H.R. 965House116th Congress (2019-2021)In Committee

CREATES Act of 2019

Introduced February 5, 2019

AI-Generated Summary

Updated April 14, 2026 at 1:36 AM UTC

The CREATES Act of 2019 is designed to speed up the entry of lower‑cost generic drugs and biosimilars by making it easier for developers to obtain samples of brand‑name products they need for testing. It creates a legal process that lets a generic or biosimilar maker sue a brand‑name holder if the holder refuses to provide enough product on fair, market‑based terms. The bill applies to any FDA‑approved drug or biologic (except those on a shortage list) and to developers seeking approval for a generic or biosimilar version.

Key Provisions

  • Defines a “covered product” (approved drug or biologic) and an “eligible product developer” (a company trying to get a generic or biosimilar approved).
  • Allows developers to file a civil lawsuit against a brand‑name license holder who does not supply sufficient product on commercially reasonable, market‑based terms within 31 days of a request.
  • Provides a fast‑track process for the HHS Secretary to grant developers permission to obtain samples of products that have a REMS with ETASU, requiring safety protections comparable to the REMS.
  • Gives license holders several affirmative defenses, such as lack of inventory or offering the product on reasonable terms that the developer declined.
  • If the developer wins, the court can order the license holder to supply the product, award attorney fees, and impose a monetary penalty (capped at the holder’s revenue from the product) to deter future refusals.
  • Amends the REMS law to state that providing samples to developers does not violate a REMS, and clarifies that the act does not limit antitrust enforcement.

Legislative Activity

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14 earlier actions
HouseCommittee Latest Action

Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.

May 16, 2019

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HouseIntro Referral

Introduced in House

February 5, 2019

HouseIntro Referral

Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

February 5, 2019

HouseCommittee

Referred to the Subcommittee on Health.

February 6, 2019

HouseCommittee

Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.

March 22, 2019

HouseCommittee

Subcommittee Consideration and Mark-up Session Held.

March 27, 2019

HouseCommittee

Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .

March 27, 2019

HouseCommittee

Committee Consideration and Mark-up Session Held.

April 3, 2019

HouseCommittee

Ordered to be Reported (Amended) by the Yeas and Nays: 50 - 0.

April 3, 2019

HouseCommittee

Committee Consideration and Mark-up Session Held.

April 30, 2019

HouseCommittee

Ordered to be Reported by Voice Vote.

April 30, 2019

HouseCommittee

Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-55, Part I.

May 10, 2019

HouseCommittee

Reported by the Committee on Judiciary. H. Rept. 116-55, Part II.

May 10, 2019

HouseCalendars

Placed on the Union Calendar, Calendar No. 33.

May 10, 2019

HouseFloor

PERMISSION TO FILE SUPPLEMENTAL - Ms. Lofgren asked unanimous consent that Committee on the Judiciary be authorized to file a supplemental report on the bill, H.R. 965. Agreed to without objection.

May 16, 2019 • 7:42 PM

HouseCommittee

Supplemental report filed by the Committee on the Judiciary, H. Rept. 116-55, Part III.

May 16, 2019

Floor Debate

21 members

What members said about H.R. 965 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…

Show 8 more
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…

Show 11 more
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

2 versions available

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Latest
Reported in HouseIssued May 10, 2019

IB

Union Calendar No. 33

116th CONGRESS

1st Session

H. R. 965

[Report No. 116–55, Parts I and II]

IN THE HOUSE OF REPRESENTATIVES

February 5, 2019

Mr. Cicilline (for himself, Mr. Sensenbrenner, Mr. Nadler, Mr. Collins of Georgia, Mr. Welch, and Mr. McKinley) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

