ParaGard TV Spot Misrepresents Contraceptive’s Risks, US FDA Says
‘Untitled’ letter is FDA's third in the past eighteen months to target promotions for women’s health products. In the case of advertisement for CooperSurgical's copper-containing intrauterine device, which is regulated as a drug, the agency took issue with distracting visuals and reliance on superimposed text.
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Proposed rule issued in March 2010 requires ‘major statement’ on a drug’s side effects in ‘a clear, conspicuous, and neutral manner’ for TV and radio ads. Bill would mandate a final rule within six months.
The agency's "Bad Ad" program issued a warning letter that claims the promotion for CooperSurgical's copper-containing intrauterine contraceptive lacked any safety information.
CooperSurgical is hit with second letter for misleading promotion of its copper-containing intrauterine contraceptive. Video lacked any safety information, agency says in request for corrective communication.