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By Michelle Meadows
The anthrax attacks in the fall of 2001 shocked the nation and killed five people. In all, the Centers for Disease Control and Prevention (CDC) reported 22 cases of bioterrorism-related anthrax in 2001, mostly in employees of the U.S. Postal Service and news outlets. Half of the people had cutaneous (skin) anthrax and half had inhalational (lung) anthrax, the deadliest form.
Before this time, there had been only 18 other cases of inhalational anthrax during the 20th century, according to the CDC. The last had occurred in 1976. Most of those cases affected textile mill workers who were exposed to goat hair, wool, and other animal products infected with the spore-forming bacterium Bacillus anthracis.
At the time of the 2001 attacks, the Food and Drug Administration had approved three types of antibiotics to prevent or treat anthrax: Cipro (ciprofloxacin), drugs in the tetracycline class such as doxycycline, and some drugs in the penicillin class such as procaine penicillin G. Most of those diagnosed with anthrax were treated with antibiotics, and more than 10,000 people took them as a precautionary measure, according to the CDC. The incident heightened awareness of the need to improve the preparedness for dealing with bioterrorist attacks in the United States.
Since then, federal agencies have strengthened partnerships to develop and improve medical countermeasures--human and animal drugs, vaccines and other biologics, blood and blood products, diagnostic tests, and devices that can prevent, diagnose, and treat illnesses related to a terrorist attack. The cornerstone of this effort is the Project BioShield Act, which President Bush signed into law in July 2004.
Project BioShield establishes a permanent funding source through which the federal government can buy medical countermeasures from private companies. The fiscal year 2004 appropriation for the Department of Homeland Security includes close to $6 billion over 10 years for buying "next-generation" countermeasures against anthrax, smallpox, and other infectious agents, as well as antidotes against chemical and radiological threats. This encourages researchers to improve medical products that have stayed the same over the last few decades. The currently licensed smallpox vaccine, for example, is the same as what was used during the 1960s.
Health and Human Services Secretary Tommy G. Thompson and Homeland Security Secretary Tom Ridge oversee Project BioShield. "This law is a clear signal that the U.S. government is prepared to be a full partner with the research community in the fight against bioterrorism," Thompson says. "From our research scientists at NIH to the pharmaceutical staff at FDA, we are moving forward, and now with Project BioShield, we will be able to better protect the health and safety of all Americans."
The administration already has begun to acquire various countermeasures, including new smallpox vaccines, new anthrax vaccines that will be stockpiled in 2005, new anthrax treatments that are intended to neutralize anthrax toxins, and an antitoxin for botulinum toxin. This adds to the Strategic National Stockpile (SNS), which is intended for use in response to national emergencies. The SNS is a stockpile of antibiotics, antitoxins, vaccines, medical supplies, medications, and surgical items. The stockpile now has more antibiotics to treat anthrax than ever before and more treatments for radiation poisoning, chemical agent exposure, and other biological pathogens. And there is now enough smallpox vaccine for every person in the United States--286 million doses.
Project BioShield also provides more money to support research and development on medical countermeasures through the National Institutes of Health (NIH). The National Institute of Allergy and Infectious Diseases (NIAID) is the main institute supporting biodefense research. The NIAID will have more authority to award contracts and research grants to develop medical countermeasures against biological, radiological, or nuclear attack. The grant process for biodefense medical research normally takes up to two years. HHS estimates the process under Project BioShield will take roughly six months.
Using the CDC's listing of biological agents that pose the greatest threats to the public health, the FDA works with the NIH, the CDC, and other HHS agencies to identify the need for better treatments. The highest priority is on agents labeled by the CDC as "Category A," which include the organisms that cause anthrax, plague, smallpox, tularemia, viral hemorrhagic fevers, and botulism.
"We've encouraged manufacturers to come to us for early-stage meetings to see if we can help focus studies that accelerate product development," says Cynthia Kelley, senior adviser for counterterrorism/medical countermeasures in the FDA's Center for Biologics Evaluation and Research (CBER). "CBER researchers are also working to develop new and improved methods to evaluate the safety, purity, and potency of biological products needed in the fight against terrorism."
The FDA, the NIH, and HHS recently collaborated on two workshops on improving medical countermeasures. A workshop in June 2004 focused on strategies for developing anthrax treatments. Another workshop in October 2004 explored the use of animal models that may be most appropriate for evaluating new plague vaccines, as well as which immune responses may indicate protection against plague.
Project BioShield gives the FDA authority to make promising drugs, biologics, diagnostics, or devices quickly available in emergencies. The FDA will interpret safety and effectiveness information by considering a product's stage of development, available scientific data, whether the product is approved for another use, the seriousness of the clinical condition, specific circumstances of the emergency, and whether alternative treatments are available.
"In the traditional drug development setting, FDA considers a product investigational until it is found to be safe and effective in the formal review process," says Brad Leissa, M.D., deputy director of the FDA's Division of Counter-Terrorism in the Center for Drug Evaluation and Research. "However, with the advent of the emergency use authorization, an investigational medical countermeasure might effectively be deployed to save lives during a public health emergency. From a logistical and operational standpoint, this new authority assures that we can respond more efficiently to a terrorist attack."