Pharmacia is requesting that FDA modify the physician package insert for Novartis' Transderm Scop motion sickness patch to remove a statement claiming superiority to OTC oral dimenhydrinate.

The scopolamine patch label statement, located in the "Clinical Results" section, reads: "Transderm Scop provided significantly greater protection than that obtained with oral dimenhydrinate." Dimenhydrinate is the active ingredient in Pharmacia's Dramamine.

The superiority claim is "simply false, rendering the product misbranded," Pharmacia maintained in a March 7 citizen petition. "The statement is not substantiated by the studies that [manufacturer] Alza submitted to FDA."

Rather, the labeling is "contradicted by the very language of the publications of those studies...and is refuted by the review article which the physician package insert cites," Pharmacia asserted.

Alza, which developed the patch, submitted three studies to FDA in 1979 comparing scopolamine to oral dimenhydrinate in different settings: calm seas, rough seas and motion simulator. While there was a favorable trend toward scopolamine, the studies failed to show a statistical significance between the drugs in either time to vomiting or frequency of vomiting.

Transderm Scop's labeling references a 1985 review article "which explicitly states that there is no proven difference in efficacy" between the drugs, Pharmacia said. Since the article contradicts the labeling, the reference "renders the physician package insert internally inconsistent and confusing," the firm said.

To address FDA's concerns about the studies at the time of Transderm Scop's approval, Alza submitted a statistical analysis pooling the data, which it said demonstrated the Rx patch's superiority. Pharmacia's citizen petition maintains, however, that the data cannot be combined because of the studies' different endpoints and methodologies.

The citizen petition further challenges that Novartis is "misusing" the physician package insert in DTC advertising comparing Transderm Scop to Dramamine. Claims that the patch is "clinically more effective than Dramamine" appear in print ads and on the brand's website.

FDA approved Transderm Scop labeling in 1979 "only after being told by Alza that its concerns about comparative language being 'primarily promotional' were wrong because the statement was intended to provide doctors with a clinical perspective," not to be used in consumer promotions, Pharmacia maintained.

"Over the past few years, however, Novartis has ignored that representation and has instead used the comparative physician packaging insert statement as support - indeed as the sole support - for its national comparative [DTC] advertising campaign."

Pharmacia made similar arguments in its case brought before the National Advertising Division of the Council of Better Business Bureaus. The ad review group agreed with Pharmacia and recommended Novartis modify the ads (¹ Also see "Novartis Transderm Scop Superiority Claims To OTC In DTC Ads Disputed" - Pink Sheet, 13 November, 2000.).

Novartis unsuccessfully appealed to the National Advertising Review Board. Novartis "offered nothing to substantiate the establishment claim...other than to rely on FDA's approval of the physician insert language," NARB concluded March 5.

Novartis is modifying Transderm Scop advertising to comply with NARB's ruling. The company is also preparing a response to Pharmacia's citizen petition.

While the voluntary NAD/NARB regulatory system typically has been used to settle consumer product disputes, the onset of prescription DTC ads has led to a rise in Rx drug cases.

NAD has jurisdiction in advertising cases where the "specific language" in an ad is not addressed by federal law or regulation, NARB's decision clarifies.

Novartis argued in its appeal that NAD should defer to FDA in the case, but NARB disagreed. "The FDA insert approval occurred more than 20 years ago, diminishing confidence that the same rigor and review that would likely be afforded today was present," especially since DTC ads were prohibited in 1979.

In addition, NARB maintained that "there is no agency decision-making trail that would inform the panel on FDA's rationale for allowing the insert statement," or that FDA would make the same decision today.

Novartis Transderm Scop Superiority Claim Disputed By Pharmacia In Petition

More from Archive

More from Pink Sheet