July 28, 2014 – FDA and Centers for Medicare & Medicaid Services (CMS) policies are barriers to ongoing evidence development and communication, Dr. Gregory Schimizzi told the House Energy and Commerce Committee’s Subcommittee on Health July 22 at a hearing to explore “21st Century Cures.”
Schimizzi, a member of the board of directors and past president of the Coalition of State Rheumatology Organizations (CSRO), explained to the subcommittee that the “outdated practices” of the FDA are hamstringing physicians as they try to make sound decisions about circumstances where medically accepted off-label uses are the standard of care and when standard, accepted treatments fail in common diseases.
“Despite the lack of FDA-approved indications, those patients still require treatment and, as their physicians, we endeavor to use whatever information is available to help with informed decision-making,” Schimizzi’s testimony states. He adds that the FDA does not allow pharmaceutical companies to distribute key information about an on-label indication that is not explicitly referenced in the package insert and that medically acceptable alternative use information can only be shared if a clinician specifically requests such information.
“By limiting the sharing of information, physicians are hampered in their ability to access all available sound medical evidence and firm scientific rationale necessary to treat patients with difficult problems,” he said. “It would be preferable to allow the pharmaceutical company with its wealth of information to share key data in order to inform and assist in decision-making.”
Schimizzi added that the CSRO urges the FDA to:
- Expand the current process of review of materials beyond what is included in the package insert to also cover other key data; and
- Develop standards through a public process for qualifying real-world data, so that clinicians can be better informed.
He also devoted time during his testimony to address how the CMS Sunshine Act regulations have become an obstacle to the flow of information. Part of that discussion focused on CMS’ recently proposed elimination of the continuing medical education (CME) exemption under the Sunshine Act and a reliance on a standard related to whether the applicable manufacturer does not know or is unaware of the compensation.
Because this less-defined standard “does not afford clarity and fails to acknowledge the value of CME,” moving forward with this change “would significantly disrupt the practice of CME and the confidence of doctors, educators and others,” according to Schimizzi’s testimony. In this case, the CSRO is asking Congress and CMS to reconsider its proposal to eliminate this exception and to opt instead to expand the list of certified CME accrediting/issuing agencies beyond the five currently listed in the regulation.