S.1865 - Patient Access to Medical Innovation Act112th Congress (2011-2012)
Summary: S.1865 — 112th Congress (2011-2012)
Introduced in Senate (11/15/2011)
Patient Access to Medical Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act to extend for five years and revise the program for humanitarian exemptions for pediatric medical devices. Removes provisions requiring the device to have been approved on or after September 27, 2007. Eliminates the authority of the Secretary of Health and Human Services (HHS) to establish an annual distribution number setting the maximum number of devices that could be distributed under the exemption. Sets such number as the number of devices needed to treat, diagnose, or cure a population of 4,000 individuals in the United States. (Currently, this is the maximum number the Secretary may set.)
Eliminates the limitation on the number of waivers the Secretary may grant from conflict of interest provisions pertaining to service on an advisory committee. Requires the Secretary to ensure that each determination to waive such provisions considers the scope and magnitude of the financial interest at issue with the public health need for the expertise of the member on the committee.