ISPE’s Regulatory Commenting Process

What is Commenting?

As regulatory agencies invite public comment on a new or revised regulation or guidance, they look to ISPE for input on the latest scientific and technical developments. ISPE submits official comments when we are able to provide that input.

ISPE’s commenting process is overseen by ISPE’s Regulatory Quality Harmonization Committee (RQHC) and managed by ISPE regulatory staff.

How Does It Work?

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. Although an individual can provide input or comments directly to the authority, their input can have a greater impact when many industry segments pool their comments and submit them as a group document.

In the guide “A Guide to Writing Public Interest Comments Using Economic Analysis,” Jerry Ellig (Oct 2014) presents six fundamental actions that will give comments the maximum advantage:

1. Understand the regulatory process.
2. Appreciate the regulatory agency’s definition of “the public interest.”
3. Know the key topics.
4. Recognize the agency’s legal authority and constraints.
5. Write your comment in the appropriate format, language, and tone.
6. Tell other interested parties about your comment.

ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. As a basis for evaluating the fundamental quality of proposed regulations or guidance provided for review by regulatory authorities, several core ISPE values serve as the basis for evaluating the quality of those proposed regulations:

1. Professional excellence based on scientific and technical merit.
2. Practical, sustainable and compliant solutions achieved through open interaction among all. facets of industry, government, and academia.
3. Intellectual honesty and objective judgments based on integrity, trust, respect, and commitment.
4. Continuous improvement through sharing of best practices.

The ISPE values serve as a basis for assessing the quality of regulations or guidance issued by regulatory authorities based on the technical and scientific content of the document.

In the book: The Art of Commenting: How to Influence Environmental Decision Making with Effective Comments 2^nd ed. (Nov 2013) Elizabeth Mullin provides tips such as using strong verbs and active voice. Mullin highlights that the reader should audit the document for errors and omissions, accuracy, and consistency with other documents. Some specific tips from her book are:

1. Suggest specific language when possible and appropriate.
2. Indicate what you support, as well as what you disagree with.
3. Give specific examples to illustrate concerns.
4. Provide supplemental information, if needed.
5. Offer helpful solutions.

Appropriate Language and Tone of Voice

An effective comment should be aimed at helping the agency improve the document. Please keep in mind when contributing comments submitted via ISPE that the comments – although anonymized – will be shared publicly as part of a permanent record. Therefore, it is essential that you base your comments and justifications on solid reasoning, scientific evidence, and how the industry will be impacted. The US government provides a document, Tips for Submitting Effective Comments, which states “A comment can express simple support or dissent for a regulatory action. However, a constructive, information-rich comment that clearly communicates and supports its claims is more likely to have an impact on regulatory decision making.”

Ensure your responses are polite and scientific. Provide the page number, column, and paragraph citation for any words, phrases, or sentences you comment on. Provide substantive data, facts, and expert opinions to support your comments. Take into account how the entire industry will be affected.

If you disagree with a proposed action, suggest an alternative and include an explanation or analysis of how the alternative might meet the same objective or be more effective.

The language you use in your ISPE comments should be brief and as professional as possible, avoiding asking the agency a question, and avoiding vague language like "please clarify" or "this does not make sense." It is imperative that you do not express emotional opinions in ISPE comments. While you can disagree with the content of the document, maintain a courteous attitude. When commenting to a regulatory agency, Mullin (2013) also emphasizes the importance of expressing yourself in a respectful way.

As part of the ISPE review process, all comments submitted to ISPE by members are reviewed by a team of subject matter experts, followed by a review by members of the RQHC. Lastly, the comments are approved by the ISPE President/CEO before the comments are submitted by ISPE staff to the appropriate authority.

When can I comment?

The open comment period is a defined timeframe within which agencies accept comments on documents. Our request for comments on documents will be posted in ISPE Engage and within the ISPE Communities of Practice. In order to allow time to review the comments, ISPE establishes a deadline that is prior to the final submission deadline.

What if I see a document that I think ISPE may want to comment on?

Many regulatory agencies around the world publish a variety of guidelines and draft documents. The RQHC welcomes inquiries from ISPE members or groups who wish to comment on a document through ISPE. If you find a draft document that relates to a topic within the scope of ISPE, please contact us at regulatorycomments@ispe.org Furthermore, you may wish to participate in a committee or CoP where you will be able to contribute as a subject matter expert and serve on a comment lead team when we need support.

If you are interested in reading more about the ISPE commenting process, you may visit the ISPE website at this link Regulatory Commenting | ISPE | International Society for Pharmaceutical Engineering and see past comments that ISPE submitted since 2004.

View the Full Series of Regulatory Digest

• Bob Tribe, ISPE Asia-Pacific Regulatory Advisor, Retires
• ISPE’s Regulatory Commenting Process
• ISPE Launches Enabling Global Pharma Innovation: Delivering for Patients
• Regulatory Panel Discussions: Annex 1 Implementation from the Regulators’ Point of View