Section 6004 of the Patient Protection and Affordable Care Act (Act) requires manufacturers and authorized distributors of record (ADRs) to disclose information related to drug sample requests and distributions on or before April 1, 2012, and each year thereafter. Earlier this year, the Food and Drug Administration (FDA) issued a draft guidance for industry on the reporting of drug sample distribution information. The FDA also issued the “ACA Industry Submission Specifications User Guide,” which provides the technical requirements for the proper submission of files through its Electronic Submissions Gateway (ESG). During this time, the FDA also indicated that it did not intend to object until at least October 1, 2012, if manufacturers and ADRs did not submit drug sample information as required by the Act. The FDA has stated that it would provide notice before it begins enforcing the drug sample reporting requirement. The FDA also asked that interested parties submit comments and suggestions regarding the draft guidance.
Today, the FDA announced on its website that it is currently reviewing the comments it has received regarding the draft guidance and the ESG, and that it “expects to issue further guidance regarding its compliance policy, including the timing of agency enforcement decisions, in early 2013.”
Please see the FDA website for additional information on the federal sample disclosure requirements.