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U.S. Department of Health and Human Services


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Affordable Care Act (ACA 6004)

Last 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 expects to issue further guidance regarding its compliance policy, including the timing of agency enforcement decisions, in 2013. Pending publication of the Guidance, we are not revising our enforcement statement.

While publication of further guidance is pending, we encourage manufacturers and ADRs who have not done so to submit their 2011 and 2012 data. FDA is reminding manufacturers and ADRs that the Gateway is available to accept submissions. A draft technical guidance, entitled Guidance for Industry -- Compliance Policy on Reporting Drug Sample Distribution Information Under the Affordable Care Act, April 3, 2012, as well as an FAQ and a sample submission are available (below). Further, a help desk is available to assist if there is a problem with your submission. Contact information for the help desk can be found in our ACA 6004 Submission FAQ.  

Draft Guidance for Industry, Availability: Compliance Policy for Reporting Drug Sample Distribution Information

On March 23, 2010, the Affordable Care Act (ACA) was signed into law. Among other things, the ACA amends the Social Security Act, 42 U.S.C. 1301 et seq., by adding section 6004. This new section requires the submission of certain drug sample information to FDA on or before April 1, 2012.

The Affordable Care Act explicitly states that manufacturers and authorized distributors must submit the following information concerning 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 determined appropriate by the Secretary.