American Pediatric Society & Society for Pediatric Research

Public Policy Council

 March 2005 Legislative Report 

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The 109th Congress was sworn in on January 4, 2005, and immediately faced numerous challenges.  In addition to the ongoing challenges of homeland security and the war in Iraq, the President's budget, released on February 7, found an ever increasing deficit in FY 2004 of $413 billion and a projected deficit of $427 billion in FY 2005, therefore making funding for child health programs look very bleak, including proposals to cut the Medicaid program by billions of dollars over the next 10 years.

The new Congress has provided Republicans with net gains in both the Senate and House.  The new ratios are: 55 Republicans, 44 Democrats and 1 Independent in the Senate; 232 Republicans, 201 Democrats, 1 Independent and 1 open seat (following the death of Rep. Bob Matsui, D-CA) in the House.  With both bodies skewing more conservative in the 109th Congress, the pediatric community will have to work very hard to make sure the interests of children and adolescents are assured in the coming year, and that public health programs in general are provided adequate funding.

The following is an update and summary of recent federal legislative and regulatory activities of interest to the pediatric academic community that will assist you in your advocacy in the months ahead. We encourage you to share this information with your colleagues. As the first session of the 109th Congress gets underway, members of the American Pediatric Society, Society for Pediatric Research and the Association of Medical School Pediatric Department Chairs are urged to reach out to their Members of Congress to advocate for key health and pediatric-specific issues. 

This report includes information on the following issues:

• Pediatric Research

• Pediatric Medical Devices

• Pediatric Workforce

• FY 2005 Appropriations

• FY 2006 Budget

• Emergency Medical Services for Children

• Health Insurance Coverage and Access to Healthcare

• Immunizations

• 2005 PAS Annual Meeting

• Join the Federal Advocacy Action Network

• How To Contact Congress/White House

• Congressional Calendar

PEDIATRIC RESEARCH   

National Institute of Health (NIH)/Appropriations: Through its advocacy with and leadership in the Ad Hoc Group for Medical Research Funding, the PPC has supported a sustained and an adequate increase in funding for the NIH. The Ad Hoc Group has one mission: to enhance the federal investment in biomedical, behavioral, and population-based research by increasing the funding for the NIH. To continue the progress and research investment of the past five years, the PPC joined with over 200 organizations to support the Ad Hoc Group's FY 2005 recommendation of a 10% increase above FY 2004 - $30.6 billion. In addition, in conjunction with the Friends of the NICHD, the PPC supported $1.3 billion for the National Institute of Child Health and Human Development in FY 2005. The final FY 2005 omnibus funding bill contained $28.371 billion for the NIH, a $571 million increase (2.1%) over FY 2004, and contained $1.2 billion for NICHD.

The President's FY 2006 budget proposal, released on February 7, contains a very small increase for the NIH of $196 million (0.7%) - $2.8.845 billion. Through its work with the Ad Hoc Group for Medical Research Funding, the PPC will seek a FY 2006 NIH budget of at least $30 billion, a 6 percent increase over FY 2005.

National Children's Study (NCS): The pediatric community continues to be involved with and participate in various aspects of this important national longitudinal study.  The professional judgment of those involved with the study has indicated that the study needed $27 million in FY 2005 to begin collecting data and enrolling participants in 2006. However, the final FY 2005 budget did not include this amount for the NCS. The PPC is working with other advocates, such as the March of Dimes, to secure adequate funding for the study, which has been estimated as needing at least $70 million in FY 2006, assuming the initial sites have started to enroll subjects. It is estimated that the total cost of the NCS over 25 years will be between $2–$3 billion. The FY 2005 omnibus appropriations bill included language that commended NICHD for its leadership on the National Children's Study and requested that the NICHD provide Congress by March 2005 a projection of total and annual costs of the study. Further information and updates are available at - http://www.nationalchildrensstudy.gov. 

