The FDA has issued draft guidelines for THEA labeling updates after the withdrawal of reference drugs

July 8th, the FDA released draft guidelines for the ANDA label update after the withdrawal of the drug. Describes how the FDA expects ANDA applicants to respond in this situation and what type of changes are made.
THE FDA made it clear in its guidelines that the guidelines do not apply to the FDA's proposed labeling requirements for generic drugs, but said the guidelines provide the FDA's expectation that THEDA applicants will change labels under FDA guidance under certain circumstances or in supplementary applications (PAS) that have previously been approved. In footnote 11 to the draft guidelines, the FDA further recommends: "The FDA has issued proposed regulations that allow ANDA holders to independently submit CBE0-0 supplemental applications based on newly obtained information and to make certain safety-related updates to the labels." The proposed provision is still under review, together with the reviews collected. If the proposed provisions are finalized, the final provisions will determine the process of implementing label updates to the extent specified. The process described in this guide will not change the responsibility of ANDA holders to maintain the latest labels, whether within the current regulatory framework or in the event of the finalization of future proposed provisions.
FDA explains that OFTEN, when references to drugs (LD) are withdrawn for reasons other than safety or effectiveness, ANDA labels may need to be updated for reasons such as changes in the scientific literature, changes in adverse reaction reporting, or even changes in other RLD products that may contain the same or similar active ingredients, or changes in classification labels for specific treatment categories of drugs. The guide provides some examples but is not exhaustive.
addition, the FDA noted that NDARLD, which has ceased to sell on the market but has not been withdrawn, still has the same responsibility to guarantee the latest labels, even if the product is no longer sold.
Regarding the actions proposed in the draft guidelines, the FDA notes in footnote 7: "The methodology proposed in this guide is consistent with the FDA's statement that certain withdrawal drugs are not withdrawn for safety or validity reasons, including a statement to the general purpose that "if the FDA decides that the labels of these drugs should be revised to meet current standards, the FDA will recommend that ANDA applicants submit such labels." "See, for example, 80FR27320-27321 (2015.05.13) (deciding that SODIUMSULAMYD (sodium sulfonamide) eye drops and eye ointments are not withdrawn for safety and ability reasons)."
in this particular draft guideline, the FDA noted that ITA applicants could submit PAS for certain proposed changes or CBE-0 under FDA guidance. If submitted to PAS, the FDA will review the proposed changes and, if it believes that changes can be made, notify all bidders for the product that specific changes must be implemented for all the same products and announce the time limit for implementing the changes in accordance with the importance of the proposed changes.
FDA will take advantage of section 505 (o) (4) of the Mandatory Safety Label Change (SLC) Act and will direct the bider to implement the SLC as the FDA considers appropriate.
the draft guidelines prompt a change in the FDA's position on final labeling requirements? As noted above, the FDA has not given any clear views on this issue, but it is interesting to see that the FDA's proposal in this guide is similar to GPhA and PhRMA's alternative approach to generic labeling changes. The alternative is to use the FDA as the final arbiter before any changes are implemented.
FDA noted that label changes may be required under the guidelines if
is labeled consistent with other products with the same pharmacological or therapeutic classification as other active ingredients or an active ingredient, or, where appropriate, consistent with labels of other products approved for the same adaptation
to correct
outdated information relating to previously approved adaptations; The guide (e.g., according to s314.94 (a) (8) (iv)))
FDA further explains:
Specific examples of certain label changes that can be expected from the guidelines
The procedures used to implement the changes
the relationship between the guidelines and existing FDA mandates and procedures
since the guidelines are currently published in draft form, it is not clear when the FDA would like companies to begin implementing the provisions of the guidelines. Responsibility, costs and the impact on generics companies were not discussed, but they would certainly be asked by industry and lawyers. Generic drug companies need to keep an eye on any new developments in this draft guideline, as it could significantly affect the next steps.