The FDA and the Fight Against Terrorism

by Food and Drug Administration (FDA)

Minutes after two hijacked airliners crashed into the World Trade Center on the morning of Sept.11, 2001, the Federal Aviation Administration stopped all flights from U.S. airports. It marked the first time that air traffic came to a halt nationwide. Soon after, a third plane crashed into the Pentagon, and a fourth plane thought to be headed for another target in Washington, D.C., crashed into a field in Somerset County, Pa.

All told, more than 3,000 people died. Experts from the Food and Drug Administration immediately became involved. They ensured that blood could be collected quickly from people living near the disaster sites to help the injured survivors. Other agency experts evaluated burn wound dressings that could be used to treat victims and checked on reserves of drugs and medical supplies.

And while the country was still reeling from these tragedies, terrorists launched more attacks through the mail in October 2001. Letters containing anthrax spores (Bacillus anthracis) were mailed to U.S. senators and members of the media. The Centers for Disease Control and Prevention (CDC) recorded 22 cases of anthrax. There were 11 cases of cutaneous (skin-based) anthrax and 11 cases of inhalational anthrax. Among the inhalational cases, there were five deaths.

A key challenge for public health workers was the fact that early inhalational anthrax symptoms are similar to those of common illnesses such as the flu. Lung infections with anthrax can rapidly become fatal unless appropriate antibiotic treatment is started very soon after symptoms develop.

Two postal workers at the Brentwood mail facility in Washington, D.C., were among those who died from exposure to inhalational anthrax. They initially presented with non-specific symptoms and were diagnosed as having common infections that did not require hospitalization. Their doctors considered the possibility of anthrax only after they became aware of media reports about other postal workers with inhalational anthrax. Experts from the National Institutes of Health, the Johns Hopkins Schools of Medicine and Public Health, and area hospitals published a report on the two anthrax-related deaths in the Nov. 28, 2001, issue of the Journal of the American Medical Association. The authors concluded that rapid communication of information between public health agencies and health care professionals is needed in the event of a serious infectious disease outbreak.

At the time of the terrorist attacks, the FDA had already approved the drug Cipro (ciprofloxacin) to prevent the progression of anthrax following inhalation of anthrax spores under the FDA's accelerated approval regulations. In November 2001, the agency clarified that two more drugs — doxycycline and procaine penicillin G — also were approved to treat inhalational anthrax. The FDA initiated public education about the treatments, which included providing dosing regimens and answering questions about the use of antibiotics in children and pregnant or nursing women.

The FDA worked closely with blood banks in anthrax-affected areas to determine whether people incubating this disease may have donated. This enabled the removal of potentially unsafe blood from the blood supply.

Later, when operators of some Web sites seeking to capitalize on the threat sold unapproved foreign-made Cipro over the Internet, the FDA issued warnings and reminded consumers that only FDA-approved products can be legally marketed in the United States.

A Comprehensive Approach

"It was always our job to protect the public health," says Jeff Shuren, M.D., J.D., assistant commissioner for policy at the FDA. "But in an environment of heightened security, we are applying even more resources to counterterrorism in all areas of the agency."

This means safeguarding all products that the agency regulates, including food, drugs, medical devices, cosmetics, and animal feed. The FDA also works to speed the development of 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. FDA Commissioner Mark B. McClellan, M.D., Ph.D., has identified counterterrorism as one of his strategic priorities.

The FDA's Office of Regulatory Affairs (ORA) is responsible for ensuring that all FDA-regulated products are in compliance with laws and regulations that the FDA is charged with enforcing. The agency responds rapidly to emergencies and redirects efforts when necessary to respond to incidents of product tampering and other unforeseen events. The FDA's Office of Criminal Investigations (OCI), part of ORA, maintains relationships with domestic and foreign law enforcement agencies and serves as the FDA's liaison with the intelligence community.

To bolster the FDA's counterterrorism efforts, McClellan appointed Margaret Glavin, one of the nation's foremost food safety experts, to the new position of Assistant Commissioner for Counterterrorism Policy in October 2003. In addition to serving as the Commissioner's senior adviser on counterterrorism, Glavin oversees the newly established Office of Counterterrorism Policy.

"We're implementing a comprehensive, integrated counterterrorism program that can only be done by working closely with other agencies and industry," Glavin says. "Of course, working with the FDA centers to prevent a terrorist attack against food and medical supplies will be a major part of our efforts, but we are also working on other key priorities that the Commissioner has laid out." Glavin also coordinates with other agencies within the U.S. Department of Health and Human Services (HHS), such as the CDC and the National Institutes of Health (NIH), as well as the U.S. Department of Defense (DoD), the White House Homeland Security Council, and the Department of Homeland Security (DHS).

The FDA is working with the NIH, CDC, DoD, industry, and foreign governments to ensure the availability of drugs and vaccines through the Strategic National Stockpile (SNS), which is intended for deployment in response to national emergencies. The SNS is a stockpile of antibiotics, antitoxins, vaccines, medical supplies, medications and surgical items.

Emergency drug packages known as Push Packs are strategically located in warehouses across the country and can be sent to any destination in the United States within 12 hours of a federal decision to deploy them. In addition, under pending legislation called BioShield, promising new products that have not been approved, licensed, or cleared by the FDA could be used temporarily under new emergency authorization procedures if alternatives are not available to cope with a terrorist attack.

A top priority is relaying information about counterterrorism to the public quickly. The FDA's Web site (www.fda.gov) is a primary way the agency communicates with consumers. A section of the site is devoted to counterterrorism, along with links to other government agencies and tips on how to avoid bogus counterterrorism products.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.