May 10, 2019

Additional sponsors: Mr. Meadows, Ms. Finkenauer, Mr. Doggett, Mr. Cole, Mr. Gallagher, Mr. Lipinski, Mr. Rush, Ms. McCollum, Mr. Pallone, Mr. Perry, Mr. Ruiz, Mrs. Dingell, Ms. Eshoo, Ms. Matsui, Mrs. Craig, Mr. Tonko, Mr. Gohmert, Mr. Van Drew, Ms. Clarke of New York, Mr. Courtney, Mr. Allred, Ms. Schakowsky, Mr. Crow, Mr. Gonzalez of Ohio, Mr. Larson of Connecticut, Mr. McAdams, Mr. Schrader, Mr. Rodney Davis of Illinois, Mr. Pappas, Mr. Kennedy, Ms. Davids of Kansas, Mr. Norcross, Ms. Spanberger, Mr. Quigley, Mr. Deutch, Mr. Langevin, Mr. Cooper, Mrs. McBath, Mr. Raskin, Ms. Mucarsel-Powell, Mr. Stanton, Mr. Jordan, Ms. Wild, Mr. Cohen, Mr. Kim, Ms. Schrier, Mr. Joyce of Ohio, Mr. Case, Mr. Khanna, Mr. David Scott of Georgia, Ms. Houlahan, Mr. Casten of Illinois, Mr. Norman, Ms. Pingree, Mr. Carbajal, Mr. Smith of Washington, Ms. Wexton, Mr. Cisneros, Mr. Connolly, Ms. Underwood, Ms. Garcia of Texas, Ms. Meng, and Mrs. Bustos

May 10, 2019

Reported from the Committee on Energy and Commerce with an amendment

Strike out all after the enacting clause and insert the part printed in italic

May 10, 2019

Reported from the Committee on the Judiciary; committed to the Committee of the Whole House on the State of the Union and ordered to be printed

For text of introduced bill, see copy of bill as introduced on February 5, 2019

A BILL

To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.


1.

Short title

This Act may be cited as the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019.

2.

Actions for delays of generic drugs and biosimilar biological products

(a)

Definitions

In this section—

(1)

the term commercially reasonable, market-based terms means—

(A)

a nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug, as defined in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B));

(B)

a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection (b)(2)(A)(iv); and

(C)

no additional conditions are imposed on the sale of the covered product;

(2)

the term covered product—

(A)

means—

(i)

any drug approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or biological product licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262);

(ii)

any combination of a drug or biological product described in clause (i); or

(iii)

when reasonably necessary to support approval of an application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), or section 351 of the Public Health Service Act (42 U.S.C. 262), as applicable, or otherwise meet the requirements for approval under either such section, any product, including any device, that is marketed or intended for use with such a drug or biological product; and

(B)

does not include any drug or biological product that appears on the drug shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e), unless—

(i)

the drug or biological product has been on the drug shortage list in effect under such section 506E continuously for more than 6 months; or

(ii)

the Secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage.

(3)

the term device has the meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321);

(4)

the term eligible product developer means a person that seeks to develop a product for approval pursuant to an application for approval under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or for licensing pursuant to an application under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k));

(5)

the term license holder means the holder of an application approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or the holder of a license under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) for a covered product;

(6)

the term REMS means a risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1);

(7)

the term REMS with ETASU means a REMS that contains elements to assure safe use under section 505–1(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(f));

(8)

the term Secretary means the Secretary of Health and Human Services;

(9)

the term single, shared system of elements to assure safe use means a single, shared system of elements to assure safe use under section 505–1(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(f)); and

(10)

the term sufficient quantities means an amount of a covered product that the eligible product developer determines allows it to—

(A)

conduct testing to support an application under—

(i)

subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); or

(ii)

section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)); and

(B)

fulfill any regulatory requirements relating to approval of such an application.

(b)

Civil action for failure To provide sufficient quantities of a covered product

(1)

In general

An eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the United States alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable, market-based terms.

