Senate Bill 3 Synopsis
Protecting America in the War on Terror Act of 2005
Prepared by: The National Vaccine Information Center
(Pharma-Shield)

Title 1- BIOPREPAREDNESS
Sec 111 Expansion of Countermeasures covered by Bioshield
Within 12 months of date of enactment, Secretary to determine how the United States can accept contributions or guarantees from private organizations, international health agencies, non-governmental agencies to enhance the procurement or development of drugs, biological products, detection technologies or research tools used as countermeasures for terrorism.

Sec 113 Restoration of Patent Term
To provide patent incentives and an incentive for capital formation to fund countermeasures and vaccine research- must be certified under the Homeland Security Act of 2002.
-will provide patent extensions for existing and future providers of countermeasures
(Patent extensions)

Sec 114 International Harmonization of Regulations
Secretary reports annually to Congress on activities undertaken, progress made and barriers to implementation regarding international harmonization of regulations and efforts to establish international standards for data exclusivity.
(Sets the stage for a global tracking system)

Sec 115 Development of Additional Animal Models
Secretary, NIAID, CDC shall establish and award grants to study the physiological responses of certain animal species to bioterrorism agents and other infectious agents.
-must have a biosafety level of 3 or 4
-research results belong to NIAID

Sec 116 Collaboration and Coordination
Limited Antitrust Exemptions

Chapter 2 - ENSURING REGULATORY EFFICIENCY

Sec 121 - Commission on Countermeasure and Vaccine Regulation
Establish a Commission consisting of 7 members appointed by HHS, including those with expertise and experience in the manufacture, regulation, distribution and use of vaccines:
- 2 shall have qualifications to inspect manufacturing facilities and may be HHS employees;
- 2 shall represent manufacturers
- 1 shall represent vaccine consumers
- Chairperson appointed and not an HHS employee
Functions: To conduct a study of the statutes, regulations, guidelines and compliance, inspection and enforcement practices and policies of HHS that are applicable to vaccines intended for human use that are in periodic short supply in the US.
-Study to include:
-a review of regulatory requirements, guidelines, practices and policies-
(1) for development and licensing and licensing of manufacturing facilities;
(2) for inspections and other activities that maintain compliance and enforcement of the requirements to such vaccines and facilities;
(3) that may have contributed to temporary or long-term shortages of vaccines
Report and Recommendations: Within 6 months after date of enactment the report shall be submitted to HHS, HELP Committee in the Senate and Energy and Commerce Committee in the House and shall contain:
(1) results of the study;
(2) recommendations to regulatory requirements, guidelines and practices, policies to reduce waste, increase efficiency and ensure rapid availability of safe and effective products.
(Creates another government-industry dominated federal committee)

Sec 122 - Technical Assistance
Secretary and FDA Commissioner shall establish within the FDA a team of experts on manufacturing and regulatory activities to provide both off-site and on-site technical assistance to the manufacturers of vaccines, if the Secretary determines that a shortage or potential shortage may occur.

Sec 566 - Requirement to Fully Inform
Requires manufacturers to promptly submit all communications between manufacturer and the regulatory body of a foreign government if the content of the communications could impact the introduction of a drug into the interstate commerce of the US.

Sec 125- Accelerated Approval of Countermeasures or Vaccines
Secretary has the authority to designate a vaccine or counter-measure as a "fast-track" product. This Act will allow the Secretary to make the designation prior to the submission of (1) a request for a designation by the sponsor; or (2) prior to a drug application being submitted.
(Will allow vaccines to be licensed with fewer studies instead of more)

Sec 126 - National Uniformity for Approved Products
Added to:
"Subchapter H- NATIONAL UNIFORMITY FOR APPROVED PRODUCTS"
Sec. 761- National Uniformity for Drugs, Vaccines, and Other Biological Products
No State or judicial system of a State may establish or continue in effect any requirement-
(1) that relates to the regulation of a drug intended for use by humans (including a vaccine or other biological product); and
(2) that is different from the Fair Packaging and Labeling Act
(Would repeal CA and IA mercury free laws and prohibit other states from passing laws like these)

Sec 762- Warning Uniformity
No State may establish or continue in effect under any authority any notification requirement for drug, vaccine or other biological product that provides for a warning concerning the safety of the drug, vaccine or biological product or any component unless it fits under the notification requirement of this Act. (1)Any mandatory disclosure relating to the dissemination of information about a drug, vaccine or biological product in any manner such as labels, labeling, public notices, advertising or any other means of communication. (2) The term warning means any statement, vignette, or other representation which indicates, directly or by implication, that the drug, vaccine or biological product presents or may present a hazard to human health and safety.
(Prohibits the state from giving warnings to citizens about vaccines outside of Federal standards)

