SEC. 601. Reauthorization of Provision Relating to Exclusivity of Certain Drugs Containing Single Enantiomers.
Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(u)(4)) is amended by striking “ 2017” and inserting “ 2022”.
Title VI — Reauthorizations and Improvements Related to Drugs
TITLE VI Reauthorizations and Improvements Related to Drugs
SEC. 602. Reauthorization of the Critical Path Public-Private Partnerships.
Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–5(f)) is amended by striking “ 2013 through 2017” and inserting “ 2018 through 2022”.
SEC. 603. Reauthorization of Orphan Grants Program.
Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended by striking “ 2013 through 2017” and inserting “ 2018 through 2022”.
SEC. 604. Protecting and Strengthening the Drug Supply Chain.
Diverted Drugs.— Paragraph (1) of section 801(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended—
by striking “ (d)(1) Except as” and inserting “ (d)(1)(A) Except as”; and
by adding at the end the following:
“(B) Except as authorized by the Secretary in the case of a drug that appears on the drug shortage list under section 506E or in the case of importation pursuant to section 804, no drug that is subject to section 503(b)(1) may be imported into the United States for commercial use if such drug is manufactured outside the United States, unless the manufacturer has authorized the drug to be marketed in the United States and has caused the drug to be labeled to be marketed in the United States.”
Counterfeit Drugs.— Subsection (b) of section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the following:
“(8) Notwithstanding subsection (a), any person who violates section 301(i)(3) by knowingly making, selling or dispensing, or holding for sale or dispensing, a counterfeit drug shall be imprisoned for not more than 10 years or fined in accordance with title 18, United States Code, or both.”
SEC. 605. Patient Experience Data.
Section 569C(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c(c)(2)(A)) is amended by striking “ impact of such disease or condition, or a related therapy,” and inserting “ impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation”.
SEC. 606. Communication Plans.
in subparagraph (B), by striking “ ; or”;
in subparagraph (C), by striking the period and inserting “ ; or”; and
by adding at the end the following:
“(D) disseminating information to health care providers about drug formulations or properties, including information about the limitations or patient care implications of such formulations or properties, and how such formulations or properties may be related to serious adverse drug events associated with use of the drug.”
SEC. 607. Orphan Drugs.
in subsection (a), in the matter following paragraph (2), by striking “ such drug for such disease or condition” and inserting “ the same drug for the same disease or condition”;
in subsection (b)—
in the matter preceding paragraph (1), by striking “ If an application” and all that follows through “ such license if” and inserting “ During the 7-year period described in subsection (a) for an approved application under section 505 or license under section 351 of the Public Health Service Act, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if”;
in paragraph (1), by striking “ notice” and all that follows through “ assure” and inserting “ of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure”; and
in paragraph (2), by striking “ such holder provides” and inserting “ the holder provides”; and
by adding at the end the following:
“(c) Condition of Clinical Superiority.—
“(1) In general.—If a sponsor of a drug that is designated under section 526 and is otherwise the same, as determined by the Secretary, as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection (a) for the same rare disease or condition as the already approved drug, the Secretary shall require such sponsor, as a condition of such exclusive approval or licensure, to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug.
“(2) Definition.—For purposes of paragraph (1), the term ‘clinically superior’ with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy, greater safety, or by providing a major contribution to patient care.
“(d) Regulations.—The Secretary may promulgate regulations for the implementation of subsection (c). Beginning on the date of enactment of the FDA Reauthorization Act of 2017, until such time as the Secretary promulgates regulations in accordance with this subsection, the Secretary may apply any definitions set forth in regulations that were promulgated prior to such date of enactment, to the extent such definitions are not inconsistent with the terms of this section, as amended by such Act.
“(e) Demonstration of Clinical Superiority Standard.—To assist sponsors in demonstrating clinical superiority as described in subsection (c), the Secretary—
“(1) upon the designation of any drug under section 526, shall notify the sponsor of such drug in writing of the basis for the designation, including, as applicable, any plausible hypothesis offered by the sponsor and relied upon by the Secretary that the drug is clinically superior to a previously approved drug; and
“(2) upon granting exclusive approval or licensure under subsection (a) on the basis of a demonstration of clinical superiority as described in subsection (c), shall publish a summary of the clinical superiority findings.”
