Proposed Vaccine Safety Act in the USA.

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Statement of Rep. Dave Weldon, M.D. (Fl-15)July 26, 2006 -------------------------VACCINE BILL SECTION BY SECTIONSection 1. Short Title; Table of ContentsThis act may be cited as the "Vaccine Safety and Public ConfidenceAssurance Act of 2006.'Section 2 FindingsSection 3 PurposeTo direct that vaccine safety monitoring and research focus on activesurveillance, researching biological mechanisms for acute and chronicadverse events following vaccination, developing prevaccinationscreening methods within a framework that is free from actual andperceived biases, and developing a vaccine safety research agenda.Section 4. Establishment of Agency for Vaccine Safety Evaluation(inserted as Subtitle 3 of Title XXI of the Public Health Service Act)Sec. 2141 EstablishmentThe Agency for Vaccine Safety Evaluation (AVSE) is established withinHHS, to be

directed by the Director for Vaccine Safety Evaluation. Sec. 2142 Authoritiesa) With respect to vaccines, the Director shall:(1) Conduct or support safety research, including research on:a. Acute and chronic adverse reactionsb. Vaccine componentsc. Delivery mechanismsd. Potential presence of adventitious agents in vaccines(2) Conduct or support long- and short-term monitoring(3) Develop a vaccine safety research agenda(4) Conduct or support research across a range of disciplines(5) Conduct or support research to address claims of injury (6) Develop, evaluate, and test hypotheses about potential adversereactions(7) Evaluate and promote compliance of healthcare providers andvaccine manufactures with Federal requirements related to adverseevent reporting(8) Conduct or support research for the purpose of developingtools to prescreen individuals at risk for a vaccine-related adversereactions(9)

Conduct or support research into the biological mechanisms ofpotential adverse reactions(10) Conduct long-term monitoring of new or altered vaccines,including monitoring changes to the childhood and adolescentimmunization schedule of CDC(11) Provide a public database of pre and post licensure vaccinestudies. Personnel conflict-of-interest issues:1) Senior management positions (GS15 and higher) may not be filledby individuals who have been previously employed by CDC, FDA vaccinemanufacturers to carry out any function related to vaccine safety ormonitoring or vaccine development or by NIH in vaccine development fora period of 5 years.2) All personnel must be free of professional, familial, orfinancial conflicts of interest.c) Grant recipients are also subject to

conflict-of-interestrequirements, including financial conflicts that may compromise theperceived integrity of the research.d) Vaccine Safety Datalink Project(1) Responsibility for overseeing the VSD is transferred to the AVSE.(2) CDC and FDA have access to the VSD as needed to support theirefforts.(3) External access to the VSD is facilitated by the AVSE in amanner similar to that recommended by the IOM in their 2005 report.e) The Director is also directed to review internationalactivities of the Federal Government related to vaccine safety anddevelop plans for reducing any conflicts of interest uncovered duringthe review. A report of the review must be submitted to Congress.f) The Director may also establish a fellowship program fortraining individuals in vaccine safety research. Fellowshiprecipients are also subject to certain conflict of interest provisions.g) Grants will be awarded using the peer

review system, subject tothe provisions of the NIH peer review system.h) The FDA shall provide the agency complete access to vaccinesafety information, but the agency must keep this informationconfidential, subject to the same confidentiality provisions as FDA.i) The Director shall submit a report on the Agency's activitiesto: ACIP, NVAC, NVPO, NVICP, HRSA, and any other entity deemedappropriate. These reports shall be made publicly available.Sec. 2143 Post-marketing vaccine safetya) The Director shall, in consultation with the FDA, requiremanufacturers to provide for post-marketing surveillance and clinicaltesting for any acute or chronic reactions associated with allvaccines approved after January 1, 2006. These trials shall beconducted by researchers, free from conflicts of interest, recommendedby the Advisory Council and approved by the Director. The protocolsmust be similarly approved, and the data must

be made available forobjective, independent evaluation. FDA and CDC maintain the ability to monitor vaccine safetythrough VAERS.c) The Director may also award grants to conduct comparativestudies of vaccines licensed for preventing or mitigating the samedisease, and the results of these studies shall be made publiclyavailable.d) Clinical Trials (pre- and post-licensure) must beregistered-prior to their completion-subject to requirements similarto those imposed by the International Committee of Medical JournalEditors.Sec. 2144 Transfer of CDC Functions related to monitoring adversereactions related to licensed vaccines.a) The following are transferred from CDC to the AVSE:(1) The Vaccine Safety Datalink Project(2) The Clinical Immunization Safety Assessment

Centers(3) Other vaccine safety assets of CDC This transfer will be overseen by the Secretary of HHS, in anorderly fashion.c) Nothing in this bill, except with respect to the functionslisted in (a) shall be construed so as to prohibit CDC from conductingvaccine surveillance and response, particularly with respect to acutereactions.Sec. 2145 Advisory Council (p. 23)a) The Secretary is directed to establish an Advisory Council The Advisory Council's duties include: formulatingrecommendations for research on vaccines, developing a vaccine safetyresearch agenda, reviewing grant applications and makingrecommendations to the Secretary regarding

funding of those applications.c) The Secretary is required to consider the recommendations ofthe Advisory Council when making final funding decisions. If theSecretary decides not to accept the recommendations of the council,he/she must explain in writing to the Advisory Council the reasons forthese decisions. This letter should be made publicly available.d) The Advisory Council shall be composed of 18 members, including:a. Not more than two representatives of the vaccine manufacturingindustryb. One practicing pediatricianc. One infectious disease expertd. Five adults who are each either a victim of a vaccine injury ora parent of the victim of a vaccine-related injury.e. One representative of the general public who is free from biasf. One toxicologistg. One neurologisth. One geneticisti. One immunologistj. One state or local public health officialk. Not less than 4 and not more than 6 additional

representativesAt least one-third of the council must be selected from amongindividuals who are vaccine-injured or who have a child who has beenvaccine injured (regardless of whether or not there has been ajudicial or administrative finding of injury).The Advisory Council is also subject to certain conflict of interestprovisions with following exceptions: 2 of the vaccine-injured parentsmay have claims pending in the Vaccine Injury Compensation Program,and the 2 industry representatives are not subject to the conflict ofinterest provisions.Sec. 2146 Full-time liaisons The agency shall employ individuals asfull-time liaisons to other agencies involved with vaccine researchand development, including DoD, NIH, FDA, CDC.Sec. 2147 DefinitionsSec. 2148 Authorization of Appropriations $80,000,000 for the firstyear, such sums thereafter. http://www.latitudes.org/forums/lofiversion/index.php?t1715.html After all, they (the pro-vaccine lobbyists) say to themselves, you can't make an omelette withoutbreaking eggs. But the eggs being broken are small, helpless, and innocent babies, while the omelette is being enjoyed by the pediatricians and vaccine manufacturers. - Harris L. Coulter, PhD

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