Sec 763 - Exemptions from Uniformity
Secretary may give exemptions after notice and opportunity for written and oral presentations from a State. The State must show (1) justified and compelling and unique local conditions;(2) protects an important public interest that would otherwise be unprotected; (3) would not cause the product to be in violation of any Federal law; (4) would not unduly burden interstate commerce.
(State would have to apply to a non-elected federal official in Washington for permission to warn citizens)

Subtitle B- Litigation Reform
Chapter 1-PROTECTION FOR COUNTERMEASURES AND PRODUCTS PROTECTING AGAINST PANDEMICS, EPIDEMIC AND BIOTERRORISM

Sec 319-F-3 - Liability Protections for Pandemics, Epidemics and Countermeasures
Secretary to administer this section and applies to both Federal and non-Federal sales and purchases of qualified countermeasures or qualified pandemic or epidemic technologies.

Creates an exclusive Federal cause of action for claims. United States district court will have exclusive jurisdiction over all actions.
No punitive damages will be allowed
Non-economic damages are not to exceed $250,000 (losses of physical and emotional pain, suffering) Can only recover non-economic damages if there is physical harm.
Any recovery will be reduced by other forms of compensation, if any.
(Forces families into federal court for injury or death cases outside the Vaccine Compensation Program and gives comprehensive liability protection to drug companies)

(4)GOVERNMENT CONTRACTOR DEFENSE - Protects manufacturers, health care providers and any other producer of a countermeasure device or technology that may be used in anticipation of and preparation for or response and recovery of an emergency.
-gives protection for all products approved or cleared by FDA or
-is a countermeasure that the Secretary determines there is sufficient research data or clinical experience to support a reasonable conclusion that the countermeasure would qualify for approval within 8 years or
-is authorized for emergency use.
(Allows any manufacturer of an FDA licensed product or a product that could be licensed, government contractor protections- can't be sued in civil court)

Who Gets Liability Protection?
Definitions- QUALIFIED PANDEMIC OR EPIDEMIC TECHNOLOGY
-any product (including drugs, vaccine and other biologics), equipment, service (including support services), device, or technology (including information technology) designed, developed, modified or procured for the specific purpose of preventing a pandemic or epidemic or limiting the harm that the pandemic/epidemic might cause.
-Health care provider - anyone who lawfully prescribes, administers, or provides a facility to administer a qualified countermeasure.

CHAPTER 2 - VACCINE INJURY COMPENSATION PROGRAM
Sec 141- Vaccine Injury Compensation and Vaccine Litigation Reform

(a) Congress finds that -
(1) there are shortcomings in the VICP and loopholes that have been exploited in a manner that has contributed to a decline in the availability of vaccines and a decline in the number of manufacturers; and
(2) this condition presents a barrier to the development of vaccines needed for bioterror countermeasures.
RECOMMENDATIONS- Based on recent litigation and the Institute of Medicine report the Secretary and Attorney General will jointly submit recommendations to the appropriate committees of Congress concerning necessary modifications to the VICP and Federal rules regarding litigation involving vaccines. Report is due within 6 months of date of enactment.
(Puts the defendants in charge of writing new rules which will result in fewer payments for vaccine injured children)

Sec 142 -Modifications to Vaccines for Children Program
Expansion of definition of federally vaccine-eligible child and repeals price caps for pre-1983 vaccines

CHAPTER 3 - ENCOURAGING VACCINE AND COUNTERMEASURE PRODUCTION CAPACITY

Sec 151 -Incentives for the Construction of Vaccine and Countermeasure Manufacturing Facilities

Allows a tax credit for any taxable year in an amount equal to 20 percent of the qualified investment for the year with the effective date being December 31, 2004
(Tax credit for manufacturers)

Sec 152- Credit for Medical Research Related to Developing Vaccines or Countermeasures

Allows for a vaccine research credit, which is an amount equal to 35 percent of the qualified vaccine or countermeasure research expenses in a given year. Includes a credit for research and development expenses related to re-formulating existing vaccines.

Sec 153- Grants to Construct and Improve Research and Development and Manufacturing of Countermeasures or Vaccines

Secretary may award grants to a manufacturer to purchase or improve property used in the research and development, manufacture, or distribution of a countermeasure or vaccine. The amounts to be awarded are defined as "such sums as may be necessary".
(Grants to manufacturers)

Sec 154 - Revenue Recognition for Adult and Pediatric Vaccine and Other Countermeasures Against Potential Acts of Terrorism
Revenue derived under a Federal contract from the stockpiling, holding, storing, rotating or other management of inventory of vaccines or countermeasures will be deemed as income to the manufacturer.

