The Food and Drug Administration this week gave the final green light to two guidances which focus on manufacturer-to-payer product communications and how to communicate products in line with FDA-required labeling, according to a Regulatory Affairs Professionals Society report.
According to the report, the guidances include changes influenced by comments from the drafts released in January 2017.
FDA Commissioner Scott Gottlieb says the payer communications guidance has the potential to cut drug spending by facilitating manufacturer-to-payer product communications.
“Payers seek a range of information on the effectiveness, safety and cost-effectiveness of approved/cleared medical products, including information from pharmaceutical manufacturers, to help support product selection, formulary management and/or coverage and reimbursement decisions,” Gottlieb said.
The second guidance finalizes product communication as it relates to labeling strategies in line with FDA regulations.
“Labeling is subject to content requirements and limitations to ensure that it effectively communicates information,” Gottlieb says. “It’s not intended to exhaustively address all that’s known about a product for its approved or cleared uses.”
To read the full report by RAPS, click here.