H.R. 938House116th Congress (2019-2021)In Committee

BLOCKING Act of 2019

Introduced January 31, 2019

AI-Generated Summary

Updated April 14, 2026 at 1:19 AM UTC

The BLOCKING Act of 2019 amends the Federal Food, Drug, and Cosmetic Act to change how the 180‑day exclusivity period for the first generic drug applicant works. By redefining when that exclusivity starts and adding conditions that end it if the first applicant hasn’t been approved after a set time, the bill aims to remove a barrier that blocks later generic drugs, encouraging more competition and lower drug prices. It affects drug manufacturers seeking FDA approval for generic versions of brand‑name medicines.

Key Provisions

  • Changes the start of the 180‑day exclusivity period for the first generic applicant to begin on the earlier of the first commercial marketing of the drug (or its listed version) by any first applicant, or a new “applicable date” defined below.
  • Creates a new “applicable date” that is reached when: (a) the FDA could approve the first applicant’s submission but is blocked by the exclusivity rule; (b) at least 30 months have passed since the first applicant’s submission; (c) the first applicant’s submission is not precluded by other rules; and (d) no first applicant’s application has been approved at that time.
  • When the applicable date is met and no first applicant has been approved, the 180‑day exclusivity ends, allowing the FDA to approve subsequent generic applications.

Legislative Activity

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8 earlier actions
HouseCalendars Latest Action

Placed on the Union Calendar, Calendar No. 24.

May 2, 2019

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HouseIntro Referral

Introduced in House

January 31, 2019

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

January 31, 2019

HouseCommittee

Referred to the Subcommittee on Health.

February 2, 2019

HouseCommittee

Subcommittee Consideration and Mark-up Session Held.

March 27, 2019

HouseCommittee

Forwarded by Subcommittee to Full Committee by Voice Vote .

March 27, 2019

HouseCommittee

Committee Consideration and Mark-up Session Held.

April 3, 2019

HouseCommittee

Ordered to be Reported by Voice Vote.

April 3, 2019

HouseCommittee

Reported by the Committee on Energy and Commerce. H. Rept. 116-46.

May 2, 2019

HouseCalendars

Placed on the Union Calendar, Calendar No. 24.

May 2, 2019

Floor Debate

21 members

What members said about H.R. 938 on the floor

8 Republicans13 Democrats
Greg Walden
Rep. Greg WaldenR-OR-2 · May 16, 2019

Mr. Chairman, I rise in opposition to the amendment. Mr. Chairman, I reserve the balance of my time. Mr. Chairman, I yield myself such time as I may consume. So let's talk about the navigator…

Greg Walden
Rep. Greg WaldenR-OR-2 · May 16, 2019

Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, The Washington Post said it best. Allow me to quote this headline from yesterday: ``Democrats Are Putting a Political Pothole in…

Frank Pallone, Jr.
Rep. Frank Pallone, Jr.D-NJ-6 · May 16, 2019

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and add extraneous material on H.R. 987, the Strengthening Health Care…

John Shimkus
Rep. John ShimkusR-IL-15 · May 16, 2019

Mr. Chairman, I claim the time in opposition. Mr. Chairman, I reserve the balance of my time. Mr. Chairman, I believe I have the right to close. Mr. Chairman, it is great being on the floor with a…

Sheila Jackson Lee
Rep. Sheila Jackson LeeD-TX-18 · May 16, 2019

Mr. Chairman, I am pleased to rise and support, enthusiastically, H.R. 987, the Strengthening Health Care and Lowering Prescription Drug Costs Act. This omnibus bill combines three key bills to lower…

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Nancy Pelosi
Rep. Nancy PelosiD-CA-12 · May 16, 2019

Mr. Chair, congratulations. What a joy to see the gentleman in the chair. I thank Chairman Pallone for his extraordinary leadership as chair of the Energy and Commerce Committee and Congresswoman…

Kathy Castor
Rep. Kathy CastorD-FL-14 · May 16, 2019

Mr. Chairman, Democrats are doing everything that we can to lower the cost of healthcare and prescription drugs, so I strongly support the act that is on the floor today. It contains two bills that I…

Steny H. Hoyer
Rep. Steny H. HoyerD-MD-5 · May 16, 2019

Mr. Chair, if you put patients before politics, you will vote for this bill because patients care about prescription drugs, but they also care about access to affordable, quality healthcare. Now, you…

Lisa Blunt Rochester
Rep. Lisa Blunt RochesterD-DE · May 16, 2019

Mr. Chairman, I thank Chairman Pallone for yielding and for his leadership. Mr. Chairman, I rise in strong support of H.R. 987, the Strengthening Health Care and Lowering Prescription Drug Costs Act.…

Michael C. Burgess
Rep. Michael C. BurgessR-TX-26 · May 16, 2019

Mr. Chairman, I thank the gentleman for yielding, and I do rise today to speak in opposition to H.R. 987. Mr. Chairman, I am concerned that the Democrats are using bipartisan drug pricing bills to…

Peter Welch
Rep. Peter WelchD-VT · May 16, 2019

Mr. Chairman, this legislation is going to help make healthcare more affordable and more accessible. There are two things: One, we finally are attacking the explosion in the cost of prescription…

Jahana Hayes
Rep. Jahana HayesD-CT-5 · May 16, 2019

Mr. Chair, I have an amendment at the desk. Mr. Chair, I yield myself such time as I may consume. It is fitting that H.R. 987, a bill that would protect the progress of the Affordable Care Act,…

