Drugs
Affordable Care Act (ACA 6004)
Earlier this year, FDA issued a draft compliance policy for public comment, in which we stated that the Agency did not intend to object until at least October 1, 2012 if manufacturers and ADRs did not submit information under section 6004. It further stated that before we would begin to enforce this provision we intended to provide notice. FDA has not provided such notice. The agency is currently reviewing comments it has received on the draft guidance and the Gateway, and expects to issue further guidance regarding its compliance policy, including the timing of agency enforcement decisions, in early 2013.
On March 23, 2010, the Affordable Care Act (ACA) was signed into law. Among other things, the ACA amends the Social Security Act, 42 U.S.C. 1301 et seq., by adding section 6004. This new section requires the submission of certain drug sample information to FDA on or before April 1, 2012.
The Affordable Care Act explicitly states that manufacturers and authorized distributors must submit the following information concerning drug sample distribution to FDA: (1) the identity and quantity of drug samples requested; (2) the identity and quantity of drug samples distributed; (3) the name, address, professional designation, and signature of any person who makes or signs for the request, and (4) any other category of information determined appropriate by the Secretary.
- Contact Us by e-mail at: CDER-OBI-ACA6004@fda.hhs.gov
