Confused About the Force of FDA Draft Guidance? You Are in Good Company!

The issue of when to apply FDA Draft Guidance has always been a bit confusing and sometimes an amusing subject.  FDA Guidance (whether in draft or final form) is supposed to represent the FDA’s current thinking on a specific matter.  If the Draft Guidance is newly issued and is still within a reasonable comment period, then it may be best to contact FDA to see if the Guidance is likely to change.  Sometimes you can look at the comments submitted to the appropriate Docket to see if there appears to be controversial issues raised by the industry or other government components.  The real problem comes when a Draft Guidance is issued and the comment period has passed and months or years go by where the Guidance just sits there in limbo before being finalized.

Our clients often ask, should I apply the tenets in the Draft Guidance?  Can I rely on the FDA’s “current’ thinking when it issued the Draft Guidance?  Excellent questions and, I can tell you from experience, the answer is most of the time elusive!  Oftentimes, when a firm steps out on the Draft Guidance limb, the response from FDA is “you can’t do that because it is only a Draft Guidance and has not yet been finalized.”  On the other side of that coin, FDA will sometimes state in a deficiency or complete response letter that you should have applied the principle in one of its Draft Guidance documents.  Obviously, there is no clear cut “guidance” for industry to make that decision.

Well, at least four members of Congress, Lamar Alexander, Orin Hatch, Richard Burr and Johnny Isakson, are wondering the same thing.  In a letter dated May 6, 2014, the four asked the FDA about their process and procedures for draft guidance and the process for their finalization.

The Congressmen state in the letter:

We write today to express significant concern about the U.S Food and Drug Administration’s (FDA) use of draft guidances to make substantive policy changes.

According to the FDA website “Level I guidances set forth the agency’s initial interpretations of new significant regulatory requirements; describe substantial changes in FDA’s earlier interpretation or policy; and deal with complex scientific or highly controversial issues.”

Stakeholders tell us that draft guidances are increasingly becoming default by FDA policy and position.  Draft guidances state that the “guidance document is being distributed for comment purposes only.” However, in the absence of finalized guidance, drafts are the only information that FDA review staff, clinicians, and FDA-regulated entities have on the agency’s more current thinking on important issues.

The questions and concerns by the lawmakers reflect many of the same concerns that industry has expressed over the years.   One would think, especially for a Draft Guidance that is two years old and has not been finalized, that the FDA thinking has not changed based on comments received to the Docket.  Perhaps there should be a deadline imposed on FDA to revise, finalize or withdraw a Guidance document after a specified period of time.  This may impose somewhat of a hardship on the FDA-as we all know, Congress likes to impose legislation with new initiatives for the FDA to carry out all the time, but fails to give FDA adequate resources to implement the new requirements.  But, in this case ,and, as far as FDA Guidance is concerned, perhaps there should be a requirement for FDA to come to a conclusion on a specific issue in a reasonable set period of time – say 180 days after the comment period closes.  Maybe we should take a page from the 1938 Federal Food, Drug and Cosmetic Act and have Guidance Documents that FDA fails to finalize in that time frame become “deemed” to be finalized.  FDA Guidance is important for both the Agency and industry, as it instructs what FDA believes is the way in which things need to be done in order to satisfy FDA expectations.  The four lawmakers ask FDA for lots of information and documents on its process.  Let’s hope that this Congressional inquiry leads to some affirmative action!