
4. FDA, ``Innovation or Stagnation, Challenge and Opportunity on
the Critical Path to New Medical Products,'' March 2004.
5. Tufts Center for the Study of Drug Development,
``Backgrounder: How New Drugs Move Through the Development and
Approval Process,'' November 2001.
Dated: May 18, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-11612 Filed 5-21-04; 1:17 pm]
BILLING CODE 4160-01-S