Subtitle C- PUBLIC HEALTH PREPAREDNESS
CHAPTER 1-CAPACITY TO RESPOND
Sec 171 -Pandemic Influenza Preparedness and Response Plan
(1) Funding for research to develop improved influenza vaccines
(2) Activities to increase public awareness on the need to be vaccinated
(3) Activities to improve international and State influenza surveillance
-conduct influenza vaccine safety and efficacy data collection
(4) Epi studies and other research concerning novel influenza viruses
(5) Improve Communication in the case of production problems or shortages
(6) Direct distribution
AUTHORIZATION OF APPROPRIATIONS: $100,000,000 FOR f y 2006 and such sums as may be necessary for 2007-2011.

Sec 172 - National Notifiable Disease Surveillance Program
Secretary shall certify a list of infectious diseases, environmental exposures or poisons and other conditions. CDC Director, within 1 year shall establish and maintain a national electronic surveillance program that:
(1) Creates a standardized form for data collection and analysis
(2) Creates a procedure for data reporting
(3) A procedure for states to report new trends that may not be listed
(4) A procedure for surveillance or private sector health-related electronic data (such as pharmaceutical purchase data and health insurance claims)
(5) (Section I) A procedure to enable the program to receive and report data relating to non-notifiable diseases, including vital records, registries, chronic disease and maternal and child health
(d) NATIONAL BIOINTELLIGENCE UNIT
The Director of the CDC shall analyze data maintained by the national electronic surveillance program and data from other sources, to report on the prevalence and incidence of notifiable diseases and conditions, trends and patterns in public health, emerging health problems, regional differences, and other analyses determined appropriate by the Director of the Centers for Disease Control and Prevention.

(3) Health Alert Registration and Information
-Establishes a system to register all health providers so the Secretary can issue public health emergencies that require active surveillance.

(f) Grants to States for Disease Reporting
-Allows grants to enable States to conduct passive, active and syndromic surveillance and timely reporting of notifiable diseases.

Penalties for Not Reporting Notifiable Diseases
Beginning in 2008, if a State is not reporting all notifiable diseases in a timely manner through the use of an electronic system, the State will lose block grant funding. Health care providers will also be penalized through the Social Security Act for not reporting.
(Creates and funds a national disease electronic surveillance program operated by the CDC to track vital records and registries, diseases and new trends and patterns in public health. Does not include penalties for failure to report vaccine reactions)

CHAPTER 2 - PUBLIC HEALTH WORKFORCE

Sec 780- PUBLIC HEALTH WORKFORCE LOAN REPAYMENT PROGRAM

Establishes a Public Health Workforce Loan Repayment Program to assure adequate supply of public health professionals to eliminate critical public health preparedness shortages in State, Federal and Local agencies.
- Secretary will repay loans on behalf of individuals who qualify and who have accepted employment at a Federal health agency upon graduation for college.
- For each year of service the repayments of loans could be up to $35,000
- Hiring priority is given to those in the Program
- Authorization is "such sums as may be necessary".

CHAPTER 3- PREPAREDNESS UPDATES

Sec 191- REPORT ON PREPAREDNESS
Requires the Comptroller General to provide for the conduct of a study within three months of the date of enactment to evaluate products, stockpiles, State and local responses and processes etc.

Sec 192- ENHANCING GLOBAL RESPONSE CAPABILITIES
It is the sense of the Senate that the US cooperates with global and regional organizations, and other countries to establish, enhance and intensify a wide range of global activities to help prevent, detect, and contain infectious disease outbreaks and bioterrorism attacks.

TITLE II- INCREASED BENEFITS FOR FAMILIES OF DECEASED MEMBERS OF THE ARMED FORCES

Sec 201- INCREASE IN DEATH GRATUITY PAYABLE WITH RESPECT TO DEATHS OF MEMBERS OF THE ARMED FORCES FROM COMBAT-RELATED CAUSES OR FROM SERVICE IN OPERATION ENDURING FREEDOM OR IRAQI FREEDOM

Current death benefit is $12,000 would be raised to $100,000 and would be retroactive to October 7, 2001.

Sec 202- INCREASE IN AUTOMATIC MAXIMUM COVERAGE UNDER SERVICE MEMBERS' GROUP LIFE INSURANCE AND VETERANS' GROUP LIFE INSURANCE
Life insurance maximum is increased from $250,000 to $300,000 for service members and veterans and becomes effective the first day of the month after date of enactment.

Sec 203- INCREASED PERIOD OF CONTINUED TRICARE COVERAGE OF CHILDREN OF MEMBERS OF THE UNIFORMED SERVICES WHO DIE WHILE SERVING ON ACTIVE DUTY FOR A PERIOD OF MORE THAN 30 DAYS
Allows for continued coverage of health insurance for dependents of active duty service members who die and will apply to deaths that occurred on or after October 7, 2001.

(The remainder of the proposed legislation deals with Homeland Security issues including antiterrorism improvements and protecting critical infrastructure. These sections were not included in this document.)