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HR 6155 116th Congress House Health Drug safety, medical device, and laboratory regulation Licensing and registrations Prescription drugs

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.

Introduced: March 9, 2020 Introduced by: Grothman, Glenn Republican · Wisconsin See on congress.gov
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 9, 2020
Referred to the House Committee on Energy and Commerce.
Mar 9, 2020
Introduced in House
 Plain-English summary Congressional Research Service

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.)

What's happening now March 9, 2020

Referred to the House Committee on Energy and Commerce.

 Committees of jurisdiction 1