The FDA has posted new draft regulations on its website. While these guidelines aren’t binding, they will help improve approval process by avoiding problems with omitting or minimizing important risk factors and information.

The FDA will take public comment for 90 days before issuing new guidelines.

Now the guidelines suggest instead of generally stating "certain monitoring" the label should state exactly what type of monitoring is needed along with its frequency. For example, certain monitoring should be replaced with monthly blood tests for liver damage.

The FDA will be reviewing the "net impression" of advertising to determine if the information relays an accurate impression.

For example, smiling people, changing camera angles, and upbeat music may obscure the more serious message of the potential for harm. The FDA could consider these tactics as overall misleading impression.

Last year, a congressional hearing criticized Schering-Plough’s Nasonex, an anti-allergy medication ad campaign. The ad featured a bee that flew around during a description of side effects but simply hovered while benefits were explained.

For more information please see:

http://www.fda.gov/cder/guidance/7427dft.pdf

http://online.wsj.com/article/SB124339082067457033.html

http://www.reuters.com/article/latestCrisis/idUSN26516199

Labels: FDA, guidelines, monitor, Nasonex, regulation

On Monday, May 18, the FDA issued a class I recall for SmartMonitor 2 Infant Apnea Monitor. A class I recall is the highest recall level that can be issued and is only issued when a product has a reasonable probability of causing serious injury or death. The recalled Apnea monitor is manufactured by Respironics, a Pennsylvania based health care device manufacturer.

The SmartMonitor 2 is used by both hospitals and consumers alike. It is used as a monitoring device in order to continuously watch an infant’s breathing and heart rate. The recall was issued because the SmartMonitor2 can fail to alarm when an infant’s breathing stops or his/her heart rate drops to a dangerously low level. The models that are being recalled were manufactured between January 16, 2008 and November 13, 2008. They were distributed from January 13, 2008 to December 31, 2008. The model numbers being recalled include model 4002 and 4003. The serial numbers of the recalled models are 3000033364 through 3000038740. The FDA advises that all stop using the product immediately and to report any problems to their doctor and the FDA. Currently, there have been no recorded fatalities from this device.

More than 4,900 defective infant apnea monitors have been voluntarily recalled. The potential defect is the failure of the audible alarm, which may cause the alarm not to sound when it should. The FDA stated that on April 23, 2009 Respironics notified medical supply companies of the potential defect in the SmartMonitor 2 infant apnea monitors. Respironics wanted all monitors in the companies’ inventories retuned.
Customers with questions or concerns regarding the SmartMonitor2 infant apnea monitor recall may contact Respironics at 1-888-345-4630.The FDA requests that Health care professionals and consumers may report adverse reactions or quality problems related to the recalled infant apnea monitors to the FDA's MedWatch Adverse Event Reporting program via:
Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
FAX: 1-800-FDA-0178

For more information please see: http://www.fda.gov/MedWatch/safety/2009/safety09.htm#SmartMonitor
http://www.fda.gov/cdrh/recalls/recall-042309.html

Labels: apnea, children, devices, FDA, monitor, recall