Survey: FDA and Industry Relationship Complicated

PricewaterhouseCoopers (PwC) most recent survey ‘Improving America's Health V- A survey of the working relationship between the life sciences industry and FDA' outlines a complicated and strained relationship between the life sciences industry and its chief regulator, the US Food and Drug Administration (FDA) according to reports.

Specifically, the survey highlights that the complications occur because of rising public demand for safety and the need for faster development of medical products. It also outlined that 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.

Breakdown

Within the survey, 38 percent of life sciences companies said they feel that the overall working relationship with FDA has improved over the past two years. 80 percent said that FDA is providing better guidance about its expectations. 68 percent of companies said they are incorporating this feedback into product development.

64 percent of companies that met with the FDA before submitting raw material said that it improved the quality of their applications. 87 percent said it expedited their applications, but industry did not always take advantage of the meetings and only about half (53 percent) said FDA consistently encouraged these meetings.

60 percent of companies expressed frustration that FDA had changed its position during a review, and 40 percent said some products were denied because of FDA's inadequate review resources.

The FDA were also accused of not keeping up with rapidly advancing technology, while only eight percent of drug and device makers think FDA is doing enough to advance personalized medicine.

51 percent of consumers think FDA does a good job, but a significant portion (over a third) said they had lost confidence in the agency in the last two years following high profile safety concerns and product recalls. And 97 percent 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."

"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," said Michael Mentesana, PwC's US Pharmaceutical and Life Sciences Research and Development Advisory Services Leader.

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