Alerts and Updates
FDA Issues Draft Guidance on Affordable Care Act Prescription Drug Sample Transparency Program: Reporting Deadline Informally Extended to October 1, 2012
April 4, 2012
Until at least October 1, 2012, the FDA does not intend to object if manufacturers and authorized distributors of record do not submit the information required under the prescription drug sample transparency program.
On April 3, 2012, the U.S. Food and Drug Administration (FDA) published notice of a Draft Guidance detailing its current compliance policy for the Patient Protection and Affordable Care Act's (ACA) Prescription Drug Sample Transparency program (the "Program"). As detailed in an earlier Duane Morris Alert, the Program mandates that starting April 1, 2012, and annually thereafter, manufacturers and distributors of prescription drugs must track and report certain information regarding the distribution of drug samples to licensed practitioners or to pharmacies of hospitals or other healthcare entities. The report must include information, such as the identity and quantity of drug samples requested by a licensed practitioner; the identity and quantity of drug samples distributed pursuant to such request; the name, address, professional designation and signature of the practitioner (or his or her designee) making the request; and any other information deemed appropriate by the U.S. Department of Health and Human Services.
In its April 3 Draft Guidance, the FDA described how it is currently working to implement the Program and stated that until at least October 1, 2012, it does not intend to object if manufacturers and authorized distributors of record do not submit the information required under the Program.
The FDA intends to provide notice before revising its discretion on compliance with the Program. Nonetheless, if manufacturers or authorized distributors of record seek to comply with the Program while the FDA's current policy is in place, they may use the Electronic Submissions Gateway, which can be accessed here.
For Further Information
If you have any questions about this Alert, please contact Frederick R. Ball, Elinor L. Hart, any member of the Pharmaceutical, Pharmacy & Food industry group or the attorney in the firm with whom you are regularly in contact.
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