Regulatory and Washington

NEW YORK — The National Advertising Division has referred to the Federal Trade Commission advertising claims made by Brain Research Labs, for Procera AVH, following the company’s failure to abide by the terms of an NAD decision.

In an underlying 2009 decision, NAD recommended that the advertiser discontinue a wide range of claims and testimonials for Procera AVH, including the unqualified claim that Procera AVH was “clinically shown to restore the memory and brain power you had 10-15 years ago" and claims that the product is “fast-acting.”

WASHINGTON — The Biotechnology Industry Organization and the Indiana Health Industry Forum on Thursday commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

The policies outlined in the identical SB 262 align with BIO’s principles on biologic substitution, therefore BIO and IHIF support passage of this bill as it moves along for consideration by the Indiana House of Representatives.

PROVIDENCE, R.I. — A proposed state health department regulation that would require children up to ages 5 years and older to get an annual flu immunization and would keep those with medical exemptions out of school or day care during flu outbreaks has received opposition from the Rhode Island chapter of the American Civil Liberties Union, according to the Associated Press.

SILVER SPRING, Md. — A pair of Food and Drug Administration advisory committees will be meeting Feb. 10 to talk about heart risks associated with use of NSAIDs and whether or not Bayer's Aleve (naproxen) carries a lower risk profile than other NSAIDs. The FDA is also considering potentially revoking OTC status of certain nonprescription NSAIDS, according to published reports. 

WASHINGTON — A call to make 2014 a year of action and for the government to work on behalf of Americans was the underlying theme of President Obama’s State of the Union address Tuesday evening.

During his remarks, Obama touched upon a string of topics ranging from immigration reform, to education, to job creation. He also called for the raising of minimum wage and urged businesses to do what they can to raise employees’ wages, citing Costco as an example.

NEW YORK — The Veterans Health Administration is weighing new guidelines that would enable nurse practitioners with advanced education to practice medicine without direct supervision by physicians — a move that is being applauded by the dean of Columbia University School of Nursing.

In 2012, compounding made headlines when 64 people died as a result of fungal meningitis caused by contaminated compounded products.

History

DUBLIN — Actavis last week announced that it has signed and completed an agreement for Zhejiang Chiral Medicine Chemicals Co. to acquire Actavis' interest in Actavis (Foshan) Pharmaceuticals Co., an Actavis subsidiary based in Foshan, China.  

Actavis intends to continue further commercial operations in China in collaboration with its preferred business partners.