Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in PharmExec.com in “Medical Apps Tricky for Pharma.”
Following is an excerpt:
The degree of oversight is somewhat gray for apps that link to patients’ health records and drug ordering systems or provide medication reminders and tools to help physicians select proper treatment for a specific disease or to calculate drug dosage. Apps that guide prescribing may fit the category of “clinical decision support” (CDS) software; much-anticipated guidance from FDA is slated to clarify how the agency plan to regulate this area. Many CDS products designed to help physicians diagnose patient conditions and recommend treatment may fall in the enforcement discretion area, but when developed by pharma companies to be used in conjunction with a certain product, FDA may consider them “drug labeling” that must conform to its broader rules for drug advertising and promotion, explains Epstein Becker attorney Bradley Thompson.
