American Pediatric Society & Society for Pediatric Research

Public Policy Council

 August/September 2004 Legislative Report 

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As the 108th Congress winds down, it is becoming increasingly clear that all roads lead to the 2004 election.  While precious little time remains before the target adjournment date of October 1, much work remains to be done, and the looming elections and all that the four-year build-up entails are occupying the time and pre-occupying the minds of Members of Congress.  Most pressing, 12 of the 13 required FY 2005 appropriations bills remain unfinished, and the increasingly common omnibus "catch-all" bill is beginning to look like the probable outcome.  With homeland security - specifically the 9/11 Task Force and related fall-out - driving much of the work schedule, it appears that the pediatric community will once again need to work extremely hard to ensure adequate funding for public health programs.

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. 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 in August and for the remainder of this session 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 Budget/Appropriations

• Emergency Medical Services for Children

• Health Insurance Coverage and Access to Healthcare

• Immunizations

• 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 Public Policy Council (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 has joined with over 200 organizations in support the Ad Hoc Group's FY 2005 recommendation of a 10% increase above FY 2004, for a total of $30.6 billion. The PPC also supports an increase in funding for the National Institute of Child Health and Human Development (NICHD) at the NIH.  NICHD is currently funded at $1.2 billion. In conjunction with the Friends of the NICHD, the PPC is supporting $1.3 billion for this institute in FY 2005. President Bush's FY 2005 recommendation for the NIH proposed a below-inflation increase of 2.6% ($28.8 billion).  Though the Labor/HHS/Education appropriations bill has not gone to the House floor, the House Appropriations Committee in July approved $28.5 billion for NIH, $727 million above last year.  The Senate Appropriations Subcommittee is tentatively scheduled to take up its version of the FY 2005 bill after the summer congressional recess.

ACTION NEEDED: Urge your Senators and Representatives to maintain and sustain the investment in and adequate funding for NIH in the FY 2005 L/HHS/Education bill.   

Congressional Hearing on "Publication and Disclosure Issues in Anti-Depressant Pediatric Clinical Trials":  On July 20, 2004, Rich Gorman, MD, Chair of American Academy of Pediatrics (AAP) Committee on Drugs was scheduled to testify on behalf of the AAP and PPC before the House Energy and Commerce Subcommittee on Oversight and Investigations on "Publication and Disclosure Issues in Anti-Depressant Pediatric Clinical Trials."  This hearing has been postponed until September 9th.  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. 

IRB Registration:  The HHS Office for Human Research Protections (OHRP) has issued for comment a proposal to require and standardize registration of IRBs that review research involving human subjects. The PPC will likely use this opportunity to reinforce the recommendation made to the Institute of Medicine's Committee on Clinical Research Involving Children that IRBs have adequate pediatric expertise.

ACTION NEEDED: PPC members are encouraged to submit comments to HHS.  Comments on the proposed rule are being accepted by OHRP until October 4, 2004.  For more information, go to:  http://www.hhs.gov/ohrp/news/irbnotice.pdf  

National Children's Study: 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 needs $27 million in FY 2005 to begin collecting data and enrolling participants in 2006.  However, the President's FY 2005 budget request falls short of what is needed, providing only $12 million. The pediatric community is working with other advocates such as the March of Dimes in requesting an additional $15 million in new funding above the President's request for FY 2005. In FY 2006, the NCS will need at least $70 million 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 NCS Advisory Committee met in June 2004 to update and discuss the current status of the NCS including the fact that the planning phase of the NCS is nearing completion. 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, (http://www.lrp.nih.gov) 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.  NIH expects its FY 2004 and FY 2005 funding for the program to be comparable to that of FY 2003 so it will award about the same amount in both years.  It is very important that the loan repayment 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.

"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 September and December. Additional information about the President's Council, including meeting transcripts and reports, is available online at www.bioethics.gov.

