National Institutes of Health [Funding]: On January 19, 1999, Senators Arlen Specter (R-PA) and Tom Harkin (D-IA) introduced S. Res. 19 to express the sense of the Senate that "Federal investment in biomedical research should be increased by $2 billion in the fiscal year 2000." [Note: a "Sense of the Senate Resolution" is a non-binding statement of the Senate’s position on an issue.]

On February 1, 1999, the President presented a very modest 2.1% increase in NIH funding as part of his FY 2000 budget proposal, bringing the total funding recommendation to $15.9 billion. In stark contrast to the FY 1999 increase of 15%, Donna Shalala, Secretary of the Department of Health and Human Services, stated that the President remains committed to increasing the NIH budget by 50% in 5 years. The Public Policy Council [PPC] will continue to work with the biomedical research community, including the Ad Hoc Group for Medical Research Funding, to advocate for increasing the National Institutes of Health [NIH] funding in FY 2000 by 15% -- $18 billion. However, it is important this increase must not come at the expense of other vital public health services and programs.

Pediatric Research Initiative: Now in its fourth year, the Pediatric Research Initiative (PRI) provides money to fund new NIH extramural research devoted to the illnesses and conditions of children. Currently, the money is located in the Office of the NIH Director. In FY 1999, report language instructed NIH to fund the PRI at a level greater than FY 1998 ($38.5 million). Staff is currently working with the National Association of Children’s Hospitals and with congressional staff to seek authorizing language for the PRI. Both Senators Mike Dewine (R-OH) and Kit Bond (R-MO) again have expressed interest in proposing authorizing language for this initiative. In addition, this year the pediatric research community will pursue adding funds to increase pediatric clinical research training and the number of pediatric researchers.

Research data availability under the Freedom of Information Act: Included in Public Law 105-227, the Omnibus Appropriations bill from the 105^th Congress, was a provision to instruct the Office of Management and Budget [OMB] to amend Circular A-110 (Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and other Non-Profit Organizations) "to ensure that all data produced under a [research] award will be made available to the public through the Freedom of Information Act" [FOIA].

Prior to the release of the February 4, 1999, Federal Register notice, members of the research community, including the AAMC, the National Academy of Sciences, the Association of American Universities, as well as several members of Congress, submitted letters of concern about the potential adverse impact this provision could have on research. In addition, in January Representative George Brown (D-CA) introduced H.R. 88, a bill to repeal the legislative provision. This legislation currently has no cosponsors. It is unclear at this time if the bill will move independently or as part of another legislative proposal.

As mentioned above, OMB has issued a proposed revision for public comment in the Federal Register. While the OMB’s proposed revision is far less damaging than rumors predicted, there is still substantial cause for concern about the potential adverse impact that this provision could have on research, especially the potential premature or inappropriate release of research data.

Stem cell research: Last summer’s discoveries of human pluriopotent stem cells through non-Federally funded human embryo research have generated an extensive political, legal and ethical debate. President Clinton, also concerned about this issue, requested that the National Bioethics Advisory Committee [NBAC] convene and examine the issue closely. During the January 19 NBAC meeting, Harold Varmus, MD, Director, NIH, presented the determination of the Department of Health and Human Services [DHHS] General Counsel that the NIH could legally fund research with existing human stem cells under the current ban on human embryo research. Dr. Varmus announced his intent to not fund such research at this time but to convene a subcommittee to the Advisory Committee to the Director to develop guidelines and a system of oversight for future research. In February, the Public Policy Council joined approximately 50 other organizations to endorse a sign-on letter, generated at the request of members of Congress, supporting the decision of the DHHS General Counsel. The NBAC will produce a report on human stem cell research by June 1999.

Senate Arlen Specter (R-PA) and Tom Harkin (D-IA) held hearings in the Senate Labor/Health and Human Services Appropriations Subcommittee in December 1998 and January 1999. The Senators remain very interested in the potential benefits of future stem cell research and are closely examining the value of permitting federally funded research in this field. However, opposition to stem cell research is gaining some momentum.

Several patient-groups, such as the American Heart Association, the Juvenile Diabetes Foundation, the Aging Alliance and others are actively encouraging the pursuit of this promising research. Staff will continue to closely monitor this issue. [Note: Background information is available on the NIH web-site at <www.nih.gov>.]

Animal Research: For the third time, Representative Charles Canady (R-FL) has re-introduced the Pet Safety and Protection Act of 1999, H.R. 453. The bill currently has 22 co-sponsors. This legislation is based on the erroneous notion that research institutions obtain stolen pets for use in research activities. The bill would have an adverse impact on the ability of medical schools to obtain random-source animals for research and teaching.

ACTION NEEDED: Urge your members of Congress to oppose HR 453.

Clinical Laboratory Improvement Act (CLIA): On February 3, 1998, Representative Bill Archer (R-TX) reintroduced the Clinical Laboratory Improvement Act Amendments of 1999, HR 528. Identical to earlier legislative attempts to eliminate the burden of CLIA, H.R. 528 seeks to exempt physicians’ office labs from the clinical lab requirements under CLIA but maintains oversight of pap smear testing (the initial impetus for CLIA’s enactment). H.R. 528 currently has no cosponsors and has been referred to the House Commerce Committee. Working with the American Academy of Pediatrics, the PPC will continue its involvement with other medical societies to seek meaningful CLIA relief in 1999.

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Last Modified: March 14, 2001