Dr. Sinha, along with other members of the PORTAL Research Group, noted in Health Affairs Blog and JAMA that they are concerned about the impact of the Cures Act on patients (JAMA. 2017;317:581-582). “Allowing drug approvals on the basis of less rigorous data—such as through the limited population pathway for antibiotics—will lead to numerous products becoming available without clear evidence of benefit to guide physician and patient decision-making,” he said. For example, it will be increasingly difficult for physicians to base their confidence in a drug’s safety and efficacy on FDA approval alone, particularly as biomarkers and other surrogate measures replace meaningful clinical endpoints in pivotal studies leading to approval. “Of course, all of these products will invariably be extremely expensive as well, which will put a strain on limited healthcare budgets and possibly detract from already available, well-proven therapies.”