Pediatric Research Loan Repayment: The NIH loan repayment program, including pediatric and clinical research, continues to be successful. According to information released from NIH in November —NIH has awarded almost 1200 student loan repayment contracts totaling $63.3 million in FY 2003 under the 5 loan repayment programs (clinical research, pediatric research, health disparities, clinical research LRP for individuals from disadvantaged backgrounds and contraception and infertility research). This is a 65.6% increase over FY 2002—63.3% of those who applied received awards. More then 1/2 went to MDs, over 1/3 to PhDs, 8% MD/PhDs and 5% to persons with other doctoral degrees. There were 298 awards in FY 2003 for pediatric loan repayments in contrast to 168 in 2002.  It is very important that this program, that allows eligible researchers and trainees supported by governmental (including AHRQ) and private, nonprofit grants to apply to the NIH for loan repayment, continues to be well publicized and utilized by pediatricians to ensure ongoing funding for this critical program.  The 2005 application cycle loan repayment ended on December 15, 2004 (http://www.lrp.nih.gov). 

IRB Registration:  In the summer of 2004, the HHS Office for Human Research Protections (OHRP) issued for comment a proposal to require and standardize registration of IRBs that review research involving human subjects. The PPC joined with the AAP in submitting comments to HHS, reinforcing the recommendation made to the Institute of Medicine's Committee on Clinical Research Involving Children that IRBs have adequate pediatric expertise. The letter urged that the new registration requirements be modified to require an indication of whether each IRB member has child health care and research expertise, and expanded to include an estimate of the number of protocols an IRB reviewed during the preceding calendar year that involved children.

Publication and Disclosure Issues in Clinical Trials:  On September 9, 2004, Rich Gorman, MD, Chair of the AAP Committee on Drugs, testified before the House Energy and Commerce Subcommittee on Oversight and Investigations on "Publication and Disclosure Issues in Anti-Depressant Pediatric Clinical Trials." The PPC reviewed and formally endorsed the AAP testimony. The testimony asserted that it is not an issue of IF there is a need to provide health care professionals and patients appropriate information about clinical trials findings; rather it is a matter of HOW the information is provided.  Additionally, the Subcommittee was urged to broaden their investigation to include all medications, rather than simply anti-depressants, and that thoughtful and deliberative assessment of how data collection and registries are developed is essential - with an emphasis on exploring fully the role of peer-review of studies.

The issue of publication and disclosure in clinical trials is one that Congress is growing increasingly interested in.  Sens. Dodd (D-CT), Johnson (D-SD), Kennedy (D-MA), and Wyden (D-OR) and Reps. Markey (D-MA) and Waxman (D-CA) introduced S. 2933 and H.R. 5252, respectively, in the 108th Congress calling for a centralized, comprehensive, mandatory database for all publicly and privately funded clinical trials involving drugs or biological products. The PPC is working closely with the primary authors of the legislation to make sure that the voice of the pediatric research community is heard, as similar legislation is expected to be introduced in the 109th Congress.

Agency for Healthcare Research and Quality (AHRQ)/Appropriations: The PPC, as part of a broad-based coalition, the Friends of AHRQ, supported increased funding in FY 2005 for AHRQ of at least $443 million. Congress and the administration continue to request that AHRQ undertake new and important responsibilities but additional dollars for the agency to complete these new tasks is rarely forthcoming. The final FY 2005 omnibus appropriations bill funds AHRQ at $319 million for an additional $15 million (5%) over last year. However, the $15 million, according to conference committee report language, is to be used for clinical effectiveness research as authorized in the Medicare Modernization Act.

The President proposes level funding at $319 million for AHRQ in FY 2006, with all funds allocated via transfers from other public health service agencies. The budget designates $50 million for health information technology, $34 million for patient safety, and $15 million for comparative effectiveness research. Through it's work with the Friends of AHRQ the PPC will support $440 million for AHRQ in FY 2006.

