The Affordable Care Act was signed into law on March 23, 2010, and one of its provisions, section 6004, amended the Social Security Act by adding section 1128H (42 U.S.C. 1320a-7i). This new section requires the submission of certain drug sample information to the FDA not later than April 1 of each year, beginning in 2012. The FDA did not release to the industry the format for reporting to the FDA until March 29, 2012. This only provided the industry with days to prepare for reporting of the distribution of samples to healthcare practitioners. Then with- out notice the FDA reported on its website on March 30, 2012, that the FDA would extend the reporting deadline until October 1, 2012.

The first report to the FDA will need to consist of samples distributed to HCPs during 2011 in a standard XML format utilizing the FDA Electronic Submissions Gateway and include the following:
• Calendar year when samples were distributed
• Name of Manufacturer or Distributor
• Practitioner Designation (per the table provided by FDA on their website)
The report must also include the HCP’s first name, middle initial, and last name; the HCP’s address, city, state, and zip code; the brand name and dosage; the package size; the quantity requested aggregated by brand name and dosage and quantity distributed aggregated by brand name and dosage; and confirmation of signature on-file for sample request and sample receipt.

Even though the FDA has clearly provided the type of data and format required there will still remain challenges in accurately reporting this data to the FDA. Some of the challenges that manufacturers and authorized distributors of record will face include: The ability to accurately aggregate sample disbursements from multi-channel disparate source systems to a single HCP (examples include: CRM, direct-to-practitioner via 3rd party vendors or internal distribution centers, etc.), the ability to identify the best address for each HCP, the ability to comply with FDA’s file naming conventions and file size limitations, and the ability to align practitioner designations with FDA’s professional designation listing. A recent 2012 transparency survey conducted by Cegedim found that over 70% of individuals responsible for compliance with payment disclosure under the “Sunshine Act” also were involved with ensuring that their company complies with sample disclosure reporting. This finding reinforces the fact that as with any type of transparency disclosure reporting the foundation for quality should focus on the following points:
• Customer master strategy that is leveraged not only internally but also by 3rd parties
• Standard import formats leveraged by all disparate source systems
• Transparency solution that provides users with a flexible business rule engine that can adapt and automate unique transparency requirements as they continue to evolve.
• Single-transparency solution that can be leveraged for both payment and sample dis- closure at a local, regional, and global level.
Whether it’s payments or prescription drug samples, transparency disclosure is here to stay, at least for the time being. With increased public exposure to this data, quality and accuracy of reporting remains the foundation.

  • Bill Buzzeo

    Bill Buzzeo is an authority on regulatory requirements facing today's pharmaceutical industry, specifically those involving the Prescription Drug Marketing Act (PDMA); international, federal, and state transparency and reporting requirements; and the Controlled Substances Act (CSA).

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