Biodefense and Pandemic Vaccine and Drug Development Act of 2005
Encyclopedia
The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 , nicknamed "Bioshield Two" and sponsored by Senator Richard Burr
(R-North Carolina
), aims shorten the pharmaceutical development process
for new vaccine
s and drugs
in case of a pandemic
, and to protect vaccine makers and the pharmaceutical industry from legal liability for vaccine injuries. The proposed bill would create a new federal agency, the Biomedical Advanced Research and Development Agency (BARDA), that would act "as the single point of authority" to promote advanced research and development of drugs and vaccines in response to bioterrorism
and natural disease
outbreaks, while shielding the agency from public Freedom of Information Act (FOIA) requests. BARDA would be exempt from long-standing open records and meetings laws that apply to most government departments.
The Senate Health, Education, Labor and Pensions Committee approved the bill, co-sponsored by Bill Frist
(R-TN
), Mike Enzi (R-WY
), and Judd Gregg (R-NH
), by voice vote, despite Democratic objections.
Several other proposals have contained, in part, similar provisions (or protections) as those found in the Biodefense and Pandemic Vaccine and Drug Development Act of 2005.
, a barely two-year-old program also meant to encourage production of vaccines and drugs.
BARDA would receive a first-year budget of $1 billion. Other key aspects of the proposed legislation include:
(PhRMA) and its members. In the 2002 election cycle, PhRMA contributed $3,505,052 to politicians, with 95% going to Republicans. The top recipient in the Senate was the bill's sponsor, Senator Richard Burr, who received $288,684, according to the non-partisan Center for Responsive Politics
.
Senator Burr said the legislation "creates a true partnership" between the federal government, the pharmaceutical industry and academia to "walk the drug companies through the Valley of Death" in bringing a new vaccine or drug to market.
Exemptions from open records and meetings laws would streamline the development process, safeguard national security and protect the proprietary interests of drug companies, say Republican backers of the bill.
Richard Burr
Richard Mauze Burr is the senior United States Senator from North Carolina and a member of the Republican Party. Previously, Burr represented North Carolina's 5th congressional district in the United States House of Representatives....
(R-North Carolina
North Carolina
North Carolina is a state located in the southeastern United States. The state borders South Carolina and Georgia to the south, Tennessee to the west and Virginia to the north. North Carolina contains 100 counties. Its capital is Raleigh, and its largest city is Charlotte...
), aims shorten the pharmaceutical development process
Drug development
Drug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
for new vaccine
Vaccine
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
s and drugs
Approved drug
In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo an extensive FDA approval process. This process involves first testing the drug on animals or in medical labs. If found to be safe by the FDA and approved for the next phase of study, the drug is then...
in case of a pandemic
Pandemic
A pandemic is an epidemic of infectious disease that is spreading through human populations across a large region; for instance multiple continents, or even worldwide. A widespread endemic disease that is stable in terms of how many people are getting sick from it is not a pandemic...
, and to protect vaccine makers and the pharmaceutical industry from legal liability for vaccine injuries. The proposed bill would create a new federal agency, the Biomedical Advanced Research and Development Agency (BARDA), that would act "as the single point of authority" to promote advanced research and development of drugs and vaccines in response to bioterrorism
Bioterrorism
Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents are bacteria, viruses, or toxins, and may be in a naturally occurring or a human-modified form. For the use of this method in warfare, see biological warfare.-Definition:According to the...
and natural disease
Disease
A disease is an abnormal condition affecting the body of an organism. It is often construed to be a medical condition associated with specific symptoms and signs. It may be caused by external factors, such as infectious disease, or it may be caused by internal dysfunctions, such as autoimmune...
outbreaks, while shielding the agency from public Freedom of Information Act (FOIA) requests. BARDA would be exempt from long-standing open records and meetings laws that apply to most government departments.
The Senate Health, Education, Labor and Pensions Committee approved the bill, co-sponsored by Bill Frist
Bill Frist
William Harrison "Bill" Frist, Sr. is an American physician, businessman, and politician. He began his career as an heir and major stockholder to the for-profit hospital chain of Hospital Corporation of America. Frist later served two terms as a Republican United States Senator representing...
(R-TN
Tennessee
Tennessee is a U.S. state located in the Southeastern United States. It has a population of 6,346,105, making it the nation's 17th-largest state by population, and covers , making it the 36th-largest by total land area...
), Mike Enzi (R-WY
Wyoming
Wyoming is a state in the mountain region of the Western United States. The western two thirds of the state is covered mostly with the mountain ranges and rangelands in the foothills of the Eastern Rocky Mountains, while the eastern third of the state is high elevation prairie known as the High...
), and Judd Gregg (R-NH
New Hampshire
New Hampshire is a state in the New England region of the northeastern United States of America. The state was named after the southern English county of Hampshire. It is bordered by Massachusetts to the south, Vermont to the west, Maine and the Atlantic Ocean to the east, and the Canadian...
), by voice vote, despite Democratic objections.
Several other proposals have contained, in part, similar provisions (or protections) as those found in the Biodefense and Pandemic Vaccine and Drug Development Act of 2005.
