Perspectives on Life Sciences

Generic pharmaceutical drugs are versions of brand-name counterparts with one major difference: they typically cost a lot less.

As the dust settles on a campaign cycle that was unprecedented in many ways, we have composed this biennial post-election analysis to assist our clients in assessing the potential impact of the elections on their organizations and their industries.

Below is a roundup of headlines that matter and key takeaways from the industries and issues we’re following closely. We’ll be back later today with more in-depth analysis.

WASHINGTON — Twenty-four Arent Fox LLP practices have been recognized in the 2019 “Best Law Firms” rankings that are published annually by US News & World Report and Best Lawyers.

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.

Efforts to update FDA’s personal care products regulations continue as Rep. Jan Schakowsky (D-IL) recently introduced H.R. 6903, the “Safe Cosmetics and Personal Care Products Act of 2018.” 

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.

Intellectual Property Practice Group Co-Leaders Imron Aly and Sailesh Patel were featured in Leading Lawyers Magazine—2018 Business Edition for their successful track record in challenging giant pharmaceutical companies to bring generic drugs to the marketplace.

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.

Schiff Hardin has been ranked as ‘Recommended’ by Managing Intellectual Property magazine in the Illinois IP Stars Patent Contentious category.

Hatch-Waxman and Biosimilars Practice Group Leader Sailesh Patel was featured on the ongoing Biologics Price Competition and Innovation Act (BPCIA) Litigation he is watching.

A New Jersey-based company, Aromaflage, and its owners have agreed to settle charges brought by the Federal Trade Commission (FTC) regarding the company’s sale of sprays and candles that claim to be insect-repelling.

Hatch-Waxman and Biosimilars Practice Group Leader Imron Aly examines how current Hatch-Waxman legal proceedings can be applied to Biologics Price Competition and Innovation Act (BPCIA) litigation.

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.

Arent Fox is pleased to announce the launch of a new Blockchain group that pulls together attorneys from a number of the firm’s top practices to help clients navigate this emerging technology.

In the last 60 days, Schiff Hardin advised on the initial public offerings (IPO) for two companies and a public offering for another company, two in pharmaceuticals and one in the tech sector.

Yesterday, USDA formally announced that it “does not regulate or have any plans to regulate plants” created using new breeding techniques, such as gene editing, as long as such plants “are developed without the use of a plant pest as the donor or vector and they are not themselves plant pests.”

Partner Kevin Nelson was quoted on the Knowledge Ecology International’s urging of the National Institutes of Health (NIH) to leverage the Bayh-Dole Act in order to combat rising drug prices.