As the August congressional recess begins, the second session of the 107th Congress is rapidly coming to an end. The proposed creation of a new cabinet-level Department of Homeland Security, funding for all 13 appropriations bills, impending mid-term congressional elections, and an uncertain economy have so dominated the agenda in recent weeks that there is serious talk that Congress may return for a lame duck session to complete its business after the November election. In short, much remains to be done. The following is an update and summary of recent federal legislative and regulatory activities of interest to the pediatric academic community. 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 the remaining weeks and months of this session of Congress.

This report includes information on the following issues:

• Pediatric Research
• Pediatric Drug Studies
• Pediatric Workforce
• FY 2003 Appropriations
• Terrorism
• Immunizations
• How To Contact Congress/White House
• Join the Federal Advocacy Action Network
• Congressional Calendar
• Public Policy Forum

National Institute of Health (NIH)/Appropriations: Through its work with the Ad Hoc Group for Medical Research Funding, the Public Policy Council (PPC) is supporting the final year in the five-year doubling effort of the NIH budget - $27.3 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. The PPC is also supporting $1.284 billion for the National Institute of Child Health and Human Development (NICHD) in FY 2003.

On July 18, the Senate Appropriations Committee completed its mark-up of the FY 2003 Labor/HHS/Education appropriations bill and included $27.2 billion for the NIH. There has been no Senate floor action and the House Appropriations process must still occur in the early fall.

Pediatric Research Initiative: The Senate Appropriations Committee recently approved report language for the FY 2003 Labor/HHS appropriations bill that once again supports the Pediatric Research Initiative (PRI). The PRI 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." The FY 2003 Labor/HHS/Education Senate Appropriations Committee Report language states:

The Committee is pleased that the Office of the Director is implementing its Pediatric Research Initiative, as authorized by the Child Health Act of 2000. The Committee strongly supports the intent of the initiative, to provide additional funds to encourage the growth of support for pediatric research across Institutes and to stimulate new and promising areas of pediatric research.

Pediatric Research Loan Repayment: The Senate Appropriations Committee Report also includes specific language supporting funding for the pediatric research loan repayment program in FY 2003.

The Children's Health Act of 2000 established the Pediatric Research Loan Repayment Program to ensure the future supply of researchers dedicated to the care and research needs of children. The Committee is pleased with the expeditious initial implementation of this program, and it urges the NIH to expand it, particularly in the areas of Duchenne muscular dystrophy and Fragile X. The Committee requests that the Director prepare a report by April 1, 2003, detailing the progress of this program.

"Therapeutic Cloning"- President's Council on Bioethics: President Bush's Council on Bioethics met in June and again in July to discuss issues pertaining to the ethics and policies of genetic and reproductive technologies and the patentability of human organisms. Following the July meeting the Council recommended a ban on human cloning to produce humans and a four-year moratorium on human cloning for medical research. Ten members of the Council supported the recommendation while seven Council members disagreed and felt medical research should proceed under federal guidelines. Additional information about the President's Council, including meeting transcripts, is available online at www.bioethics.gov. Throughout this session of Congress, the PPC has supported the advocacy efforts of over 200 biomedical research scientists, patient groups and others to urge the Senate to oppose legislation that would criminalize an important research pathway, somatic cell nuclear transfer (SCNT) - "therapeutic cloning."

Agency for Healthcare Research and Quality (AHRQ)/Appropriations: The Public Policy Council, as part of the Friends of AHRQ, continues to support $390 million in funding for AHRQ in FY 2003. The Senate Appropriations Committee's, expressing its disappointment in the administration's proposed 16% cut in funding for AHRQ, recommends $308.6 million in funding for AHRQ in FY 2003, almost $10 million above current year funding. Of course the appropriations process is no where near completion but this is an initial good sign. On the House side, Congressman Ernest Istook (R-OK) a member of the House Appropriations Committee has expressed some interest in increasing funding for AHRQ to address the issue of the high health care costs.

National Children's Study: Created by the Children's Health Act of 2000 (PL 106-310) the National Children's Study is a national study of environmental effects (including physical, chemical, biological and psychosocial) on child health and development. It is an interagency collaboration for biomedical research including most NIH Institutes and Centers, 11 HHS agencies and 9 cabinet departments. In its planning phase, the lead federal agencies are the National Institute of Child Health and Human Development, 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. Additional and more detailed information is available at: http://NationalChildrensStudy.gov or join the listserv at ncs@mail.nih.gov.