Virginia Foxx
Rep. Virginia FoxxR-NC-5 · May 16, 2019

Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, I rise as leader of the Republicans on the committee of jurisdiction over employer-sponsored healthcare, the House Committee on…

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Robert C. "Bobby" Scott
Rep. Robert C. "Bobby" ScottD-VA-3 · May 16, 2019

Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, I rise today in support of this bill to improve access to quality health coverage, protect the Affordable Care Act, and cut…

David P. Roe
Rep. David P. RoeR-TN-1 · May 16, 2019

Mr. Chairman, I rise today in opposition to H.R. 987, the Democrats' ObamaCare bailout act. This legislation includes three bipartisan bills that could help lower the cost of prescription drugs.…

Earl L. "Buddy" Carter
Rep. Earl L. "Buddy" CarterR-GA-1 · May 16, 2019

Mr. Chair, I thank the gentleman for yielding. Mr. Chair, I come before you today a very disappointed person; a disappointed Member of Congress; a disappointed pharmacist. I am disappointed that my…

Lisa Blunt Rochester
Rep. Lisa Blunt RochesterD-DE · May 16, 2019

Mr. Chairman, I have an amendment at the desk. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, this is a simple amendment designed to ensure that Congress is able to review the…

Tim Walberg
Rep. Tim WalbergR-MI-7 · May 16, 2019

Mr. Chairman, I rise today in opposition to H.R. 987, and I truly lament the fact that the other side is once again, under their leadership's direction, trying to score political points instead of…

Donna E. Shalala
Rep. Donna E. ShalalaD-FL-27 · May 16, 2019

Mr. Chairman, I have an amendment at the desk. Mr. Chairman, I yield myself such time as I may consume. Mr. Chair, this amendment expresses a sense of Congress that the Secretary of Health and Human…

Lucy McBath
Rep. Lucy McBathD-GA-6 · May 16, 2019

Mr. Chair, I have an amendment at the desk. Mr. Chair, I yield myself such time as I may consume. Mr. Chair, I am so proud to be voting today to stabilize healthcare for millions of Americans and to…

Donna E. Shalala
Rep. Donna E. ShalalaD-FL-27 · May 16, 2019

Mr. Chairman, this amendment expresses the sense of Congress that the secretary should not do anything that prohibits State insurance commissioners from allowing for so-called silver loading. Let me…

David B. McKinley
Rep. David B. McKinleyR-WV-1 · May 16, 2019

Mr. Chairman, I rise as the designee of the gentleman from Indiana (Mr. Bucshon), and I have an amendment at the desk. Mr. Chairman, the bills to recognize lower drug prices passed the Energy and…

David N. Cicilline
Rep. David N. CicillineD-RI-1 · May 16, 2019

Mr. Chairman, every day in kitchens and living rooms all across America, working men and women sit down and try to figure out how to pay for their prescription drugs. That is because 25 percent of…

Mark DeSaulnier
Rep. Mark DeSaulnierD-CA-11 · May 16, 2019

Mr. Chairman, I have an amendment at the desk. Mr. Chairman, my amendment seeks to find information that will help with the high cost of prescription drugs in the United States, to help inform this…

Bill Text

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Reported in HouseIssued May 2, 2019

IB

Union Calendar No. 24

116th CONGRESS

1st Session

H. R. 938

[Report No. 116–46]

IN THE HOUSE OF REPRESENTATIVES

January 31, 2019

Mr. Schrader (for himself and Mr. Carter of Georgia) introduced the following bill; which was referred to the Committee on Energy and Commerce

May 2, 2019

Additional sponsors: Mrs. Craig, Mrs. Dingell, Mr. Ruiz, Mr. Pallone, Ms. Eshoo, Mr. Kennedy, Ms. Matsui, Mr. Rush, Mr. Van Drew, Ms. Clarke of New York, Mr. Walden, Ms. Schakowsky, Mr. McAdams, Ms. Mucarsel-Powell, and Mr. Meadows

May 2, 2019

Committed to the Committee of the Whole House on the State of the Union and ordered to be printed


A BILL

To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes.


1.

Short title

This Act may be cited as the Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019.

2.

Change conditions of first generic exclusivity to spur access and competition

Section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amended—

(1)

in subclause (I), by striking 180 days after and all that follows through the period at the end and inserting the following:

180 days after the earlier of—

(aa)

the date of the first commercial marketing of the drug (including the commercial marketing of the listed drug) by any first applicant; or

(bb)

the applicable date specified in subclause (III).

; and

(2)

by adding at the end the following new subclause:

(III)

Applicable date

The applicable date specified in this subclause, with respect to an application for a drug described in subclause (I), is the date on which each of the following conditions is first met:

(aa)

The approval of such an application could be made effective, but for the eligibility of a first applicant for 180-day exclusivity under this clause.

(bb)

At least 30 months have passed since the date of submission of an application for the drug by at least one first applicant.

(cc)

Approval of an application for the drug submitted by at least one first applicant is not precluded under clause (iii).

(dd)

No application for the drug submitted by any first applicant is approved at the time the conditions under items (aa), (bb), and (cc) are all met, regardless of whether such an application is subsequently approved.

.

May 2, 2019

Committed to the Committee of the Whole House on the State of the Union and ordered to be printed