Memorandum of Understanding Between FDA and CMS
This post was written by Paul Sheives and Areta Kupchyk.
The FDA and CMS have entered into a Memorandum of Understanding (MOU), effective June 25, 2010, to promote collaboration and enhance knowledge and efficiency by sharing information and expertise. In particular, the MOU highlights the agencies’ “common needs for evaluating the safety, efficacy, utilization, coverage, payment, and clinical benefit of drugs, biologics, and medical devices.” Included among the action items in the MOU are the appointment of a liaison for each agency, the establishment of a joint agency meeting to discuss implementing the MOU, an agreement to set reasonable expectations on responses to requests for information, and the implementation of certain safeguards to protect the transmittal and use of trade secret and confidential information.
