Opinion ID: 2780871
Heading Depth: 2
Heading Rank: 2

Heading: Changing The Label

Text: There are two ways pertinent to this lawsuit in which a manufacturer of a brand name prescription drug can change the drug's label. First, the default rule is that a manufacturer must secure FDA approval for a proposed change prior to distributing the product with the changed label. 21 C.F.R. § 314.70(b)(2)(v)(A). -6- Second, under what is known as the Changes Being Effected (CBE) regulation, id. § 314.70(c)(6)(iii), a manufacturer can make certain types of changes to its label, without prior FDA approval, by sending the FDA a supplement submission. To make a change under the CBE regulation, the manufacturer must satisfy at least two requirements. First, the change must reflect newly acquired information. Id.; see also id. § 314.3(b) (defining newly acquired information). Second, the change must be for the purpose of accomplishing at least one of the five following objectives: (A) To add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling . . .; (B) To add or strengthen a statement about drug abuse, dependence, psychological effect, or overdosage; (C) To add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product; (D) To delete false, misleading, or unsupported indications for use or claims for effectiveness; or (E) Any labeling change normally requiring a supplement submission and approval prior to distribution of the drug product that FDA specifically requests be submitted under this provision. Id. § 314.70(c)(6)(iii). -7-