Rule of Construction.— Nothing in the amendments made by subsection (a) shall affect any determination under sections 526 and 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb, 360cc) made prior to the date of enactment of the FDA Reauthorization Act of 2017.
SEC. 608. Pediatric Information Added to Labeling.
Section 505A(o) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(o)) is amended—
in the subsection heading, by striking “ under section 505(j)”;
in paragraph (1)—
by striking “ under section 505(j)” and inserting “ under subsection (b)(2) or (j) of section 505”; and
by striking “ or by exclusivity under clause (iii) or (iv) of section 505(j)(5)(F)” and inserting “ , or by exclusivity under clause (iii) or (iv) of section 505(j)(5)(F), clause (iii) or (iv) of section 505(c)(3)(E), or section 527(a), or by an extension of such exclusivity under this section or section 505E”;
in paragraph (2), in the matter preceding subparagraph (A)—
by inserting “ clauses (iii) and (iv) of section 505(c)(3)(E), or section 527,” after “ section 505(j)(5)(F),”; and
by striking “ drug approved under section 505(j)” and inserting “ drug approved pursuant to an application submitted under subsection (b)(2) or (j) of section 505”; and
by amending paragraph (3) to read as follows:
“(3) Preservation of pediatric exclusivity and extensions.—This subsection does not affect—
“(A) the availability or scope of exclusivity under—
“(i) this section;
“(ii) section 505 for pediatric formulations; or
“(iii) section 527;
“(B) the availability or scope of an extension to any such exclusivity, including an extension under this section or section 505E;
“(C) the question of the eligibility for approval under section 505 of any application described in subsection (b)(2) or (j) of such section that omits any other aspect of labeling protected by exclusivity under—
“(i) clause (iii) or (iv) of section 505(j)(5)(F);
“(ii) clause (iii) or (iv) of section 505(c)(3)(E); or
“(iii) section 527(a); or
“(D) except as expressly provided in paragraphs (1) and (2), the operation of section 505 or section 527.”
SEC. 609. Sense of Congress on Lowering the Cost of Prescription Drugs.
It is the sense of the Congress that the Secretary of Health and Human Services should commit to engaging with the House of Representatives and the Senate to take administrative actions and enact legislative changes that—
will lower the cost of prescription drugs for consumers and reduce the burden of such cost on taxpayers; and
in lowering such cost, will—
balance the need to encourage innovation with the need to improve affordability; and
strive to increase competition in the pharmaceutical market, prevent anticompetitive behavior, and promote the timely availability of affordable, high-quality generic drugs and biosimilars.
SEC. 610. Expanded Access.
Patient Access to Investigational Drugs.—
Public meeting.—
In general.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs, in coordination with the Director of the National Institutes of Health, and in consultation with patients, health care providers, drug sponsors, bioethicists, and other stakeholders, shall, not later than 270 days after the date of enactment of this Act, convene a public meeting to discuss clinical trial inclusion and exclusion criteria to inform the guidance under paragraph (3). The Secretary shall inform the Comptroller General of the United States of the date when the public meeting will take place.
Topics.— The Secretary shall make available on the internet website of the Food and Drug Administration a report on the topics discussed at the meeting described in subparagraph (A) within 90 days of such meeting. Such topics shall include discussion of—
the rationale for, and potential barriers for patients created by, research clinical trial inclusion and exclusion criteria;
how appropriate patient populations can benefit from the results of trials that employ alternative designs;
barriers to participation in clinical trials, including—
information regarding any potential risks and benefits of participation;
regulatory, geographical, and socioeconomic barriers; and
the impact of exclusion criteria on the enrollment in clinical trials of particular populations, including infants and children, pregnant and lactating women, seniors, individuals with advanced disease, and individuals with co-morbid conditions;
clinical trial designs and methods, including expanded access trials, that increase enrollment of more diverse patient populations, when appropriate, while facilitating the collection of data to establish safe use and support substantial evidence of effectiveness, including data obtained from expanded access trials; and
how changes to clinical trial inclusion and exclusion criteria may impact the complexity and length of clinical trials, the data necessary to demonstrate safety and effectiveness, and potential approaches to mitigating those impacts.
