```

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5497 Introduced in House (IH)]

<DOC>

116th CONGRESS
  1st Session
                                H. R. 5497

 To amend the Federal Food, Drug, and Cosmetic Act to establish a time-
limited conditional approval pathway, subject to specific obligations, 
               for certain drugs, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           December 19, 2019

Mr. Westerman (for himself, Mr. Gallagher, and Mr. Burchett) introduced 
 the following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL

 
 To amend the Federal Food, Drug, and Cosmetic Act to establish a time-
limited conditional approval pathway, subject to specific obligations, 
               for certain drugs, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Conditional Approval Act''.

SEC. 2. CONDITIONAL APPROVAL OF NEW HUMAN DRUGS.

    (a) In General.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 
the end the following:

``SEC. 524B. CONDITIONAL AND TIME-LIMITED APPROVAL PATHWAY FOR NEW 
              DRUGS.

    ``(a) Pathway Requirements.--The Secretary shall, at the request of 
the sponsor of a new drug, grant provisional and time-limited approval 
of such drug under this section, if the Secretary determines--
            ``(1) it is likely that the sponsor will be able to provide 
        comprehensive clinical data after such drug is conditionally 
        approved;
            ``(2) such drug is intended for the treatment, prevention, 
        or medical diagnosis of a seriously debilitating disease, a 
        life-threatening disease, or a chronic condition;
            ``(3) the expected benefits of the drug outweigh the 
        potential risks to patients, taking into account the fact that 
        additional data are still required to assess the drug and the 
        severity of the underlying disease or condition the drug is 
        intended to treat;
            ``(4) there are no existing meaningful treatments for the 
        disease or condition that the drug is intended to treat;
            ``(5) confirmatory clinical trials are difficult or costly 
        to conduct; and
            ``(6) such drug is intended to treat a disease or condition 
        for which no more than 2 meaningful treatments currently exist.
    ``(b) Approval Requirements.--
            ``(1) In general.--Not later than 180 days after the date 
        on which the Secretary receives a request for conditional 
        approval under subsection (a) with respect to a new drug, the 
        Secretary shall require the sponsor of such drug to--
                    ``(A) complete in a timely manner clinical 
                investigations to provide full demonstration of safety 
                and effectiveness as described under section 505 of the 
                Federal Food, Drug, and Cosmetic Act or section 351 of 
                the Public Health Service Act, as applicable;
                    ``(B) conduct clinical trials other than 
                confirmatory trials, to demonstrate a certain degree of 
                safety and efficacy of the drug; and
                    ``(C) demonstrate that necessary post-market 
                surveillance and risk-management tools are in place 
                with respect to the drug.
            ``(2) Period of conditional approval.--The period of 
        conditional approval for a drug under this section is effective 
        for a 1-year period and is thereafter renewable by the 
        Secretary annually for up to 4 additional 1-year terms. A 
        conditional approval shall be in effect for no more than 5 
        years from the date of approval under this section.
            ``(3) Time limitation.--If any conditionally drug approved 
        under this section is not brought to market within 3 years of 
        the conditional approval, any conditional approval granted 
        under this section with respect to such drug shall be deemed 
        invalid.
            ``(4) Requirements.--As a condition on receipt of 
        conditional approval under this section, the Secretary shall 
        require the sponsor of the drug to agree to the following:
                    ``(A) Complete in a timely manner such clinical 
                investigations to provide a full demonstration of 
                effectiveness as the Secretary determines to be 
                necessary for approval of the drug under section 505 of 
                this Act or section 351 of the Public Health Service 
                Act, as applicable.
                    ``(B) Submit to the Secretary an annual report on 
                the progress of the sponsor in conducting the clinical 
                investigations required under this section.
                    ``(C) Ensure that all labeling and promotional 
                materials for the drug bear the statement 
                `conditionally approved by the FDA pending a full 
                demonstration of effectiveness under applicable ___' 
                (specifying the application number assigned by the 
                Secretary in place of the blank).
            ``(5) Applying for full approval.--The sponsor of a drug 
        granted conditional approval pursuant to this section may, at 
        any point, submit an application for full approval as described 
        under section 505 of the Federal Food, Drug, and Cosmetic Act 
        or section 351 of the Public Health Service Act, as applicable.
            ``(6) Utilization of real world evidence to support full 
        approval.--The Secretary shall allow the use of real world 
        evidence, as defined in section 505F(b), and collected by the 
        sponsor of a drug during the duration of conditional approval 
        granted approval to this subsection, to supplement an 
        application for full approval, in addition to other post-
        approval studies.
    ``(c) Limitation on Liability.--
            ``(1) In general.--With respect to any claim under State 
        law alleging that a drug sold or otherwise made available 
        pursuant to a grant of conditional approval under this section 
        is unsafe or ineffective, no liability in a cause of action 
        shall lie against a sponsor or manufacturer, unless the 
        relevant conduct constitutes reckless or willful misconduct, 
        gross negligence, or an intention tort under any applicable 
        State law.
            ``(2) Rule of construction.--Except as set forth in 
        subparagraph (A), nothing in this subsection shall be construed 
        to modify or otherwise affect the right of any person to bring 
        private action under any Federal or State product liability, 
        tort, consumer protection, or warranty law.
    ``(d) Definitions.--In this Act:
            ``(1) Seriously debilitating diseases.--The term `severely 
        debilitating diseases' means diseases or conditions that cause 
        major irreversible morbidity.
            ``(2) Life-threatening diseases.--The term `life-
        threatening diseases' means--
                    ``(A) a disease or condition where the likelihood 
                of death is high unless the course of the disease is 
                interrupted; or
                    ``(B) a disease or condition with potentially fatal 
                outcomes, where the end point of clinical trial 
                analysis is survival.
            ``(3) Chronic condition.--The term `chronic condition' 
        means a disease or condition that--
                    ``(A) usually lasts for 3 months or longer; and
                    ``(B)(i) requires ongoing medical attention; or
                    ``(ii) limits activities of daily living.''.
    (b) Regulations and Guidance.--Not later than 1 year after the date 
of the enactment of this Act, the Secretary of Health and Human 
Services shall issue final regulations and guidance for carrying out 
section 524B of the Federal Food, Drug, and Cosmetic Act.
    (c) Conforming Amendment.--Section 505(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(a)) is amended by inserting ``, 
or there is in effect a conditional approval under section 524B with 
respect to such drug'' before the period.
                                 <all>
```