The first session of the 108th Congress is well underway. Members of Congress face a number of tough challenges including homeland security, a war and reconstruction in Iraq and a growing federal budget deficit. There are also several health-related issues on the congressional agenda that were not completed in the 107th Congress and remain issues this year. These include but are not limited to medical malpractice, Medicare reform, prescription drugs for seniors, proposed Medicaid cutbacks, patient safety, the growing number of uninsured, and an adequate and viable smallpox vaccine delivery and compensation program. Members of the American Pediatric Society, Society for Pediatric Research and the Association of Medical School Pediatric Department Chairs are urged to make your views heard throughout this session of Congress.

The following is an update and summary of recent federal legislative and regulatory activities of interest to the pediatric academic community. This report includes information on the following issues:

National Institute of Health (NIH)/Appropriations: Through its work with the Ad Hoc Group for Medical Research Funding, the PPC will support a 10% increase above current year funding in FY 2004 for the NIH. This is $30 billion. The Ad Hoc Group for Medical Research Funding is a coalition of more then 300 patient and voluntary health groups, medical and scientific societies, academic and research organizations, and industry. Its mission is to enhance the federal investment in biomedical, behavioral, and population-based research by increasing the finding for the NIH. In addition, the PPC will support an adequate increase for the National Institute of Child Health and Human Development (NICHD) to $1.3 billion in FY 2004. NICHD is currently funded at $1.213 billion.

After essentially completely the five-year doubling of the NIH budget, the President's FY 2004 budget proposal, released on February 3, contained a very modest 2% increase - $27.7 billion - for NIH. 

National Children's Study: Created by the Children's Health Act of 2000, the National Children's Study is a national longitudinal study of environmental effects (including physical, chemical, biological and psychosocial) on child health and development. The goal of the study is to improve the health and well-being of children. The study will examine these effects on the health and development of more than 100,000 children across the United States, following them from before birth until age 21. The study will be conducted through an interagency collaboration for biomedical research including most NIH Institutes and Centers, 11 HHS agencies and 9 cabinet departments. Currently in its planning phase, the lead federal agencies are the NICHD, the National Institute of Environmental Health Sciences and the Environmental Protection Agency. To carry out this research, approximately 30 - 40 National Children's Study Centers will be established across the U.S. Currently there are 22 Working Groups, including working groups on asthma, birth defects, ethics, health disparities, to name just a few. The pediatric community is working closing with the NICHD on this important study. The Study's Advisory Committee, which includes several pediatricians, last met in March 2003. Further information is available at - http://www.nationalchildrensstudy.gov.

Pediatric Research Loan Repayment: The NIH has indicated that in the current fiscal year it is estimated that approximately $56 million in funding will be available to double the pediatric loan repayment program. In October 2002, NIH released its new loan repayment program for pediatric and clinical researchers' policy (http://www.lrp.nih.gov). The new policy allows for eligible researchers and trainees supported by governmental (including AHRQ) and private, nonprofit grants to apply to NIH for loan repayment. Previously, only NIH-supported researchers were eligible to apply for support. Applications were due at the end of January and decisions on loan repayment funding will be made in the late spring or early summer of 2003. In the March 31, 2003, Federal Register notice (http://www.access.gpo.gov/su_docs/fedreg/a030331c.html) the NIH announced the availability of educational loan repayment under the NIH Pediatric Research Loan Repayment Program (PR-LRP). 

The pediatric academic community will work with the 108th Congress to ensure the continued need and support for these important loan repayment programs across a spectrum of pediatric research needs. 

"Therapeutic Cloning"- President's Council on Bioethics: President Bush's Council on Bioethics met several times last year and again in January 2003, to discuss issues pertaining to the ethics and policies of genetic and reproductive technologies and the patentability of human organisms. The Council has recommended a ban on human cloning to produce humans and a four-year moratorium on human cloning for medical research. The Council has also recently discussed pediatric psychopharmacology, biotechnology and public policy and will next meet in June. Additional information about the President's Council, including meeting transcripts, is available online at www.bioethics.gov. 

