HEALTH

Industry voices concern over Matrixx Initiatives AER case

BY DSN STAFF

WASHINGTON —The pharmaceutical industry earlier this month weighed in on the case “Matrixx Initiatives vs. James Siracusano and NECA-IBEW Pension Fund.”

Both the Consumer Healthcare Products Association and the Council for Responsible Nutrition, and separately the Natural Products Association, filed supporting briefs to the U.S. Supreme Court arguing that the mere nondisclosure of adverse event reports to shareholders should not give rise to liability under federal securities laws without applying a statistical significance standard. The Supreme Court had agreed to place the case on its docket in June.

“The statistical significance standard recognized by most courts of appeals appropriately recognizes that adverse event reports, standing alone, are not ‘material’ for purposes of federal securities laws,” CHPA and CRN wrote in its amicus curiae. “The statistical significance standard addresses the quality of the evidence of a relationship between an adverse event and a product, and therefore it is not the kind of ‘bright-line’ rule that [the Supreme] Court rejected in Basic Inc. vs. Levinson, 485 U.S. 224 (1988).”

“The practical consequence of the Ninth Circuit’s decision, if it is not reversed, is that manufacturers…very likely will be forced to disclose all AERs, however insignificant, in order to avoid meritless—but expensive—strike suits against the supplement industry,” said Jonathan Cohn, who authored the NPA’s separate amicus curiae.

“Companies cannot possibly guess in advance what will be deemed adequate disclosure years later in collateral litigation,” said Scott Bass, a partner at Sidley Austin, which is counsel for the NPA. “The [Dietary Supplement and Nonprescription Drug Consumer Protection Act] explicitly states that AERs are not proof of causation.”

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Pfizer recalls lot of ThermaCare HeatWraps Menstrual

BY Alaric DeArment

NEW YORK Pfizer’s over-the-counter division recalled one lot of a ThermaCare product over the possibility of leaks.

 

Pfizer Consumer Healthcare announced Friday the voluntary recall of lot number E06931 of its ThermaCare HeatWraps Menstrual product and notified the Food and Drug Administration.

 

 

The company said possible leaks in the wraps could cause skin injury, such as irritation and burning.

 

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AstraZeneca-Bristol drug just as effective as generic on market, trial results show

BY Alaric DeArment

STOCKHOLM An investigational diabetes drug works as well as a generic already on the market, according to results of a late-stage clinical trial announced Friday by AstraZeneca and Bristol-Myers Squibb.

 

The two companies said phase-3 trial results showed that their investigational drug dapagliflozin combined with the widely available generic metformin was as effective as glipizide combined with metformin, compared with metformin alone. In addition, patients in the dapagliflozin group experienced weight loss, compared with weight gain in those taking glipizide, as well as a reduced number of patients experiencing abnormally low blood sugar, known as hypoglycemia.

 

 

Results from the study were presented at the 46th annual meeting of the European Association for the Study of Diabetes.

 

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