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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.

2/8/2022, 11:17 PM

Congressional Summary of HR 6155

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.)

Current Status of Bill HR 6155

Bill HR 6155 is currently in the status of Bill Introduced since March 9, 2020. Bill HR 6155 was introduced during Congress 116 and was introduced to the House on March 9, 2020.  Bill HR 6155's most recent activity was Referred to the House Committee on Energy and Commerce. as of March 9, 2020

Bipartisan Support of Bill HR 6155

Total Number of Sponsors
1
Democrat Sponsors
0
Republican Sponsors
1
Unaffiliated Sponsors
0
Total Number of Cosponsors
0
Democrat Cosponsors
0
Republican Cosponsors
0
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill HR 6155

Primary Policy Focus

Health

Potential Impact Areas

- Drug safety, medical device, and laboratory regulation
- Licensing and registrations
- Prescription drugs

Alternate Title(s) of Bill HR 6155

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.
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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