National Institute of Health (NIH)/Appropriations: Congress approved the FY 2002 Labor, Health and Human Services, and Education (L/HHS) appropriations bill on December 20^th and the president signed the bill on January 10, 2002. The bill provided $23.285 billion for NIH, a $2.9 billion increase over FY 2001. Of that amount, $1.113 billion is provided for the National Institute of Child Health and Human Development (NICHD). Through its work with the Ad Hoc Group for Medical Research Funding the Public Policy Council (PPC) members will support the final year in the five-year doubling effort of the NIH budget - $27.3 billion.

Pediatric Research Initiative: The conference report for the FY 2002 L/HHS appropriations bill concurs with Senate-passed language in support of the Pediatric Research Initiative (PRI), authorized by the Children’s Health Act of 2000, P.L. 106-310 (H.R. 4365). This legislation, signed into law at the end of 2000, authorizes the NIH Director to establish a Pediatric Research Initiative to "conduct and support research that is directly related to diseases, disorders, and other conditions in children." It also provides for increased training grants for pediatric training, additional career development awards for health professionals intending to build careers in pediatric basic and clinical research, and a pediatric research loan repayment program of up to $35,000 per year for qualified health professionals who "agree to conduct pediatric research."

The Senate-passed language includes specific language supporting funding for the pediatric research loan repayment program in FY 2002, "particularly in the areas of Duchenne muscular dystrophy and fragile X." The language also instructs NIH to provide a status report on the Initiative by April 2002. AMSPDC president and chair of the AAP’s Committee on Pediatric Research, Russ Chesney, MD joined two representatives from the National Association of Children’s Hospitals, Drs. Ralph Kaufman and Tom Hansen, at a meeting with Acting NIH director, Ruth Kirschstein, MD to discuss the status of the PRI. Issues raised at this meeting included: NIH’s plans to implement the Pediatric Research Initiative, the challenges that NIH faces in implementing the PRI and the types of steps that could help result in effective NIH implementation of the PRI.

NIH Loan Repayment Information: The NIH Extramural Loan Repayment Program for Clinical Researchers is now available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-024.html and the notice for the NIH Extramural Pediatric Research Loan Repayment Program is located at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-025.html. Applications for both programs were due on February 28, 2002. Application submitted by this date will be considered for funding in FY 2002, ending Sept. 30, 2002. The Agency for Healthcare Research and Quality (AHRQ) is exploring ways to develop a similar loan repayment program in FY 2003.

President Bush signed into law on January 4, 2002, the Best Pharmaceuticals for Children Act, S. 1789 (formerly S. 838/H.R. 2887). 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.

As enacted by Congress, P.L. 107-109 includes several provisions that will enhance the current pediatric drug studies provision. For example, the Act establishes a mechanism through which the NIH Foundation can study off-patent drugs used by children. In addition, the Act creates an Office of Pediatric Therapeutics within FDA to coordinate, review and support all pediatric activities undertaken by the FDA and requires that a toll-free number for reporting adverse events be on drug labels approved under the pediatric studies provision.

The PPC worked closely with the Academy and others with the House and Senate to move the bills through the committee and floor process. Throughout the debate, the PPC joined in the advocacy efforts to ensure that the focus of the bill remain on enhancing the information available to pediatricians treating children and providing children with the best medicines.

The Senate version of the bill, introduced by Senators Christopher Dodd (D-CT) and Mike DeWine (R-OH), was passed by voice vote on October 18, 2001. The House version of the bill, introduced by Representatives Jim Greenwood (R-PA) and Anna Eshoo (D-CA), was passed on November 15, 2001, by a vote of 338-86. The pediatric studies provision was scheduled to expire on January 1, 2002.

The next steps include the implementation of several provisions of the law that the pediatric community will need to play an active role.

GME Financing in Children’s Hospitals/Appropriations: The FY 2002 L/HHS appropriations measure (P.L. 107-116) provides $285 million for Children’s Hospitals GME in FY 2002, the fully authorized amount and a $50 million increase over FY 2001. This funding increase followed significant advocacy work by the Academy, Public Policy Council, and the National Association of Children’s Hospitals. The President’s FY 2003 budget proposal includes only $200 million for the children’s hospitals GME program. The budget states that this reduction "…represents an effort to moderate spending. Since 2000, this program has been expanded seven-fold." The pediatric community will support and advocate for $285 million (plus inflation) for FY 2003.

