Toxic Shock: FDA Warns J&J Over Vaginal Products

Just one month into his new job as ceo at Johnson & Johnson and Alex Gorsky has received his first warning letter from the FDA. Actually, the May 22 letter was addressed to Teresa Gorecki, who is vp of quality assurance at McNeil PPC, a J&J unit that markets various consumer items. These include K-Y Liquibeads; K-Y Jelly; K-Y Touch Massage 2 in 1; K-Y Sensual Silk Ultra Gel; O.B. Tampons; Reach Floss; and Stayfree and Carefree Menstrual Napkins, all of which were described in the letter as adulterated because of a lack of good manufacturing practices.

The warning letter stems from an FDA inspection conducted last December and January at a facility in Skillman, New Jersey, and was issued after J&J sent four separate responses this past winter and spring. The infractions are varied and numerous, such as failures to adequately investigate medical complaints; establish and maintain adequate procedures for validating the device design, such as botching a stability study for the K-Y Liquibeads Vaginal Moisturizer; and report instances of a death or serious injury on a timely basis to the FDA. One of these involved a patient who developed Toxic Shock Syndrome after using a Tampon, but the report was filed more than 30 days late.

The gaffes occurred less than a year after J&J signed a consent decree in the aftermath of systemic manufacturing problems at two other facilities (see this). The decree came amidst an extraordinary period in which J&J recalled tens of millions of over-the-counter products made at these plants, including such well-known brand names as Tylenol, Motrin, Zyrtec, and Benadryl. The health care giant compounded its difficulties by attempting to cover up some recalls by hiring outside contractors to purchase products from store shelves.

However, the many problems were not confined to over-the-counter items. J&J has also recalled contact lenses, epilepsy drugs and hip replacement devices, among other items. There were also persistent shortages of Tampons and shampoos. The continual problems led to highly publicized congressional hearings; a closed plant in Fort Washington, Pennsylvania, and accompanying job losses; several high-level managerial changes; eroded consumer confidence; various lawsuits and hundreds of millions of dollars in lost sales.

Upon winning the recent horse race to succeed former ceo J&J Bill Weldon, who remains chairman, Gorsky maintained a determination to overcome these problems and that doing so successfully is a key priority. This may prove more challenging than he imagined. Shortly afterward, J&J announced a recall of Immodium, an over-the-counter tablet for gas and diarrhea (read here).

As for the recent warning letter, the FDA chastised J&J for failing to adequately evaluate and investigate 68 of 227 complaints concerning K-Y Liquibeads Vaginal Moisturizer There were also instances in which K-Y Liquibeads complaints associated with product subject codes "Does Not Dissolve" and "Uncharacteristic Consistency/Texture" were closed without any written justification. And complaints with a subject code of "Does Not Perform as Expected" were closed without further investigation or review by quality assurance.

There were also 19 investigation records of reportable complaints about devices that were reviewed during the FDA inspection, but nine records did not contain all of the required information, which the FDA noted is a repeated regulation deficiency that was observed during an FDA inspection at the Skillman, New Jersey facility in August 2009.

What else? The K-Y Liquibeads Vaginal Moisturizer product label states that the product is compatible with latex condoms. According to a Condom Compatibility Memo from April 2011, J&J "retrospectively reviewed condom compatibility by means of a silicone lubricant study using data from a previous study. The study did not include the K-Y Liquibeads Vaginal Moisturizer product and did not assess latex condom compatibility with fractionated coconut oil and fractionated coconut oil-lecithin, both of which are used in the formation of the shell of the K-Y Liquibeads ovule."

A J&J spokeswoman send us this statement: "We take the issues raised by the FDA seriously. We will respond fully to their concerns and take whatever steps are needed to resolve these issues."

Here is the FDA warning letter.