In addition to imposing payment and physician ownership disclosure requirements, the federal Patient Protection and Affordable Care Act (Act) also requires manufacturers and authorized distributors of record (ADRs) to disclose information related to drug sample requests and distributions. Specifically, the Act states that beginning April 1, 2012, and each year thereafter, each manufacturer and ADR of an applicable drug that makes distributions by mail, common carrier, or other means is required to report to the Secretary of the Department of Health and Human Services (Secretary) the identity and quantity of drug samples requested and distributed during the preceding calendar year. This information must be aggregated by the name, address, professional designation, and signature of the requesting practitioner, or any individual who makes or signs for the request on behalf of the practitioner. The Act states that manufacturers and ADRs must submit the following information concerning drug sample distribution:
- The identity and quantity of drug samples requested;
- The identity and quantity of drug samples distributed;
- The name, address, professional designation, and signature of any person who makes or signs for the request, and
- Any other category of information determined appropriate by the Secretary.
In April 2012, the federal Food and Drug Administration (FDA) issued a draft guidance entitled "Compliance Policy on Reporting Drug Sample Distribution Information," as well as instructions for the proper submission of drug sample information through the FDA's Electronic Submissions Gateway (ESG). During that time, the FDA 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 also stated that it would provide notice before it begins enforcing the drug sample reporting requirement. On July 11, 2014, the FDA posted on its website a draft guidance titled "Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act" (Draft Guidance). The Draft Guidance revises and replaces the previous April 2012 guidance, and provides information on who is required to submit drug sample information, how drug sample information should be reported, and the drug sample information that should be included in a submission. Additionally, the Draft Guidance states that the "FDA expects manufacturers and ADRs to comply with [the Act] according to the policies set forth in this guidance, beginning with the submission of data for 2014 due no later than April 1, 2015."
The FDA has asked that interested parties submit comments and suggestions regarding the Draft Guidance by October 9, 2014. Parties may submit comments electronically at the following website: http://www.regulations.gov.
Written comments may be submitted to:
The Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061