S. 1865 · 112th Congress
Patient Access to Medical Innovation Act
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Never voted on. It didn't reach a floor vote before the 112th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
FrankenSponsor3 cosponsors · 2 D, 1 R
3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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.
What it does: CRS summary · Introduced in Senate · Nov 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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Patient Access to Medical Innovation Act
Latest action (Nov 15, 2011): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Nov 15, 2011
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.