Insights on Life Sciences

On July 7, 2015, the US Court of Appeals for the Ninth Circuit overruled a 23-year-old False Claims Act precedent, relaxing its test for deciding when a whistleblower can overcome a motion to dismiss because the allegations in the complaint were publicly disclosed. 

After a two-year bipartisan effort, the US House of Representatives approved the 21st Century Cures Act (H.R. 6), by an overwhelming vote of 344-77. 

In April, Senator Byron Dorgan published an article with Automotive Law360 following Toyota’s recent launch of the Mirai, a new hydrogen fuel cell car.

Automotive suppliers should take note that California’s Proposition 65 now imposes a duty on suppliers to warn consumers about risks associated with exposure to several plasticizers or softeners added to certain soft plastics that are commonly used in automotive products.

An Arent Fox team led by noted commercial litigator Hunter T. Carter prevailed at the US Court of Appeals for the Second Circuit.

Earlier this week, the owners of the egg distribution firm, Quality Egg, LLC (Quality Egg), were sentenced to three months in prison, given one year of supervised probation, and required to each pay a $100,000 fine after pleading guilty to selling eggs in 2010 that were contaminated with salmonella.

Last week, 14 state attorneys general sent a letter to Congress requesting that it investigate the herbal supplements industry, as well as consider giving the US Food and Drug Administration (FDA) stronger oversight authority over the marketing of such products in the US.

Recently, the US Food and Drug Administration issued a Warning Letter to L’Oreal USA for marketing its cosmetic products, “Rosalic AR Intense” and “Mela-D Pigment Control,” with claims deemed by FDA to be drug claims.

On January 28, 2015, Sen. Richard Durbin (D-IL) and Rep. Rosa DeLauro (D-CT) introduced respective companion food safety legislation in the Senate (S.287, the “Safe Food Act of 2015”) and House (HR.609).

The US Food and Drug Administration (FDA) recently issued a draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance — Questions and Answers — Draft Guidance for Industry and Food and Drug Administration Staff.”

The US Food and Drug Administration (FDA) recently issued a draft guidance document announcing that it does not intend to regulate low-risk products intended for general wellness only as medical devices.

The last decade has seen enormous growth in the human tissue products industry, following the Food and Drug Administration’s establishment, in 2001, of a tiered approach to the regulation of these products (referred to as “human cells, tissues and cell- and tissue-based products,” or “HCT/Ps”).

The Food and Drug Administration (FDA) has just issued its long-awaited Draft Guidance on Current Good Manufacturing Practice (CGMP) Requirements for Combination Products.

The Food and Drug Administration (FDA) has issued a dozen Warning Letters to dairy farms across the country.

The Food and Drug Administration (FDA) recently issued Guidance that describes circumstances that could occur during a drug facility inspection that might be deemed to constitute a “delay,” “denial,” “limitation,” or “refusal” of an inspection.

The US Food and Drug Administration (FDA) issued final regulations requiring that calorie information be listed on menus and menu boards in chain restaurants, and retail food establishments, and final regulations governing mandatory calorie declaration on food sold in vending machines.

The General Accounting Office (GAO) recently released a report critical of the Food and Drug Administration’s (FDA) and the United States Department of Agriculture’s (USDA) pesticide residue monitoring programs for food.

On September 30, 2014, the US Court of Appeals for the Ninth Circuit unanimously held that the first-in-the-nation Safe Drug Disposal Ordinance passed by Alameda County, California is constitutional.

On September 30, 2014, the US Court of Appeals for the Ninth Circuit unanimously held that the first-in-the-nation Safe Drug Disposal Ordinance passed by Alameda County, California is constitutional.

Washington, DC

On July 11, 2014, the FDA issued a new Draft Guidance (the Guidance) that will require drug companies to submit information on most drug samples that they distribute in the United States. The new Guidance is entitled “Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act.”

In an 8-0 decision, the US Supreme Court ruled last week that a private party may bring a Lanham Act claim challenging a food label regulated by the Federal Food Drug and Cosmetic Act (FDCA).

The US Supreme Court has agreed to consider a dispute between Pom Wonderful (Pom) and The Coca-Cola Company related to whether a drink label can be considered deceptive under federal false advertising laws, but permissible under regulations of the Food & Drug Administration (FDA).

On January 13, 2014, the FDA issued a Draft Guidance entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”

The US Food and Drug Administration recently published a proposed rule relating to food defense, as part of its implementation of the FDA Food Safety Modernization Act of 2011 (FSMA or the Act).