Ask the Expert: Commenting on Draft Regulations

Regulatory agencies, such as FDA and the European Medicines Agencies, and other industry standard setting bodies, such as the International Council for Harmonisation and the US Pharmacopeia, often publish draft versions of the guidance documents they are developing to gather feedback from the public, which includes those scientists and engineers working in the pharmaceutical industry. But who should comment and why?

“You know, there's an opportunity before regulations get approved for industry to participate and offer their comments on the regulation. This has worked in many cases where, for instance, in the US, way back in 2013, 2014, there was a proposal for metrics. And it was through the commenting period that was open to the public, where industry

was able to put forth a case to get the agency to consider some other metrics

that we thought were important, that they were not originally in the proposal,” explains Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates. “So, the way it works is anytime there's a new regulation or a change to an already existing regulation, the FDA will announce it in what we call the Federal Register. It's kind of like the daily newspaper for the government. It's that time when they open it up for comments from industry. And so, it's very important because you can change the final regulation before it becomes official by putting your comments in through this vehicle.”

“Absolutely anyone can comment,” stresses Siegfried Schmitt, PhD, is vice president, Technical at Parexel. “You don't have to be the ultimate expert. If you feel you have something to say, absolutely, you can. Now, perhaps it is advisable or sensible to not just comment as an individual but perhaps comment through your company. Perhaps your company as such is interested in providing comments.”

Both Schmitt and Schniepp also suggest commenting through a trade association, such as the Parenteral Drug Association. “I like commenting through industry associations because usually, they gather a group of experts together proposed regulation topic, And you get to hear not only your perspective voiced, but other experts' perspectives voiced,” Schniepp says.

Click the video above to watch Sue and Siegfried answer the following question:

“I often see regulators publishing draft guidance documents for public consultation. Can I and should I comment?”

About the experts

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of Pharmaceutical Technology®'s Editorial Advisory Board.

Siegfried Schmitt, PhD, is vice president, Technical at Parexel and a member of Pharmaceutical Technology®'s Editorial Advisory Board.

Ask the Expert Video Series

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to PTProjects@mmhgroup.com, and it may appear in a future episode or print column.

We hope you enjoy the discussion!