Perspectives on Life Sciences

Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy, with a 60-day comment period ending around September 3, 2017.

Continuing a trend that is certain to keep growing, three consumer groups recently filed a lawsuit against Sanderson Farms alleging false advertising for their poultry products labeled “100 percent natural.”

On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency’s rules have been, in the agency’s view, “gamed” to create obstacles that delay generic drug approvals to reduce generic competition.

In a widely anticipated move, the FDA announced this week that it will extend the July 2018 compliance date for the revision to the Nutrition Facts panel. The revised panel will display calories more prominently on the label, as well as list added sugars.

The 2017 edition of Legal 500 US has rated 50 Arent Fox LLP attorneys as national leaders in their field. In addition, 17 of the firm’s practice areas were ranked among the best in the country. Legal 500 highlighted Arent Fox’s extensive capabilities across a number of areas of the law.

Chambers USA: America’s Leading Lawyers for Business has recognized 32 Arent Fox LLP attorneys as leaders in their field.

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.