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Industry and regulators keen to collaborate, but FDA expert warns about perception

This article was originally published in Scrip

Executive Summary

"Collaboration" and "partnership" between the pharma industry and regulators were key buzzwords on the last day of 7th annual TOPRA meeting in London this week, but one FDA expert warned about their possible negative connotations.

"In the past we always saw them [regulators] as saying 'no', but, in fact, nowadays they want to collaborate," declared Professor Trevor Jones, director of Allergan and former director general of the UK industry association ABPI, in his opening speech before the regulator's perspective in the session on "Improving access: how can all stakeholders make a contribution".

Murray Lumpkin, deputy commissioner for international programs at the Office of the Commissioner at the US FDA (in picture below), told the 650 or so industry/regulatory affairs delegates that: "'Partner' is an appropriate [term] in this room together as we know what that means, but that is a word that is loaded that makes other stakeholders uneasy."

He questioned what regulators do with their stakeholders, where for the FDA, at least, there is an "overflowing cornucopia" of them including industry, healthcare professionals, patients, NGOs, advocacy groups, the investment community, government, payers and buyers. "Do we collaborate or engage with them?"

He says that when other stakeholders hear "we want to collaborate with industry", this has "negative connotations".

"We need to watch the verbs [we use], they need to be more neutral...because addressing perception is more important than addressing the reality. I would like to use the word 'engage' as it does not have the same connotations of other verbs."

As the FDA has a very diverse group of stakeholders, this creates challenges because they can have opposing views and sometimes there is no "common ground". Some want to comment on every issue, while others do not.

He pointed out that some stakeholders were better organised, funded or sophisticated than others on how they "navigated" Washington. "Where do you draw the line between engagement and lobbying as it has legal obligations if that line is being crossed?"

Other challenges in relation to stakeholders he noted were: "how to assure a level playing pitch when it comes to access to FDA and influence on any given process" and "how to assure transparency with regard to process and decision-making and how to incorporate various viewpoints of stakeholders with equities – without compromising responsibilities regarding legally mandated confidentiality of certain data and activities?" Overall, he says, there is a difference between "stakeholder" and "customer"; for the FDA, it has one customer, which is protecting and promoting public health in the US.

US ... and them? FDA's Murray Lumpkin talking to 'collaborators' .

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