Titles VII and VIII-Health Professions Training Grants/Appropriations: While the President requested only $140 million for the Titles VII and VIII health professions training and education programs in FY 2002 – a 60 percent decrease from FY 2001 – Congress rejected this cut and provided $378 million for the programs as part of the FY 2002 L/HHS appropriations bill. This amount includes $93 million for primary care programs such as pediatrics and internal medicine. The President’s budget for FY 2003 proposes a significant decrease - 71% - for these programs. Although the budget proposal acknowledges concerns regarding geographic maldistribution of physicians, it contends that the success of Titles VII and VIII in addressing this maldistribution is unproven. The FY 2003 proposal also repeats previous claims that a physician shortage no longer exists in the US. The PPC will join with over 40 organizations in the Health Professions and Nursing Education Coalition to support $550 million for these programs in FY 2003.

The FY 2002 L/HHS measure (P.L. 107-116) includes $732 million for the Maternal and Child Health (MCH) Block Grant, $23 million more than was requested by President Bush. The President’s FY 2003 budget proposal provides only level funding for the MCH programs. The budget also includes language to justify the elimination of separate funds for newborn screening and trauma care, noting the MCH block grants provide support for "…newborn screening, trauma care, lead poisoning and injury prevention."

• $23.3 billion for the National Institutes of Health, including $1.113 billion for the National Institute for Child Health and Human Development;
• $299 million for the Agency for Healthcare Quality and Research;
• $285 million for Children’s Hospitals Graduate Medical Education, the fully authorized amount;
• $378 million for the Titles VII and VIII health professions training and education , including $93 million for primary care programs such as pediatrics and dentistry;
• $1.190 billion for the Ryan White program, including $71 million for Ryan White pediatric demonstrations; and
• $732 million for Title V, the Maternal and Child Health Block Grant.

Funding for these and other child and adolescent health care programs are uncertain in FY 2003 if, as expected, the recession continues, the deficit continues to grow ($21 billion in FY 2002), the surplus is shrinking and additional funds are diverted to bioterrorism and defense initiatives. Emergency and supplemental appropriations related to the terrorist attacks of September 11^th coupled with a less-robust economic forecast have and will continue to significantly realign and/or drain federal spending priorities for other health discretionary programs.

As expected, the President’s $2.1 trillion FY 2003 budget proposal primarily focuses on defense spending and homeland security, thus setting up an inevitable fight between Congress and the White House over spending on other discretionary programs. Annual tensions may be exacerbated this year by the fact that a budget deficit is projected for at least the next three fiscal years, and that there is a strong indication that there may not be a congressional Budget Resolution for FY 2003. Add-in November’s mid-term elections and the fact that there are no longer statutory caps on discretionary spending for the first time in 10 years, and you have the groundwork for heated budget and appropriations debate.

Some of the key provisions of the President’s FY 2003 budget proposal include:

• $27.3 billion for NIH, a 15.7% increase and the completion of a five-year effort to double the NIH budget. NIH research priorities identified by the President include: bioterrorism, cancer, diabetes, HIV/AIDS, minority health and health disparities, and Parkinson’s Disease;
• $3.5 billion for the Indian Health Service, a net increase of $61 million over FY 2002;
• $200.4 million for Children’s Hospitals GME, a 30% decrease over FY 2002.
• $252 million for the Agency for Healthcare Research and Quality, a 16% reduction over FY 2002;
• Level funding for many programs of interest to the pediatric community, including CDC’s childhood immunizations programs ($631 million) family planning ($266 million), Ryan White AIDS programs ($1.91 billion), poison control ($21 million), and EMS for children ($19 million); and
• Total elimination of funds for several pediatric programs such as universal newborn hearing and the primary care/general pediatrics health professions programs in Title VII.

In addition, the President’s FY 2003 budget proposal reflects the Administration’s effort to consolidate all agency public affairs and congressional relations offices into one office under the auspices of the Office of the Secretary. Buildings/Facilities and personnel offices similarly are consolidated under the President’s FY 2003 budget proposal.

The PPC-supported Bioterrorism Preparedness Act of 2001 (S. 1765) was passed by the Senate on December 20, 2001. The bill, introduced by Senators Bill Frist (R-TN) and Edward Kennedy (D-MA), would, among other things: establish a National Task Force on Children and Terrorism; ensure that the National Pharmaceutical Stockpile meets the needs of children; provide funding for pediatric education and training of providers; require state preparedness plans address the needs of children; allow children’s hospitals to be designated as bioterrorism response medical centers; and ensure that all countermeasures research and develop consider children’s needs. While the House-passed bioterrorism bill, H.R. 3488, does contain several children-specific provisions, it is less comprehensive than S. 1765. House-Senate conferees are expected to meet shortly to reconcile their bills before final passage.