Embryonic Stem Cell Research:  A bipartisan group of members of Congress led by Representatives Mick Castle (R-DE) and Diane DeGette (D-CO) have introduced a bill that would expand the current policy on federal funding of embryonic stem cell research.  The "Stem Cell Research Enhancement Act of 2004" (H.R. 4682) currently has 148 bipartisan cosponsors. This followed an earlier bipartisan letter signed by 206 of their colleagues to President Bush urging a modification to and expansion of the current federal embryonic stem cell policy that was established in August 2001. The legislation attempts to address some of the challenges with the current embryonic stem cell policy. 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 embarked on a similar effort earlier in the year 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.

The PPC joined a letter, initiated by the Coalition for the Advancement of Medical Research and signed by over 140 organizations, urging the Administration to modify its policy, which limits federal funding for research on embryonic stem cells to those cells derived prior the Aug. 9, 2001, date when the policy was announced.

In July, Health and Human Services Secretary Tommy Thompson announced that the "NIH is taking new steps to create a National Embryonic Stem Cell Bank that will provide a ready source of human embryonic stem cells to scientists, ensure consistent quality of the lines and provide other technical support that will make it easier for scientists to use these lines. The NIH is also creating three new Centers of Excellence for Translational Stem Cell Research with the goal of exploiting new discoveries in basic embryonic and stem cell biology."

IOM Committee on Clinical Research Involving Children: In 2003 the IOM convened a Committee on Clinical Research Involving Children to 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. The Committee finished its work, and released its report - The Ethical Conduct of Clinical Research Involving Children - to Congress at a briefing held in March 2004. A copy is available on line http://books.nap.edu/catalog/10958.html.

There is now an interest by several members of Congress to consider legislation to implement some of the recommendations made in the IOM report. These include the need for pediatric expertise on IRBs, the collection and reporting of data, developing best practices when involving children in clinical research and the education of researchers, institutions, families and patients involved in clinical research.

Secretary's Advisory Committee on Human Research Protections (SACHRP): The Secretary's Advisory Committee on Human Research Protections (SACHRP) 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).  Among the issues the subgroup is currently addressing are the merits of a federal advisory committee (FAC)-level review process for section 407 protocols, definitions of "minimal risk", "condition" and other statutory terminology, a uniform vs. relative standard for assessing risk in children involved in clinical trials, and the concept of a central IRB.  The Committee will meet next in October 2004.  Additional information, including its charter and the children's subcommittee roster, can be found on the Committee's website, at http://ohrp.osophs.dhhs.gov/sachrp/sachrp.htm.

Agency for Healthcare Research and Quality (AHRQ)/Appropriations: The PPC, as part of a broad-based coalition, the Friends of AHRQ, supports increased funding in FY 2005 for AHRQ of at least $443 million—up from $303.7 million, the current funding level.  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 not forthcoming. For example, the Medicare Modernization Act of 2003 includes a $53 million authorization for the agency to conduct comparative efficacy studies of health services and to convene the Citizens' Health Care Working Group. In addition, the administration has requested that AHRQ strengthen its current investments in patient safety and health information technology. However, the President's FY 2005 proposed budget does not include additional funding for either of these provisions but rather freezes AHRQ spending at FY 2004 levels. Unfortunately, the House Appropriations Committee in July followed suit, approving level funding for AHRQ in FY 2005: $303.7 million. 
  

PEDIATRIC MEDICAL DEVICES

Pediatric medical devices has become a very active issue both within Congress and the Administration, to explore the unmet needs and possible solutions to improving the availability of medical devices for neonates, infants, children and adolescents.  In June, PPC member Jon Abramson, MD, FAAP participated in a meeting of key stakeholders who have an interest in the development of pediatric devices.   Participants included representatives from the Food and Drug Administration, National Institutes of Health, Institute of Medicine, device industry, pediatricians, pediatric organizations and biomedical engineers, who came together to identify unmet pediatric device needs, barriers to addressing those needs, and possible mechanisms for increasing the availability of pediatric appropriate products.

Perhaps the most significant outcome of the meeting 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.

Congressional Activities:  Senate staff remains interested in developing legislation that will address the unmet pediatric needs for the pediatric population, though it is increasingly unlikely that pediatric device legislation will move before the end of the year.  The pediatric community continues to meet regularly with congressional staff to ensure that legislation is comprehensive and adequately addresses the needs of pediatricians and their patients. 

Regulatory Activities:  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 is seeking 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 request for information will assist the FDA in preparing a report to Congress, which is due October 1, 2004. 

ACTION NEEDED: PPC members are encouraged to submit comments to the FDA at HHS.   Comments on the proposed rule are being accepted by FDA until August 20, 2004. It is important that the FDA hears from as many pediatricians as possible because of the critical importance of this issue. For more information, go to:  http://www.fda.gov/OHRMS/DOCKETS/98fr/04-13872.htm  

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 will testify before an IOM hearing on August 31, 2004, presenting an AAP statement reviewed and endorsed by the PPC and the Ambulatory Pediatric Association.
 

PEDIATRIC WORKFORCE

Children's Hospitals Graduate Medical Education (CHGME): To the surprise of many, in light of last year's budget proposal that significantly cut the CHGME, the President's FY 2005 budget proposal included $303 million - the same amount as the current fiscal year. The administration's budget proposal also contained language that stated that "the CHGME program has a clear purpose and since the program was initiated the percentage of children's hospitals with negative margins has declined."  Throughout this session of Congress the PPC has been collaborating with the National Association of Children's Hospitals (NACH) to vigorously advocate to support the President's proposal for $303 million in FY 2005 CHGME program.  In July, the House Appropriations Committee approved the full amount requested for FY 2005, $303 million.

In June, long-standing supporters Sens. Kit Bond (R-MO), Ted Kennedy (D-MA), Mike DeWine (R-OH) and Patty Murray (D-WA) and Reps. Nancy Johnson (R-CT), Deborah Pryce (R-OH), Sherrod Brown (D-OH), Jim Greenwood (R-PA) and Anna Eshoo (D-CA) introduced H.R. 4578 and S. 2526, a bill to reauthorize the federal Children's Hospitals GME Payment Program for five years, FY 2006 through FY 2010. 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 House bill has 96 cosponsors and the Senate bill has 10. The current authorization expires at the end of FY 2005, on September 30, 2005. The PPC will continue to collaborate with the NACH in these advocacy efforts.

ACTION NEEDED: PPC members are urged to contact your senators and representative to support and cosponsor H.R.4578/S.2526.

Titles VII and VIII-Health Professions Training Grants/Appropriations: As in FY 2003 and 2004, the President's FY 2005 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 it does address the nursing shortage through a modest increase for Title VIII.  The PPC sent a joint letter with the AAP and internal medicine community to House and Senate appropriators in July, urging increased funding for the general internal medicine and pediatrics provision.  The House Appropriations Committee in July provided $416.3 million for Titles VII and VIII, restoring at least in part the overall program's funds cut by the President.  However, this is still below the $436.2 allocated in FY 2004.  Additionally, the funding for training in primary care took a bigger proportional cut in the committee than any other Title VII program, receiving only $63.8 million, down 21% from the FY 2004 level of $81.8 million.

Following a tradition of the past several years, the pediatric community along with other health professions groups 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 2005. The PPC will also advocate for $40 million in funding for the general internal medicine/general pediatrics provision of Title VII.

ACTION NEEED: Urge your Senators/Representative to restore and support adequate funding for health professions education and training programs, in particular, $40 million for general internal medicine/general pediatrics.  Describe specific examples of its importance in faculty development and to training/educating more pediatricians in a variety of ambulatory and community-based settings.

Reauthorization: The Title VII program was due to be reauthorized in 2002 but was not; nor was it taken up during the first session of the 108th Congress.  At this time there is little indication that it will happen in the short time before adjournment of the second session this fall.  The pediatric community is continuing its conversations with colleagues in the internal medicine community in anticipation of possible reauthorization in the 109th Congress. 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. [Contact: kbutterfield@aap.org]. 
 

FY 2005 BUDGET/APPROPRIATIONS

Budget: In the weeks and months prior to the summer recess, the House and Senate attempted to hammer out their differences in the budget resolution conference report.  The report was passed by the House on May 19, but, after much partisan wrangling, was eventually dropped from the Senate calendar.  As has increasingly been the case, the Congress has proceeded on to the appropriations process without a formal budget resolution in place. 