Report.— Not later than 1 year after the Secretary issues the report under paragraph (1)(B), the Comptroller General of the United States shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on individual access to investigational drugs through the expanded access program under section 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). The report shall include—
a description of actions taken by manufacturers and distributors under section 561A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–0);
consideration of whether Form FDA 3926 and the guidance documents titled “Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers” and “Individual Patient Expanded Access Applications: Form FDA 3926”, issued by the Food and Drug Administration in June 2016, have reduced application burden with respect to individuals and physicians seeking access to investigational new drugs pursuant to section 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) and improved clarity for patients, physicians, and drug manufacturers about such process;
consideration of whether the guidance or regulations issued to implement section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) have improved access for individual patients to investigational drugs who do not qualify for clinical trials of such investigational drugs, and what barriers to such access remain;
an assessment of methods patients and health care providers use to engage with the Food and Drug Administration or drug sponsors on expanded access; and
an analysis of the Secretary’s report under paragraph (1)(B).
Guidance.—
In general.— Not later than 1 year after the publication of the report under paragraph (1)(B), the Secretary, acting through the Commissioner of Food and Drugs, shall issue one or more draft guidances regarding eligibility criteria for clinical trials. Not later than 1 year after the public comment period on each such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.
Contents.— The guidance documents described in subparagraph (A) shall address methodological approaches that a manufacturer or sponsor of an investigation of a new drug may take to—
broaden eligibility criteria for clinical trials and expanded access trials, especially with respect to drugs for the treatment of serious and life-threatening conditions or diseases for which there is an unmet medical need;
develop eligibility criteria for, and increase trial recruitment to, clinical trials so that enrollment in such trials more accurately reflects the patients most likely to receive the drug, as applicable and as appropriate, while establishing safe use and supporting findings of substantial evidence of effectiveness; and
use the criteria described in clauses (i) and (ii) in a manner that is appropriate for drugs intended for the treatment of rare diseases or conditions.
Improving Institutional Review Board Review of Single Patient Expanded Access Protocol.— Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue guidance or regulations, or revise existing guidance or regulations, to streamline the institutional review board review of individual patient expanded access protocols submitted under 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). To facilitate the use of expanded access protocols, any guidance or regulations so issued or revised may include a description of the process for any person acting through a physician licensed in accordance with State law to request that an institutional review board chair (or designated member of the institutional review board) review a single patient expanded access protocol submitted under such section 561(b) for a drug. The Secretary shall update any relevant forms associated with individual patient expanded access requests under such section 561(b) as necessary.
Expanded Access Policy Transparency.— Section 561A(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–0(f)) is amended—
in the matter preceding paragraph (1), by striking “ later” and inserting “ earlier”;
by striking paragraph (1);
by redesignating paragraph (2) as paragraph (1);
in paragraph (1) as so redesignated, by striking the period at the end and inserting “ ; or”; and
by adding at the end the following:
“(2) as applicable, 15 days after the drug receives a designation as a breakthrough therapy, fast track product, or regenerative advanced therapy under subsection (a), (b), or (g), respectively, of section 506.”
SEC. 611. Tropical Disease Product Application.
In General.— Subparagraph (A) of section 524(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(4)) is amended—
in clause (i), by striking “ and” at the end; and
by adding at the end the following:
“(iii) that contains reports of one or more new clinical investigations (other than bioavailability studies) that are essential to the approval of the application and conducted or sponsored by the sponsor of such application; and
“(iv) that contains an attestation from the sponsor of the application that such reports were not submitted as part of an application for marketing approval or licensure by a regulatory authority in India, Brazil, Thailand, or any country that is a member of the Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme prior to September 27, 2007.”
Effective Date.— The amendments made by subsection (a) shall apply to human drug applications submitted after September 30, 2017.