H.R. 5803 – SAFETY Act of 2018

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Updated April 15, 2026 at 9:44 PM UTC

The SAFETY Act of 2018 would change the federal drug‑approval process by requiring the Health and Human Services Secretary to evaluate the potential for misuse or abuse of a drug—especially those that are or contain controlled substances—when deciding whether to approve it. It also adds a new reason for the Secretary to withdraw an already‑approved drug if new information shows it poses abuse‑related safety risks. The changes affect all pharmaceutical companies seeking FDA approval and any existing drug products that contain controlled substances.

Key Provisions

Amends the FDA’s drug‑approval criteria (section 505(d)) to allow the Secretary to refuse approval if a drug is unsafe because of abuse or misuse risks, or if there isn’t enough information to assess those risks.
Adds a new ground for withdrawing an approved drug (section 505(e)) when new data indicate the drug is unsafe due to abuse or misuse, particularly for drugs that are or contain controlled substances.
Includes a rule of construction stating that these amendments do not limit any other existing approval or withdrawal criteria in the law.

Legislative Activity

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HouseIntro Referral Latest Action

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

May 15, 2018

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HouseIntro Referral

Introduced in House

May 15, 2018

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

May 15, 2018

Bill Text

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Introduced in HouseIssued May 15, 2018

I

115th CONGRESS

2d Session

H. R. 5803

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.

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.

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)).