The signing into law of the Patient Protection and Affordable Care Act (ACA) in March, 2010 held many ramifications for the Life Sciences and Healthcare industries. While some of the new policies and requirements mandated by ACA came into immediate effect, others are being implemented through a phased approach over the next several years.
One new policy, outlined in ACA Section 6004, relates to prescription drug sample distribution. This section of the Act mandates that manufacturers and distributors of prescription drugs submit information to FDA annually concerning their drug sample distributions during the previous year. Required data elements for these submissions include the types and quantities of the samples requested and distributed, and the names, addresses and professional designations of the healthcare practitioners in receipt of these samples, as well as other possible data elements.
FDA has recently indicated that it will require industry to submit this information electronically via the Electronic Submissions Gateway in an XML format.
ACA 6004 stipulates that this information be submitted each year on or before April 1, beginning in 2012. However, FDA has indicated that there will be a six-month implementation period for these reporting requirements and that it “does not intend to object until at least October 1, 2012.”
As your trusted SPL vendor, Reed Tech is developing a solution to meet your needs for ACA 6004 submissions. We are currently engaged in a pilot project for ACA 6004 submissions and will keep you informed concerning this new service offering. Be assured that we have you covered.
For more information on ACA 6004 and FDA’s implementation of its requirements, please visit the FDA pages below: