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It's Official: Industry Finds FDA Greatly Improved

It's Official: Industry Finds FDA Greatly Improved
A new report shows how a majority of life sciences industry executives believes that their relationship with FDA is improving. 

In October, there was love in the air in Chicago.

At the annual conference of AdvaMed, the medical devices industry's largest lobby group, you couldn't go two steps in McCormick Place without hearing how great the Food and Drug Administration was. This was in marked contrast to the barbs that has been thrown at the agency over the years from device makers citing charges that the agency was slow in responding, burdensome and inconsistent in its requests for data and profoundly mercurial.

In response to a question from this reporter at the conference about this "love fest" FDA's Jeffrey Shuren remarked that the agency had listened to industry and made changes to become more collaborative, more efficient and less opaque.

Now the results are in of that effort.

A report from PricewaterhouseCoopers released on Monday shows that a whopping 78% of life science industry executives - both from the pharma and device worlds - believe that "the FDA has improved the quality and frequency of it communication in the past two years."

Another 76% responded that the agency provided actionable feedback while 70% thought that the agency offered more "applicable guidance, rules and regulations," according to the report. Entitled "FDA and Industry: A recipe for collaborating in the New Health Economy," the report polled 100 senior executives from the life sciences industry.  

Here's a snapshot of how premarket approval times of devices have improved over the past five years. This is revealing especially compared to the same for drugs.

PMA approval times, device approvals, FDA approvals

There was another very interesting highlight from the report, which brings to light how large companies and small companies differ in their interactions with the agency. Some 42% of executives from large companies reported always participating in meetings with the FDA at key moments during clinical development or before submitting an application. Compare that to only 23% of executives from small companies who did the same. Another 40% reported rarely participating.

But meeting with the FDA appears to have a direct correlation with how good the relationship is between the two parties. An even 70% of executives who always attended meetings with the FDA said their relationship with the agency improved over the previous two years. Compare that to only 38% of company executives who rarely met with the FDA who responded similarly.

Small companies might want to revisit their hesitation in attending meetings with FDA reviewers.

"For newer companies, the reluctance to meet with the FDA is that it may foster other questions about their product," said Susan Alpert, a consultant, former FDA official and senior executive at Medtronic, in the report. "But my opinion is not taking advantage of FDA meetings is shortsighted on the part of a company.”

[Photo Credit: user Lisa-Blue]

-- By Arundhati Parmar, Senior Editor, MD+DI
[email protected]

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