Secretary's Advisory Committee on Human Research Protections (SACHRP): The Secretary's Advisory Committee on Human Research Protections (SACHRP) has created a Subcommittee for Research Involving Children, which includes several notable pediatricians. The subcommittee was formed to take the lead on addressing the Committee's charge of creating a national review process for section 407 protocols (research not otherwise approvable under CFR 46.404-406, and which examines a serious problem affecting the health of children).  At its most recent meeting on January 31st, the Committee heard a lengthy report from the Subcommittee.  Among the issues the subgroup is currently addressing are definitions of "minimal risk", "condition" and other statutory terminology used in 404-406 protocols, a uniform vs. relative standard for assessing risk in children involved in all clinical trials, and the concept of a central IRB.  Additional information, including its charter and the pediatric subcommittee roster, can be found on the Committee's website, at http://ohrp.osophs.dhhs.gov/sachrp/sachrp.htm.

"Therapeutic Cloning"- President's Council on Bioethics: President Bush's Council on Bioethics continues to meet regularly to discuss issues pertaining to the ethics and policies of genetic and reproductive technologies and the patentability of human organisms, stem cell research and biotechnology related issues. 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.  In March 2004, the Council released a fifth report, entitled "Reproduction and Responsibility: The Regulation of New Biotechnologies" which critically assess the various oversight and regulatory measures that now govern the biotechnologies and practices of assisted reproduction, human genetics, and human embryo research.  The report's recommendations fall into three broad categories: studies and data collection, oversight and self-regulation by professional societies, and targeted legislative measures to "institute a moratorium on certain particularly questionable practices", including prohibitions on the transfer, for any purpose, of any human embryo into the body of any member of a non-human species. The Council will meet again in March 2005. Additional information about the President's Council, including meeting transcripts and reports, is available online at www.bioethics.gov.

Embryonic Stem Cell Research:  In the last Congress, a bipartisan group of Members, led by Representatives Mick Castle (R-DE) and Diane DeGette (D-CO), introduced a bill that would have expanded the current policy on federal funding of embryonic stem cell research.  The legislation attempts to address some of the challenges with the current embryonic stem cell policy that was established in August 2001. These challenges include the fact that the embryonic stem cell lines available to researchers were originally thought to be more than 60 in number may now only be 19 according to the NIH registry. In addition there are also issues including whether of not all of the available stem cell lines are contaminated with mouse feeder cells, making their therapeutic use for humans uncertain; and scientists are reporting that it is increasingly difficult to attract new scientists to this area of research because of concerns that funding restrictions will keep this research from being successful. The Senate also embarked on a similar but failed effort in 2004, with more than a majority of the Senate supporting expansion of the stem cell policy. Senators Orrin Hatch (R-UT), Diane Feinstein (D-CA), Arlen Specter (R-PA), Tom Harkin (D-IA), and Ted Kennedy (D-MA) led the Senate effort.

Throughout the 108th Congress the PPC was involved in a variety of efforts to urge the Administration to modify its current stem cell policy, which limits federal funding for research on embryonic stem cells to those cells derived prior to the August 9, 2001, date when the policy was announced.

On February 16, 2005, a bipartisan group of House and Senate members led by Representatives Castle and DeGette and Senators Specter and Harkin reintroduced legislation - Stem Cell Enhancement Act of 2005 - to modify the current stem cell policy. In addition, several states are contemplating introducing stem cell legislation following the success of the California stem cell ballot initiative in 2004.
 

PEDIATRIC MEDICAL DEVICES

Pediatric medical devices has become a very active issue both within Congress and the Administration and among pediatric health advocates, to examine the unmet needs of and possible solutions to improving the availability of medical devices for neonates, infants, children and adolescents.  In an ongoing effort to improve therapeutics and diagnostics for pediatric populations, the AAP, the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), the National Organization for Rare Disorders (NORD), the National Association of Children's Hospitals (NACH) and the Advanced Medical Technology Association (AdvaMed) hosted a series of four invitational meetings to discuss pediatric device availability and needs during the summer and fall of 2004.  PPC member and chair of pediatrics at Wake Forest, Jon Abramson, MD, represented the AAP and PPC at the meetings.