Legislation: Throughout the 107th Congress, the PPC supported the advocacy efforts of over 200 prominent biomedical research scientists, patient groups and others to urge Congress to oppose legislation that would criminalize an important research pathway, somatic cell nuclear transfer (SCNT) - "therapeutic cloning." Similar efforts are already underway in the 108th Congress. In February, Senators Orrin Hatch (R-UT), Dianne Feinstein (D-CA), Arlen Specter (R-PA), Edward Kennedy (D-MA), Tom Harkin (D-IA), and Zell Miller (D-GA) introduced S.303, a bill that would ban human reproductive cloning but allow somatic cell nuclear transplantation (SCNT) to move ahead with federal oversight. The "Human Cloning Ban and Stem Cell Protection Act of 2003" makes it a crime to clone or attempt to clone a human being, but permits nuclear transplantation to be conducted on unfertilized eggs for up to 14 days, under strict ethical and federal regulation. This bill currently has nine co-sponsors. Also in February, in contrast, the House Judiciary Committee approved HR 534, a bill sponsored by Reps. Dave Weldon (R-FL) and Bart Stupak (D-MI) that would totally ban all human cloning, including SCNT. The committee rejected by party-line votes a number of amendments offered by Democrats, including proposals to allow the use of SCNT for therapeutic and research uses and to permit the importation of medical treatments derived from human cloned embryos. After defeating an alternative amendment, the House passed the bill on February 24, by a vote of 241 - 155. Senators Sam Brownback (R-KS) and Mary Landrieu (D-LA) introduced a senate companion bill to the Weldon-Stupak legislation, S.245. The Brownback-Landrieu bill has 27 co-sponsors.

IOM Committee on Centers Of Excellence: The Institute of Medicine Committee on Assessment of NIH Centers of Excellence Programs is seeking input from professional and scientific societies and other groups on the use of research center grants by the National Institutes of Health, focusing in particular on the criteria and procedures used in deciding to adopt the use of centers, how they are designed and administered, comparisons with other mechanisms of research support, their impacts and costs, and how they are evaluated. The Public Policy Council submitted a comment letter to the IOM Committee providing examples from the PPRU, neonatal, and CHRC networks, and calling the centers "worthy examples of the best kind of investment the NIH can make." Additional information and a roster of the committee members can be found on the IOM web site: http://www.iom.edu/IOM/IOMHome.nsf/Pages/HSP+NIH+Excellence

IOM Committee on Clinical Research Involving Children: An IOM committee will review and consider federal regulations, federally prepared or supported reports, federally supported evidence-based research, and other sources of available information related to research involving children. Based on this review the IOM will prepare a report that includes. The Committee is chaired by Richard Behrman, MD, Executive Chair of the Pediatric Education Steering Committee of the Federation of Pediatric Organizations and includes several pediatricians including Drs. Russ Chesney (a member of the PPC), Francis Sessions Cole, III, Robert "Skip" Nelson, David Poplack, Bonnie Ramsey and Stephen Spielberg. A public hearing and meeting is planned for July 2003. Additional information is available on the IOM web site at: http://www.iom.edu/IOM/IOMHome.nsf/Pages/HSP+Research+Involving+Children

Agency for Healthcare Research and Quality (AHRQ)/Appropriations: The PPC, as part of a broad coalition, the Friends of AHRQ, supported $390 million in funding for AHRQ in FY 2003 and will once again recommend that level of funding in FY 2004. AHRQ current funding is $303.7 million an increase of 1% over last year's level. This includes $55 million for research on reducing medical errors. The President proposed in his FY 2004 budget $279 million. 

Impact on Research of the Health Insurance Portability and Accountability Act (HIPAA): On April 14, 2003, the new federal health information privacy regulations take effect. These regulations are part of the Health Insurance Portability and Accountability Act (HIPAA) and will require new practices and policies of all medical schools and teaching hospitals institutions. The Association of American Medical Colleges (AAMC) has formed a consortium to monitor and document the effects of HIPAA on medical and health services research to identify any needed legislative or regulatory relief efforts in the future. One of its first charges is to develop a network across the various disciplines of medical and health research to build a database and provide an effective mechanism for receiving and recording credible data on HIPAA's impact on research. The Public Policy Council (APS/SPR/AMSPDC) is participating in this consortium. For further information contact Rina Hakimian, JD, MPH, Regulatory Counsel, AAMC Division of Biomedical and Health Sciences Research, rhakimian@aamc.org, 202.828.0484
 

QUALITY—PEDIATRIC DRUG STUDIES

Pediatric Studies Provision within the Food and Drug Administration Modernization Act (FDAMA): Last year President Bush signed into law the Best Pharmaceuticals for Children Act (BPCA). The measure, P.L. 107-109, reauthorizes the pediatric studies provision that provides a 6-month incentive to pharmaceutical companies that conduct pediatric studies that have been requested by the Food and Drug Administration. 

