• Regulatory NewsRegulatory News

    FDA Cracks Down on TV Ad for Prescription Weight Loss Drug

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) sent its first untitled letter of 2017 to Orexigen Therapeutics for a television advertisement that created a misleading impression about the safety of the weight loss drug Contrave (naltrexone HCl and bupropion HCl). OPDP found the ad , which opens with groups of women simulating a brain, contained efficacy claims for Contrave, but failed to include important risk information....
  • Could the Claim of 'Crazyballs' Constitute a Promotional Claim and Violate Federal Law?

    • 19 February 2013
    The patient is male, middle-aged and has just suffered a massive heart attack. For now, he's sedated, covered by blue cloth and being operated on by a female surgeon, with another attending surgeon and two residents standing nearby in the darkened room. Today's course of treatment will not be the same given to nearly 600,000 Americans who experience a heart attack each year. Instead the man will be given a device called the Parachute-a small device that looks like a smal...
  • Warning Letter Analysis: Device Companies Hit for Marketing, Social Media Problems

    • 13 June 2012
    Alleged marketing deficiencies were the subject of nearly identical warning letters sent to two separate manufacturers of hypoerthermic medical devices, both of whom were accused of using online advertisements to promote their respective devices for conditions not cleared or approved by the US Food and Drug Administration (FDA). ThermaSolutions Incorporated (Medical Device)  [See: 22 June 2012 Update] In its 7 May warning letter to Minnesota-based medical device ...