Posted on June 12, 2018
WASHINGTON, June 12, 2018 — Senate health committee Chairman Lamar Alexander (R-Tenn.) today said “smart action” by the Food and Drug Administration would help remove barriers to lower drug prices, as required by the 21st Century Cures Act.
“Today’s action by the FDA means insurance companies can negotiate better prices on drugs and devices for the patients they cover. Right now, a drug or medical device company is limited in what information they can share with insurance companies if the company discovers that a drug or device treats another condition besides the one for which it is approved. They are also limited in telling insurance companies about drugs or devices that are about to be approved and come to market. This guidance will make it clear that companies can legally share more information, including for uses that may not be approved yet.”
Food and Drug Administration Commissioner Scott Gottlieb today announced the agency was taking another step in implementing the Trump Administration’s drug pricing blueprint by issuing guidance that clarifies drug and device manufacturers can share information with insurance companies on the different uses of their products, including on certain uses for drugs and devices that may not yet be approved by the FDA.
Today’s action is part of the FDA implementing the 21st Century Cures Act, which clarified the allowable exchange of information between drug and device manufacturers and insurance companies.