The Food & Drug Administration and the Centers for Medicare and Medicaid are opening up their plans for concurrent evaluations of pre-market, FDA-regulated medical products to public comment.
The two agencies are working to promote data-sharing between themselves and signed a memorandum of understanding over the proposed collaboration June 23. A partnership between FDA and Medicare could make the approval process for new drugs and devices more efficient. A 90-day public comment period on the possible collaboration begins tomorrow.
FDA spokesperson Dick Thompson told MassDevice that the plan is "the initial stages" of the agencies’ cooperative attempt to speed up approvals for medical products.
MassDevice blogger Edward Berger wrote in July that FDA and CMS have wanted to share information for years.
"Indeed, a 2005 policy statement from then-HHS secretary Tommy Thompson presented broad inter-agency information sharing, including parallel review “at the request of an applicant, and with the concurrence of both agencies,” as a fait accompli," Berger wrote.
From the device reimbursement perspective, benefits from the MOU could be limited because devices gain FDA approval without sufficient clinical data to support an informed coverage policy determination, Berger wrote.
After companies receive clearance or approval for a new device, they sweat over whether insurance companies will be willing to pay for it. Medicare’s reimbursement decisions often guide the insurance industry’s decisions on whether to pay for new treatments.
"While there are some highly visible examples of Medicare coverage and payment determinations that were essentially simultaneous with FDA market clearance (e.g. human recombinant erythropoietin for chronic dialysis patients, drug-eluting stents), we can say with certainty that the vast majority of new technologies and drugs have not benefited from the compressed timeline to coverage that is the attraction of a parallel review process," Berger wrote.
Comments on the proposal can be submitted electronically at regulations.gov.
