Report: regulatory innovation should adapt to new health economy
Consumers and drug and device manufacturers are changing practices and shifting attitudes toward the 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. Those changes will likely put pressure on the FDA to consider changes as well, according to a new report from PricewaterhouseCoopers (PwC) Health Research Institute (HRI), based on findings from surveys of consumers and senior industry leaders. PwC’s Health Research Institute provides new intelligence, perspectives and analysis on trends affecting all health-related industries.
“To meet 21st century demands for innovation, it will be important for drug and medical device manufacturers to collaborate with the FDA to consider changes to the regulatory framework,” said Mike Swanick, global pharmaceuticals and life sciences leader, PwC. “While recognizing the FDA’s investments to improve its relationships with manufacturers and speed drug and device delivery, manufacturers still want greater flexibility in product development and review.”
The report, titled The FDA and industry: A recipe for collaborating in the New Health Economy, reveals how drug and device companies are adapting to the new health economy, including consumer and insurer focus on cost-effectiveness as well as medical benefit. Forty three percent 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.
Additional key findings of the report include:
• 78% of executives said the FDA has improved the quality and frequency of its communications in the past two years
• 76% think the agency provides actionable feedback and 70% think it offered more applicable guidance, rules and regulations in the past two years
• 71% believe the FDA can accelerate approval programs by balancing swifter approval with increased post-market surveillance.
The survey found healthcare consumers want input into developing therapies. Relatively few (39%) believe the FDA incorporates their views in its review process, and only 38% say drug and device manufacturers adequately consider their views.
“With greater access to medical information than ever before, consumers are assuming responsibilities that have historically resided with the FDA or industry—such as developing guidance, creating incentive programs and funding research and development directly,” said Michael Mentesana, PwC's U.S. pharmaceutical and life sciences R&D advisory services leader. “As a result, companies have a real opportunity to seek out and use consumer feedback to better demonstrate value over existing therapies.”
The report is part of a series of Improving America’s Health surveys conducted by PwC that explore the industry’s relationship with the FDA and how it is changing to reflect recent trends. In the summer of 2014, HRI surveyed 100 senior executives on issues such as regulations, the development of new therapies and patient engagement.
Previous surveys were conducted in 1995, 1997, 1999, 2006 and 2010. In the most recent survey, respondents included CEOs, COOs, presidents, vice presidents and department directors responsible for managing their companies’ relationships with the FDA.
Industry trade association Biocom in Southern California helped recruit survey respondents, which represented a broad cross-section of the pharmaceutical and life sciences industry in terms of head count, revenue and product lines. In addition, 1,000 adult consumers also were polled about their views of the FDA, the pharmaceutical/life sciences industry and consumer access to therapies. Consumers were U.S. residents and were randomly selected to participate in an online survey.
HRI helps executive decision makers navigate change through primary research and collaborative exchange. Its views are shaped by a network of professionals with executive and day-to-day experience in the health industry. HRI research is independent and not sponsored by businesses, government or other institutions.