Key provisions
The Bioshield Two bill would shift the main responsibility for developing bioterrorism countermeasures out of the Department of Homeland Security and into the new BARDA agency within the Department of Health and Human Services. The proposed new agency would improve on Project BioShieldProject Bioshield Act
The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. This was a ten-year program to acquire medical countermeasures to biological, chemical, radiological and...
, a barely two-year-old program also meant to encourage production of vaccines and drugs.
BARDA would receive a first-year budget of $1 billion. Other key aspects of the proposed legislation include:
- Provision of rebates or grants as incentives for domestic manufacturing of vaccines and medical countermeasures against bioterrorismBioterrorismBioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents are bacteria, viruses, or toxins, and may be in a naturally occurring or a human-modified form. For the use of this method in warfare, see biological warfare.-Definition:According to the...
and natural diseaseDiseaseA disease is an abnormal condition affecting the body of an organism. It is often construed to be a medical condition associated with specific symptoms and signs. It may be caused by external factors, such as infectious disease, or it may be caused by internal dysfunctions, such as autoimmune...
outbreaks. - Liability protections for drug makers that develop vaccines for biological weapons. The measure would make manufacturers, distibutors, health care providers, or administrators of security countermeasures immune from liability caused by a security countermeasure or any pandemic/epidemic product, by means of a limited antitrust exemption.
- Establishment of a single agency, the Biomedical Advanced Research and Development Agency, as the lead federal agency for the development of countermeasures against bioterrorismBioterrorismBioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents are bacteria, viruses, or toxins, and may be in a naturally occurring or a human-modified form. For the use of this method in warfare, see biological warfare.-Definition:According to the...
. The new agency would report directly to the Secretary of Health and Human Services, which would have sole authority to decide whether a manufacturer violated laws mandating drug safety. Citizens would be banned from challenging such decisions in the civil court system. The agency would 'partner' with drug makers while placing information about such partnerships outside of public view. - Extension of some prescription drug patents.
- Allow the Department of Health and Human Services to sign exclusive sales contracts with particular manufacturers for a particular product.
- Forbid government purchases of genericGeneric drugA generic drug is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use." It has also been defined as a term referring to any drug marketed under its...
versions of such new drugs or vaccines as well as public sales of the products for use as countermeasures. - Exempt countermeasures from certain federal cost oversight requirements.
Support
Much of the support for the bill comes from Pharmaceutical Research and Manufacturers of AmericaPharmaceutical Research and Manufacturers of America
Pharmaceutical Research and Manufacturers of America , founded in 1958, is a trade group representing the pharmaceutical research and biopharmaceutical companies in the United States. PhRMA's stated mission is advocacy for public policies that encourage the discovery of new medicines for patients...
(PhRMA) and its members. In the 2002 election cycle, PhRMA contributed $3,505,052 to politicians, with 95% going to Republicans. The top recipient in the Senate was the bill's sponsor, Senator Richard Burr, who received $288,684, according to the non-partisan Center for Responsive Politics
Center for Responsive Politics
The Center for Responsive Politics is a non-profit, nonpartisan research group based in Washington, D.C. that tracks money in politics and the effect of money and lobbying activity on elections and public policy and maintains a public online database of its information.Their database...
.
Senator Burr said the legislation "creates a true partnership" between the federal government, the pharmaceutical industry and academia to "walk the drug companies through the Valley of Death" in bringing a new vaccine or drug to market.
Exemptions from open records and meetings laws would streamline the development process, safeguard national security and protect the proprietary interests of drug companies, say Republican backers of the bill.
Opposition
Senator Chris Dodd (D-Connecticut) said "Their plan will protect companies that make ineffective or harmful medicines, and because it does not include compensation for those injured by a vaccine or drug, it will discourage first responders and patients from taking medicines to counter a biological attack or disease outbreak."See also
- Pandemic and All Hazards Preparedness ActPandemic and All Hazards Preparedness ActOn December 19, 2006, the Pandemic and All-Hazards Preparedness Act , Public Law No. 109-417, was signed into law by President George W. Bush. PAPHA has broad implications for the United States Department of Health and Human Services’s preparedness and response activities...
− , a similar bill - Public Readiness and Emergency Preparedness ActPublic Readiness and Emergency Preparedness ActThe Public Readiness and Emergency Preparedness Act , passed by the United States Congress and signed into law by President of the United States George W. Bush in December, 2005, is a controversial tort liability shield intended to protect vaccine manufacturers from financial risk in the event of a...
, a similar bill - List of vaccine topics
External links
- LasVegasSun.com - 'GOP Wants to Create Secretive Gov't Agency', Andrew Bridges, Associated PressAssociated PressThe Associated Press is an American news agency. The AP is a cooperative owned by its contributing newspapers, radio and television stations in the United States, which both contribute stories to the AP and use material written by its staff journalists...
(December 2, 2005) - FEMA.gov - 'Senate Committee Approves Legislation to Promote Bio-Defense Projects', David Ruppe, Global Security Newswire (October 19, 2005)