Insights on Life Sciences

In his first major announcement since taking office, FDA Commissioner Scott Gottlieb, M.D. finalized a major reorganization plan that had been under development since 2013. 

With organic foods now accounting for over $40 billion in total US food sales, and the accompanying larger scale of organic operations, increased scrutiny of the integrity of the National Organic Program represents a natural progression in the evolution of the program’s history.

On April 28, Arent Fox LLP attorney Alexander H. Spiegler secured a final written decision in favor of Gowan Company.

This week, Sonny Perdue became the penultimate nominee for President Trump’s cabinet to be confirmed by the Senate.

As in previous years, 2016 brought us a combination of both expected and unexpected holdings by the Supreme Court and the Federal Circuit.

A recent string of advertising and privacy crackdowns on mobile health apps should have developers on high alert as regulators are scrutinizing advertising statements and privacy policies.

Arent Fox Intellectual Property Associate Christopher H. Yaen penned a recent article published in Law360 on the recent practice of the Patent Trial and Appeal Board with respect to the rejection of claims for being in “improper Markush” format.

National Academies of Sciences, Engineering, and Medicine committee concluded that the bioeconomy is growing rapidly and the US regulatory system needs to provide a balanced approach to the many competing interests.

Responding to requests from the cannabis industry, ASTM International, one of the world’s largest voluntary standards-developing organizations, recently announced plans to develop industry standards that would apply to “the full life cycle of cannabis” and consumable cannabis products.

The Food and Drug Administration has just announced that it will hold a Public Meeting on March 9, 2017 to discuss use of the term “healthy” in the labeling of human food products.

Last month, Baxter International Inc. and Baxter Healthcare Corporation settled a qui tam False Claims Act case with the Department of Justice for $18 million. The settlement is not monumental in terms of the amount, but does highlight the unique theory of FCA liability.

The White House issued an executive order on January 30, 2017 requiring agencies and executive departments to “identify at least two existing regulations to be repealed” whenever they propose or promulgate a new regulation.

The Federal Trade Commission has announced a proposed settlement and consent order in its investigation of a US-based water filtration company.

Earlier this month, FDA finalized Guidance for Industry, Assessment of Abuse Potential of Drugs. This guidance is intended to assist researchers and sponsors of new drugs that may have central nervous system (CNS) activity evaluate whether the drug has abuse potential.

In an interview with Dope Magazine, Food and Drug associate Emily Leongini discusses how the US Food and Drug Administration (FDA) is currently responding to the proliferation of state-legalized cannabis and how that could impact the growing cannabis industry.

What is most notable about this guidance is that FDA has taken the position that this type of information may be shared before a product has been approved. 

Today, January 19, 2017, FDA and USDA published a flurry of new policy documents related to the agencies’ regulation of plants, animals, and microorganisms produced using new breeding methods, like gene editing. 

Health Care partner Linda Baumann was heavily quoted in several Bloomberg BNA publications on the outlook for health care fraud and abuse enforcement in 2017.

On December 9, 2016, the Senate Agriculture Committee filed report language for the National Bioengineered Food Disclosure Law, the legislation signed into law by President Obama in July to amend the Agricultural Marketing Act of 1946.

On December 7, 2016, FDA published a Notice in the Federal Register announcing that its Center for Food Safety and Applied Nutrition will begin publishing data extracted from adverse event reports the Agency has received for conventional foods, dietary supplements, and cosmetics.

USDA’s Food Safety Inspection Service (FSIS) recently announced that meat and poultry products may use the Nutrition Facts label recently finalized by FDA earlier this year.

Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements.

A California federal court ruled in favor of the US Environmental Protection Agency and agricultural trade associations represented by Arent Fox LLP after a group of plaintiffs, including environmental activists, alleged that the federal agency had not done enough to regulate pesticide-coated seeds.