PwC Report: Regulatory Innovation Should Adapt to New Health Economy

January 26, 2015

Applied Clinical Trials

Consumers and drug and device manufacturers are changing practices and shifting attitudes toward the Food and Drug Administration (FDA). Increased pressures for speedy access to breakthrough drugs and medical devices, and a focus on value in addition to medical benefit, are driving these changes.

A new report from PwC’s Health Research Institute (HRI) based on findings from surveys of consumers and senior industry leaders in the drug and medical device sector has uncovered changing practices and shifting attitudes toward the Food and Drug Administration (FDA). In its report, “The FDA and industry: A recipe for collaborating in the New Health Economy,” 43% of survey respondents said they are willing to have their products judged based on both clinical and economic value, compared to just 14% in 2010.

Read the full release here.

Additional key findings of the report include:

Seventy-eight percent of executives said that the FDA has improved the quality and frequency of its communications in the past two years.

Seventy-six percent think that the agency provides actionable feedback and 70 percent think it offered more applicable guidance, rules and regulations in the past two years.

Seventy-one percent believe that the FDA can accelerate approval programs by balancing swifter approval with increased post-market surveillance.