FDA ER-LA Opioid REMS Hearing
- CME Coalition Opioid REMS Resource Page
- FDA Joint Meeting on ER-LA Opioid REMS
- Medical Meetings: CME Plays a Vital Role in Remedying Opioid Crisis
- NEJM – Robert Califf, MD FDA Commissioner
Open Payments and CME
FDA ER-LA Opioid REMS Hearing
On May 3-4, 2016, the Food and Drug Administration (FDA) hosted a two-day long Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS. The FDA is seeking comments as to whether this REMS with Elements to Assure State Use (ETASU): actually assures safe use, does not unduly burden patient access to drugs, and somewhat minimizes the overall burden to the healthcare delivery system.
A legal advisory from the American Medical Association (AMA) presents the Sunshine Act reporting requirements for continuing medical education (CME), and concludes that AMA certified and ACCME accredited programs "are exempt from reporting by commercial supporters." Consistent with the October 2014 guidance issued by the Centers for Medicare and Medicaid Services (CMS), AMA concludes that when an “applicable manufacturer conveys ‘full discretion’ to the continuing education provider, those payments are outside the scope of the rule” and thus, not subject to reporting. AMA goes on to highlight the strict firewall that exists between commercial supporters and CME program participants, adding that "the rules of accreditation strictly prohibit any commercial supporter from having any direct or indirect influence or control with respect to the content, faculty, speakers, or attendees of an AMA certified or ACCME accredited educational program or activity."
In response to questions about the Sunshine Act 'reportability' for transfers of value related to the provision of accredited CME events, the CME Coalition has developed ‘template’ grant language for use in CME agreements between commercial supporters and providers. The template included below, drafted with expert legal counsel from Arnold and Porter, includes language that tracks directly with CMS’ guidance indicating that supporters have not “directed, instructed or caused” the CME provider to pay specific covered recipients.
In a letter to House Energy and Commerce Chairman Fred Upton (R-MI) and Ranking Member Frank Pallone (D-NJ), the CME Coalition "wholeheartedly endorses" the Committee's passage of the 21st Century Cures Act (H.R. 6), along with the inclusion of a provision to exempt CME and certain educational materials from the reporting requirements of the Physician Payment Sunshine Act. As an organization that represents a collection of continuing medical education provider companies, in addition to other supporters of CME and the vital role it plays in our health care system, the CME Coalition recognizes the importance of ensuring that physicians are encouraged to continue in their professional development. That's why the Coalition has come out in strong support of the provision to ensure providers that continuing medical education events will continue to be exempt from the Sunshine Act's reporting requirements.