AVAN All good news here.Particularly the part about expedited review by the FDA.Thats always the toughest part of biotech.
Title I - National Goals for Bioterrorism Preparedness
Title I of the “Bioterrorism Preparedness Act” states that “the United States should further develop and implement a coordinated strategy to prevent and, if necessary, to respond to biological threats or attacks.” It further states that it is the goal of Congress that this strategy should: (1) provide federal assistance to state and local governments in the event of a biological attack; (2) improve public health, hospital, laboratory, communications, and emergency response preparedness and responsiveness at the state and local levels; (3) rapidly develop and manufacture needed therapies, vaccines, and medical supplies; and (4) enhance the safety of the nation’s food supply and protect its agriculture from biological threats and attacks. """
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Title IV - Developing New Countermeasures Against Bioterrorism
To better respond to bioterrorism, Title IV expands our nation’s stockpile of smallpox vaccine and critical pharmaceuticals and devices. The bill also expands research on biological agents and toxins, as well as new treatments and vaccines for such agents and toxins.
Since the effectiveness of vaccines, drugs, and therapeutics for many biological agents and toxins often may not ethically be tested in humans, Title IV ensures that the Food and Drug Administration (FDA) will finalize by a date certain its rule regarding the approval of new countermeasures on the basis of animal data. Priority countermeasures will also be given enhanced consideration for expedited review by the FDA.
Because of the lack of or limitations on a market for vaccines for these agents and toxins, Title IV gives the Secretary of HHS authority to enter into long-term contracts with sponsors to “guarantee” that the government will purchase a certain quantity of a vaccine at a certain price. The government has the authority, through an existing Executive Order, to ensure that sponsors through these contracts will be indemnified by the government for the development, manufacture and use of the product as prescribed in the contract.
Title IV also provides a limited antitrust exemption to allow potential sponsors to discuss and agree upon how to develop, manufacture, and produce new countermeasures, including vaccines, and drugs. Federal Trade Commission and the Department of Justice approval of such agreements is required to ensure such agreements are not anti-competitive. """ |