The budget resolution is essentially an internal congressional document, non-binding on other committees and does not need to be signed by the President. The budget resolution however, does offer an important spending blueprint and sets in motion the process in which decisions on spending and taxes must be made - appropriations and reconciliation.

FY 2005 Appropriations: The House Labor/HHS/Education Appropriations Subcommittee reported its bill on July 8, with the full committee following suit on July 14.  The House adjourned for August recess before the bill could go to the floor. The Senate appropriations committee has yet to take up the bill - it is growing increasingly likely that the stage is being set for an omnibus "catch-all" bill this fall, which could include at least 11 or 12 of the 13 appropriations measures. 

The PPC submitted a written statement for the hearing record to the House Appropriations subcommittee. 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, increasing the funding for Title VII programs, and the inclusion of children in clinical trials.  The PPC statement is available at www.aps-spr.org

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ACTION NEEDED: The August congressional recess is an excellent opportunity to participate in town hall meetings that your Senators/Representative may be convening. Urge them to support the highest level of funding for public health programs important to your community, including biomedical and health services research, independent children's hospital GME, mental health, programs addressing infectious diseases, and substance abuse prevention and treatment programs.

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EMERGENCY MEDICAL SERVICES FOR CHILDREN

Legislation has been introduced in the U.S. House of Representatives that would eliminate 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 also includes language that would eliminate the national EMSC program by striking Section 1910 of Title XIX of the Public Health Service Act.  While H.R. 3999 does 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 has been working in partnership with the AAP to protect and preserve the national EMSC program.  There have been countless meetings with congressional staff as well as members of Congress; in addition, AAP/PPC staff has 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. Additional advocacy "action" information and materials are available on the members only channel of the AAP web site—www.aap.org/moc, click on Federal Affairs.
 

HEALTH INSURANCE COVERAGE AND ACCESS TO CARE

MediKids: On March 11, 2003, 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 supports this legislation that would create a unified health care system that would achieve the Academy's goal of health insurance for all children regardless of family income.  MediKids would make coverage automatic and promote equity, family responsibility, choice, and uniform benefits. As of August 2, 2004, the MediKids legislation has 7 Senate cosponsors and 79 House cosponsors, compared to 3 Senate cosponsors and 66 House cosponsors in the 107th Congress.

Family Opportunity Act: Legislation was reintroduced in the 108th Congress to allow states to expand Medicaid coverage to children with severe disabilities.  Similar legislation was considered in the 106th and 107th Congress but did not pass either body.

The Senate passed the Family Opportunity Act by unanimous consent on May 6, 2004.  The House was scheduled to take up the measure on June 14 however, the chairman of the House Energy and Commerce Committee, Rep. Joe Barton (R-TX) would not allow the bill to move forward without an offset to pay for the bills' projected costs of $900 million over 5 years, and proposed an offset from within the Medicaid program.  Disability and health groups, while they strongly support passage of the bill, wanted to make sure it is not at the expense of other programs of importance to the disability community.  It is hoped that another offset for the Family Opportunity Act can be found—hopefully outside of the Medicaid program—before Congress adjourns in October.

Genetic Information Nondiscrimination Act Of 2003: On May 13, 2003, Sen. Olympia Snowe (R-ME) introduced the "Genetic Information Nondiscrimination Act of 2003" (S.1053).  This legislation would prohibit health discrimination on the basis of genetic information or services.  The bill prevents employers and health insurers from discriminating against a person based on their predisposition to a disease - specifically barring employers from using individuals' genetic information when making a hiring, firing, job placement or promotion decision, and baring health insurers from underwriting based on genetic information.  The bill would also establish privacy protections for genetic information. On October 14, 2003, the Senate passed the bill by a vote of 95 to 0. 

On July 22, 2004, the House Education and Workforce Subcommittee on Employer-Employee Relations held a hearing, "Genetic Non-Discrimination: Examining the Implications for Workers and Employers".  In the House, three committees have jurisdiction over the issue, the Education and Workforce, Energy and Commerce, and Ways and Means Committees.  This shared jurisdiction is making House passage of the bill challenging in this session of Congress. 

