HR 5444 116th Congress House Health Biological and life sciences Digestive and metabolic diseases Drug safety, medical device, and laboratory regulation Drug therapy Intellectual property Licensing and registrations Prescription drugs

Lower Insulin Costs Now Act

Introduced: December 17, 2019 Introduced by: Underwood, Lauren Democratic · Illinois See on congress.gov

Everywhere this bill has been 3 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Dec 18, 2019

Referred to the Subcommittee on Health.

Dec 17, 2019

Referred to the House Committee on Energy and Commerce.

Dec 17, 2019

Introduced in House

Plain-English summary Congressional Research Service

Lower Insulin Costs Now Act

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. (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.)

The bill requires the FDA to continue reviewing an application filed not later than March 23, 2019, under the earlier procedure, even if it was not approved as of March 23, 2020.

Such an application not approved after October 1, 2022, shall be deemed withdrawn.

Such an approved application shall be deemed a biological product license.

What's happening now December 18, 2019

Referred to the Subcommittee on Health.

Committees of jurisdiction 2