Legislation could modernize FDA regulations on imaging devices, contrast

Imaging advocacy groups have lined up to support a bill providing medical imaging device and contrast drug manufacturers a clear regulatory pathway, speeding the bench-to-bedside transition.

House Resolution 2009, “Fostering Innovation in Medical Imaging Act of 2017,” was Introduced by Representatives Ryan Costello, R-Pennsylvania, and Scott Peters, D-California. The bipartisan legislation would create a more focused and efficient inspection process for the U.S. Food and Drug Administration (FDA), partially by eliminating regional variations differences in protocol and regulation.

The bill also catches the FDA up to advances in medical imaging: Many contrast agents are used for off-label indications, because there’s no approved contrast label. HR 2009 specifies the FDA’s ability to consider and approve new indications for contrast, removing the need for the off-label loophole.

“FDA’s inspections process is crucial to helping ensure the continued availability of safe and effective devices and diagnostics for patients. Unfortunately, the current process in inconsistent, unpredictable and lacks transparency, which is detrimental for both the agency and industry in addressing quality and compliance issues efficiently,” said President and CEO Scott Whitaker of the Advanced Medical Technology Association (AdvaMed), in a press release.

AdvaMed isn’t the only imaging technology group speaking up—the powerful Medical Imaging & Technology Alliance (MITA) issued a statement praising the Representatives.

“MITA and its members applaud Congressmen Costello and Peters for their efforts on behalf of patients to clear regulatory hurdles and improve access to advancements in medical imaging that help physicians detect disease earlier when it’s more treatable,” said MITA Executive Director Patrick Hope. “We look forward to working in a bipartisan manner to move this bill forward so the regulatory approval process can keep pace with medical innovation that benefits patients.” 

The bill has been referred to the House Committee on Energy and Commerce.