The National Human Research Protections Advisory Committee (NHRPAC): The NHRPAC met at the end of July to present the reports of several of its working groups. NHRPAC is a committee chartered by Congress to provide advice and recommendations to the Secretary of HHS and other departmental officials on a broad range of issues and topics associated with the protection of human research subjects, including issues surrounding pediatric research.

Among other items, the meeting featured a report by the NHRPAC's Children's Workgroup. The chair of the Children's Workgroup is APS member and Vice President, NY Academy of Medicine, Alan Fleischman, MD. The focus of the report was to clarify federal regulations governing research-involving children - most specifically, interpreting how the concept of "minimal risk" is applied. The Workgroup attempted to classify by their category of risk several common procedures used in pediatric research as a way of offering general guidance to Institutional Review Boards and thus ensuring more uniform standards and alleviating concerns about the way regulations are enforced. Several discussion participants echoed the report's caution that standards of "risk" for children varied from those for adults, as in the example of the use light sedation and the need for airway management - a major safety issue for children. The Children's Workgroup will review the recommendations made by the NHRPAC members for possible consideration and inclusion into the Children's Workgroup report. Future issues outlined for review by the Children's Workgroup include issues of compensation, and consent and assent.

 
PEDIATRIC DRUG STUDIES

Federal Register: Earlier this summer, the Food and Drug Administration published a Federal Register notice requesting public comment regarding whether changes are needed to the Pediatric Rule, in light of the recently-passed Best Pharmaceuticals for Children Act. The PPC joined over 200 individual pediatricians and organizations in submitting comments to the FDA in support of a strong, comprehensive Pediatric Rule.

Those comments included the following:

• The Pediatric Rule ensures that children are no longer a therapeutic afterthought by the pharmaceutical industry. All new drugs must be studied for pediatric use at the time a drug comes to market unless the FDA grants a waiver. This puts children on a level playing field with adults for the first time.
• The Pediatric Rule includes biological products. The BPCA provides incentives to the pharmaceutical industry to study drugs but does not address biological products. Significant portions of therapeutics used in children are biological products. Without the Pediatric Rule there is no mechanism to ensure that pediatric studies are conducted on these important medications.
• The Pediatric Rule captures drugs and age populations that the Best Pharmaceuticals for Children Act cannot. The BPCA incentive of additional market exclusivity can only be applied once during the life cycle of a drug. When FDA requests pediatric studies under BPCA, all potential pediatric uses must be anticipated in the request. This request cannot be expanded later if additional studies are needed in very young children or newborns or if a new use is discovered for a drug. Once studies have been completed and the incentive has been granted, there is no obligation on the part of participating companies to generate additional pediatric data. The Pediatric Rule may be invoked in instances where pediatric information is essential but the BPCA is no longer available.
• The Pediatric Rule is ongoing the Best Pharmaceuticals for Children Act is time-limited. The BPCA sunsets in 2007. If it is not renewed, history suggests that the industry may not see it within their scope or financial best interest to continue to do pediatric drug studies. The Pediatric Rule will allow pediatric studies to continue.
• The Pediatric Rule is mandatory the Best Pharmaceuticals for Children Act is voluntary. Because BPCA is voluntary, not all sponsors are interested in complying with the terms. The Pediatric Rule applies to all drugs and biologicals whose intended use in pediatrics is the same as adults, thus ensuring appropriate pediatric information.

The Senate Appropriations Committee also included the following report language on the pediatric drug studies in the FY 2003 Labor/HHS/Education bill.

The Committee is aware that many generic drugs have not been studied for use in pediatric patients. Therefore, the Committee encourages the NIH to take actions necessary to fully implement the new section 409I of the Public Health Service Act to study the safety and efficacy of off-patent/off-exclusivity drugs in pediatric patients. The Committee requests a report by February 1, 2004, which includes information on the number of pediatric drug studies supported; the estimated cost of each study undertaken; the nature and type of studies undertaken; the number of label changes that occurred due to the studies completed; the patent status of the drugs studied; and the number of drugs remaining on the priority list established through section 409I of the Best Pharmaceuticals for Children Act.

Legislation: In a related development, legislation was introduced in the House and Senate to codify the Pediatric Rule. The Senate bill (S. 2394) is sponsored by Senators Chris Dodd (D-CT); Mike DeWine (R-OH); Hillary Clinton (D-NY); Ted Kennedy (D-MA); and Patty Murray (D-WA). In the House, Representative Henry Waxman (D-CA) introduced H.R. 4730. The Senate Health, Education, Labor and Pensions Committee approved S. 2394 on Aug.1 by voice vote, clearing the way for floor action this fall.

