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Focus on Regulation

Sample Reporting Under Section 6004 of the Affordable Care Act

We’ve received a number of questions lately about the status of the sample reporting requirements under Section 6004 of the Affordable Care Act (ACA) of 2010.  Section 6004 requires that manufacturers and authorized distributors submit certain information about drug sample distribution to FDA: (1) the identity and quantity of drug samples requested; (2) the identity and quantity of drug samples distributed; (3) the name, address, professional designation, and signature of any person who makes or signs for the request; and (4) any other category of information required by FDA.

 In April 2012, FDA issued guidance outlining the information required under Section 6004 and stated that the agency, as matter of its enforcement discretion, did not plan to enforce these reporting requirements until at least October 1, 2012.  In September 2012, FDA posted the following note on its website:

Earlier this year, FDA issued a draft compliance policy for public comment, in which we stated that the Agency did not intend to object until at least October 1, 2012 if manufacturers and ADRs did not submit information under section 6004. It further stated that before we would begin to enforce this provision we intended to provide notice. FDA has not provided such notice. The agency is currently reviewing comments it has received on the draft guidance and the Gateway, and expects to issue further guidance regarding its compliance policy, including the timing of agency enforcement decisions, in early 2013.

For copies of FDA’s related guidance and documents, visit their Section 6004 webpage at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm292040.htm.

We have not been able to identify any subsequent announcement clarifying or revising FDA’s position on enforcement of Section 6004.  Agency officials have not responded to calls or emails.  We do know, however, that sample reporting under Section 6004 was identified as a topic for further guidance by the agency in CDER’s 2013 Guidance Agenda.  We will be sure to update the blog as soon as we hear anything further on this topic.