The President's FY 2004 budget proposal includes $30 million for the BPCA - $5 million to go to the FDA, and $25 million to NIH. As it did in FY 2003, the pediatric community will request at least $200 million to support research of off-patent drugs as well as on-patent drugs that the patent holder has declined to study.

The Pediatric Rule: In October 2002, the U.S. Federal District Court in Washington, DC, struck down the Pediatric Rule, saying Congress never intended to give the FDA power to require drug companies to test adult medicines commonly given to children. In December, the American Academy of Pediatrics (AAP) and the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) filed a motion in federal court asking for the right to intervene in the lawsuit over requiring drug companies to test medicines used in children because the FDA had not yet decided whether to appeal on its own. The FDA decided not to appeal, stating that congressional action is the surest and swiftest way to ensure that the Pediatric Rule is restored. 

Legislation to Codify the Pediatric Rule: Despite all-out efforts to secure passage of the Pediatric Rule legislation last year, Congress adjourned the 107th session before legislation was passed. In the 108th Congress reinstating the Pediatric Rule remains a top priority for the pediatric academic societies working under the leadership of and in partnership with the AAP. 

On March 18, Senators Judd Gregg, (Chair of the Senate Health, Education, Labor and Pensions Committee (HELP), Edward Kennedy (D-MA), Mike DeWine (R-OH), Christopher Dodd (D-CT), and Hillary Clinton (D-NY) introduced S. 650, the Pediatric Research Equity Act of 2003. This legislation restores critical components of the 1998 pediatric rule. The pediatric community, including APS, SPR, AMSPDC, has endorsed the legislation.

The legislation includes the following key elements of the Pediatric Rule:

• A presumption that drug and biological products that will be used in the pediatric population will be studied in those populations if the labeled indication occurs in infants, children or adolescents;

• A permanent authority for FDA to require pediatric studies of certain drugs and biological products;

• Immediate implementation of the pediatric study requirements upon enactment of the law;

• No delay in approval of drugs for adult indications.

The Senate HELP Committee held a markup of the legislation on March 19. An amendment to sunset the requirements of the legislation passed in committee. The pediatric community will continue to support the legislation, while working to remove the sunset provision during the remainder of congressional consideration.

On the House side, Chairman Tauzin has indicated he would like to move legislation to require pediatric studies early this session. To date there has been no action in the House. It is anticipated that there will be a number of industry-supported amendments offered in the House.
 

PEDIATRIC WORKFORCE

Children's Hospitals Graduate Medical Education (CHGME): The President's FY 2004 budget contained only $199 million for CHGME. The pediatric academic community will continue its efforts with the National Association of Children's Hospitals (NACH) to vigorously advocate for adequate and sustained funding - $305 million ($292 million plus an adjustment for inflation) - in FY 2004. 

Titles VII and VIII-Health Professions Training Grants/Appropriations: As in FY 2003, the President's FY 2004 budget removes all funding for primary care, interdisciplinary community projects, training for diversity, and public health. The president proposes only $11 million for the Title VII program although it does address the nursing shortage through a modest increase for Title VIII. Current funding for Titles VII and VIII is $421.2 million (including the 0.65% across-the-board cut). The PPC has joined over 40 national organizations in the Health Professions and Nursing Education Coalition (HPNEC) to support $550 million for the Title VII and VIII programs in FY 2004. In addition, the pediatric community continues to support innovative training for generalist pediatricians through appropriate funding for the General Internal Medicine/General Pediatrics program, that is part of Title VII, of at least $40 million. This represents a step towards a multi-year effort to achieve a funding level of at least $69 million for the General Internal Medicine/General Pediatrics programs, as recommended by the congressionally-established Advisory Committee on Training in Primary Care Medicine and Dentistry. Ongoing advocacy to maintain and support increased funding for the health professions training program is crucial in the 108th Congress.

