Lineage

Feb 5, 2019viewing Reported in House 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 See what changed
Feb 5, 2019 Introduced in House 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

H.R. 965 — what changed

Creating and Restoring Equal Access to Equivalent Samples Act of 2019

From Introduced in House to Reported in House. 3 sections amended between Introduced in House and Reported in House.

Sec. 2 Actions for delays of generic drugs and biosimilar biological products

(a)

added Definitions— In this section—

(1)

added the term commercially reasonable, market-based terms means—

(A)

added 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)

added 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)

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

(2)

added the term covered product—

(A)

added means—

(i)

added 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)

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

(iii)

added 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)

added 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)

added 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)

added 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)

added 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)

added 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)

added 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)

added 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)

added 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)

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

(9)

added 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)

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

(A)

added conduct testing to support an application under—

(i)

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

(ii)

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

(B)

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

(b)

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

(1)

added 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)

added Elements—

(A)

added 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)

added that—

(I)

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

(II)

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

(aa)

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

(bb)

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

(ii)

added 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)

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

(iv)

added 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)

added 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)

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

(aa)

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

(bb)

added 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)

added Authorization for covered product subject to a REMS with ETASU—

(i)

added 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)

added 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)

added 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)

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

(aa)

added

(AA)

added 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)

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

(bb)

added met any other requirements the Secretary may establish.

(iii)

added 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)

added 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)

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

(i)

added 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)

added 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)

added that—

(i)

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

(ii)

added 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)

added 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)

added 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)

added 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)

added 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)

added 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)

added certified or registered mail with return receipt requested;

(B)

added personal delivery; or

(C)

added electronic means.

(5)

added Remedies—

(A)

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

(i)

added 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)

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

(iii)

added 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)

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

(II)

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

(B)

added 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)

added beginning on—

(I)

added 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)

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

(aa)

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

(bb)

added 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)

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

(C)

added 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.

removed ~~Congress finds the following:~~

(1)

removed It is the policy of the United States to promote competition in the market for drugs and biological products by facilitating the timely entry of low-cost generic and biosimilar versions of those drugs and biological products.

(c)

changed Limitation of liability— Since their enactment in 1984 and 2010, respectively, the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98–417; 98 Stat. 1585) and the Biologics Price Competition and Innovation Act of 2009 (subtitle A ~~of title VII of Public Law 111–148; 124 Stat. 804), have provided pathways~~ license holder for ~~making lower-cost versions~~ a covered product shall not be liable for any claim under Federal, State, or local law arising out of ~~previously approved drugs and previously licensed biological products available to~~ the ~~people~~ failure of an eligible product developer to follow adequate safeguards to assure safe use of the ~~United States~~ covered product during development or testing activities described in ~~a timely manner, thereby lowering overall prescription drug costs for patients and taxpayers by billions~~ this section, including transportation, handling, use, or disposal of ~~dollars each year.~~the covered product by the eligible product developer.

(d)

changed No violation of REMS— In order for these pathways to function as intended, developers of generic drugs and biosimilar biological products (referred to in this section as “generic product developers”) must be able to obtain quantities Section 505–1 of the ~~reference listed drug or biological product with which the generic drug or biosimilar biological product~~ Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) is ~~intended to compete (referred to in this section as a “covered product”) for purposes of supporting an application for approval~~ amended by adding at the ~~Food and Drug Administration, including for testing to show that—~~end the following new subsection:

added “(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)

added Rule of construction—

(1)

added Definition— In this subsection, the term antitrust laws—

(A)

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

(B)

added 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)

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

(A)

removed a prospective generic drug is bioequivalent to the covered product in accordance with subsection (j) of section 505 of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 355), or meets the requirements for approval of an application submitted under subsection (b)(2) of that section; or

(B)

removed a prospective biosimilar biological product is biosimilar to or interchangeable with its reference biological product under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)), as applicable.

(4)

removed For drugs and biological products that are subject to a risk evaluation and mitigation strategy, another essential component in the creation of low-cost generic and biosimilar versions of covered products is the ability of generic product developers to join the manufacturer of the covered product (referred to in this section as the “license holder”) in a single, shared system of elements to assure safe use and supporting agreements as required by section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1), or secure a variance therefrom.

(5)

removed Contrary to the policy of the United States 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, certain license holders are preventing generic product developers from obtaining quantities of the covered product necessary for the generic product developer to support an application for approval by the Food and Drug Administration, including testing to show bioequivalence, biosimilarity, or interchangeability to the covered product, in some instances based on the justification that the covered product is subject to a risk evaluation and mitigation strategy with elements to assure safe use under section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1).

(6)

removed The Director of the Center for Drug Evaluation and Research of the Food and Drug Administration has testified that some manufacturers of covered products have used risk evaluation and mitigation strategies and distribution restrictions adopted by the manufacturer on their own behalf as reasons to not sell quantities of a covered product to generic product developers, causing barriers and delays in getting generic products on the market. The Food and Drug Administration has reported receiving significant numbers of inquiries from generic product developers who were unable to obtain samples of covered products to conduct necessary testing and otherwise meet requirements for approval of generic drugs.

(7)

removed In 2018, the Acting Chairman of the Federal Trade Commission testified that the Federal Trade Commission continues to be very concerned about potential abuses by manufacturers of brand drugs of risk evaluation and mitigation strategies or other closed distribution systems to impede generic competition.