The PPC supported similar legislation in the 107th Congress introduced by Rep. Louise Slaughter (D-NY); it has renewed its support of genetic non-discrimination legislation and continues to work in coalition to support passage of this legislation in the House.
 

IMMUNIZATIONS

Federal Legislation:  As the second session of the 108th Congress winds down, there has been no action on the bill Sen. Bill Frist (R-TN) introduced making modifications to the Vaccine Injury Compensation Program (VICP), the Improved Vaccine Affordability and Availability Act, S.754. Briefly summarized, under S.754, the Vaccine Injury Compensation Program (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. It would extend the statute of limitations from three to six years for families of children injured by required vaccines to file claims under VICP, and also would increase the amount of compensation that families can receive for children's pain and suffering from $250,000 to $350,000. In addition, the legislation would allow parents to receive compensation for their own pain and suffering.  Mark-up on this bill has been postponed numerous times.  Though increasingly unlikely, the hope remains that it will be considered prior to the adjournment of this congressional session in October 2004.

Additional advocacy "action" information and materials are available on the members only channel of the AAP web site—www.aap.org/moc, click on Federal Affairs.

Vaccine Programs/Appropriations:  Predicated on the professional judgment of additional need, in FY 2005 the childhood and adolescent immunization community is pursuing increased funding for the section 317 immunization program above the current level of $643 million. This includes funding to purchase vaccines for children ($77 million), funding to operate the childhood immunization program as recommended by the IOM ($15 million), and for vaccine prevention activities ($5 million). Additional funding is needed to address the 19 states that are not vaccinating approximately 500,000 children with the PCV7 vaccine as well as the need for funding to implement the new routine influenza recommendations, the flu vaccine stockpile and for additional surveillance, communication and public education activities. There is also an additional $83 million needed for adult immunization programs and vaccine purchase for adults.

While final committee report language is not yet available and the bill has not gone to the House floor, the House Appropriations Committee approved an additional $10 million for the section 317 program; the Senate Appropriations Committee has not acted as yet but expects to in September.

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.  Rep. Weldon ultimately withdrew the modified amendment on the condition that a hearing on this issue be held in September.

Institute of Medicine Immunization Safety Review Committee: The final report of the of the Immunization Safety Review Committee, chaired by Marie McCormick, MD, ScD, FAAP, was released on May 17, 2004. The report provided another review of thimerosal and vaccines. The report concluded that the body of epidemiological evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism.  The committee began in January of 2001, and has released six other reports. These include a report on MMR and autism, thimerosal, multiple immunizations and immune dysfunction, Hepatitis B vaccine and demyelinating neurological disorders, and SV40 contamination of polio vaccine.

IOM Vaccine Financing Report: In August of 2003, the Institute of Medicine released a report Financing Vaccines in the 21st Century: Assuring Access and Availability.  In this report the IOM Committee proposed a new vaccine-financing program involving a federal vaccine insurance mandate, subsidy, and voucher plan. The mandate would require all insurance plans to include vaccine benefits, and the federal government would subsidize health plans and providers for the purchase costs and administration fees created by the vaccine mandate.  The report is available on the IOM website, at http://www.iom.edu/report.asp?id=14451.  The National Vaccine Advisory Committee (NVAC) held a meeting in late June to discuss the report and is continuing to review it.
 

PAS ANNUAL MEETING

2005 PAS: The 2005 PAS Public Policy Plenary Symposium, to be held during the PAS meeting in May 2005, in Washington, DC, is tentatively planned to address the topic of clinical trial registries/databases. The focus of the session would be the implications for pediatric research and practice. The Public Policy Council and the Ambulatory Pediatric Association, who cosponsor this session, have discussed possible speakers. These include: 1) a prominent medical journal editor; 2) a clinical trials/metanalysis expert, such as the US Cochrane Collaboration; (3) someone authoritative from either NIH (ClinicalTrials.gov) or FDA to discuss legislative/regulatory aspects; or 4) perhaps someone from Capitol Hill. 

The Monday Legislative Breakfast sponsored by the Public Policy Forum will be devoted to stem cell research. PPC Chair Mike Genel, MD, will facilitate this discussion along with a speaker, still to be determined, who would bring both policy and politics to the topic.
 
 
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