An initial meeting was held in June 2004, which served, as the starting point to identify unmet pediatric device needs, barriers to addressing those needs, and possible mechanisms for increasing the availability of pediatric appropriate products.  A series of three follow-up meetings (October and November) were then held that focused discussions on several specific areas:  data collection/information sharing; administrative and regulatory issues; and market capacity and incentives.  Other issues such as reimbursement and liability were also touched on.  Participants at the meetings also included representatives from the Food and Drug Administration, National Institutes of Health, Institute of Medicine, in addition to members of the device industry, pediatric organizations and biomedical engineers.

Perhaps the most significant outcome of these meetings was the clear recognition by the group that children have medical devices needs that can differ considerably from adults across a broad range of illnesses, conditions, and subspecialties.  Other key outcomes were the identification of examples of pediatric needs across the specialties represented, the listing of current barriers to pediatric device development, and the identification of potential legislative, regulatory and other solutions to improving the availability of pediatric devices.  Additional meetings may be convened this year, if necessary, to fully examine these and other important issues.

Congressional Activities:  Senate staff remains interested in developing legislation in the 109th Congress that will address the unmet pediatric needs for the pediatric population.  The pediatric community will continue to meet regularly with congressional staff to ensure that legislation is comprehensive and adequately addresses the needs of pediatricians and their patients. 

Regulatory Activities:  In the summer of 2004 the Food and Drug Administration issued a Federal Register notice requesting comments concerning the possible barriers to the availability of medical devices intended to treat or diagnose diseases and conditions that affect children.  The FDA sought comments on:

• The unmet medical device needs for the pediatric population;

• The possible barriers to the development of pediatric devices;

• Things the FDA could do to facilitate device development. 

This information will assist the FDA in preparing a report to Congress.  The PPC and AAP submitted a comment letter to the FDA that made several recommendations, including that: 1) Congress should consider establishing the presumption that devices manufactured for adults should also be required to be designed for and tested for pediatric populations if the indication occurs in those populations; 2) Congress should consider the creation of financial incentives, including grants or guaranteed loans for R&D to small companies, modifying the existing Humanitarian Device Exemption provision to allow for profit, and financial support for prototype development and the conduct of clinical trials; and 3) A mechanism should be developed for sharing information that may be useful in helping a manufacturer identify a potential market for a new or modified product, and for identifying opportunities for collaboration between manufacturers with pediatricians or institutions. 

Institute of Medicine Activities:  The Institute of Medicine (IOM) has been charged by Congress to study the postmarket surveillance of pediatric medical devices and report back to Congress by October 2006.  Jon Abramson, MD, FAAP testified before an IOM committee hearing in August, 2004, presenting a statement reviewed and endorsed by the pediatric academic societies which concluded that postmarketing surveillance, monitoring and reporting for pediatric devices is gravely inadequate, and that fixing the problems will take the commitment by a wide number of stakeholders in order to improve the availability of appropriately studied pediatric devices for infants, children and adolescents.
 

PEDIATRIC WORKFORCE

GME Financing in Children's Hospitals: Throughout the 108th Congress, the pediatric community worked in conjunction with the National Association of Children's Hospitals (NACH) to vigorously advocate for the President's proposal for $303 million in FY 2005 CHGME program. The final FY 2005 appropriations bill contains $300.8 million, which essentially constitutes level funding after the across-the-board cut to all non-defense, non-security programs of 0.8%.

On February 9, 2005, the Senate Committee on Health, Education, Labor and Pensions (HELP) marked up and passed S.285 (Sen. Kit Bond R-MO), reauthorizing the CHGME for FY 2006 through FY  2010.  S. 285 contains the same language as the bill the Senate passed last November by unanimous consent. S. 285 now goes to the full Senate for action.  The legislation, the Children's Hospitals Educational Equity and Research (CHEER) Act, authorizes $330 million for FY 2006 and "such sums as necessary" for subsequent years. The PPC will continue to work closely in collaboration with NACH to secure final passage in the 109th Congress.

