FDA is announcing the availability of a draft guidance for industry entitled "Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act." On March 23, 2010, the Patient Protection and Affordable Care Act (ACA) was signed into law. The Secretary has delegated authority to FDA to issue guidance to identify the information to be submitted under section 6004 and oversee and make arrangements for the collection of such information. This draft guidance replaces the April 3, 2012, draft guidance for industry entitled “Compliance Policy on Reporting Drug Sample Distribution Information.” This draft updates the information in the April 2012 guidance to better assist persons using the Electronic Submissions Gateway to submit drug sample information under section 6004.
This guidance reflects FDA’s current thinking with regard to the requirements set forth in section 6004. FDA suggests manufacturers and authorized distributors of record (ADRs) comply with section 6004 according to the policies set forth in this guidance, beginning with the submission of data for 2014 due no later than April 1, 2015.
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.
ACA 6004 Submission Process Supporting Documents
- ACA 6004 Legislation
- Draft Guidance for Industry on Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act
- ACA 6004 Specifications User Guide
- ACA 6004 Submissions FAQ
- ACA 6004 XML Schema and Sample
- Practitioner Acronym Table
- Electronic Submissions Gateway
- ESG User Guide
- Contact Us by e-mail at: CDER-OBI-ACA6004@fda.hhs.gov