A Successful Comment is Not Just Angry

Editor's Note: With the deadline for comments on NDI draft guidance just around the corner--like some regulatory, presents-free Christmas--it's important not to let this matter slip this blog's attention. With that said, there will be occasional, relevant posts from qualified folks that address this subject as it progresses.

Betty Campbell, vice president of EAS Consulting Group (Alexandria, VA), is an ideal person to shed some light on this frequently contentious subject.

Everyone knows about FDA’s NDI draft guidance and almost everyone disagrees with something in the policy.  FDA has committed to responding to comments on the policies in the guidance received by Dec. 2. If you disagree with a specific position in the guidance, you should consider submitting a comment.

The agency has established procedures for dealing with comments on draft guidance documents. Comments should be submitted to the docket identified in the Federal Register notice on the draft guidance (in this case, Docket No. FDA–2011–D–0376).  All comments will be available to the public for review. The agency will review all comments, but need not specifically address every comment. FDA will review the comments and make changes to the guidance document in response to comments, as appropriate.

Of course, if you agree with a policy, you should state your agreement, but most of the comments that the agency receives on any document disagree with at least part of a policy. The key to getting FDA to change something in a draft guidance document is to provide persuasive information and rationale for the policy that you want.  FDA bases its decisions on information, not majority opinion.  Unlike Congress, FDA does not simply count the number of yeas and nays.  FDA does not have to respond to simple opinion statements like, “I don’t like this policy,” or “This policy will be too expensive for my business.”

Of my 35 years working for FDA, I spent 26 years writing regulations and handling the comments the agency received on various types of food policies.  When we got a letter that just said “I don’t like it,” and didn’t provide a basis for the opinion, we counted it and set it aside.  To get FDA’s attention a comment needs to contain information and a good rationale for the requested change in policy.  For example, if the policy will cost your company too much, include data on current costs and future costs under the draft policy. Explain what you would have to do differently that would be more costly. Describing the impact of this cost increase on the company could be useful. If there is a better way to accomplish the goal of the policy, then describe the alternative approach and explain how it would be better. If the policy is an attempt to solve a problem that does not exist, explain how the current approach is sufficient and how the proposed approach would have a negative impact and provide no benefit.

A successful comment is thoughtful, informative and persuasive, not just angry.