(2)

Elements

(A)

In general

To prevail in a civil action brought under paragraph (1), an eligible product developer shall prove, by a preponderance of the evidence—

(i)

that—

(I)

the covered product is not subject to a REMS with ETASU; or

(II)

if the covered product is subject to a REMS with ETASU—

(aa)

the eligible product developer has obtained a covered product authorization from the Secretary in accordance with subparagraph (B); and

(bb)

the eligible product developer has provided a copy of the covered product authorization to the license holder;

(ii)

that, as of the date on which the civil action is filed, the product developer has not obtained sufficient quantities of the covered product on commercially reasonable, market-based terms;

(iii)

that the eligible product developer has requested to purchase sufficient quantities of the covered product from the license holder; and

(iv)

that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable, market-based terms—

(I)

for a covered product that is not subject to a REMS with ETASU, by the date that is 31 days after the date on which the license holder received the request for the covered product; and

(II)

for a covered product that is subject to a REMS with ETASU, by 31 days after the later of—

(aa)

the date on which the license holder received the request for the covered product; or

(bb)

the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with subparagraph (B).

(B)

Authorization for covered product subject to a REMS with ETASU

(i)

Request

An eligible product developer may submit to the Secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU.

(ii)

Authorization

Not later than 120 days after the date on which a request under clause (i) is received, the Secretary shall, by written notice, authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU for purposes of—

(I)

development and testing that does not involve human clinical trials, if the eligible product developer has agreed to comply with any conditions the Secretary determines necessary; or

(II)

development and testing that involves human clinical trials, if the eligible product developer has—

(aa)
(AA)

submitted protocols, informed consent documents, and informational materials for testing that include protections that provide safety protections comparable to those provided by the REMS for the covered product; or

(BB)

otherwise satisfied the Secretary that such protections will be provided; and

(bb)

met any other requirements the Secretary may establish.

(iii)

Notice

A covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the REMS for the covered product.

(3)

Affirmative defense

In a civil action brought under paragraph (1), it shall be an affirmative defense, on which the defendant has the burden of persuasion by a preponderance of the evidence—

(A)

that, on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder—

(i)

neither the license holder nor any of its agents, wholesalers, or distributors was engaged in the manufacturing or commercial marketing of the covered product; and

(ii)

neither the license holder nor any of its agents, wholesalers, or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable, market-based terms;

(B)

that—

(i)

the license holder sells the covered product through agents, distributors, or wholesalers;

(ii)

the license holder has placed no restrictions, explicit or implicit, on its agents, distributors, or wholesalers to sell covered products to eligible product developers; and

(iii)

the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable, market-based terms from the agents, distributors, or wholesalers of the license holder; or

(C)

that the license holder made an offer to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms—

(i)

for a covered product that is not subject to a REMS with ETASU, by the date that is 14 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 7 days after the date on which the eligible product developer received such offer from the license holder; or

(ii)

for a covered product that is subject to a REMS with ETASU, by the date that is 20 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 10 days after the date on which the eligible product developer received such offer from the license holder.

(4)

Methods for transmission of requests for covered products

A written request for a covered product, offer to sell a covered product, or acceptance of such an offer between the eligible product developer and the license holder shall be made by—

(A)

certified or registered mail with return receipt requested;

(B)

personal delivery; or

(C)

electronic means.

(5)

Remedies

(A)

In general

If an eligible product developer prevails in a civil action brought under paragraph (1), the court shall—

(i)

order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable, market-based terms;

(ii)

award to the eligible product developer reasonable attorney's fees and costs of the civil action; and

(iii)

award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable, market-based terms, if the court finds, by a preponderance of the evidence—

(I)

that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification; or

(II)

that the license holder failed to comply with an order issued under clause (i).

(B)

Maximum monetary amount

A monetary amount awarded under subparagraph (A)(iii) shall not be greater than the revenue that the license holder earned on the covered product during the period—

(i)

beginning on—

(I)

for a covered product that is not subject to a REMS with ETASU, the date that is 31 days after the date on which the license holder received the request; or

(II)

for a covered product that is subject to a REMS with ETASU, the date that is 31 days after the later of—

(aa)

the date on which the license holder received the request; or

(bb)

the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with paragraph (2)(B); and

(ii)

ending on the date on which the eligible product developer received sufficient quantities of the covered product.

