Source: http://www.fdalawblog.net/2012/01/fda-denies-petition-seeking-to-add-application-information-to-drug-labels/
Timestamp: 2019-04-19 22:39:09+00:00

Document:
because an authorized generic drug shares the same NDA number as the branded innovator product, the authorized generic would not be identified separately from the branded drug in the Orange Book. Pharmacists could be confused when they look up an NDA number in the Orange Book and find only a listing for the innovator product (which would not match in certain respects the label of the authorized generic drug in hand).
because distributors that relabel or repackage drug products do not separately identify their products for listing in the Orange Book, such marketed drugs would not be traceable by searching the Orange Book. Pharmacists could be confused when they look up the application number in the Orange Book and find only a listing for the approved application holder (which would not match the label of the product in hand).
Finally, FDA notes that there are also several factors that need be taken into account when considering whether or not to amend the Agency’s drug label requirements, including “the Agency’s statutory mandate, space limitations, alternatives, potential for confusion, and potential safety risk.” “Weighing these and other considerations in deciding how to use agency resources to efficiently and effectively promote and protect the public health,” FDA concluded that it is not necessary at this time to amend its drug label regulations to require companies to identify the application number under which the product is approved and marketed.
Curiously, neither the citizen petition nor FDA’s response discusses now-repealed FDC Act § 301(l). Prior to the enactment of the 1997 FDA Modernization Act (“FDAMA”), FDC Act § 301(l) prohibited the use in labeling of any representation or suggestion that “approval of an application with respect to such drug . . . is in effect under section 505 . . . .” FDAMA § 421 removed this vestigial remnant of the 1938 FDC Act. Although the legislative history surrounding the repeal of FDC Act § 301(l) is a bit sketchy, it appears to be related to legislation introduced as far back as 1985 by Representative Henry Waxman (D-CA) – H.R. 2244, The FDA Approval Labeling Act – that proposed to amend the FDC Act to permit use of the statement “FDA Approved” in drug product labeling and advertising. Subsequent to the repeal of FDC Act § 301(l), FDA has stated, in the context of the promotion and advertising of a drug, that companies can use the statement “FDA Approved” in labeling pieces and advertisements for prescription drugs, provided the company has approval for the drug product with respect to which the statement is made.
We also note that in December 1998, FDA stated in a draft guidance document, titled “Placing the Therapeutic Equivalence Code on Prescription Drug Labels and Labeling” (FDA Docket No. 1998D-1266), that the Agency “believes it is legally permissible to allow the therapeutic equivalence code [identified in the Orange Book] linked to the proprietary name of the reference listed drug product to be placed on container labels and/or drug product labeling,” and that with the repeal of FDA Act § 301(l), “any legal arguments that therapeutic equivalence ratings should not be used in the labeling are moot.” FDA never finalized the draft guidance, and, in fact, removed the draft guidance from its website after receiving adverse comments. We understand that FDA currently has no public position on the issue of including in generic drug labeling a therapeutic equivalence code or similar information.
While we’re on the topic of application numbers, we thought it would be helpful to provide folks with a Rosetta Stone of sorts with respect to FDA’s application numbering system, which changed not too long ago with FDA’s implementation of the Document Archiving, Reporting and Regulatory Tracking System (“DARRTS”).

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