The FDA Guidance System Needs a Fix

Back in March 2010, in a posting on the FDA’s Transparency Blog – the FDA asked the question “How Can FDA Improve the Guidance Process.”  The responses in the form of comments to the posting are primarily made up of spam, which for some reason were moderated and approved.  The question was posed as a matter of transparency, but needs to be answered not only as a matter of transparency, but one of efficiency as well.  The current system for guidance development would appear to be both broken and not entirely transparent.

A case on point on which many in our community have been focused has been the Guidance on the Internet and Social Media.  The FDA held a public meeting in November 2009 and had aimed to get a draft guidance out by end of 2011, which did not happen.  In response to inquiry, a statement was released by the agency to hit “re-set” and stated that they were now targeting the first quarter of 2011 for the issuance of a draft.  That is as much as anyone knows.  The process by which the draft guidance is being developed is not known, and where it is in that process is not known.   If the draft has not yet reached the legal review stage at this point, the first quarter target may also be missed.

The statement issued by the FDA about the draft said as follows:  “Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed.” (emphasis added).  Note that the agency cannot comment further on either timing or content.  That is not very transparent and the delay is not very efficient.

In today’s Federal Register, there is a notice of withdrawal of a draft guidance. This one was regarding menu labeling that was part of the health care reform legislation and for which some provisions came immediately into law and the agency issued a draft guidance in August, 2010.  Prior to enforcement of the provisions of the law that went into effect, FDA has to provide guidance.  The withdrawal of the draft is to give the agency more time to review all of the input from stakeholders regarding menu labeling.  The delay actually was welcomed by many and it is an attempt to provide clarity on the part of the agency. However, in that case, the FDA had also stated that it intended to issue the final guidance by December 2010.   The agency is required to required to issue regulations no later than March 23, 2011 and in today’s Federal Register notice, the FDA said it will meet that deadline.

The FDA has set up a process whereby it attempts to glean a great deal of stakeholder input. It then reviews it, puts out a draft guidance, collects more public input and then issues a draft guidance.  This process can and many times does take years, not months. Clearly, the process needs to be truncated and made more public – perhaps with the advent of an advisory committee process that publicly gets comment, reviews the materials from the docket and makes some policy determinations would both speed up and make the system more transparent to the public.