The current regulatory approval process in the US and relationship between the life sciences industry and the Food and Drug Administration is being complicated by rising public demand for safety and the need for faster development of medical products, a report by PwC has concluded.
According to Improving America’s Health V- A survey of the working relationship between the life sciences industry and FDA, while life sciences companies feel communication with FDA has improved since the FDA Modernization Act came into force in 1997, growing expectations are fuelling mounting frustration with the regulatory review process.
Thirty-eight percent of survey respondents said the overall working relationship with FDA has improved over the past two years, and 80% said the FDA is offering better guidance about its expectations. But 60% of companies expressed frustration that the regulatory agency had changed its position during a review, and 40% felt some products were denied market access because of inadequate FDA resources.
Furthermore, the report found that the industry feels the FDA is failing to keep up with rapidly advancing technology, and only 8% of drug and device makers think the agency is doing enough to support the progress of personalised medicine. In addition, 56% of companies aware of the FDA’s Critical Path Initiative, which is designed to bring innovative, high priority therapies to market quickly, think the agency lacks the capability to implement the scheme.
The report notes that two developments after 2006 could explain the more negative feedback from the industry regarding the Administration – FDA reauthorization in 2007, which expanded its responsibilities despite resources being tight, and the Prescription Drug User Fee Act, under which the agency is allowed to collect fees – up to $1.25 million per drug application - from companies manufacturing certain products to help fund an accelerated review process of innovative medicines.
But forty-six percent of companies do not feel these user fees have accelerated the review process, and 48% said the FDA has not been clear about the intended purpose of user fees or how they are applied. Moreover, 38% said user fees are excessive compared with the time the FDA spends on reviews.
Interestingly, a separate survey by PwC found that only 36% of consumers are aware that the industry helps to fund the FDA’s activities, and 70% do not agree that industry fees should be used to quicken the regulatory review process, perhaps indicating that the general public views user fees as a conflict of interest.
PwC’s survey of 1,000 consumers – designed to gauge public perceptions of the FDA and this compares to the industry's views – also revealed that while the majority (93%) of Americans are confident about the safety and effectiveness of drugs and medical devices approved for use in the US, 56% also said they would be willing to use products cleared outside the country before FDA approval.
Fifty-one percent of consumers think FDA does a good job, but a significant portion – 36% - said they had lost confidence in the agency in the last two years following high profile safety concerns and product recalls. And 97% of consumers said company reputation is an important factor in deciding whether to use a medical product, with 49 percent saying it is “very important”.
Commenting on the report’s findings, Michael Mentesana, PwC’s US Pharmaceutical and Life Sciences Research and Development Advisory Services Leader, said: “Consumers want safer, more effective drugs and devices and access to the latest medical innovation. Industry wants fast and efficient product approvals. And Congress wants better quality, lower cost healthcare that demonstrates enhanced economic and clinical value”.
“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 and the quality and productivity of the FDA-industry relationship would be better on both sides if there was more collaboration and clarity around expectations,” he stressed.