AMP Expresses Concerns About Product Labeling in Letter to FDA

The Association for Molecular Pathology (AMP) has requested that the Food and Drug Administration (FDA) prohibit the inclusion of patient management instructions or other medical recommendations in the product labeling for in vitro diagnostic tests. In a May 13 letter to Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, AMP noted that while it supports the use of HPV testing as a first-line primary cervical cancer test, it is concerned about the inclusion of medical practice recommendations in the revised “Indications for Use.” The letter, signed by Elaine Lyon, M.D., AMP president, refers to FDA’s recent approval of the Roche cobas HPV test. The approval letter, dated April 24, 2014, includes the following in indication 5: “Women who test positive for HPV genotypes 16 and/or 18 by the cobas HPV Test should be referred to colposcopy. Women who test high risk HPV positive and 16/18 negative by the cobas HPV Test (12 other HR HPV positive) should be evaluated by cervical cytology to determine the need for referral to colposcopy.” Lyon writes that although these recommendations are consistent with current clinical practice guidelines, such guidelines “are and should be established by relevant professional societies, and they often change over time.” The FDA has acknowledged that the Federal Food, Drug, and Cosmetic Act was not intended to regulate the practice of medicine and has stated that “Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics, and devices according to their best knowledge and judgment.” “However, including medical practice recommendations in a device product label, even when consistent with accepted clinical practice, violates these principles by making FDA an arbiter of medical decision-making,” writes Lyon. Takeaway: Molecular pathologists are urging the FDA to refrain from making medical practice recommendations on in vitro diagnostic product labels, noting that such recommendations should be established by relevant professional societies.