 
PEDIATRIC WORKFORCE

GME Financing in Children's Hospitals/Appropriations: The pediatric community is supporting and advocating for $292 million ($285 million plus an adjustment for inflation) for Children's Hospitals GME in FY 2003. It is currently funded at $285 million the fully authorized amount. The Senate Appropriations Committee provided $290 million in its mark-up of the FY 2003 Labor/HHS/Education bill - thus rejecting the President's FY 2003 budget proposal that provided only $200 million for the program. The PPC continues to work with the National Association of Children's Hospitals, pediatric department chairs and the AAP to vigorously advocate for adequate funding in FY 2003.

Titles VII and VIII-Health Professions Training Grants/Appropriations: Current funding for the Title VII and Title VIII programs is $378 million. The PPC continues to work with over 40 national organizations in the Health Professions and Nursing Education Coalition to support $550 million for these programs in FY 2003. 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 in FY 2003. This represents the first step in 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.

The Senate Appropriations Committee, expressing "disappointment in the President's budget proposal to eliminate or cut nearly every Health Professions program under Title VII " provided $160 million for the program still considerably short of the funding need and the current level of funding. There are still several critical steps in the appropriations process that will continue in September. Ongoing advocacy to maintain and support increased funding for the health professions training program is important during the congressional recess.

Reauthorization: The Title VII program should be reauthorized before the end of this fiscal year - September 30. 2002. However, it's clear that Congress and the Administration will let this date pass and it will be taken up in the 108th Congress that begins in January 2003. PPC staff have begun working on the reauthorization of the Title VII program.

FY 2003 APPROPRIATIONS

After many delays, Congress has begun the FY 2003 appropriations process in earnest, moving forward on several of the 13 bills comprising the total federal government spending package. In April, the PPC, submitted a written statement for the hearing record to the House and Senate Appropriations subcommittees. The statement focused on the importance of ongoing biomedical research including increasing pediatric research at the NIH, supporting the training of more pediatric investigators such as through the pediatric loan repayment program, support for Children's Hospitals graduate medical education, and the inclusion of children in clinical trials.

On July 18, the Senate Appropriations Committee voted in favor of the Fiscal Year 2003 Labor-Health and Human Services-Education Appropriations bill, clearing the way for action in the fall by the full Senate. Among other items, the bill recommends just over $27 billion to fund biomedical research at the 27 Institutes and Centers that comprise the NIH. This represents an increase of nearly $4 billion over the fiscal year 2002 level, and completes the historic 5-year effort to double the funding for the NIH. It also includes: $290 million for children's hospitals GME, $308 million for AHRQ, $2 billion for Ryan White AIDS programs, $4.29 billion for the CDC, $1.5 billion for community, migrant, public housing and homeless health centers.

The House Labor/HHS/Education is tentatively scheduled to mark-up its version of the FY 2003 bill on September 5 and the full Appropriations Committee will take action thereafter. However, final action may not occur until a possible lame duck session because the difference in spending allocations between the House and the Senate bill is very significant.

TERRORISM

Bioterrorism/Legislation: The President signed comprehensive bioterrorism and disaster preparedness legislation on June 12, 2002. Passed overwhelmingly by Congress, the PPC-supported Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (H.R. 3448) authorizes federal funds for national, state and local planning, response and recovery efforts

With respect to pediatric concerns, H.R. 3448:

• establishes a National Advisory Committee on Children to guide federal activities and make recommendations regarding the pediatric preparedness of the nation's health and mental health care systems;
• requires that the national stockpile of medical supplies, equipment, drugs and vaccines provide for the emergency health security of children;
• supports the development of pediatric education and training programs for all health care personnel;
• requires that a newly established interagency working group on bioterrorism address the health needs of children;
• includes children's hospitals in all preparedness efforts;
• ensures that children's needs are included in the development of a national list of dangerous biological agents and toxins;
• allows states to use federal grants to address the health needs of children in emergencies; and
• ensures that children's needs are considered in all accelerated countermeasures research and development.

The legislation also allows the Secretary of HHS to waive Medicare, Medicaid and SCHIP participation and pre-approval requirements during designated emergency periods. This waiver will ensure that pediatricians and other providers who deliver care during times of emergency are adequately reimbursed for their services.

IMMUNIZATIONS

Vaccine Programs/Appropriations: The PPC has joined with other child and adolescent health care advocates in supporting $696 million for CDC's immunizations program (section 317). The Senate Appropriations Committee recommends $672.8 million that is $45 million above the current year funding and the White House request. The House appropriations process is not yet underway and strong advocacy is necessary to ensure that increased funding for this important immunization program in FY 2003 becomes a reality.

Federal Legislation: Several legislative proposals have been introduced to address the Vaccine Injury Compensation Program (VICP). On March 20, 2002, Sen. Bill Frist (R-TN) introduced S. 2053, the Improved Vaccine Affordability and Availability Act. The bill addresses increasing influenza immunization rates as well as requires 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 be required to collect data on adverse impacts associated with immunizations. The bill also revises 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 mark up of this bill is expected in September.

Earlier in the year House Government Reform Committee Chairman Dan Burton (R-IN) joined with ranking member Henry Waxman (D-CA) to introduce HR. 3741, the National Vaccine Injury Compensation Program Improvement Act of 2002. The bill would amend the Public Health Service Act to, among other items, increase the award for a vaccine-related death, allow compensation for expenses for family counseling and establishing guardianship, and allow payment of interim attorneys' fees and costs.

Congressional Hearings: Sen. Jean Carnahan (D-MO) chaired a hearing in June entitled "Protecting our Kids: What is causing the current shortage in childhood vaccines?" The hearing, which examined the nature of the current vaccine shortage and the steps the federal government is taking to address the crisis, included witnesses from the CDC, FDA, industry, and two pediatricians. One pediatrician is a practicing pediatrician from Baltimore, Maryland, who represented the AAP and the other pediatrician is the chief of infectious diseases section at Children's Mercy Hospital and Clinics in Kansas City, Missouri. The AAP testimony focused on the consequences the national vaccine supply disruption has had on vaccine delivery to patients and their parents, what the administrative impact has been on pediatric practice, and finally, possible strategies to consider to address this critical matter.

How To Contact Your Member of Congress:

The August district work period provides 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.

Call: You can contact your Senators and Representative's offices by calling the Capitol Hill Switchboard at (202) 224-3121.  If you do not know who your Representative is, the switch board 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, 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.

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.

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 

2002 Congressional Calendar (District Work Period)

 
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.

If you are already a member of FAAN, thank you! If you are interested in joining FAAN and have questions, please contact Kristin Butterfield (kbutterfield@aap.org) in the AAP Department of Federal Affairs at 800/336-5475. Together we can make a real difference for children and pediatricians!

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

Myron Genel, MD, Chairman
Karen M. Hendricks, JD, Washington Coordinator
Kristin Butterfield, MA, Legislative Assistant

PUBLIC POLICY FORUM

(The Public Policy Council's Advocacy/Legislative Network)

The Public Policy Forum is intended to be a communications vehicle to academic pediatricians via AMSPDC members, either the chair or someone designated in the department.

Please help us keep our mailing list up to date and help us create an e-mail list for quick response to legislative alerts. If you have not done so, please fill in/return this form as soon as possible.

NAME:______________________________________________________________________________

INSTITUTION AND DEPARTMENT FOR WHICH I AM THE FORUM CONTACT:

_____________________________________________________________________________________

MAILING ADDRESS: Please give your precise address:

_____________________________________________________________________________________

_____________________________________________________________________________________

TELEPHONE: Please list the number(s) that you can be reached at during regular business hours (for legislative alerts).

PHONE:_____________________________________FAX:______________________________________

E- MAIL ADDRESS:______________________________________________________________________

U.S. CONGRESSIONAL CONTACT:

The Representative for this district is:____________________________________________________

Describe any contact your Senator(s) or Representative may have with your facility (i.e., serving on the Board of Trustees):

____________________________________________________________________________________

____________________________________________________________________________________

I belong to the following pediatric organizations:

___ American Pediatric Society ? Society for Pediatric Research

___ AMSPDC 

___ American Academy of Pediatrics

___ Ambulatory Pediatric Association 

___ Other: _________________________________________________

* RETURN TO:

Kristin Butterfield, MA, Legislative Assistant, Public Policy Council c/o American Academy of Pediatrics, 601 13th Street, NW, Suite 400 North, Washington, DC 20005
Fax: (202) 393-6137

8/02

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