Insights on Food, Drug, Medical Device & Cosmetic

The Department of Health and Human Services (HHS) has issued a proposed rule (PR) which would require any television advertisement for a drug or biological covered by Medicare or Medicaid to include a disclosure of the product’s “current list price” for a “typical” thirty day supply.

President Trump signed into law a bill that expands the Open Payments reporting requirements.

Partner Karen Carr will moderate the panel “Upcoming USDA Bioengineered Food Regulations” at FDLI’s Food Advertising, Labeling, and Litigation Conference on September 26-27 at Covington & Burling LLP in Washington, DC.

Forty Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2019.

Earlier this week the Court of Justice of the European Union, the EU’s highest court, issued a decision clarifying whether the EU would regulate products of innovative breeding techniques, like gene editing, under the EU’s Directive 2001/18, the principal EU law governing the regulation of GMOs.

On July 24, 2018, the House of Representatives approved 283-132 a bill (H.R. 184, the Protect Medical Innovation Act of 2017) to repeal the excise tax on the sale of a medical device by the manufacturer, producer, or importer.

The United States Department of Agriculture and the Food and Drug Administration have recently initiated processes to evaluate and propose revisions to their approaches to the regulation of products of agricultural biotechnology.

Late last week, the Food and Drug Administration declared its jurisdiction over animal cell culture technology through a public meeting announcement and a statement by Commissioner Scott Gottlieb.

The National Confectioners Association (NCA) have invited Arent Fox Partner Karen Carr to present a webinar on the bioengineered food disclosure rule proposed by the US Department of Agriculture on May 4, 2018.

Arent Fox Health Care Partner Stephanie Trunk will speak at CBI’s 14th Annual Medical Device Compliance Congress (MDCC).

Arent Fox Intellectual Property Partner Alex Spiegler and FDA Associate Emily Leongini will present at the International Bar Association (IBA) 6th Annual World Life Sciences Conference.

Arent Fox Associate Emily Leongini will speak at the Food and Drug Law Institute (FDLI) Annual Conference hosted May 3-4, 2018 in Washington, DC.

Karen Carr and Emily Leongini to Present at Q1’s Annual Food Labeling Conference. Arent Fox partner Karen Carr and associate Emily Leongini are scheduled to speak at the Q1 Productions’ 5th Annual Food Labeling Conference.

Arent Fox will host the reception for the New York State Bar Association’s (NYSBA’s) Food, Drug & Cosmetic Law Section Annual Meeting on January 25th, 2018 in its New York office.

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 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.”

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. 

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.