Relying 'Solely' On FDA To Judge Safety Of Ortho Evra Patch Is A Mistake, Editorial Says

Main Category: Sexual Health / STDs
Also Included In: Women's Health / Gynecology;  Regulatory Affairs / Drug Approvals;  Medical Malpractice / Litigation
Article Date: 15 Apr 2008 - 9:00 PDT

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It would be a mistake to "rely solely" on FDA to judge the safety and efficacy of the birth control patch Ortho Evra, a New York Times editorial says. The editorial notes that the agency is short of skilled scientists and might not detect or appreciate the significance of important information buried "deep in the bowels" of a report (New York Times, 4/14).

Johnson & Johnson, which manufactures Ortho Evra, is using the legal doctrine of pre-emption as a defense against claims that the birth control patch causes blood clots or other adverse effects. Under this legal argument, if a product's safety has been approved by a federal regulatory agency such as FDA, then its safety cannot be questioned in individual lawsuits. J&J is arguing that the company should be exempt from lawsuits because FDA approved the drug and its label in 2001 and because FDA's decisions should not be second-guessed by the courts. FDA changed Ortho Evra's warning label in November 2005, and an epidemiological study has since shown that women using the patch can have up to double the risk of developing blood clots as women taking the pill (Daily Women's Health Policy Report, 4/8).

According to the Times, J&J might soon "get a helping hand" from the U.S. Supreme Court, which has blocked many lawsuits over "faulty medical devices." Pre-emption is a "perverse legal doctrine," and if it "continues to spread, the public will be deprived of a vital tool for policing companies and unearthing documents that reveal their machinations," the editorial says.

The Times concludes that although FDA "continues to insist" that Ortho Evra is safe, "[i]njured patients should not lose the right to sue if they are harmed by duplicitous manufacturers" (New York Times, 4/14).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

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