Industry voices concern over Matrixx Initiatives AER case
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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Re-evaluating Chinese currency remains a bad idea
WHAT IT MEANS AND WHY IT’S IMPORTANT Herbert Hoover is alive and well — and picking up his prescriptions at the local drug store.
(THE NEWS: Retailers urge Congress to reject Chinese currency legislation. For the full story, click here.)
Of course, he isn’t. But if he were, he might have some advice to offer current members of Congress and occupants of the White House based on his experience with the Smoot-Hawley Tariff Act of 1930, which attempted to rescue the U.S. economy by imposing tariffs on imported goods, but instead ignited a trade war that many historians blame for deepening the Great Depression.
The legislation to impose tariffs on Chinese imports as a way to force it to revalue the yuan is based on the assumption that China manipulates its currency to make its manufactured goods more competitive in the U.S. market. Thus, the reasoning goes, if China were to revalue the yuan, it would help American manufacturers by making Chinese imports more expensive and American goods more competitive in China, thereby helping to ease the U.S.-China trade deficit, which totaled $226.9 billion last year and has so far reached more than $145 billion this year, according to U.S. Census data.
But it’s not that simple. In 1930, the United States manufactured most of its own consumer goods; but that’s no longer true, and the bulk of consumer goods, from toys to digital cameras, now come from China. Also frequently lost in the melee is the fact that most of the supposedly Chinese goods are not Chinese at all, but rather products with American, Japanese, Korean and European brands that are assembled in China. Unlike in the 1970s and 1980s, when such Japanese companies as Sony were eating the lunch of such American counterparts as General Electric, the “Made in China” label now graces the products of both.
For that reason, if legislators imposed big tariffs on Chinese goods or if China dramatically revalued the yuan, it would simply force retailers to pass the extra costs to consumers. So after picking up his prescriptions, Hoover would find the digital camera he had planned to buy from behind the counter noticeably more expensive. While this would not likely lead to another Great Depression, it would certainly diminish consumers’ purchasing power.
As for the manufacturing jobs, many experts have said they would simply migrate to cheaper countries rather than returning to the United States. This trend already is under way in textiles, as many clothing companies have started moving factories from China to such countries as Bangladesh in response to the increasing costs of manufacturing in China.
Perrigo seeks approval for generic Zegerid OTC, Schering-Plough files suit
ALLEGAN, Mich. Perrigo has filed for regulatory approval of a generic version of an over-the-counter medication for frequent heartburn, prompting a lawsuit from the branded version’s manufacturer.
The company announced Friday that it had filed for approval for omeprazole and sodium bicarbonate in the 20 mg/1,100 mg strength. The medication is a generic version of Zegerid OTC, made by Schering-Plough HealthCare, a subsidiary of Merck.
Schering-Plough filed a lawsuit Monday alleging patent infringement in the U.S. District Court for the District of New Jersey to prevent Perrigo’s commercialization of the product.
Zegerid had sales of around $60 million during the 12-month period ended in the “most recent month,” according to SymphonyIRI Group.
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