Titles VII and VIII - Health Professions Training and Nursing Education Grants/Appropriations: As in previous years, the final FY 2005 appropriations bill agreed to by the House and Senate restored the funding virtually eliminated by the President.  For FY 2005, the combined programs received $450.2 million.  Title VII alone received $299.6 million, $5 million over fiscal year 2004 (even after the president recommended for the third year to eliminate primary care funding); Primary Care Medicine and Dentistry received $88.8 million, an 8.6% increase. 

As in the previous four years, President's FY 2006 proposed budget removed all funding for primary care, interdisciplinary community projects, training for diversity, and public health. The President proposed only $11 million for the Title VII program, although once again it does address the nursing shortage through a modest increase for Title VIII. 

Following a tradition of many years, the pediatric community will continue to vigorously fight to restore funding for health professions and nursing education training under both Titles VII and VIII.  Through its efforts with the Health Professions and Nursing Education Coalition, the PPC will push for $550 million in FY 2006. The PPC will also advocate for adequate funding of at least $40 million for the general internal medicine/general pediatrics provision of Title VII.

Reauthorization: The Title VII program was due to be reauthorized in the 107th Congress (2002) but was not; nor was it taken up during the 108th Congress.  The pediatric community is continuing its conversations with colleagues in the internal medicine community in anticipation of reauthorization in the 109th Congress. Additionally, the Association of American Medical Colleges (AAMC) has put together a committee of physicians to review the mission and effectiveness of the Title VII program, and make legislative recommendations for reauthorization.  The Committee met for the first time in January 2005.  Tom DeWitt, MD, chair of the AAP Committee on Pediatric Education and a past president of the Ambulatory Pediatric Association, represented the pediatric community at the committee meeting, and presented several recommendations for the program, as outlined in a letter submitted to the AAMC on December 1. Two of the recommendations were supporting primary care and interdisciplinary training and increasing the number of primary care professionals who are from underrepresented minority groups. The letter is available on the AAP members' only web site. 
 

FY 2005 APPROPRIATIONS

The House of Representatives approved the Labor/HHS/Education Appropriations bill in September after two days of debate and consideration of amendments.  The Senate Appropriations Committee reported its version of the bill in mid-September, but the full Senate did not consider the legislation before fiscal year 2005 began on October 1, and so on September 29 Congress approved the first of several Continuing Resolutions (CR) to keep the government funded at FY 2004 levels in order to allow a post-election lame duck Congress time to complete the FY 2005 process.  On December 6, the House passed the FY 2005 Labor-HHS Appropriations bill as part of a larger omnibus appropriations package that contained 9 of the 13 annual bills.  The Senate cleared this legislation on November 20, but agreed to hold onto the measure until the House adopted a correction that removed contested language (not related to public health funding) from the bill.  The correcting resolution also reduces an across-the-board cut in all non-defense and non-homeland security discretionary spending directed in the omnibus bill to .08%.  The President signed the bill on December 8, 2004.  The final FY 2005 bill contained approximately $143.3 billion LHHS, representing a 2.79% growth from fiscal year 2004. 
 

FY 2006 BUDGET

On February 7, 2005, President Bush unveiled the details of his FY 2006 budget proposal to Congress. The $2.568 trillion spending plan calls for a 0.5 percent decrease in non-defense, non-homeland security discretionary spending. The Administration's proposal includes a 0.7 percent increase for the NIH, elimination of the Title VII health professions programs and the emergency medical services for children program, level funding for AHRQ and a $100 million decrease in funding for the CHGME program.
 

EMERGENCY MEDICAL SERVICES FOR CHILDREN — AUTHORIZATION

Legislation was introduced in the U.S. House of Representatives during the 108th Congress that would have eliminated the national Emergency Medical Services for Children (EMSC) program. The legislation, H.R. 3999, was developed chiefly to reauthorize the federal trauma care grants program.  However, as introduced, H.R. 3999 included language that would have eliminated the national EMSC program by striking Section 1910 of Title XIX of the Public Health Service Act.  While H.R. 3999 did include language to allow trauma care grant funds to be used to improve emergency medical services for children, among several other activities, history has made clear that unless the national EMSC program has distinct authority and support, children's emergency medical needs will go unmet. The PPC worked in partnership with the AAP to protect and preserve the national EMSC program. There were countless meetings with congressional staff as well as members of Congress; in addition, AAP/PPC staff met with the Institute of Medicine (IOM) to discuss the work of the IOM's pediatric subcommittee on emergency medicine that will be issuing a report in late 2005/early 2006 as part of a larger assessment of the emergency medical services in the United States.

