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Defining the Relationship Between the Pharma Industry & Regulatory Agencies

I read an article at PharmTech at the tail end of 2016 that I thought was quite interesting, and it reflects Neuland’s position on regulatory agencies & issues. The article – Nurturing the Relationship Between Industry and Regulators – emphasized the need for the pharma industry to partner with regulatory agencies to provide safe and effective therapeutics.

In the PharmTech article, author Susan Haigney, points out:

“It’s a partnership that can sometimes be contentious but is, ultimately, beneficial to all.”

To me, the relationship between regulators and the life sciences industry is (or, at least, should be) fairly straightforward: regulators hold us – as an industry – to uniform and consistent standards…and that’s a plus for us. And we – the industry – have the ability to deliver the tools and know-how to help regulators in their efforts.

The life sciences industry also has an obligation to inform regulatory agencies when we think they are off-base. Analytical standards are an excellent example in which industry often provides information, data and feedback about the widespread use of newer technologies that have come to replace older, potentially less accurate standards.

The article references this, as well:  “international standard-setting organizations emphasize the importance of industry input. USP encourages pharma companies to participate in the development of public standards.”

The Industry-Regulatory Relationship: ‘It’s Complicated.’

The piece at Pharmtech also brought to mind an editorial I’d seen at DDNews on the 21st Century Cures Act, pointing to the at-times conflicting relationship industry and regulators tend to have:

As chief editor of this magazine, I have an emotional and intellectual relationship with the FDA that would, were it a Facebook status, be ‘it’s complicated.’

On the one hand, the part of me that deals with pharma and biotech business issues knows that it would be nice to trim the costs of clinical trials and other aspects of the approval process. Unlike most of the American population, I know that high drug prices are often at least as much due to the economic necessity of recouping R&D costs as they are to do with greed.

On the other hand, I also deal with the academic and clinical researcher side of the news and a lot of the people on that side (and me, too) would like to see rigorous scientific study of potential drugs. I was happy in the early talk of 21st Century Cures to hear about working in “real world” results as part of the review/approval process and possibly streamlining some FDA processes.”

Finding Common Ground: Collaborating to Improve Patient Health

Back to the PharmTech article for a moment – it pointed out some key areas (beyond standards development) in which collaborative (or at least non-combative!) efforts can make some inroads towards improving patient health in ways that benefit industry participants, as well.

Learn more about these key areas in the PharmTech article here: Nurturing the Relationship Between Industry and Regulators


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