E & C Health Subcommittee Votes to Advance Allowing Truthful Off Label Communication

Immediately before the government shutdown, the Energy and Commerce Health Subcommittee held a markup to advance three health care bills, including a measure designed to give drug and medical device companies more freedom to discuss off-label information, one that would overhaul how the Food and Drug Administration (FDA) regulates over-the-counter (OTC) drugs, and another that would shield a health care professional from liability related to “an act or omission” that occurs as a volunteer in response to a disaster. Opening Statements Opening statements were provided by E&C Committee Chairman Greg Walden, E&C Committee Ranking Member Frank Pallone, Jr., and Health Subcommittee Chairman Michael C. Burgess, M.D. E&C Chairman Greg Walden briefly summarized each of the bills, beginning with H.R. 1876, the Good Samaritan Health Professionals Act, which provides limited liability protections for health practitioners providing care to those in a federally declared disaster, such as the recent wildfires in Oregon and the West or even in a horrific event such as the Boston Marathon bombing. He then spoke about the Pharmaceutical Information Exchange (PIE) Act of 2017, H.R. 2026. This bill attempts to facilitate communication between medical product developers and payors prior to FDA approval, based on the clinical data those developers will rely on for FDA approval. Lastly, the Committee discussed the “Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018” ...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs