Title: SAFETY Act of 2018
Policy area: Health

Summary:
Saving American Families through Efficacy and Trusted Ways Act of 2018 or the SAFETY Act of 2018
This bill amends the Federal Food, Drug, and Cosmetic Act to expand the authority of the Food and Drug Administration to refuse or withdraw approval for a new drug application if the drug is unsafe due to the risk of abuse or misuse.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5803 Introduced in House (IH)]

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115th CONGRESS
  2d Session
                                H. R. 5803

  To amend the Federal Food, Drug, and Cosmetic Act to authorize the 
 Secretary of Health and Human Services to consider the potential for 
misuse and abuse when determining whether to approve certain drugs, and 
                          for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 15, 2018

   Mr. Gene Green of Texas 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 authorize the 
 Secretary of Health and Human Services to consider the potential for 
misuse and abuse when determining whether to approve 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 ``Saving American Families through 
Efficacy and Trusted Ways Act of 2018'' or the ``SAFETY Act of 2018''.

SEC. 2. CONSIDERATION OF POTENTIAL FOR MISUSE AND ABUSE REQUIRED FOR 
              DRUG APPROVAL.

    (a) In General.--Section 505(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(d)) is amended--
            (1) in the first sentence--
                    (A) by striking ``or (7)'' and inserting ``(7)''; 
                and
                    (B) by inserting ``; or (8) if the drug is or 
                contains a controlled substance for which a listing in 
                any schedule is in effect under the Controlled 
                Substances Act or that is permanently scheduled 
                pursuant to section 201 of such Act, on the basis of 
                information submitted to him as part of the 
                application, or upon the basis of any other information 
                before him with respect to such drug, the drug is 
                unsafe for use due to the risks of abuse or misuse or 
                there is insufficient information to show that the drug 
                is safe for use considering such risks;'' before ``he 
                shall issue an order refusing to approve the 
                application''; and
            (2) in the second sentence, by striking ``(6)'' and 
        inserting ``(8)''. 
    (b) Withdrawal Authority.--Section 505(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended in the first 
sentence--
            (1) by striking ``or (5)'' and inserting ``(5)''; and
            (2) by inserting the following: ``; or (6) that, in the 
        case of a drug that is or contains a controlled substance for 
        which a listing in any schedule is in effect under the 
        Controlled Substances Act or that is permanently scheduled 
        pursuant to section 201 of such Act, on the basis of new 
        information before him with respect to such drug, evaluated 
        together with the information available to him when the 
        application was approved, that the drug is unsafe for use due 
        to the risks of abuse or misuse'' after ``of a material fact''.
    (c) Rule of Construction.--Nothing in the amendments made by this 
section shall be construed to limit or narrow, in any manner, the 
meaning or application of the provisions of paragraphs (1), (2), (3), 
(4), (5), and (7) of section 505(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(d)) or paragraphs (1) and (2) of section 
505(e) of such Act (21 U.S.C. 355(e)). 
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