(C)

Avoidance of delay

The court may issue an order under subparagraph (A)(i) before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause (ii) or (iii) of subparagraph (A), or the amount of any such award.

(c)

Limitation of liability

A license holder for a covered product shall not be liable for any claim under Federal, State, or local law arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section, including transportation, handling, use, or disposal of the covered product by the eligible product developer.

(d)

No violation of REMS

Section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) is amended by adding at the end the following new subsection:

(l)

Provision of samples not a violation of strategy

The provision of samples of a covered product to an eligible product developer (as those terms are defined in section 2(a) of the Creating and Restoring Equal Access to Equivalent Samples Act of 2019) shall not be considered a violation of the requirements of any risk evaluation and mitigation strategy that may be in place under this section for such drug.

.

(e)

Rule of construction

(1)

Definition

In this subsection, the term antitrust laws—

(A)

has the meaning given the term in subsection (a) of the first section of the Clayton Act (15 U.S.C. 12); and

(B)

includes section 5 of the Federal Trade Commission Act (15 U.S.C. 45) to the extent that such section applies to unfair methods of competition.

(2)

Antitrust laws

Nothing in this section shall be construed to limit the operation of any provision of the antitrust laws.

3.

REMS approval process for subsequent filers

Section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1), as amended by section 2, is further amended—

(1)

in subsection (g)(4)(B)—

(A)

in clause (i) by striking or after the semicolon;

(B)

in clause (ii) by striking the period at the end and inserting ; or; and

(C)

by adding at the end the following:

(iii)

accommodate different, comparable aspects of the elements to assure safe use for a drug that is the subject of an application under section 505(j), and the applicable listed drug.

;

(2)

in subsection (i)(1), by striking subparagraph (C) and inserting the following:

(C)
(i)

Elements to assure safe use, if required under subsection (f) for the listed drug, which, subject to clause (ii), for a drug that is the subject of an application under section 505(j) may use—

(I)

a single, shared system with the listed drug under subsection (f); or

(II)

a different, comparable aspect of the elements to assure safe use under subsection (f).

(ii)

The Secretary may require a drug that is the subject of an application under section 505(j) and the listed drug to use a single, shared system under subsection (f), if the Secretary determines that no different, comparable aspect of the elements to assure safe use could satisfy the requirements of subsection (f).

;

(3)

in subsection (i), by adding at the end the following:

(3)

Shared REMS

If the Secretary approves, in accordance with paragraph (1)(C)(i)(II), a different, comparable aspect of the elements to assure safe use under subsection (f) for a drug that is the subject of an abbreviated new drug application under section 505(j), the Secretary may require that such different comparable aspect of the elements to assure safe use can be used with respect to any other drug that is the subject of an application under section 505(j) or 505(b) that references the same listed drug.

; and

(4)

by adding at the end the following:

(m)

Separate REMS

When used in this section, the terms different, comparable aspect of the elements to assure safe use or different, comparable approved risk evaluation and mitigation strategies means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section 505(j) that uses different methods or operational means than the strategy required under subsection (a) for the applicable listed drug, or other application under section 505(j) with the same such listed drug, but achieves the same level of safety as such strategy.

.

4.

Rule of construction

(a)

In general

Nothing in this Act, the amendments made by this Act, or in section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1), shall be construed as—

(1)

prohibiting a license holder from providing an eligible product developer access to a covered product in the absence of an authorization under this Act; or

(2)

in any way negating the applicability of a REMS with ETASU, as otherwise required under such section 505–1, with respect to such covered product.

(b)

Definitions

In this section, the terms covered product, eligible product developer, license holder, and REMS with ETASU have the meanings given such terms in section 3(a).

May 10, 2019

Reported from the Committee on Energy and Commerce with an amendment

May 10, 2019

Reported from the Committee on the Judiciary; committed to the Committee of the Whole House on the State of the Union and ordered to be printed