In a related matter, the American Academy of Pediatrics has established a Task Force on Terrorism to serve as an advisory body to the Academy’s board of directors on issues related to terrorism and other disasters. The Task Force’s mission includes: (1) assuring that the Academy is providing timely medical information to its members and the public; (2) defining gaps in knowledge and services in order to advocate for appropriate research; (3) serving in a leadership/advisory role on child-specific needs to the AAP and various governmental bodies; (4) assisting AAP Chapters in playing appropriately similar roles at the state and community levels; and (5) facilitating the organization of a broad coalition of interested groups to make sure children’s needs are adequately addressed in national, state and local disaster/public health plans. The Task Force is comprised of: Joseph Hagan, Jr., MD, Chairperson; Marion J. Balsam, MD; Richard Gorman, MD; Julia Lynch, MD; Julia McMillan, MD; Karen Olness, MD; Gary Peck, MD; Irwin Redlener, MD; David Schonfeld, MD; and Michael Shannon, MD. Academy President Louis Z. Cooper, MD, and Academy President-elect Stephen Edwards, MD, also serve on the Task Force as ex officio Members.

For FY 2003, President Bush has proposed level funding of $631 million for the CDC’s childhood immunization programs. This figure includes $135 million for global immunization activities such as polio eradication. Staff will be working with other advocates and congressional offices to ensure all vaccine programs are adequately funded in FY 2003.

Vaccine Safety/Congressional Hearing: House Government Reform Committee Chairman Dan Burton (R-IN) held additional hearings on vaccine safety in November and December, entitled "The National Vaccine Injury Compensation Program: Is It Working As Congress Intended?" Hearing witnesses included three parents who claim their children were injured by childhood vaccines, as well as Thomas Balbier, Director, Vaccine Injury Compensation Program, Department of Health and Human Services, and Paul Harris, Deputy Assistant Attorney General, Civil Division, Department of Justice. Chairman Burton is expected to hold additional hearings on vaccine safety and vaccine injury compensation next year.

Institute of Medicine Immunization Safety Review Committee: The IOM's Immunization Safety Review Committee, chaired by Marie McCormick, MD, ScD, FAAP, issued a report in on Multiple Immunizations and Immune System Dysfunction on February 20, 2002. The committee found that "the current immunization schedule calling for infants to get up to 20 vaccinations by the age of two does not increase the risk of contracting Type 1 diabetes or various infections, such as pneumonia and meningitis." The report stated that "the evidence is inconclusive as to whether the immunization schedule increases the risk of asthma." The committee also wrote that "there is no need for a federal review of the schedule for infant immunizations at this time." The committee has already scheduled a March 11 public meeting in Washington, D.C., to discuss Hepatitis B and neurological disorders. A report on that topic will be issued within 90 days of the meeting date (June 2002).

2002 PAS ANNUAL MEETING

Sunday, May 5^th - Public Policy Plenary Session: Planning is well underway for the 2002 PAS Annual Meeting, to be held in Baltimore, Maryland on May 4-7, 2002. The session, jointly sponsored with the Ambulatory Pediatric Association, is tentatively entitled Children as Research Subjects: Ethical and Regulatory Issues. This session will include an interactive panel presentation by Alan Fleischman, MD, Senior Vice President of the New York Academy of Medicine and member of the National Human Research Protections Advisory Committee, Eric Meslin, Ph.D., Director of the Indiana University Center for Bioethics, P.Pearl O’Rourke, MD, Director, Human Research Affairs, Partners HealthCare Systems, Inc. and Sara Rosenbaum, JD, George Washington University . Public Policy Council Chairman Myron Genel, MD, Professor of Pediatrics and Associate Dean of Governmental and Community Affairs at the Yale University School of Medicine will moderate this informative and certain to be lively session. During the two-hour event, audience members will be encouraged to participate in an expanded question-and-answer session.

Monday, May 6^th - Breakfast Legislative Symposium at 7:00 a.m.: Jennifer Kulynych, JD, Ph.D., Director, Division of Biomedical and Health Sciences Research at the Association of American Medical Colleges, will be the featured guest at the 2002 Legislative Breakfast to discuss the impact of U.S. Department of Health and Human Services’ new privacy regulations on medical research and research institutions.

The congressional district work periods provide a good opportunity for members of the American Pediatric Society, Society for Pediatric Research and the Association of Medical School Pediatric Department Chairs to contact their legislators in their home districts. Because 2002 is a mid-term election year – all 435 members of the House of Representatives and one-third of the Senate are up for re-election - the second session of the 107^th Congress will be fairly compact with short work weeks and regular recess/district work periods. (See dates listed below.)

2002 CONGRESSIONAL CALENDAR

Additional information and resource material on these and other pediatric and child health issues are available from:

Karen M. Hendricks, JD
Washington Coordinator
KHendricks@aap.org

601 13^th Street, NW
Suite 400 North
Washington, DC  20005
ph: 800/336-5475
fax: 202/347-8600