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 MobiHealthNews, in “FDA Seeking Feedback on New Office of Patient Affairs,” by Jonah Comstock.
Following is an excerpt:
Additionally, though, the FDA has always solicited and received input from patients, Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in the FDA, told MobiHealthNews. The problems are that (1) the FDA's mechanisms for soliciting feedback, like public comments online and at in-person meetings, haven't always been the easiest for laypeople to use, and (2) there has historically been a tendency in the agency to focus on hard data and write off patient experiences as anecdotal. Thompson thinks this could be a good way to surmount those obstacles.
“This office will be staffed presumably with people who are good at working with the general public, and explaining the FDA process, and engaging people in a true dialogue such that FDA can discern the real value in the patient experience and the patient perspective,” Thompson wrote in an email. “At the end of the day, there are not simply correct and incorrect scientific conclusions based purely on scientific evidence. All of FDA's decisions are frankly laced with value judgments, and those value judgments are often predicated on what we think is best for patients. So what could be better than hearing from patients themselves about those value judgments? ... If done well, this initiative will do much to improve the communication and result in valuable intelligence and perspective gleaned from the patient community.”