Reauthorization: The Title VII program was due to be reauthorized last year but was not; therefore, it will be taken up in the 108th Congress. This process, if past years are any example, may well take quite some time. The pediatric community is gearing up for the reauthorization process now by beginning preliminary conversations with colleagues at the internal medicine community in the upcoming month. We certainly appreciate the involvement of members of the pediatric academic societies as reauthorization moves forward. If you or your colleagues have examples of how Title VII is working in your institution, or comments on changes or additions that might be needed in the reauthorized bill, please do let us know. 
 

FY 2003 APPROPRIATIONS

Although the new fiscal year began on October 1, 2002, the lack of an agreement on overall spending levels led Congress to pass a series of short-term funding bills —"continuing resolutions" (CR)— that funded the government at FY 2002 levels until a final FY 2003 spending could be hammered out. The House and Senate finally came to an agreement on a $397.4 billion omnibus spending package—the "Consolidated Appropriations Resolution, 2003,"—on February 12, 2003, and approved it the following day, by a vote of 338 - 83 in the House and 76 - 20 in the Senate. President Bush signed the spending bill - PL 108-7 - on February 20. 
 

FY 2004 BUDGET

Committee Action: By party-line votes, the House and Senate Budget Committees both approved their respective FY 2004 budget resolutions on March 13 and 14, just five weeks after President Bush began the process with the release of his FY 2004 budget proposal. The overall focus of the Administration's FY 2004 budget proposal, which the House and Senate budget committees in part followed, is on safety of Americans, homeland security, economic well-being, Medicare, and global AIDS programs, particularly in Africa and the Caribbean. The House Budget Committee passed resolution (H Con Res 95) assumes a $1.4 billion (2.8 percent) cut in discretionary health spending in FY 2004. This category includes funding for the Agency for Healthcare Research and Quality (AHRQ), the National Institutes of Health (NIH), and the other Public Health Service agencies. It also includes instructions to reduce non-Social Security mandatory programs, including Medicare and Medicaid, by $261 billion and $110 billion respectively over 10 years. In contrast the Senate Budget Committee passed resolution (S Con Res 23) includes a very modest increase - $152 million - for AHRQ, NIH and the other Public Health Service agencies and does not include cuts to the Medicare and Medicaid programs. 

Floor Action: The House budget resolution was passed by a close vote of 215 - 212 on March 20. The PPC joined with over 125 groups in the health and child/adolescent health advocacy community to oppose the under-funding of health discretionary programs and Medicaid. Less than a week later the Senate passed its version of the budget resolution by a vote of 56 - 44. The Senate budget resolution includes an amendment offered by Senators Arlen Specter (R-PA) and Tom Harkin (D - IA) that increases health discretionary programs (Function 550) by $2.8 billion. This includes agencies such as CDC, HRSA and the NIH. At the time of this writing, the PPC is working to ensure that the final version of the FY 2004 budget resolution, that must be reconciled between the two different House and Senate versions, will not include the severe Medicaid cuts included in the House budget resolution and will include increased spending for health discretionary programs as included in the Senate budget resolution. 

The Budget Committees' timetable calls for completion of the budget resolution (which does not need to be signed by the President) by April 15. At the time of this writing it appears that Congress may meet its deadline. Although one of the biggest points of contention is the President's tax cut of $726 billion included in the House budget resolution in contrast to the scaled-back $350 billion tax cut included in the Senate budget resolution. The total budget resolution is $2.2 trillion.
 
 

HEALTH INSURANCE COVERAGE AND ACCESS TO CARE

SCHIP: There are two State Children Health Insurance Program (SCHIP) funding problems for which a legislative remedy is needed. The first is the almost $3 Billion in unused SCHIP dollars that have already or are scheduled to revert back to the federal treasury by September 30, 2003, and the second is the program funding "dip," a drop in program funding by more than $1 billion this year and in each of the next two years, the result of the balanced budget deal enacted in 1997. Over the next three years, SCHIP program funding will be reduced by 26 percent. The combination of the "SCHIP Dip" and rising SCHIP enrollment could cause many states to have insufficient funds to continue to fund their programs. The Office of Management and Budget (OMB) estimated that national SCHIP enrollment will decline by 900,000 children between 2003 and 2006 due to these reductions in federal funding.

