E&C Welcomes FDA Guidance on Unapproved Drugs and Devices

Press Release

This morning, the Food and Drug Administration (FDA) announced that it would finalize guidance on the exchange of health care economic information between manufacturers and payors regarding unapproved drugs and devices, and unapproved uses of such products.

"We are encouraged by this action, led by Commissioner Gottlieb. The committee has long pursued ways to clarify how drug and medical device companies can share health care economic or scientific information in a truthful way," said Energy and Commerce Committee Chairman Greg Walden (R-OR) and Health Subcommittee Chairman Michael C. Burgess, M.D. (R-TX). "While we were able to authorize this type of communication under the 21st Century Cures Act, we sought to provide additional clarity on it this year in legislation authored by Health Subcommittee Vice Chairman Brett Guthrie (R-KY). This action by FDA will help ensure patients can access new treatments and cures more quickly."

"I am glad to see the action FDA has taken, recognizing the importance of better communication and data sharing between biopharmaceutical companies and insurance payors to ultimately help patients," said #SubHealth Vice Chairman Guthrie. "Last year I introduced the Pharmaceutical Information Exchange Act to help facilitate this communication, so I look forward to continuing to work with Chairman Walden, Chairman Burgess, and the FDA to ensure continued clarity for manufacturers, payors, and patients."

Background:

H.R. 2026, the Pharmaceutical Information Exchange Act, authored by #SubHealth Vice Chairman Guthrie passed #SubHealth in January by a vote of 18-14, as amended.

Source