21 USC 353d - Process to update labeling for certain generic drugs

U.S Code last checked for updates: Feb 22, 2025

§ 353d.

Process to update labeling for certain generic drugs

(a)

Definitions

For purposes of this section:

(1)

The term “covered drug” means a drug approved under section 355(c) of this title—

(A)

for which there are no unexpired patents included in the list under section 355(j)(7) of this title and no unexpired period of exclusivity;

(B)

for which the approval of the application has been withdrawn for reasons other than safety or effectiveness; and

for which—

(i)

(I)

there is new scientific evidence available pertaining to new or existing conditions of use that is not reflected in the approved labeling;

(II)

the approved labeling does not reflect current legal and regulatory requirements for content or format; or

(III)

there is a relevant accepted use in clinical practice that is not reflected in the approved labeling; and

(ii)

updating the approved labeling would benefit the public health.

(2)

The term “period of exclusivity”, with respect to a drug approved under section 355(c) of this title, means any period of exclusivity under clause (ii), (iii), or (iv) of section 355(c)(3)(E) of this title, clause (ii), (iii), or (iv) of section 355(j)(5)(F) of this title, or section 355a, 355f, or 360cc of this title.

(3)

The term “generic version” means a drug approved under section 355(j) of this title whose reference listed drug is a covered drug.

(4)

The term “relevant accepted use” means a use for a drug in clinical practice that is supported by scientific evidence that appears to the Secretary to meet the standards for approval under section 355 of this title.

(5)

The term “selected drug” means a covered drug for which the Secretary has determined through the process under subsection (c) that the labeling should be changed.

(b)

Identification of covered drugs

The Secretary may identify covered drugs for which labeling updates would provide a public health benefit. To assist in identifying covered drugs, the Secretary may do one or both of the following:

(1)

Enter into cooperative agreements or contracts with public or private entities to review the available scientific evidence concerning such drugs.

(2)

Seek public input concerning such drugs, including input on whether there is a relevant accepted use in clinical practice that is not reflected in the approved labeling of such drugs or whether new scientific evidence is available regarding the conditions of use for such drug, by—

(A)

holding one or more public meetings;

(B)

opening a public docket for the submission of public comments; or

(C)

other means, as the Secretary determines appropriate.

(c)

Selection of drugs for updating

(d)

Initiation of the process of updating

If the Secretary determines that labeling changes are appropriate for a selected drug pursuant to subsection (c), the Secretary shall provide notice to the holders of approved applications for a generic version of such drug that—

(1)

summarizes the findings supporting the determination of the Secretary that the available scientific evidence meets the standards under section 355 of this title for adding or modifying information or providing supplemental information to the labeling of the covered drug pursuant to subsection (c);

(2)

provides a clear statement regarding the additional, modified, or supplemental information for such labeling, according to the determination by the Secretary (including, as applicable, modifications to add the relevant accepted use to the labeling of the drug as an additional indication for the drug); and

(3)

states whether the statement under paragraph (2) applies to the selected drug as a class of covered drugs or only to a specific drug product.

(e)

Response to notification

Within 30 days of receipt of notification provided by the Secretary pursuant to subsection (d), the holder of an approved application for a generic version of the selected drug shall—

(1)

agree to change the approved labeling to reflect the additional, modified, or supplemental information the Secretary has determined to be appropriate; or

(2)

notify the Secretary that the holder of the approved application does not believe that the requested labeling changes are warranted and submit a statement detailing the reasons why such changes are not warranted.

(f)

Review of application holder’s response

(1)

In general

(2)

Changes to labeling

After considering all responses from the holder of an approved application under paragraph (1) or (2) of subsection (e), and any discussion under paragraph (1), the Secretary may order such holder to make the labeling changes the Secretary determines are appropriate. Such holder of an approved application shall—

(A)

update its paper labeling for the drug at the next printing of that labeling;

(B)

update any electronic labeling for the drug within 30 days of such order; and

(C)

submit the revised labeling through the form, “Supplement—Changes Being Effected”.

(g)

Violation

(h)

Limitations; generic drugs

(1)

In general

(2)

Supplemental applications

(3)

Selection of drugs

(i)

Rules of construction

(1)

Approval standards

(2)

Removal of information

(3)

Secretary authority

(4)

Maintenance of labeling

(j)

Reports

Not later than 4 years after December 27, 2020, and every 4 years thereafter, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, a report that—

(1)

describes the actions of the Secretary under this section, including—

(A)

the number of covered drugs and description of the types of drugs the Secretary has selected for labeling changes and the rationale for such recommended changes; and

(B)

the number of times the Secretary entered into discussions concerning a disagreement with an application holder or holders and a summary of the decision regarding a labeling change, if any; and

(2)

includes any recommendations of the Secretary for modifying the program under this section.

(June 25, 1938, ch. 675, § 503D, as added Pub. L. 116–260, div. BB, title III, § 324, Dec. 27, 2020, 134 Stat. 2933.)

cite as: 21 USC 353d