Chrissy N. Bradshaw, Associate of Porzio, Bromberg & Newman and Director of Regulatory and Compliance Services of Porzio Life Sciences, LLC and Sarah M. Canberg, Associate of Porzio, Bromberg & Newman and Manager of Regulatory and Compliance Services of Porzio Life Sciences, LLC are quoted in the Compliance Week article "Final Version Provides Little Relief for Complex Sunshine Act.”
Some affected companies are wondering if the benefits of the disclosure are worth the trouble and expense of making such determinations. Chrissy Bradshaw commented that, “these food payments may not add up to a large sum, but there is a huge volume of data. Every day at a traditional drug company the folks in the field are bringing food into doctor's offices and hospitals. There are potentially thousands of transactions a week that could be implicated by that one issue. Companies will have to make a decision about their allocation model.”
Sarah Canberg says CMS did heed some of the concerns that emerged from the hundreds of comment letters. Among the concerns was whether the public would be able to adequately interpret the data available to them online. In the final language, CMS allows the opportunity to provide context with each interaction.
The national requirements aren’t eliminating the need for compliance with individual state laws. “It's only going to get more complicated because neither the federal nor state laws are the same,” Sarah Canberg says. “We are going to continue to have multiple requirements that are each individually nuanced, and that makes the practical implications complex.”