(8)

removed Also contrary to the policy of the United States 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, certain license holders are impeding the prompt negotiation and development on commercially reasonable terms of a single, shared system of elements to assure safe use, which may be necessary for the generic product developer to gain approval for its drug or licensing for its biological product.

(9)

removed While the antitrust laws may address the refusal by some license holders to provide quantities of a covered product to a generic product developer, a more tailored legal pathway would help ensure that generic product developers can obtain necessary quantities of a covered product in a timely way for purposes of developing a generic drug or biosimilar biological product, facilitating competition in the marketplace for drugs and biological products.

(10)

removed The antitrust laws may address actions by license holders who impede the prompt negotiation and development of a single, shared system of elements to assure safe use, and the Food and Drug Administration has some authority to waive the requirement of a single, shared system. Clearer regulatory authority to approve different systems that meet the statutory requirements to ensure patient safety, however, would limit the effectiveness of bad faith negotiations over single, shared systems to delay generic approval. At the same time, clearer regulatory authority would ensure all systems protect patient safety.

Sec. 3 REMS approval process for subsequent filers

added 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)

added in subsection (g)(4)(B)—

(a)

removed ~~Definitions—~~ ~~In this section—~~

(1)

removed ~~the term commercially reasonable, market-based terms means—~~

(A)

removed 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)

removed ~~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)

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

(2)

removed ~~the term covered product—~~

(A)

removed ~~means—~~

(i)

removed 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)

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

(iii)

removed 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)

removed 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 the shortage will not be promptly resolved—

(i)

removed ~~as demonstrated by the fact that the drug or biological product has been in shortage for more than 6 months; or~~

(ii)

removed ~~as otherwise determined by the Secretary;~~

(3)

removed ~~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)

removed 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)

removed 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)

removed ~~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)

removed ~~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)

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

(9)

removed 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)

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

(A)

removed ~~conduct testing to support an application under—~~

(i)

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

(ii)

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

(B)

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

(b)

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

(A)

changed ~~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~~ clause (i) by striking “or” after the ~~eligible product developer on commercially reasonable, market-based terms.~~semicolon;

(B)

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

(2)

removed ~~Elements—~~

(A)

removed ~~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)

removed ~~that—~~

(I)

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

(II)

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

(aa)

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

(bb)

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

(ii)

removed ~~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)

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

(iv)

removed ~~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)

removed ~~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)

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

(aa)

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

(bb)

removed ~~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)

removed ~~Authorization for covered product subject to a REMS with ETASU—~~

(i)

removed ~~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)

removed ~~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)

removed ~~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)

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

(aa)

removed

(AA)

removed 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)

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

(bb)

removed ~~met any other requirements the Secretary may establish.~~

(iii)

removed ~~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.

(C)

changed ~~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~~ adding at the ~~evidence—~~end the following:

added “(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.”

(A)

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

(i)

removed ~~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)

removed 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; or

(B)

removed ~~that—~~

(i)

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

(ii)

removed ~~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)

removed 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.

(4)

removed ~~Remedies—~~

(A)

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

(i)

removed ~~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)

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

(iii)

removed award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide other 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)

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

(II)

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

(B)

removed ~~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)

removed ~~beginning on—~~

(I)

removed ~~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)

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

(aa)

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

(bb)

removed ~~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)

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

(C)

removed ~~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.

(2)

changed ~~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~~ subsection (i)(1), by striking subparagraph (C) and inserting the ~~eligible product developer.~~following:

added “(C)

added “(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—

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

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

added “(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)

changed ~~No violation of REMS—~~ ~~The provision of samples of a drug pursuant to an authorization under~~ in subsection ~~(b)(2)(B) shall not be considered a violation of~~ (i), by adding at the ~~requirements of any risk evaluation and mitigation strategy that may be in place under section 505–1 of~~ end the ~~Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) for such drug.~~following:

added “(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.”

(4)

added by adding at the end the following:

added “(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.”

(e)

removed ~~Rule of construction—~~

(1)

removed ~~Definition—~~ ~~In this subsection, the term antitrust laws—~~

(A)

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

(B)

removed ~~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)

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

Sec. 4 Rule of construction

(a)

added 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)

added 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)

added 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.

removed ~~Section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) is amended—~~

(b)

changed Definitions— In this section, the terms “covered product”, “eligible product developer”, “license holder”, and “REMS with ETASU” have the meanings given such terms in ~~subsection (g)(4)(B)—~~section 3(a).

(A)

removed ~~in clause (i) by striking “or” after the semicolon;~~

(B)

removed ~~in clause (ii) by striking the period at the end and inserting “; or”; and~~

(C)

removed ~~by adding at the end the following:~~

removed ~~“(iii) accommodate different, comparable approved risk evaluation and mitigation strategies for a drug that is the subject of an application under section 505(j), and the applicable listed drug.”~~

(2)

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

removed ~~“(C)~~

removed “(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—

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

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

removed “(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)

removed ~~by adding at the end the following:~~

removed “(l) 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.”

H.R. 965 — what changed

Sec. 2 Actions for delays of generic drugs and biosimilar biological products

Sec. 3 REMS approval process for subsequent filers

Sec. 4 Rule of construction

Cite this provision

Incoming references