HEARING: #SubHealth to Examine Medical Product Manufacturer Communications
WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), announced a hearing for Wednesday, July 12, 2017, at 10:15 a.m. in room 2322 of the Rayburn House Office Building. The hearing is entitled, “Examining Medical Product Manufacturer Communications.”
#SubHealth will examine ways Congress could clarify how drug and device companies can responsibly disseminate truthful and non-misleading data and information that is not included in their product labeling. According to a series of recent court decisions, FDA’s ability to restrict such communication in a manner that does not run afoul of First Amendment protections is very limited.
“This is an important issue that can and should be bipartisan, allowing us to clearly establish the rules of the road so that when companies share off-label information, they do so responsibly and in the appropriate context,” said Chairman Burgess.
#SubHealth will also discuss the need for manufacturers to share clinical and economic information about their medical products with entities that make coverage decisions prior to FDA approval.
Legislative text can be found online here. The Majority Memorandum, witness list, and witness testimony for the hearing will be available at the same link as they are posted.