[Federal Register: May 24, 2004 (Volume 69, Number 100)]
[Page 29544-29545]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



[Docket No. 2004S-0233]

Solicitation of Comments on Stimulating Innovation in Medical 

AGENCY: Department of Health and Human Services.

ACTION: Notice.


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 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.


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 
    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 

    \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.

    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 
    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 
    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]