Industry and the American public have lost faith in the federal agency in charge of overseeing the country’s drug and medical device industry, according to an annual survey by PricewaterhouseCoopers LLP.
PWC and Biocom, a trade association representing 550 California life science firms, interviewed 1,000 individuals and executives at 50 medical device, drug and diagnostic companies. The pollsters found that slightly more than half (51 percent) expressed a favorable opinion of the Food & Drug Administration’s performance, but that high-profile drug recalls had damaged confidence in the watchdog agency.
The survey, “Improving America’s Health V — A survey of the working relationship between the life sciences industry and FDA,” found that 28 percent of respondents weren’t confident in the agency’s ability to monitor medical products after their release.
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The safety concerns are complicated by industry’s high expectations for drug and device approvals. Although the study found that life science companies feel communication with the FDA has improved steadily since the FDA Modernization Act of 1997, many feel that the federal watchdogs don’t have the capacity to match industry’s pace of innovation. Thirty-eight percent of the firms polled felt that the their working relationship with FDA improved over the past two years. Eighty percent said that the agency is providing better guidance about its expectations from companies, but 60 percent said the FDA had changed its position during a review.
Forty percent also felt that some products were denied approval or clearance because of the FDA’s “inadequate review resources,” and 8 only percent of device and drug makers believe the agency is doing enough to advance personalized medicine. The 56 percent who were familiar with the FDA’s Critical Path Initiative, agency designed to bring innovative, high-priority therapies quickly to market, said the agency lacks the capability to implement the plan.
“Hope lies in accelerating scientific and technological advancement as we learn more about genetic differences and individual responses to treatments. But the promise of faster product development has yet to be realized,” PWC pharmaceutical and life science research head Michael Mentesana said in prepared remarks. “Consumers want safer, more effective drugs and devices and access to the latest medical innovation. Industry wants fast and efficient product approvals,” Mentesana said.
Overall, the public’s confidence in the FDA is high. Ninety-three percent of the individuals surveyed said they are confident in the safety and effectiveness of approved devices and drugs, while two-thirds said the FDA has the the highest standards in the world. But the number of respondents who would products approved outside the U.S. is not far behind that number, with 56 percent saying they would feel comfortable using medical products approved outside the country. That’s significant, because drugs and devices are rarely cleared for market in the U.S. ahead of European CE Mark approval.
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The U.S. medical device and pharmaceutical industries and the FDA may take comfort in that the public is largely behind their offerings — 88 percent of consumers said that the benefits of devices and drugs outweigh their risks.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
