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“I often see regulators publishing draft guidance documents for public consultation.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!

Transcript

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Okay, hello, everyone. My name is Siegfried Schmitt. I'm vice president technical with PAREXEL, and I'm one of the Ask the Expert experts for the series here, and I'm Sue Schniepp, and I'm part of regulatory compliance associates, which is a subsidiary of Nelson labs, and I am Siegfried's counterpart for Ask the Expert series.

Okay. Oh, hello, Sue. Nice to see you again. Hi, Siegfried, good to see you too well.

So we got another question here for Ask the Expert series, and this is that there are several new regulations being published in draft in Europe. And of course, there are always some being published in the US as well, and the person writing in was wondering, so how can one do this? This commenting and well, is it the done thing? Because he or she feels well, perhaps this is not something that everyone should do. Can you perhaps comment on this?

Yeah, 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, now you're the expert on the European arena, but in the US, way back in 2014 2013 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. So the way it works is, anytime there's a new regulation or a change to already existing regulation, the FDA will announce it in the what we call the Federal Register. It's kind of like the daily newspaper for the government, and it's that time where 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.

That's very interesting. Thank you. Sue and perhaps to add, in Europe, not every regulation is open for public comment, but many are, and so as the person writing in was asking is, can anyone do this? Absolutely, anyone can comment. 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 many companies do, or perhaps through an industry association like ispe, PDA, raps, you name it there. There are many out there. So perhaps so, because you have done this many times, you could say a few words why this is such a good way to comment. If you do it through an industry association.

Well, I like doing it through the industry associations because usually they gather a group of experts together on the topic, proposed topic, regulation, topic, and you get to hear not only your perspective is voiced, but other experts perspectives are voiced. So I like the broad scope information that working with a team of experts on this topic brings you, it makes the comments more robust. And I, I think the trade organizations have a certain because they're representing multiple experts, multiple companies. There's a little bit more weight kind of associated with it, from my perspective as a commenter, right rather than an individual. I'm not saying that the FDA or the regulatory authorities puts more weight in the comments of a trade organization over an individual. I'm saying that as. As a commenter, I feel there's more weight in my comments when they go in under a trade association. That's a personal feeling, though.

Well, to pick up on this Sue, particularly if you're an inexperienced person in commenting on regulations, I think it's very valuable to be part of such a group, in an industry association, because many of those who will be part of this group will have done it before, and there are certain things that regulators will simply ignore if you put things in that cannot be acted upon. So you can learn an awful lot how you can effectively influence, a regulation, a guidance, and what things are best left out. So it's a very good learning experience, and it helps one understand how, in fact, these regulations are being put together.

Yes, it puts a perspective for the the new person who might be new to this commenting game. I think we've restricted our discussion right now to regulation proposals, but there are other publications that are open for comment, such as the European Pharmacopeia or the United States Pharmacopeia, and it's important for people to understand those two have a comment period where You can influence the outcome of the work that they're doing and establishing, you know, the standards and some of the guide interpretation of guidances and how to enact those do?

They also have these expert advisory groups. I believe they're pharmacopeias.

They do. They have expert committees, both in the EU and the USP, I think that I'm not sure about the Japanese Pharmacopeia. And those advisory panels will propose the change to the Pharmacopeia, and then it will go, usually, through what they call, at least in the US, it's called the pharmacopeial forum, where it's open for review. I forget what they call it in Europe, but it's kind of similar to the same process.

Okay, yes, and perhaps, as you say, it's not just these draft regulations that are open for comment, where you can influence what will be the ultimate regulation, or how things will be regulated, because you and I, we are both members of industry associations and help them write best practice guides, yes, and these best practice guides are sometimes even cited by the agencies like FDA and Emma and so on, because they complement the regulations. Yes, not everything can be in a regulation. Certain things are better said in a guidance document, which may come from an industry association. Well,

there's also, and you're very active in PDA, as I am, and to use them, and as an example, we do publish technical reports on topics that may not quite have made it into the regulation, but are important and implementing some of this standards and expectations of regulatory authorities, and those often can be cited by the regulators, as as you said, Best Practice documents indeed. So coming back to the question that was asked of us, really, it is, it is very advisable to get involved. You do not have to be the ultimate expert, but you learn for yourself also about the processes. You learn about how regulations are being put together, and how, really, industry does have quite an influence on how these regulations will be written. So we can only encourage, I think, become part of these associations, be become an active part, not just the consumer, yes, and I think there's many more, you know, you're touching on a topic near and dear to my heart there. Siegfried, it's not only just commenting, but try to get involved. You know, if you think you have an expertise, maybe you want to put in your nomination. And for a USP expert committee or EP expert committee member. There's also American National Standards Institute. If you're in the US, you can join ANSI, or you can try to join a organization that works to develop ANSI standards. And then there's Amy, right So, and I know there's European organizations, maybe you have some of those that you but to put your name in the hat and say, I'd like to volunteer and I'd like to be on this committee is another great way to try and influence or get the best regulation out there.

And again, if you do work for a company, then your managers will be very interested in this, because it really helps you, but it also helps the company. It raises the profile, doesn't it?

Yes, it does Totally agree.

Well, thank you very much. So I think we've covered this topic for today.

I agree. Thank you. Siegfried, always a pleasure to talk with you.