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SEC Files Disclosure Fraud Case Against Elan Corporation
Company Agrees To Settle Charges And Pay A $15 Million Penalty The Securities and Exchange Commission today announced the filing of a settled civil action against Elan Corporation, plc, a pharmaceutical company headquartered in Dublin, Ireland. The Commission charged Elan with violating the antifraud provisions of the federal securities laws for failing to disclose material information about the company's financial results in periodic reports filed with the Commission and in quarterly earnings press releases disseminated to investors in the United States.
According to the complaint, during 2000 and 2001, Elan represented in its public statements that it was generating record amounts of revenue, net income and operating cash flow from drug sales and licensing activities. Elan also claimed that it was making significant progress towards achieving its goal of transforming itself into a fully integrated pharmaceutical company and generating $5 billion of annual revenue by 2005. The complaint alleges that these statements were materially misleading because Elan failed to disclose, or inadequately disclosed, certain transactions that were critical to Elan's perceived success. As a result, investors were led to believe that Elan had achieved record results through improvements in the company's business, when in fact it had not.
Without admitting or denying the allegations in the complaint, Elan consented to the entry of a final judgment that permanently enjoins the company from violating the antifraud provisions of the federal securities laws, Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder, as well as the reporting and internal controls provisions, Sections 13(a) and 13(b)(2)(B) of the Exchange Act and Rules 12b 20, 13a 1 and 13a 16 thereunder. The judgment also orders Elan to pay $1 in disgorgement and a $15 million civil penalty, which is intended to be distributed to investors harmed by the alleged violations. The final judgment is subject to Court approval.
Many over the counter drugs were once prescription drugs
Americans buy about 5 billion over-the-counter drugs each year, according to government estimates, to treat their headaches, heartburn, coughs and colds, and other routine health problems. According to the Consumer Healthcare Products Association, a trade
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Definition:
A supplement is an application to allow a company to make changes in a product that already has an approved new drug application (NDA). CDER must approve all important NDA changes (in packaging or ingredients, for instance) to ensure the conditions origin
Product Number
Definition:
A product number is assigned to each drug product associated with an NDA (New Drug Application). If a drug product is available in multiple strengths, there are multiple product numbers.
Label
Definition:
The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety
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