The Office of Prescription Drug Promotion (“OPDP”) of the Federal Drug Administration (“FDA”) issued ten enforcement letters in the first six months of 2013, far less than in recent years. All ten letters issued in the first half of 2013 were Untitled Letters or “notice of violation letters.” In 2012, OPDP issued a total of twenty-eight enforcement letters, with seventeen issued in the first half of 2012. While the total number of FDA enforcement letters have decreased in recent years, Warning Letters, specifically, have decreased from thirteen in 2010, five in 2011, three in 2012, and none to date in 2013.
The most common violation cited in the 2013 letters was “Minimization, Omission or Misleading Presentation of Risk Information or Material Fact,” cited in nine of the ten enforcement letters. Other common violations included: “Misleading or Unsubstantiated Comparative Claims” (cited in five letters) and “Misleading or Unsubstantiated Efficacy Claims” (also cited in five letters).
The most common type of violative promotional material was directed to consumers in the form of a print advertisement, user guide, brochure and video news release. Three of the enforcement letters cited violative webpages and websites, and three letters targeted violative promotional labeling directed to healthcare professionals in the form of an email, sales aid, and detailer.
Of particular interest, FDA issued an Untitled Letter to CBA Research, Inc., addressing a violative website that promoted an investigational new drug as safe and effective for the purposes for which it was being investigated. The website’s claims suggest that CBT-1, an investigational new drug, is safe and/or effective for use as an adjunct to chemotherapy for cancers which have multi-drug resistant characteristics, when, according to OPDP, it has not been approved for this or any use.
Life sciences commentators have suggested that the court ruling in United States v. Caronia, that negated off market penalties, and budget cuts known as sequestration that have reduced funding for federal programs, including FDA, may have contributed to FDA’s decline in enforcement letters. We are now in the second half of 2013 and have not yet seen any enforcement letters from OPDP.