The first report must be filed with the FDA (under the authority of the U.S. Department of Health and Human Services) by April 1, 2012, for the preceding year and each year thereafter.
Manufacturers and distributors of prescription drug samples should stay tuned in the coming weeks, as the U.S. Food and Drug Administration (FDA) prepares to implement the Patient Protection and Affordable Care Act's (ACA) prescription drug sample transparency program. As part of the ACA’s push toward enhanced transparency of industry relationships, the act 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 first report must be filed with the FDA (under the authority of the U.S. Department of Health and Human Services) by April 1, 2012, for the preceding year and each year thereafter. The report must include 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 Department of Health and Human Services.
The FDA has not yet issued regulations or guidance on this reporting requirement; however, it has stated that reporting will be through an "Electronic Submissions Gateway." As more information becomes available, we will provide updates on the FDA's implementation of this section and any additional guidance on complying with this new reporting requirement.
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 and Food industry group or the attorney in the firm with whom you are regularly in contact.
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