#ForcedAccountability Updated 7/29/2014
Johnson & Johnson sells the K-Y Jelly Division
Johnson & Johnson who last year opted out of filling out the proper paperwork the FDA required regarding some of their KY-Brand, it appears has learned how to fill out paperwork for a different reason. Pharmaceutical giant Reckitt Benckiser announced that it has signed a definitive agreement to acquire global rights to Johnson & Johnson’s KY-Brand.According to the article the focus is gradually shifting from medical devices (KY is a medical device) and consumer products to pharmaceutical business, and in other words, the move is in line with the company’s core strategy. That statement is actually inconsistent and contradictory to what CEO Alex Gorsky has publically stated:In the latest in a string of Johnson & Johnson recalls, the health products giant's McNeil unit removed three types of K-Y Jelly from pharmacy and grocery store shelves, and recalled packages from wholesalers after a FDA warning letter.
"As part of ongoing and detailed internal reviews we decided that these products may require submission of new data and application for a new medical device" approval, McNeil spokeswoman Samantha Lucas wrote in an email response to questions. "Because we decided against submitting new paperwork, we recalled the small amount of product that was still in the market. "This was a business-driven decision," she added.
You might not realize that K-Y Jelly is a medical device, but it is, and it was knowingly filed that way by Johnson & Johnson, but the U.S. Food and Drug Administration (FDA) is not happy about claims made by Johnson & Johnson concerning the personal lubricant. Johnson & Johnson has decided that revenue loss of an estimated $17 million on this recall and lost product sales and expensive, ongoing factory upgrades have cost Johnson & Johnson over $1 billion but these products aren't worth the submitting new paperwork?
My health is not a "business-driven decision," but my buying power as a consumer is!!!!
Johnson & Johnson really wants consumers to know that 'they decided' or was it prompted by the FDA Warning letter?
Submitting new paperwork must be hard because how does a Company 'decide' to walk away from over
Maybe it's just me, but it seems like Johnson & Johnson may have gotten caught with their pants down by the FDA and without any lube by their own doing.
This RECALL Johnson & Johnson tired to 'fast lane' the FDA's product approval, previously they failed to adequately evaluate and investigate 68 medical complaints it received over its K-Y Liquibeads vaginal moisturizer over an 18-month period from June 2010 to December 2011
Consumer need to ask:
Would Johnson & Johnson have kept profiting off of consumers for years to come if the FDA hadn't issue a WARNING LETTER?
Call to Action:
Demand Johnson & Johnson be accountable to consumers and BOYCOTT all Johnson & Johnson K-Y Products until the Company files the proper 510 (k) paper work to bring back the ALL recalled products.