21 U.S.C. § 353d — Process to update labeling for certain generic drugs
submitted 88 years ago by Pub. L. 116-260 to r/title-21-FOOD-AND-DRUGS · 1,498 words · no verdicts yet
This law lets the FDA update outdated labels on certain generic drugs. It works when the original brand-name drug's approval lapsed and new science or accepted medical use isn't reflected on the label. The FDA notifies generic makers, who must agree to the change or explain why they won't.
(a) Definitions. This section uses five special terms. A "covered drug*" is a drug approved under section 355(c) that has no unexpired patents or exclusivity periods left, whose approval was withdrawn for a reason other than safety or effectiveness, and where at least one of these is true: there's new science about how it's used that the label* doesn't show; the label doesn't meet today's legal and regulatory format rules; or doctors commonly use it in a way the label doesn't mention. Updating the label must also benefit public health. "Period of exclusivity" means certain time periods where competitors are blocked from copying the drug, listed under specific parts of sections 355, 355a, 355f, and 360cc. A "generic version" is a drug approved under section 355(j) that copies a covered drug. A "relevant accepted use" is a use in medical practice backed by evidence that meets the Secretary's approval standards. A "selected drug" is a covered drug the Secretary* has decided, through the process in subsection (c), needs a label change.
(b) Identification of covered drugs. The Secretary may look for covered drugs whose labels should be updated. To help find them, the Secretary may hire outside groups to study the science, or ask the public for input — through public meetings, written comments, or other methods — about whether doctors' accepted use isn't reflected on the label or whether new science exists.
(c) Selection of drugs for updating. If the Secretary decides the available science meets section 355's standards for adding, changing, or supplementing the label, the Secretary may start the process described in subsection (d).
(d) Initiation of the process. The Secretary must notify each company holding an approved generic version of the drug. The notice must: (1) summarize the findings behind the Secretary's decision; (2) clearly state what information should be added, changed, or supplemented — including adding the accepted use as a new label indication; and (3) say whether the change applies to the whole class of that drug's generics or to just one specific product.
(e) Response to notification. Within 30 days of the notice, each generic maker must either (1) agree to make the change, or (2) tell the Secretary it disagrees and submit a written statement explaining why the changes aren't warranted.
(f) Review of the maker's response. If a maker disagrees, the Secretary must promptly review the reasons. If the Secretary still disagrees, the Secretary must offer to discuss the disagreement with the maker to try to reach agreement on whether and how the label should change. After considering all responses and any discussion, the Secretary may order the maker to make the label changes the Secretary decides are appropriate. If ordered, the maker must: (A) update the paper label the next time it's printed; (B) update any electronic label within 30 days of the order; and (C) file the change using the "Supplement—Changes Being Effected" form.
(g) Violation. If a maker doesn't follow subsection (f)(2)'s requirements after being ordered, its generic drug is treated as misbranded under section 352.
(h) Limitations for generic drugs. (1) A generic drug is treated as having the same conditions of use and the same label as its reference brand-name drug for purposes of certain approval rules; a label change ordered under this section has the same legal effect on the maker as if it had filed and received approval for an ordinary supplemental label update matching a change to the brand-name drug's label. (2) Label changes made under this section can't earn the maker any exclusivity period. (3) The Secretary can't pick a drug as "covered" or select its label for updating based only on new safety information. But once a drug is already identified as covered for other reasons, the Secretary may then also weigh new safety information (as defined in section 355–1(b)) in deciding whether to select it and what changes to make.
(i) Rules of construction — ways this section should not be read. (1) It doesn't change the normal standards for approving drug applications under section 355; any change ordered under this section must still meet those same approval standards. (2) It doesn't give the Secretary any new power to remove an approved use from a drug's label, beyond the authority already described in this section. (3) It doesn't limit the Secretary's separate power to order label changes under section 355(o). (4) It doesn't change a generic maker's existing duty to keep its label updated under the usual FDA regulations, including subpart B of part 201 and sections 314.70 and 314.97 of title 21 of the Code of Federal Regulations.
(j) Reports. Starting no later than four years after December 27, 2020, and every four years after that, the Secretary must send a report to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions. The report must (1) describe the Secretary's actions under this section, including how many and what kinds of covered drugs were selected for label changes and why, and how many times the Secretary entered discussions over a disagreement with a maker and what was decided, if anything; and (2) include any recommendations the Secretary has for improving this program.