HEALTH INSURANCE COVERAGE AND ACCESS TO CARE

President's FY06 Budget Proposal for Medicaid/ SCHIP: The President released his FY06 Budget Proposal on February 7, 2005.  It included approximately $60 billion in cost-savings, or cuts, to the Medicaid program over 10 years.  The pediatric community is greatly concerned about the impact that this decrease in federal funding will have on the program for children and for pediatricians.

 Although the President's budget included policy recommendations for how to find the cuts in the Medicaid program, there is much doubt in Washington as to whether these recommendations will actually amount to anywhere near $60 billion.  The great majority of the cost-savings target state practices of "gaming" the system to maximize federal funds.  Because there are past and ongoing efforts by the Administration to reduce such "maximization" practices, through intergovernmental transfers for example, there is concern that other types of reform will be necessary to realize the proposed program savings.  Irrespective of the policy recommendations of the President as to how to accomplish these cuts to the Medicaid program, these cuts will result in a $60 billion dollar decrease in funding that will have a dramatic effect on the program and its largest beneficiary population, children. 

Advocacy efforts to protect the Medicaid program are now focused on ensuring that Congress does not pass a Budget Resolution that includes cuts to the Medicaid program, particularly in the form of reconciliation instructions.  Such instruction would direct the House Energy and Commerce Committee and the Senate Finance Committee to develop Medicaid reform legislation that the Congressional Budget Office (CBO) determines will result in the targeted savings, or cuts, to the program.  The pediatric community is concerned that in order for CBO to score savings in a reform bill to achieve $60 billion in savings, Congress will have to make changes to the Medicaid reform that will be harmful for children (e.g. capping the federal funding of the program or enforcing a per capita cap on spending).  AMSPDC is working with the AAP to ensure that Congress does not pass a budget resolution with cuts to the Medicaid program, or any reconciliation instructions to achieve cost-savings.

The President's FY 2006 Budget outline also included a proposal to move up the reauthorization of SCHIP. Currently, SCHIP is scheduled for reauthorization in 2007.  Details on the President's proposals related to an early reauthorization have yet to be revealed; however, the Academy along with the pediatric societies will monitor this issue closely and will work together to protect this program for near poor children and families. 

Kids Come First Act of 2005: On January 24, 2005, Sen. John Kerry (D-MA) introduced the Kids Come First Act of 2005 (S.114).  This legislation is an effort to provide affordable health insurance to all children, with an emphasis on reforms to Medicaid and SCHIP to enroll all children up to 300 percent of the federal poverty level (FPL).  Included in the proposal is a "swap" for the states that would provide a 100 percent federal match for all children in the Medicaid mandatory population, in exchange for their expansion of their SCHIP program up to 300 FPL.  Through this "swap", states will get much needed fiscal relief and nearly all uninsured children will be enrolled through either Medicaid or SCHIP.  For those uninsured children who are above 300% FPL, there will now be an option for these families to buy affordable coverage through the SCHIP program. 

In order to enroll all eligible children in either Medicaid or SCHIP, the legislation includes outreach and enrollment efforts that have long been supported by the Academy such as: presumptive eligibility; 12-month continuous eligibility; acceptance of self-declaration of income; adoption of express lane eligibility; elimination of face-to-face interview for re-determination; no waiting lists for children under SCHIP; no assets tests for children; and no 5-year waiting period for legal immigrant children (previously supported ICHIA legislation).  Importantly, the legislation also provides for an increase in pediatric provider payments under Medicaid. 

