PHARMACY

Judge overturns two provisions in FDA tobacco law

BY Allison Cerra

WASHINGTON A federal judge found that two provisions in a law gives the FDA regulatory control over tobacco unconstitutional.

The overturned stipulations included the ban of colorful cigarette ads and the prevention of tobacco companies from stating that their products are regulated by the Food and Drug Administration.

Tobacco companies — including R.J. Reynolds, maker of Joe Camel cigarettes and known for their eye-catching advertisements — argued that the conditions violate the companies’ right to free speech and expression.

Public health advocates fear that by permitting tobacco companies to claim their products are regulated by the FDA, the general public may view the products as safe, despite the warning labels they carry.

While supporters of the law were pleased with overall decision, namely, the American Heart Association, the federal judge’s decision to overturn such provisions could be harmful to the general population, the organization claimed.

“We strongly believe the two provisions that were struck down are essential to preventing tobacco use among children and educating consumers about the health hazards associated with smoking. Slick graphics, colors, and false claims of product safety will not disguise the fact that tobacco is a danger to smokers and nonsmokers alike,” said AHA CEO Nancy Brown, M.D.

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Report: Cipla in generic drug supply talks with GSK, Teva

BY Allison Cerra

NEW YORK An India drug maker is in generic drug supply talks with two companies, according to reports.

Cipla said it is in talks with GlaxoSmithKline and Teva to supply the companies with generic drugs.

“It may be specifically for one or two products — it is not a down-the-line drug deal,” Cipla chairman Yusuf Hamied told Reuters.

Cipla is one of the world’s biggest producers of low-cost antiretroviral drugs to fight HIV and AIDS. Last month, the company announced the launch of a generic H1N1 treatment.

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Taro elects directors in shareholders meeting; Sun disapproves

BY Allison Cerra

HAWTHORNE, N.Y. An Israeli drug maker said that its shareholders voted to elect all of the directors who were up for election, with the exception of the statutory external directors, at its annual shareholders meeting held Dec. 31.

The shareholders also approved the ratification of indemnification for non-executive directors and the appointment of the Taro’s independent auditors.

The company said that it stands behind its nominees for statutory external directors and their qualifications, and further stated that it would continue its efforts to elect statutory external directors as required by Israeli law, despite the efforts of Sun Pharmaceutical Industries to block their election. Sun has claimed that Barrie Levitt, Taro’s chairman, signed contractual obligation to sell Taro’s shares to Sun at a pre-defined price in June 2008. Sun said, however, that Levitt and the company “have prevented the close of this transaction through improper use of Taro resources.”

Sun has sought to acquire Taro for some time. In August 2008, Sun’s tender offer to acquire the company expired, but said that it would once again seek to acquire Taro. In late September, Taro sued Sun in the U.S. District Court for the Southern District of New York, alleging that Sun failed to disclose information to Taro shareholders, and misappropriating confidential information about Taro as part of its efforts to acquire the company – which it has sought to do since June 2008 – and illegally using it to undermine Taro’s relationships with customers and revenues.

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