Insights on Life Sciences

As was widely reported, Congress approved legislation late Monday, January 22, 2018 to provide continuing appropriations for federal agencies through February 8, 2018, ending the government shutdown that began Saturday.

This year brought us very significant changes in patent jurisprudence from the Supreme Court and Federal Circuit affecting Chemical & Life Sciences patent practice.

Recently, the FDA announced that it does not intend to enforce certain provisions in four of the rules that implement the FDA Food Safety Modernization Act. 

The Pharmaceutical Research and Manufacturers of America (PhRMA) filed a lawsuit against the state of California in response to the state’s new drug price law. 

The US Food and Drug Administration recently issued warning letters to four companies.

On November 8, 2017, the Federal Trade Commission held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.”

Twenty-two Arent Fox LLP practices have been recognized in the 2018 “Best Law Firms” rankings that are published annually by U.S. News & World Report and Best Lawyers.

When the National Bioengineered Food Disclosure Standard was signed into law last year, it represented the culmination of an extended period of regulatory and legislative activity on food labeling issues.

The US Department of Agriculture needs to strengthen its controls over the approval and oversight of agreements for the import of organic products into the US, according to a recent audit report issued by the Office of the Inspector General at USDA.

The food industry potentially faces a new challenge on disclosure at the local level with the recent passage of a San Francisco ordinance addressing antibiotic use.

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations.

While acknowledging some notable challenges, a recent USDA study concluded that most consumers seeking information on their food purchases would be able to access this information, given the proper education and tools to do so.

Last week, FDA Commissioner Gottlieb issued a statement describing the Agency’s “new” policy for regulating stem cell therapies and regenerative medicine. 

Forty-two Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2018.

On July 21, the US District Court for the District of Columbia upheld FDA’s authority to regulate e-cigarettes and other electronic nicotine delivery systems (“ENDS”) as though they are tobacco, even though these products do not actually contain tobacco. 

One of the primary reasons the United States lacks a national animal identification system is the fervent perception among farmers and ranchers that such a system would result in government control over their livestock and an invasion of privacy.

On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and accelerating the access of the public to lower-cost alternatives to innovator drug therapies is maintained under the Drug Price Competition and Patent Term Restoration Act.

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.