For purposes of this section:
The term “covered drug*” means a drug approved under section 355(c) of this title—
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;
for which the approval of the application has been withdrawn for reasons other than safety or effectiveness; and
for which—
there is new scientific evidence available pertaining to new or existing conditions of use that is not reflected in the approved labeling*;
the approved labeling does not reflect current legal and regulatory requirements for content or format; or
there is a relevant accepted use in clinical practice that is not reflected in the approved labeling; and
updating the approved labeling would benefit the public health.
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.
The term “generic version” means a drug approved under section 355(j) of this title whose reference listed drug is a covered drug.
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.
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.
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:
Enter into cooperative agreements or contracts with public or private entities to review the available scientific evidence concerning such drugs.
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—
holding one or more public meetings;
opening a public docket for the submission of public comments; or
other means, as the Secretary determines appropriate.
If the Secretary determines, with respect to a covered drug, that the available scientific evidence meets the standards under section 355 of this title for adding or modifying information to the labeling or providing supplemental information to the labeling regarding the use of the covered drug, the Secretary may initiate the process under subsection (d).
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—
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);
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
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*.
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—
agree to change the approved labeling to reflect the additional, modified, or supplemental information the Secretary has determined to be appropriate; or
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.
Upon receipt of the application holder’s response, the Secretary shall promptly review each statement received under subsection (e)(2) and determine which labeling changes pursuant to the Secretary’s notice under subsection (d) are appropriate, if any. If the Secretary disagrees with the reasons why such labeling changes are not warranted, the Secretary shall provide opportunity for discussions with the application holders to reach agreement on whether the labeling for the covered drug should be updated to reflect available scientific evidence, and if so, the content of such labeling changes.
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—
update its paper labeling for the drug at the next printing of that labeling;
update any electronic labeling for the drug within 30 days of such order; and
submit the revised labeling through the form, “Supplement—Changes Being Effected”.
If the holder of an approved application for the generic version of the selected drug does not comply with the requirements of subsection (f)(2), such generic version of the selected drug shall be deemed to be misbranded under section 352 of this title.
With respect to any labeling change required under this section, the generic version shall be deemed to have the same conditions of use and the same labeling as its reference listed drug for purposes of clauses (i) and (v) of section 355(j)(2)(A) of this title. Any labeling change so required shall not have any legal effect for the applicant that is different than the legal effect that would have resulted if a supplemental application had been submitted and approved to conform the labeling of the generic version to a change in the labeling of the reference drug.
Changes to labeling made in accordance with this section shall not be eligible for an exclusivity period under this chapter.
The Secretary shall not identify a drug as a covered drug or select a drug label* for updating under subsection (b) or (c) solely based on the availability of new safety information. Upon identification of a drug as a covered drug under subsection (b), the Secretary may then consider the availability of new safety information (as defined in section 355–1(b) of this title) in determining whether the drug is a selected drug and in determining what labeling changes are appropriate.
This section shall not be construed as altering the applicability of the standards for approval of an application under section 355 of this title. No order shall be issued under this subsection unless the scientific evidence supporting the changed labeling meets the standards for approval applicable to any change to labeling under section 355 of this title.
Nothing in this section shall be construed to give the Secretary additional authority to remove approved indications for drugs, other than the authority described in this section.
Nothing in this section shall be construed to limit the authority of the Secretary to require labeling changes under section 355(o) of this title.
Nothing in this section shall be construed to affect the responsibility of the holder of an approved application under section 355(j) of this title to maintain its labeling in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and 314.97 of title 21, Code of Federal Regulations (or any successor regulations).
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—
describes the actions of the Secretary under this section, including—
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
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
includes any recommendations of the Secretary for modifying the program under this section.
Source credit: (June 25, 1938, ch. 675, § 503D, as added Pub. L. 116–260, div. BB, title III, § 324, Dec. 27, 2020, 134 Stat. 2933.)
- 1938Enacted · Pub. L. 116-260 · 134 Stat. 2933
A history note hasn’t been published yet. The record shows enactment by Pub. L. 116-260 on 1938-06-25.
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