MediKids: In the 108th Congress Rep. Pete Stark (D-CA-13) and Sen. John Rockefeller (D-WV) reintroduced the MediKids legislation (H.R. 1205/ S. 588). The pediatric community strongly supported this legislation that would have created a unified health care system that would achieve the goal of health insurance for all children regardless of family income. The legislation also would have made coverage automatic and promote equity, family responsibility, choice, and uniform benefits. The MediKids legislation will be reintroduced in the 109th Congress by Rep. Pete Stark (D-CA-13) in the House, and Sen. John Rockefeller (D-WV) in the Senate.  The PPC will work closely with the AAP on this important legislation.

Genetic Information Nondiscrimination Act of 2003: On February 7, 2005, Sen. Olympia Snowe (R-ME) reintroduced the "Genetic Information Nondiscrimination Act of 2005" (S. 306).  This legislation would prohibit health discrimination on the basis of genetic information or services by preventing employers and health insurers from discriminating against a person based on their predisposition to a disease.  The bill would also establish privacy protections for genetic information. On February 17, the Senate passed the bill by a vote of 98 - 0.  A House companion bill has not been introduced to date.

Association Health Plans: The pediatric community opposed legislation introduced last year that would have allowed association health plans—groups of small employers that band together and purchase health coverage—to be exempt from state regulation, oversight and mandates. This legislation threatened the progress that has been made in ensuring that insured children have appropriate access to preventive and well-child care because families who purchase health coverage from these plans would no longer be protected by state laws.  Fortunately, it did not pass in the 108th Congress, but will likely be re-introduced this year.  The PPC will continue to urge Congress to consider legislative solutions for small businesses that will provide affordable quality health insurance to families.
 

IMMUNIZATIONS

Federal Legislation:  As the 108th Congress came to a close, no action had been taken on the bill Sen. Bill Frist (R-TN) introduced making needed modifications to the Vaccine Injury Compensation Program (VICP). The Improved Vaccine Affordability and Availability Act of 2003 (S.754) - a bill similar to one he introduced in the 107th Congress, with additional changes offered by the AAP and the Advisory Commission on Childhood Vaccines (ACCV) makes several changes to the VICP including data collection on adverse impacts associated with immunizations, extending the statute of limitations from three to six years for families of children injured by required vaccines to file claims under VICP, and increasing the amount of compensation that families can receive for children's pain and suffering from $250,000 to $350,000.  The pediatric community will work for the introduction of similar legislation in the 109th Congress.

Vaccine Programs/Appropriations:  The childhood and adolescent immunization community pursued increased funding for the 317 program above the FY 2004 level of $643 million. Additional funds were needed to purchase vaccines for children, to operate the childhood immunization program as recommended by the IOM, for vaccine prevention activities, for funding to address the 19 states that are not vaccinating approximately 500,000 children with the PCV7 vaccine and for funding to implement the new routine influenza recommendations, the flu vaccine stockpile and for additional surveillance, communication and public education activities.

During the appropriations process both the House and Senate had each included a modest increase with the final FY 2005 omnibus appropriations bill including $469.9 million for immunization discretionary programs including section 317 and program operations.  There is also $138.3 million appropriated for global immunization including polio eradication. [NOTE: The difference in funding levels is pursuant to the reorganization of the CDC with certain funds related to the CDC/NIP immunization program in other funding lines.]

Weldon Amendment on Thimerosal: During the House Appropriations Committee's markup of the FY 2005 funding bill, a troubling amendment was offered by Rep. Dave Weldon (R-FL). As originally crafted the amendment would have prohibited the CDC from purchasing and funding influenza vaccines containing thimerosal or trace thimerosal (subsequently eliminated in offered amendment) given to children under age 6 (subsequently this, too, was changed to 3 years of age and under) during the 2005-2006 flu season.  In letters to the House Appropriations Committee the AAP, the Association of State and Territorial Health Officials and others expressed strong opposition to the amendment. Rep. Weldon ultimately withdrew the modified amendment on the condition that a hearing on this issue be held. PPC and AAP staff worked very closely with the staff of the House Labor/HHS/Education Appropriation Subcommittee Chairman Ralph Regula (R-OH) and other congressional offices to insure that accurate information on the flu vaccine and thimerosal was provided for the hearing.

