House, Senate reach agreement on new regulations for medical gases
WASHINGTON, June 21, 2012—The American Association for Homecare reported that House and Senate leaders reached an agreement on the Food and Drug Administration (FDA) Safety and Innovation Act, which includes a measure to improve the regulation of medical gases.
The legislation was working its way through the House last week, and is expected to move through the Senate this week. AAHomecare had pressed the House Energy and Commerce Committee to replace the existing, unclear system for regulating medical gases with “a clear, targeted regulatory structure.”
Under the agreement, the FDA must increase efforts to ensure that patients receive quality care and access to new therapies. That includes allowing the FDA to establish a set of rules for medical gases outside the burdensome process required for new drug applications.