As part of the effort to provide greater transparency into how Life Sciences companies provide drug samples to Healthcare Professionals (HCPs), Section 6004 was included in the Affordable Care Act (ACA) when enacted by Congress in 2010. Starting on April 1st, 2012, and on April 1st of each year thereafter, it mandates that manufacturers and authorized distributors of record (ADRs) of drugs annually report to the Secretary of the Department of Health and Human Services (HHS) the identity and quantity of drug samples that were requested and distributed to HCPs.
To facilitate the collection of this data, the HHS Secretary directed the Food and Drug Administration (FDA) to issue guidance on the data to be submitted and design and oversee a system for its collection and management. The FDA created a sophisticated XML format for data submission and leveraged the Electronic Submissions Gateway (ESG) to provide the means through which manufacturers and ADRs submit this data. Manufacturers and ADRs must report on the name, address, professional designation, and signature of the HCP who requested the sample(s) and of the individual who requested or accepted delivery of the sample(s) on behalf of the HCP. Manufacturers and ADRs must register with the ESG, collect data related to samples distributions for the entire calendar year, format the data according to FDA requirements, and submit the report by the following April 1st.
For more information on Section 6004 of the ACA and the FDA ESG, visit the FDA website: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm292040.htm.
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