As discussed in an earlier blog post, US President Donald Trump signed the Further Consolidated Appropriations Act, 2020, into law on December 20, 2019, which includes bipartisan legislation intended to facilitate the development of generic and biosimilar products. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act enhances access by generic manufacturers to brand-name drug samples for the development of generic versions.
The Open Payments program established by the Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of covered drugs, medical devices, biologicals, and medical supplies (applicable manufacturers) to report annually to the Centers for Medicare and Medicaid Services (CMS) certain payments and other transfers of value made in the previous calendar year to “covered recipients,” which currently are defined as US-licensed physicians and teaching hospitals. Applicable manufacturers and Group Purchasing Organizations also must report any ownership or investment interests held by physicians or members of their immediate family. CMS makes this information available to the public on the agency’s Open Payments webpage and refreshes it annually.