Hot Topics
Extensive Device Recalls
Japanese manufacturer Nipro Corp. is involved in two extensive recalls announced in January. Nipro Medical Corp., a Miami-based subsidiary of the firm, has issued a recall of all its GlucoPro insulin syringes with expiration dates prior to November 2011. There is concern over a defect which may cause the needles to detach during use.
In an even more extensive move, Nipro has voluntarily recalled over 2 million of the Exel/Exelint Huber needles and infusion sets it makes for Exelint International Corp. During an October 2009 inspection of Nipro’s manufacturing facilities in Japan, FDA found that over 60% of the needles tested cut slivers of silicone when in use. This “coring” defect poses a high risk of introducing silicone into the veins or surrounding tissues of patients. The recall is being classified as a Class I recall, indicating a “reasonable probability” that use of the product could cause “serious adverse health consequences or death”.
Here you’ll find documents on GlucoPro and Huber syringes, as well as warning letters regarding previous concerns over Nipro products.
Direct-to-Consumer Marketing
Direct-to-consumer (DTC) marketing has been a hot topic since its inception and certainly since the start of television DTC ads in 1997. Concerns ranging from the downplaying of potential product side effects to ads influencing consumers to demand unnecessary prescriptions have prompted heavy scrutiny of the practice from not only the FDA but Congress as well.
The past five years has been a particularly busy period. Since 2005, FDA has significantly increased the number of staff monitoring advertisements and many television ads have been pulled or changed at FDA’s urging. The issue of presenting side effect/ risk information has become quite prominent. Everything from the music and graphics used in ads to the length of time devoted to risk information has been scrutinized. Memorable criticisms and ad changes have altered the DTC landscape.
From Nasonex and its “distracting” flying bee to new Viagra ads toning down sexual innuendo to Chantix ads with over a minute devoted to risk information, you’ll find many situations addressed in our collection of DTC-relevant documents. Included are FDA guidance documents, FDA untitled letters, Congressional correspondence and much more—--don’t miss out!