Multiple legislative proposals have been introduced in both the Senate and the House in order to extend the availability of the expiring SCHIP funds. These proposals differ in their provisions on the redistribution and retention of the unspent funds and also on whether states can use the funds to pay for Medicaid child expansions. The pediatric community will support legislative efforts that seek to keep SCHIP program dollars for vital child health programs in the states. Legislation to remedy the SCHIP "dip" has yet to be introduced this year.

Medicaid Reform/SCHIP Proposal: The Bush Administration's 2004 budget includes a proposal to reform the Medicaid and State Children's Health Insurance Programs (SCHIP) by combining the two programs into one state block grant. 

This Medicaid/SCHIP proposal would divide up an estimated $12.7 billion in additional funding over seven years that would be loaned to those states that agree to have their Federal funding for Medicaid and SCHIP capped for the next 10 years. Federal funding for Medicaid and SCHIP would be provided in two annual allotments, with one allotment for acute care and another for long-term care. These annual capped amounts would be given to states based on its level of spending in 2002 for Medicaid and SCHIP, and would be increased each year based on a formula. 

States that do not choose the new proposal option would continue to administer their Medicaid and SCHIP programs under existing rules, but will not receive any additional federal funds for fiscal relief. 

This proposal clearly poses a risk to the child health care safety net. Medicaid currently has open-ended Federal financing. If the costs of the state program grow, the Federal funding automatically grows - with no cap. Through capped allotments, this proposal limits federal funds states would receive in the future for coverage of low-income children regardless of increases in enrollment or needed services. The proposal provides states tremendous flexibility concerning the Medicaid "optional" population, which includes over 8 Million enrolled children. Such flexibility, combined with limited federal funds, poses a serious risk to all children's health benefits under Medicaid and SCHIP, including benefits for children with special needs. Pediatricians are urged to contact their governor, senators and representative to oppose the Administration's Medicaid proposal and to ask them to protect the Medicaid and SCHIP programs.

The pediatric community will closely monitor this issue in the weeks and months ahead.
 

IMMUNIZATIONS

Federal Legislation: Several legislative proposals have been introduced to address the Vaccine Injury Compensation Program (VICP). This time last year, Sen. Bill Frist (R-TN) introduced the Improved Vaccine Affordability and Availability Act. The bill addressed increasing influenza rates as well as required the HHS Secretary to provide for a program of research, demonstration projects, and education to ensure that public and private health care providers routinely offer immunizations to adults and adolescents. The VICP program would have been required to collect data on adverse impacts associated with immunizations. 

The bill also revised provisions governing VICP, such as: equitable relief; third party petitions; jurisdiction to dismiss improperly brought claims; vaccine-unrelated injury; an increase in the award for pain and suffering in the case of a vaccine-related death. A companion bill also was introduced in the House by Representatives Jim Greenwood (R-PA) and Edolphus Towns (D-NY) and will be introduced again later this year. 

Although the Senate did not pass this legislation in the 107th Congress, a similar Frist proposal had been introduced as Title III of S.15, legislation that includes the Administration's new Project Bio-shield anti-terrorism counter-measures initiative and a "no-fault" smallpox vaccine compensation program. As anticipated, this provision was stripped from S.15 and it has now been introduced as "free-standing" VICP legislation - Improved Vaccine Affordability and Availability Act - similar to the bill introduced last year by Senator Frist with additional modifications recommended by the Academy and the Advisory Commission on Childhood Vaccines (ACCV). Mark-up on this important legislation has been postponed three times and is now tentatively rescheduled for April 30. The principles that any amendments to this important legislation must be measured are:

1. The Vaccine Injury Compensation Program (VICP) must guarantee a safe and stable supply of childhood vaccines;

2. The scientific credibility of the VICP must be preserved; and

3. The VICP must stand as the first contact for all alleged vaccine-related injuries before pursing legal action.

Also, in the 108th Congress, Senators DeWine (R-OH), Clinton (D-NY), and Reed (D-RI) introduced S. 371, the Childhood Vaccine Supply Act. Echoing the recommendations of the General Accounting Office's September 2002 report, S. 371, requires a national six-month stockpile for routine childhood vaccines, and requires manufacturers to give one-year's advance notice when they intend to stop producing a vaccine, enabling the CDC and FDA to better monitor the supply stream of vaccines coming into the market, and allows them more time to prepare for potential shortfalls. 
 

