H.R. 6155 · 116th Congress
To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the…
Full title
To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products, and for other purposes.
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Never voted on. It didn't reach a floor vote before the 116th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
GrothmanSponsorNo cosponsors.
This bill requires the Food and Drug Administration (FDA) to continue to review applications for certain biological products under an earlier review process, notwithstanding recent FDA guidance. Specifically, the bill applies to applications that were filed under the earlier process on or before March 23, 2019, and were still pending on March 23, 2020.
What it does: CRS summary · Introduced in House · Mar 9, 2020
This bill requires the Food and Drug Administration (FDA) to continue to review applications for certain biological products under an earlier review process, notwithstanding recent FDA guidance. Specifically, the bill applies to applications that were filed under the earlier process on or before March 23, 2019, and were still pending on March 23, 2020. (A 2009 law established a new procedure for approving biological products but allowed certain products in an already approved product class to receive approval under the earlier procedure until March 23, 2020; subsequently, in December 2018, the FDA issued guidance stating that an application filed under the earlier procedure that is not approved by March, 23, 2020, will not be approved.)
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products, and for other purposes.
Latest action (Mar 9, 2020): Referred to the House Committee on Energy and Commerce.
Policy area: Health · Origin: House · Introduced: Mar 9, 2020
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.