Elite Med products. Spokesperson Tom Kelley said the agency doesn’t comment on ongoing investigations. Mr. Kelley did say the attorney gen- eral is acting against physicians for pur- chasing Elite Med products “because this amounted to doing business with an unlicensed entity [Elite]. None of the products that the doctors injected into Texas consumers that were purchased from Elite were approved for use in the U.S. These were clear violations of the Texas Food, Drug, and Cosmetic Act and the Deceptive Trade Practices Act.” He adds that the agency doesn’t take into account whether the physicians it investigates knowingly and intentional- ly purchase products from an unlicensed distributor.
“The statute does not have a require- ment of knowingly or intentionally. The products were misbranded because the labeling was in a foreign language, and there are FDA-required caution state- ments that should have been on the la- bels/labeling that were not present,” Mr. Kelley said.
AG sues over unapproved IUDs The attorney general sued Women’s Inte- grated Healthcare, PA, of Grapevine, and six physicians after a DSHS inspection revealed that the clinic sold 490 unau- thorized Mirena IUDs purchased through a Canadian distributor.
The lawsuit sought up to $20,000 in civil penalties for each violation and a court order requiring the clinic to sell only FDA-approved IUDs. The agency also wanted the clinic to ensure the IUDs it sells feature labeling in English. (See “Consider the Source,” January 2011 Tex- as Medicine, pages 49–52.) To view the lawsuit, log on to
www.oag.state.tx.us/newspubs/ releases/2010/102110womens_health care_pop.pdf.
The lawsuit says Bayer Healthcare Pharmaceuticals produces different ver- sions of the Mirena IUD, but the FDA says only one version meets its standards for use in the United States. TheraCom distributes the approved IUD. Bayer’s plant in Finland manufactures all the IUDs.
Jamie Hawkes, spokesperson for 52 TEXAS MEDICINE August 2011
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