Margaret Hamburg, the new commissioner of the US Food and Drug Administration, has said that her first priority is to reinvigorate the troubled agency. Doing so, she said, will restore its credibility with the public and policy makers.

In an interview with The Wall Street Journal, the commissioner said that she is taking a “hard look” at the medical device division and a “fresh look” at the abbreviated framework it uses to approve many riskier and implantable products. “This is a high priority,” she said.

Scientists at the FDA’s Center for Devices and Radiological Health have sent letter to Congress and the White House alleging that political and corporate influence have trumped science at the division. The device industry is concerned that the FDA or Congress might toughen standards in applying the abbreviated approval process, called 510(k), to devices that would otherwise go through a lengthy review involving more clinical trials and safety data.

A government report in January said that the 510(k) process has been overused.

Dr. Hamburg said that a new transparency task force at the FDA is weighing the need to transmit emerging data about potential drug side effects against claims by corporations that want to keep commercial information confidential.

A recall has been announced on hand sanitizers made by Clarcon Biological Chemistry Laboratory.  The Food and Drug Administration (FDA) reported that the products being recalled contain high levels of disease-causing bacteria.

“Serious deviations” were found in recent tests dealing with government required practices.  According to the statement the analysis, “revealed high levels of various bacteria, including some associated with unsanitary conditions.  Some of these bacteria can cause opportunistic infections of the skin and underlying tissues.  Such infections may need medical or surgical attention, and may result in permanent damage.”

Some of the products recalled include: Citrushield Lotion, Dermasentials DermaBarrier, Dermassentials by Clarcon Antimicrobial Hand Sanitizer, Iron Fist Barrier Hand Treatment, Skin Shield Restaurant, Skin Shield Industrial, Skin Shield Beauty Salon Lotion, Total Skin Care Beauty, and Total Skin Care Work.

The company located in Roy, Utah, has voluntarily recalled the products.  The FDA advises that anybody with these defective products should throw them away immediately.

A new warning will be added to Botox according to the Food and Drug Administration (FDA).  The warning will be added to Botox A and B labels and patient information.

Botox is widely used throughout the U.S. to help children who have Cerebral Palsy, but the treatment has never been approved by the FDA for use in the doses that are required to affect spastic muscles.

The FDA released the following statement: Botulinum toxin products have been approved by FDA for one or more of the following uses: temporary improvement in the appearance of glabellar lines (frown lines between the eyebrows), treatment of strabismus (crossed eyes), cervical dystonia (involuntary sustained or repetitive contraction of the neck muscles), blepharospasm (abnormal tics and twitches of the eyelids), and primary axillary hyperhidrosis (severe underarm sweating).  For theses used, botulinum toxin is injected into the skin or into muscle tissue.

It has been recently reported from many people that the Botox injections spread beyond the target area and have injured or even killed the victims.  These are cases of botulism and include symptoms such as difficulty breathing, muscular weakness, and speech disorder.

If you or someone you know is seeing these signs up to three weeks after the injection, you are urged to contact your local hospital.