Today’s forecast: partly cloudy with a chance of law news: Will California lawmakers succeed in keeping fracking out of the state? (LXBN) Could President Obama’s proposed new cap on tax-favored retirement benefits do a lot more harm than good? (Osler) According to FINRA, employee social media privacy laws may conflict with securities regulations and threaten… Read more »
“The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision.” (Sheppard Mullin) Earlier this month, the Ninth Circuit issued an opinion that sends an important warning to pharmaceutical manufacturers: the First Amendment doesn’t protect off-label marketing… Read more »
From online privacy, to revised labor laws, to health care considerations, and more … here’s a roundup of recent legal advisories covering a broad range of issues on doing business in the People’s Republic of China. For your reference: Privacy in China: New Rule to Protect Personal Information (Dechert LLP): “The Standing Committee of the… Read more »
“In an opinion that will certainly be welcomed by many in the industry, the court rejected the government’s interpretation of the Food, Drug and Cosmetic Act’s (FDCA) misbranding provisions, holding, ‘We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful off-label use of an… Read more »
Earlier this month, the Federal Trade Commission proposed a new set of reporting requirements for the acquisition or transfer of pharmaceutical patents. From the FTC press release: “The Federal Trade Commission is seeking public comments on proposed changes to the premerger notification rules that could require companies in the pharmaceutical industry to report proposed acquisitions… Read more »
On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. The new legislation extends through 2017 the FDA’s program of charging user fees on drug applications – used to pay the agency’s employee salaries – in exchange for a quicker and more transparent product review process.… Read more »
For your convenience, recent legal advisories on a broad range of corporate issues related to doing business in and with China: China’s Anti-Monopoly Law Makes it Easier to Sue in Cases of Anti-Competitive Conduct (McDermott Will & Emery) “Recently, the Supreme People’s Court of China issued final rules to build a working framework for civil… Read more »
On April 17, 2012, the Supreme Court ruled in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S that generic drug makers can sue brand-name drug makers when the latter claim exaggerated descriptions of indications covered by their patented drugs. The Food and Drug Administration has historically allowed brand-name drug makers to write their own descriptions… Read more »
On March 12, 2012, India’s Patent Office granted Indian drug manufacturer Natco Pharma a compulsory license to sell a generic version of Bayer AG’s kidney and liver cancer drug Nexavar. It’s the first time an Indian company has been granted a compulsory license under the Indian Patent Act of 2005, the law which allows the… Read more »
On February 9, The Food and Drug Administration released its draft guidelines for drug makers on the abbreviated approval pathway for biosimilars, a move that could open the door to cheaper generic versions of branded biotech drugs. For your reference, here’s a roundup of legal commentary on the proposed rules: FDA Publishes Draft Guidelines for… Read more »
It’s estimated that one in five prescriptions treat ailments other than those for which the drug was originally intended. Off-label use of pharmaceuticals and medical devices, as this practice is called, is big business. But for manufacturers seeking to inform the public about the benefits and dangers of using medications off-label, it’s also risky business: while… Read more »
