FDA says Pearson is marketing ADHD product without proper approval
(Update: Pearson response)
Pearson, the giant education company, has been marketing a program called Quotient ADHD System, which, the Web site says, “is an innovative device that objectively measures three core symptoms of ADHD: hyperactivity, attention and impulsivity.” It further says:
‘Based on research from the McLean Hospital, a Harvard Medical School Affiliate, this easy-to-administer tool uses advanced motion tracking technology to track a child or adult’s micromovements while they complete a 15-20 minute computerized test. After the test is completed, patterns of motion, accuracy of the responses, and fluctuations in attention state are quickly analyzed and scored using proprietary algorithms. Scores and test data from these analyses provide valuable insights into both the existence of ADHD and the severity of the disorder.Cleared by the FDA with the intended use: “to provide clinicians with objective measures of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD”. [Bold-faced added]
It turns out the Federation Drug Administration isn’t as on board as all of that. A letter dated Aug. 20, 2015, from the FDA to Pearson says:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Quotient ADHD System in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Pearson spokeswoman Laura Howe said in an e-mail:
“In August, Pearson received a letter from the FDA regarding marketing language for its Quotient program and has since taken steps to ensure all materials are in compliance with federal regulations.”
Here’s the full text of the letter:FDA says Pearson is marketing ADHD product without proper approval - The Washington Post: