New reporting requirements for drug manufacturers and distributors in the USA's Health Care Reform Law

On March 23, US President Barack Obama signed into law HR 3590, the Patient Protection and Affordable Care Act (the Act). Subsequently, on March 30, he signed a companion bill, HR 4872, to amend certain provisions contained in HR 3590 and to reconcile the Senate and the House versions of the legislation.

As a result, this article - prepared by the law firm Arnall Golden Gregory ' discusses the requirements of HR 3590, as amended by HR 4872, which we are publishing as an aid to the understanding of the legislation for our readers. However, The Pharma Letter does not take responsibility for the law firm's views.

The new federal law amends Title XI of the Social Security Act (42 USC No 1301) and contains several transparency initiatives that address new reporting requirements for the pharmaceutical and medical device industries. For example, section 6004 specifically addresses the reporting of information relating to drug samples, and section 6002 of the Act imposes significant obligations on drug and device manufacturers by requiring annual disclosure filings that detail their financial relationships with physicians and teaching hospitals.