FACT SHEET: Executive Order on Optimizing the Security of Biological Select Agents and Toxins in the United States
"Today, President Barack Obama issued an Executive Order that directs fundamental changes to the way highly hazardous pathogens and toxins in the United States are secured against misuse. Research on such so-called Biological Select Agents and Toxins (BSAT) is critical for the development and availability of public health and medical tools that are needed to detect, diagnose, recognize, and respond to outbreaks of infectious disease of both natural and deliberate origin. At the same time, the expansion since 2001 of infrastructure and resources dedicated to work with BSAT – coupled with the revelation that the perpetrator of the 2001 Bacillus anthracis (anthrax) attacks likely was a United States Government researcher – have raised concerns regarding the need to ensure BSAT are properly secured against those who would deliberately misuse them to harm people, animals, plants, or the environment.

To address these concerns, the Administration led a review of Federal policies and procedures associated with the security of BSAT. This review – informed by a number of studies performed by experts in the United States Government, academia, and the private sector – highlighted the need for significant improvements in the structure, coordination, and oversight of these activities across the Federal government. Importantly, the review concluded that as part of these improvements, Federal activities for securing BSAT should be more fully consolidated under a revised Select Agent Program/Select Agent Regulations (SAP/SAR) that will continue to be jointly led by the Departments of Health and Human Services (HHS) and Agriculture (USDA) with key support from the Department of Justice (DOJ) and Federal Bureau of Investigation (FBI)..."

FDA Gives Update on Botulinum Toxin Safety Warnings; Established Names of Drugs Changed
"The U.S. Food and Drug Administration today announced an update to a previous safety alert on four botulinum toxin drug products, noting that all of them now have boxed warnings on their labels and have developed Medication Guides for patients, as directed by the agency in April 2009.

The boxed warning cautions that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include potentially life-threatening swallowing and breathing difficulties and even death.

These symptoms have mostly been reported in children with cerebral palsy being treated with botulinum toxin for muscle spasticity, a use of the drugs that has not been approved by FDA. Symptoms have also been reported in adults treated both for approved and unapproved uses.

The affected products are:
- Botox (new established name: onabotulinumtoxinA)
- Botox Cosmetic (new established name: onabotulinumtoxinA)
- Myobloc (new established name: rimabotulinumtoxinB)
- Dysport (abobotulinumtoxinA) was approved in April 2009 with the boxed warning and is not making any name or label changes at this time..."