Skip to main content
H.R. 5444 116th Congress House

Lower Insulin Costs Now Act

Official title: To amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain products from approval as a drug to licensure as a … Show full official titleShow less

Official title: To amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain products from approval as a drug to licensure as a biological product, and for other purposes.

Introduced: December 17, 2019 Introduced by: Lauren Underwood Democratic · Illinois See on congress.gov
Health Biological and life sciencesDigestive and metabolic diseasesDrug safety, medical device, and laboratory regulationDrug therapy
More subjectsShow fewer subjects
Intellectual propertyLicensing and registrationsPrescription drugs
Sign in to write a letter Sign in to watch
This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 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
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 Latest action December 18, 2019

Referred to the Subcommittee on Health.

 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.

 Related & companion bills 2
  • HR 19 Lower Costs, More Cures Act of 2019
  • HR 1865 Further Consolidated Appropriations Act, 2020
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 6
All 6 Democratic 1 Republican 4
R
Perry, Scott
Pennsylvania · Dec 23, 2019
 R
Fitzpatrick, Brian K.
Pennsylvania · Dec 18, 2019
 R
Guthrie, Brett
Kentucky · Dec 17, 2019
 R
Kelly, Mike
Pennsylvania · Dec 17, 2019
Levin, Andy
· Dec 17, 2019
 D
Schakowsky, Janice D.
Illinois · Dec 17, 2019
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 5444: Lower Insulin Costs Now Act. 116th Congress. Open America. https://openamerica.io/bill/116-HR-5444/
MLA
"H.R. 5444: Lower Insulin Costs Now Act." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-5444/.
Bluebook (legal)
H.R. 5444, 116th Cong. (2026), https://openamerica.io/bill/116-HR-5444/.
Markdown link
[H.R. 5444: Lower Insulin Costs Now Act](https://openamerica.io/bill/116-HR-5444/)
Report a problem