• Regulatory NewsRegulatory News

    DOJ: Device Manufacturers Can Relay ‘Truthful’ Info on Unapproved Uses

    A US Department of Justice attorney for the first time explained in a set of jury instructions that it is legal for a device company or its sales representatives to provide doctors with “wholly truthful and non-misleading information” about off-label medical device uses. The jury instructions, filed earlier this month by Richard Durbin, Jr., the US Attorney for the Western District of Texas, explain what speech is illegal under the Food, Drug, and Cosmetic Act (FDCA) in ...
  • Regulatory NewsRegulatory News

    Implied Claims of Superiority Lead to Untitled Letter for Pharma Company

    The US Food and Drug Administration (FDA) has sent a warning to Cipher Pharmaceuticals over an email marketing piece sent by the company to promote its cholesterol drug Lipofen, saying the piece over-stated the drug's effectiveness. The Untitled Letter was sent by FDA's Office of Prescription Drug Promotion (OPDP), which has sent six other Untitled Letters so far this year. Unlike FDA's Warning Letters, Untitled Letters do not threaten immediate enforcement action if a...
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    Rare FDA Warning Letter Shows Spanish Drug Claims no Match for Agency Translators

    A Warning Letter issued this week by the US Food and Drug Administration (FDA) to a marketer of pharmaceutical products is a rare example of FDA cracking down on promotional claims made in Spanish and aimed at an audience outside the continental US. Background The 30 June 2014 letter (released to the public on 5 August 2014) is based on FDA's review of a website reportedly owned by a Puerto Rican proprietor, Ramon Rosa. The letter itself is fairly straightforward in ...
  • In Rare Warning Letter, FDA Hits Company for Making Unapproved Claims About Device

    The US Food and Drug Administration (FDA) this week sent a rare Warning Letter to a medical device manufacturer chiding it for promoting its product for a purpose not approved by the agency. The 26 February 2014 Warning Letter to NeoMedix Corporation references the company's Trabectome High Frequency Generator, a device cleared earlier for use with compatible electrosurgical instruments in low-power microsurgical applications for the removal, destruction and coagulation...
  • Company's Facebook Page Gets it in Trouble with FDA

    The US Food and Drug Administration (FDA) has issued a new Untitled Letter to a pharmaceutical company for allegedly misbranding its hypothyroidism drug on Facebook. Untitled Letters are essentially unofficial warnings from FDA that a practice-Untitled Letters are most often reserved for alleged marketing violations-runs afoul of federal advertising regulations. Unlike a Warning Letter, Untitled Letters do not threaten subsequent enforcement action by FDA. In its latest...