Suit Against FDA Could Affect Hand Sanitizers

The most amusing title I have ever seen on an FDA guidance document is “Is it a Cosmetic, a Drug or Both? (Or is it soap?)” http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm. This guidance addresses common misconceptions about how certain products are regulated.  Hand sanitizers and antibacterial soaps are examples of products whose regulatory status is confusing to many and so we have decided to send this update to our friends and clients working in both the drug and cosmetic sectors.

A recent blog post from Hyman & Phelps discusses a law suit in which the Natural Resources Defense Council is suing FDA to force the agency to finalize the over the counter drug monograph for tricolsan and triclocarban, common ingredients in many hand sanitizers and antibacterial soaps.  Work began on this monograph in 1974 and has languished since 1994; NRDC claims the delays are unnecessary. While not final, FDA states that the monograph reflects the agency’s opinion on the topic and no matter what the result of this lawsuit, companies that comply with the tentative monograph will not have to reformulate their products or change their labeling.  The tentative status of the monograph has been exploited as a loophole of sorts by some companies that market hand sanitizers and antimicrobial soaps with triclosan, triclocarban and other nonmonograph active ingredients. If the NRDC prevails in this case and FDA rapidly finalizes the monograph, companies using active ingredients other than isopropyl alcohol, denatured alcohol, povidon and various forms of iodine will have to reformulate their products.

To read more about the legal issues surrounding this lawsuit, please read the entire Law Blog post at:

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/08/nrdc-sues-fda-for-failing-to-take-action-on-triclosan-and-triclocarban.html

FDA and FCC to work Jointly on the Development of Wireless Medical Devices

Hello!

Last week the Food and Drug Administration and the Federal Communications Commission issued a joint statement regarding their intent to proactively address issues that arise when medical devices send patient information to physicians wirelessly.  Issues such as the reliability and privacy of the communication are of particular concern.  If the communication link is not reliable it could affect patient care and health outcomes if vital data is either incomplete or simply not received by the physician.  It is also vitally important to ensure that patient data cannot be obtained by eavesdropping or overt hacking.

You may read the agencies’ statement at: http://www.fda.gov/MedicalDevices/NewsEvents/ucm220277.htm

Bioscience Translation & Application has expert associates ready to serve you in the area of medical device regulation and we welcome your questions regarding these products.Visit us at www.BioTransApp.com.