Vaccine Supply: It was at the October hearing on the flu vaccine and thimerosal that the CDC announced a severe shortage in the nation's supply of flu vaccine pursuant to one of the company's inability to complete its order of almost 50 million doses.  In the weeks following the announcement, several bills were introduced to address issues surrounding the manufacture, distribution, and supply of influenza vaccine.  None of these bills were approved before Congress adjourned in December. It is expected that similar legislation may be reintroduced in the 109th Congress. In addition, the National Vaccine Advisory Committee (NVAC) held a second workshop in late January 2005 on the next steps in addressing the overall vaccine supply issue.  The PPC will continue to monitor any such efforts.

NVAC Public Participation Working Group: Last fall, the NVAC Public Participation Working Group convened a meeting to examine models for enhancing public involvement in vaccine decision-making.  The Working Group heard from representatives of various public and private groups, mostly outside the public health sector, which engage citizen involvement in information gathering, policy development, and decision-making.  The Working Group will consider which models might be appropriate for vaccine issues, and will present a report to NVAC at an upcoming meeting. 
 

PAS ANNUAL MEETING

2005 PAS: The 2005 PAS Public Policy Plenary Symposium will address the topic of clinical trial registries/databases.  Entitled "Clinical Trial Registries: Challenges and Opportunities", the session will be held on Sunday, May 15, and will be moderated by Myron Genel, MD, Chair, Public Policy Council and Professor Emeritus of Pediatrics, Yale University School of Medicine. The 2-hour plenary session will include the following presentations:

• Why We Need a Uniform, Comprehensive Registry of Clinical Trials
  Kay Dickersin, Director, U.S. Cochrane Center and Professor of Community Health, Brown University, Providence, RI

• Registering Clinical Trials - The Response from Medical Journals
  Christine Laine, Deputy Editor, Annals of Internal Medicine and Executive Secretary, International Committee of Medical Journal Editors

• ClinicalTrials.gov—For All and Open to All
  Donald Lindberg, Director, National Library of Medicine, NIH, Bethesda, MD

• Implications for Pediatric Research
  David Schonfeld, Chair, American Academy of Pediatrics Committee on Pediatric Research, New Haven, CT

At 7:00 a.m. on Monday, May 16, the Public Policy 19th Annual Legislative Breakfast Symposium will feature the session: "Politics of Stem Cell Research."  The speaker will be Anthony J. Mazzaschi, Director of CAS Affairs and Senior Associate Vice President for Biomedical and Health Sciences Research, Association of American Medical Colleges, Washington, DC.  The focus of the session would be the implications for pediatric research and practice.

Also on Monday, May 16, Drs. Duane Alexander and Peter Scheidt will provide an update on the Status of the National Children's Study since the 2004 PAS Meeting. The time and location will be available in early 2005 (visit www.pas-meeting.org).
 

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 Taryn Houghton Rosenkranz (trosenkranz@aap.org) in the AAP Department of Federal Affairs at 800/336-5475.  Together we can make a real difference for children and pediatricians!
 
 

HOW TO CONTACT YOUR MEMBER OF CONGRESS:

Write: The letter remains the most popular choice of communication with a congressional office.  If you decide to write a letter, remember to be courteous, to the point, and include key information and examples to support your position.  Address only one issue in each letter and, if possible, keep the length to one page.

Fax: Currently it is best to fax your letter to Congress.  Fax numbers are available through the Capitol Hill Switchboard (202) 224-3121, or you can look up your members of Congress on "Thomas" the official website for Congress, available at http://thomas.loc.gov/, by going to "House Directory" or "Senate Directory" from the front page. 

Call: You can contact your Senator's and Representative's offices by calling the U.S. 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 American Academy of Pediatrics' Members Only website, www.aap.org/moc.

E-mail: All of members of Congress now have e-mail addresses, but there is no set format for them. On some members web sites there is a mechanism to directly email most notably if you are a constituent.  We suggest calling the congressional office to get an accurate e-mail address or visit www.aap.org/moc the Members Only website of the AAP.

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