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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.

USA116th CongressHR-6155| House 
| Updated: 3/9/2020
Glenn Grothman

Glenn Grothman

Republican Representative

Wisconsin

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.)
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Timeline
Mar 9, 2020
Introduced in House
Mar 9, 2020
Referred to the House Committee on Energy and Commerce.
  • March 9, 2020
    Introduced in House


  • March 9, 2020
    Referred to the House Committee on Energy and Commerce.

Health

Related Bills

  • S 116-2103: Affordable Insulin Approvals Now Act
  • S 116-1895: Lower Health Care Costs Act
  • HR 116-19: Lower Costs, More Cures Act of 2019
Drug safety, medical device, and laboratory regulationLicensing and registrationsPrescription 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.

USA116th CongressHR-6155| House 
| Updated: 3/9/2020
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.)
View Full Text

Suggested Questions

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Timeline
Mar 9, 2020
Introduced in House
Mar 9, 2020
Referred to the House Committee on Energy and Commerce.
  • March 9, 2020
    Introduced in House


  • March 9, 2020
    Referred to the House Committee on Energy and Commerce.
Glenn Grothman

Glenn Grothman

Republican Representative

Wisconsin

Energy and Commerce Committee

Health

Related Bills

  • S 116-2103: Affordable Insulin Approvals Now Act
  • S 116-1895: Lower Health Care Costs Act
  • HR 116-19: Lower Costs, More Cures Act of 2019
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationLicensing and registrationsPrescription drugs