Focus on Health Care Reform: Drug Sample Reporting

The Patient Protection and Affordable Care Act places many new disclosure requirements on pharmaceutical and medical device manufacturers from such companies to physicians or teaching hospitals.

Beginning on April 1, 2012 and annually thereafter, each manufacturer and authorized distributor of record of an applicable drug shall report the name, quantity and dosage of all drug samples given to physician offices as well as the date that the samples were provided (sect. 6004).  The name, address, professional designation and authorized signature for the practitioner receiving the drugs must also be reported for all sample distributions.  Manufacturers or distributors of record are also required to report any theft or losses of samples to the Secretary of Health and Human Services. 

Under current law manufacturers and distributors are only required to make this information available to HHS if requested. In 2012 companies are required to begin proactively reporting the information which will be made available to the public.

It is important to note that under this section of the new law, the Secretary of Health and Human Services can require that any other category of information also be reported.  It is uncertain if a formal rule-making procedure would be necessary to make such a change.

The Affordable Care Act does not seem to direct new requirements on individual physicians or practices to report information regarding drug samples. However, it is possible that the increased reporting requirements for manufacturers and distributors of drug samples may result in additional administrative obligations for medical practices.


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