Issues regarding the safety and efficacy of new medical products intersect at the table where FDA regulators and companies negotiate approvals. At present, both parties are constrained: regulators face many “but what if” disincentives, and companies are wary of losing money and development time. Too often, inaction seems the safest course.
Patient advocates could strengthen this process by serving as mediators. In his newly published Hastings Center Report article, “A Third Seat at the Table,” Roth proposes a model that would give patient representatives a role in weighing product safety and efficacy concerns. Speaking for the people who have the most at stake in health care advances, patient advocates can help regulators and companies identify new pathways to nurture innovation, build public trust, cut costs, and address “quality of life” issues.