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The Ortho Evra Label Changes:


Are They Timely Ortho-FDA Collaborative Warnings, Or Are They FDA Sanctioned Excuses for the Manufacturer

The FDA has been in the news quite often, recently. Lately, consumers have seen news about caustic and blinding eye care solutions (Bausch & Lomb’ ReNu MoistureLoc and AMO’s Complete MoisturePlus), E. coli in spinach, and most recently the Salmonella laced produce outbreak. The FDA first associated the Salmonella outbreak with tomatoes, but had a hard time determining which tomatoes were causing the problem. And now the FDA suspects that other fresh produce may also be contaminated, but cannot determine the source.

Is commerce and technology outpacing the FDA’s ability to help keep consumers safe?

Turning to the Ortho Evra contraceptive patch (the “Patch”), there have been three years of close cooperation between the FDA and Patch manufacturer, Ortho-McNeil (“OM”), a subsidiary of Johnson & Johnson (J&J). For example, on July 25, 2005, 10 women filed a class action lawsuit against J&J and its subsidiary, OM, claiming that the Patch was defectively designed and unreasonably dangerous Plaintiffs alleged that using the Patch as OM had directed caused them to suffer strokes and blood clots. By November 10, 2005 The FDA and J&J had combined efforts to update labeling for the Patch. The updated label urged women using the Patch to work with their health care providers to “balance the potential risk.”

A study had emerged that the Patch exposed women to 60% more of the contraceptive chemical than they received using oral contraception. And that study was the impetus behind the FDA’s participation in fashioning a label change with OM.

When the FDA issued its 2005 Patch update, the FDA’s notice mentioned that there would be continued monitoring of safety reports for the Patch. In addition, the FDA informed the public that OM was already conducting additional studies to compare the risk of women developing serious blood clots when using the Patch, to the risk involved in using typical oral contraceptives that depended on the same chemical metabolite for efficacy. The FDA’s cooperation with OM did not end in 2005.

A little over a year later in September 2006, the OM Patch label contained the results of two conflicting epidemiological studies, which OM’s parent, J&J, had sponsored to evaluate the risk of VTE (traveling blood clots in the bloodstream). And, J&J had already released an interim report concerning those studies in February 2006. Very quickly on September 20, 2006, the FDA announced a second Patch label update that centered consumers’ attention on the risk that oral contraceptives posed by contributing to the formation of life threatening, venous and arterial blood clots. However those same studies revealed that the Patch posed a greater risk of VTE than did conventional oral contraceptives. Yet the FDA’s cooperation with OM did not end in 2006.

Most recently on January 18, 2008, the FDA approved still another update to the Patch’s label. This time the update was due to a third J&J funded study, showing a two-fold increase in the risk of VTE among users of the Patch. Let’s pause to recapitulate events:

1) The Boston Collaborative Drug Surveillance Program (BCDSP) conducted the first study that found that use of the Patch versus use of oral contraceptives (the pill) compared statistically in the occurrence of VTE.

2) About the same time, i3 Ingenix produced a study showing a two-fold increase in medically-verified VTE events in Patch users versus those using oral contraceptives.

3) A few years later, BCDSP conducted a study similar to the one the i3 Ingenix had conducted, confirming the i3 Ingenix findings.

Therefore, despite a three-year track record of uncertainty, concerning Patch safety, the FDA made the following statement in January 2008:

“This is an example of FDA working in tandem with the drug manufacturer to keep the public informed of new safety data and epidemiological studies that may impact health decisions about the use of FDA approved products.”

If the manufacturer and the FDA did not know and still do not know the full extent of the risk after three years investigating problems with the Patch, what would make anyone draw a logical conclusion that that doctors should have been, and continue to be able to work with their patients to effectively determine the risk? And a second question also comes to mind: Why not revert back to oral contraception and recall the Patch until OM can more accurately determine the risk?

It seems that the FDA and OM/J&J would rather fashion multiple excuses, than to stop distribution now, investigate problems with the Patch more fully, and then re design, manufacture, and distribute a safer, more predictable Patch to consumers.

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