An Allegheny County judge has ruled that the "different manufacturers exception" to 21 U.S.C. Section 355(j)(2)(A)(v), which permits a generic drugmaker’s warning label to deviate from the brand-name manufacturer’s label in certain respects, does not allow generic manufacturers to include warnings that are not also disclosed on the brand-name equivalent’s label.
In Krelic v. Mutual Pharmaceuticals, Allegheny County Court of Common Pleas Senior Judge R. Stanton Wettick Jr. granted defendant Mutual Pharmaceuticals’ motion to dismiss the plaintiffs’ failure-to-warn claims on the grounds that the claims were pre-empted by federal law.
Wettick said the different manufacturers exception, which requires that a generic drug get the same label as its brand-name equivalent "’except for changes required because of differences approved under a petition … or because the new drug and the listed drug are produced by or distributed by different manufacturers’" does nothing to change the U.S. Supreme Court’s 2011 holding in Pliva v. Mensing.
In Pliva, according to Wettick, the court ruled that state law requiring a generic manufacturer to use different safety and efficacy labeling than the brand-name manufacturer is pre-empted by federal law, which requires that the generic drugmakers use the labeling that has already been approved by the U.S. Food and Drug Administration for the brand-name drug.
Wettick said the different manufacturers exception does not allow generic manufacturers to deviate from this mandate.
"The different manufacturers exception refers to changes ‘required’ because the manufacturers are different," Wettick said. "The use of the word ‘required’ refers to changes to the label of the generic manufacturer that are triggered by the manufacturer of the generic drug not being the same as the manufacturer of the brand-name drug. The active ingredients of a generic and a brand-name drug are identical, so changes are not ‘required’ with respect to warnings and other safety-related information."
In Krelic, according to Wettick, plaintiffs Curt and Diane Krelic filed suit, alleging Mutual Pharmaceuticals had failed to change its label to include a warning about the risk of developing central serous retinopathy as a side effect.
Mutual Pharmaceuticals, however, argued that the claim was pre-empted, and Wettick agreed.
Wettick said that, because most drugs on the market are generic, the plaintiffs’ interpretation of the different manufacturers exception would cause the requirement that generic drugs use the same FDA-approved label as the brand-name manufacturer to be "rendered almost meaningless."
Wettick pointed to 21 C.F.R. Section 314.94(a)(8)(iv), in which the FDA characterized the scope of the different manufacturers exception as allowing for "’differences in expiration date, formulation, bioavailability, or pharmacokinetics, labeling revisions made to comply with current FDA labeling guidelines or other guidance, or omission of an indication or other aspect of labeling protected by patent or accorded exclusivity under Section 505(j)(5)(F) of the act.’"
In addition, according to Wettick, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, wrote in a February 2012 letter that the FDA has interpreted the different manufacturers exception "’to apply when the [generic drug] differs in an aspect that is not required by the statute or regulation to be the same as the [brand-name drug] (e.g. a difference in inactive ingredients).’"
Wettick said that when the brand-name and generic manufacturer are separate entities, which is typically the case, the inactive ingredients of the two drugs don’t need to be the same.
"Thus, the labeling as to the inactive ingredients need not be the same," Wettick said, but noted that Woodcock also said in her letter that the active ingredients in both drugs must be identical and therefore both drugs require identical warnings listing the side effects and safety of the active ingredients.
Wettick said he also found Pliva’s argument before the U.S. Supreme Court to be persuasive.
According to Wettick, Pliva had noted that the FDA rejected two comments it received when it proposed the generic manufacturers exception that had asked for allowance of generic labels to deviate from brand-name labels by including additional contraindications, precautions, warnings, adverse reactions and other safety information.
Wettick noted that neither the plaintiffs’ brief nor any of the amicus briefs filed in the Pliva case addressed the different manufacturers exception.
In addition, Wettick said, the dissenting opinion in Pliva characterized the majority’s holding as applying to all generic drugs.
"The only explanation for the failure of the briefs supporting plaintiffs or the Supreme Court’s opinions in Pliva to discuss the different manufacturers exception is that the exception does not permit different labeling as to safety and efficacy," Wettick said.
Counsel for the plaintiffs, Daniel W. Ernsberger of Behrend & Ernsberger in Pittsburgh, could not be reached for comment.
Counsel for Mutual Pharmaceuticals, Constantine J. Passodelis of JonesPassodelis in Pittsburgh, declined to comment.
(Copies of the 11-page opinion in Krelic v. Mutual Pharmaceuticals, PICS No. 13-1028, are available from The Legal Intelligencer. Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information.) •