FDA Issues Updated Draft Guidance on Reporting Drug Samples

by Morgan Lewis

The guidance calls for 2014 reporting by April 1, 2015.

When signed into law in March 2010, the Affordable Care Act (ACA) put a renewed focus on transparency. While section 6002, the Physician Payment Sunshine Act, took center stage with broad tracking and reporting requirements related to payment or transfers of value made to physicians and teaching hospitals, section 6004 also took effect with significantly less fanfare.


At the most basic level, section 6004 requires manufacturers and distributors to submit annually to the Food and Drug Administration (FDA) certain data regarding drug samples requested and provided to licensed practitioners, including the identity and quantity.[1] The requirements to maintain information related to the distribution of drug samples have long been in place under the Prescription Drug Marketing Act of 1987 (PDMA).[2] PDMA includes the following:

  • Requirements for the distribution of drug samples to physicians and pharmacies of hospitals and other healthcare entities, including labeling requirements and the retention of a physician-signed request form for the sample, as well as acknowledgement of receipt upon delivery of the sample, both with specific information mandated (e.g., name, address, professional designation) 
  • Requirements for manufacturers and distributors to review their inventory of drug samples, investigate discrepancies and any identified significant losses or thefts, and file appropriate reports with the FDA

To be eligible to receive a drug sample, a practitioner must be licensed to prescribe drugs within the state in which he or she practices.

On April 3, 2012—around the time that the ACA requirement to begin reporting data to the FDA became effective—the FDA issued “Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution Information.”[3] This draft guidance communicated the availability of the FDA’s Electronic Submission Gateway (the Gateway) as the system to use to report this information. The guidance also explained that the FDA intended to use enforcement discretion until at least October 1, 2012 for companies that had not submitted information under those reporting provisions. The FDA later announced that it expected to issue further guidance in 2013.[4]

The recent draft guidance document, “Guidance for Industry—Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act,” was issued on July 11, 2014 and replaces the prior draft guidance.[5] This new guidance better outlines the requirements to assist those individuals who use the Gateway to submit data. The FDA expects that companies will comply with section 6004 reporting requirements as set forth in the updated guidance, which is summarized below.

Reporting Requirements

Although manufacturers and authorized distributors of record (ADRs)[6] that dispense drug samples have long since implemented the compliance programs necessary to comply with PDMA requirements, the actual submission of this data to the FDA adds a layer of complexity to an already onerous process. The required data will now have to be maintained in a manner that can easily be transferred into the FDA-required format for electronic submission through the Gateway.

Data regarding the type and quantity of drug samples requested and distributed must now be submitted to the FDA. This information must be aggregated by individual name, address, and professional designation and must indicate that signature information is on file for the practitioner who makes the request and the practitioner or the practitioner’s designee who receives the distributed drug sample. Key data elements or required fields will include the following:

  • The date of the transaction (i.e., the date of the request from the practitioner and the date the sample was distributed to the practitioner)
  • The trade name and dosage of the drug sample distributed (Trade Name A, 100 mg)
  • The sample package size, including the units per package (One bottle of 1,000)
  • The total quantity of the drug requested by the practitioner during the calendar year
  • The total quantity of the drug distributed to the practitioner during the calendar year
  • The name (first, last, and middle initial) of the practitioner
  • The professional designation of the practitioner (e.g., M.D., D.O.)
  • The address of the practitioner, including street number, street name, suite or room number, city, state, and zip code
  • A signature-on-file indicator to confirm that the practitioner actually signed the request for samples
  • A signature-on-file indicator to confirm that the practitioner or designee actually signed the acknowledgement of receipt upon delivery of the sample

Visit the FDA website to access the XML schema that shows the format for reporting this data through the Gateway.

Key Dates

The FDA expects manufacturers and ADRs to comply with section 6004 reporting requirements according to the policies set forth in the guidance, beginning with the submission of data for the calendar year 2014 due no later than April 1, 2015.

The FDA has offered a comment period for this guidance. Electronic or written comments on the draft guidance must be submitted by October 9, 2014, and comments concerning the proposed collection of information must be submitted by September 9, 2014.[7]

Other Considerations

The requirement to submit drug sample information under section 6004 of the ACA applies to each manufacturer and ADR of an applicable drug that makes sample distributions. Essentially, this means that both manufacturers and ADRs of applicable drugs have the authority to submit drug sample information to the FDA. However, the FDA requires that only one party submit the required drug sample information. The FDA believes that manufacturers are best positioned to determine who will do the reporting for their drug samples and advises manufacturers to ensure that ADR agreements specify who is responsible for reporting the required drug sample information to the FDA.

Requests and the distribution of drug samples should be reported for the year in which they occurred. The guidance indicates that the FDA recognizes that, as a consequence, the number of requests and deliveries may not be the same for a given reporting period. In other words, if a request is made in December 2014 and not distributed until January 2015, only the information related to the request would be submitted with the calendar year 2014 data.

In preparation for the upcoming data-submission deadline, manufacturers and ADRs should review current standard operating procedures and remodel as necessary to account for this new requirement. For example, while practitioner signatures are required for requests and delivery acknowledgement, internal processes regarding whether any data field within the system(s) used to track drug samples is populated to evidence the receipt of these signatures may need to be revisited and revised.

Additionally, some evaluation of current information technology capabilities may also be needed to ensure that all necessary data components are captured within the system and that the necessary data transfer can occur as required.

[1]. See 21 U.S.C. § 353(d)(2), (d)(3).

[2]. See 21 CFR pt. 203 subpart D.

[3]. Docket No. FDA-2012-D-0300.

[4]. Read the announcement here.

[5]. View the full text of the new draft guidance document here.

[6]. ADRs are defined within the updated guidance document as “distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer’s products.”

[7]. Comments may be submitted here.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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