Drug Sample Distribution Reporting Deadline Extended By FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA is giving manufacturers six more months to provide HHS with information on the distribution of drug samples as it plans further guidance; the Affordable Care Act mandated that the data be submitted by April 1.
FDA is giving industry six more months to comply with a law requiring manufactures to submit information on the distribution of drug samples.
The agency issued a draft guidance stating that it would not object until at least Oct. 1, 2012, if manufacturers and authorized distributors of record (ADRs) do not submit information on their distribution of drug samples. The Patient Protection and Affordable Care Act mandates that the data be submitted to HHS by April 1, 2012 and annually thereafter. HHS delegated FDA to issue guidance to identify the information to be submitted and to oversee and make arrangements for its collection.
The Affordable Care Act requires manufacturers and authorized distributors to submit the identity and quantity of drug samples distributed. The information must be aggregated by the name, address, professional designation, and signature of the practitioner making the request or of any individual who makes or signs for the request on behalf of the practitioner. FDA said it plans to use its Electronic Submissions Gateway to collect drug sample data.
“FDA recognizes that the requirement to submit information to the agency under section 6004 [of the ACA] is new to industry and believes that providing additional time to manufacturers and ADRs is likely to improve the quality of submissions under this section and facilitate use of the gateway as the method of providing required information to the agency,” the guidance states.
FDA has been using the gateway to collect a variety of information electronically. The agency is working on a final rule that would require safety reports to be submitted in an electronic format (Also see "FDA’s Rulemaking To-Do List Includes Clarifying Citizen Petitions And Orphan Drug Designations" - Pink Sheet, 6 Feb, 2012.). And it also plans to issue a notice of proposed rulemaking requiring electronic submission of clinical and bioequivalence data (Also see "FDA's Rulemaking To-Do List Includes Dampening Pedigrees, Boosting Electronic Labeling" - Pink Sheet, 25 Jul, 2011.).
In an April 3 Federal Register notice announcing the guidance, FDA said it expects to issue further guidance on drug sample distribution reporting requirements later in 2012.
Comments on the draft guidance are due June 4.