2003 PEDIATRIC ACADEMIC SOCIETIES ANNUAL MEETING

Public Policy Plenary Session: The title for this year's PPC annual Public Policy plenary session, a popular feature of the PAS Annual Meeting jointly sponsored with the Ambulatory Pediatric Association, is "The Changing Spectrum of Pediatric Specialty Care: Implication for Pediatric Generalist and Specialist." The 2-hour session will be held on Sunday, May 4. It will focus on the generalist-specialist interface and the roles of these groups in the new century. Our speakers are: James Perrin, MD, Director of General Pediatrics, MassGeneral Hospital for Children, Julia McMillan, MD, Vice Chair for Education and Residency Program Director, Johns Hopkins University School of Medicine and Robert Haslam, MD, Emeritus Professor and Chairman of Pediatrics, University of Toronto and Emeritus Pediatrician-in Chief of the Hospital for Sick Children, Toronto. This session will be moderated by Russell Chesney, MD, Chair, Department of Pediatrics, University of Tennessee -Memphis and member of the PPC. We look forward to an exciting and informative exchange.

Legislative Breakfast: The PAS legislative breakfast is the following morning, Monday, May 5 at 7:00 a.m. David Rimoin, MD, PhD, will lead a presentation tentatively titled "Clinical Research at a Crossroads: Overcoming the Translational Roadblocks: Report from the IOM's Clinical Research Roundtable". We look forward to seeing you and your colleagues at both of these events.
 

CONSIDER JOINING THE AAP FEDERAL ADVOCACY ACTION NETWORK (FAAN)

The American Academy of Pediatrics invites you to become a member of the Federal Advocacy Action Network (FAAN).  Coordinated by the AAP Department of Federal Affairs, FAAN is a network of AAP members who help support federal legislative and regulatory activities from their position as constituents.  FAAN members play an important role in passing federal legislation that benefits children and pediatricians.

The AAP Department of Federal Affairs gives FAAN members the information and tools you need to persuade your legislators.  For example, each month via e-mail you will receive FAAN MAIL with updates on AAP legislative priorities in Washington, D.C.  We will keep you up to date with timely information with "THIS JUST IN."  You will also receive "SPECIAL ALERTS" when immediate action is needed by you on a key issue. 

To join FAAN go to the Members Only Channel of the AAP web site, www.aap.org/moc, and click on Federal Affairs, then click on Join FAAN and follow the easy directions.   The Members Only Channel has some great tools to make your advocacy work easy.  Find the names of Congressional representatives, contact legislators via e-mail, read about daily congressional activity, view actual bills and use the media contact list.

HOW TO CONTACT YOUR MEMBER OF CONGRESS:

Write: Be courteous, to the point, and include key information, using examples, if possible, to support your position. Address only one issue in each letter and, if possible, keep the length to one page.

Call: You can contact your Senators and Representative's office by calling the Capitol Hill Switchboard at 202-224-3121. If you do not know who your Representative is, the switchboard operator will be able to direct you to the proper office. Ask to speak to the staff member who works on health care issues. Be prepared to leave a very short message as well as your name and address. You can also call your legislators in their home districts: information about local offices is available on the Academy's Members Only website at www.aap.org/moc

Fax: Most offices have fax machines, so you can call and ask for the fax number if you would like to fax your letter. Some offices do not give out their fax numbers, however.

E-mail: All of members of Congress now have e-mail addresses, but there is no set format for them. We suggest calling the member's office to get an accurate e-mail address or visit www.aap.org/moc the Members Only website of the American Academy of Pediatrics. 

HOW TO CONTACT THE PRESIDENT: 

Write:
The Honorable George W. Bush
The White House
1600 Pennsylvania Avenue
Washington, DC 20500

Call: 202-456-1414

Fax: 202-456-2461

Email: president@whitehouse.gov