Brian J. Malkin

The Food, Drug and Cosmetic Law Section this year has focused its program in selecting topics of a cross-functional nature, as discussed below.

Tobacco Product Law

First, a panel will address a new initiative undertaken by the U.S. Food and Drug Administration (FDA) to reduce the highly-addictive drug, nicotine, found in most tobacco products. Next, the panel will consider how the Center for Tobacco Products (CTP) utilizes a substantial equivalence process for certain tobacco products that shares many similarities with substantial equivalence used for 510(k)-type medical devices, as well as another look at tobacco flavors.

Animal Health Law

The Animal Health Law Panel then plans to discuss leveraging approved human drugs in the process to obtain animal drug approvals and features speakers from animal health companies offering their perspectives on key features in the animal drug regulatory approval process and business considerations affecting the process.

Food Law

Next, the Food Law panel features speakers discussing issues related to genetically-modified organisms (GMOs) that result in food and animal products tied to how the FDA and the U.S. Department of Agriculture (USDA) regulates those products. The science that brings us to GMOs are genes and biologic manipulation, which shares some technologic features to gene-based therapies that will be discussed in the biologics and medical device panels.

Biologics Law

The Section’s Biologics panel features discussions on FDA’s approval of the first gene therapies, intellectual property considerations for patenting such therapies, and an update on biosimilar market entrants, and how the Supreme Court decision on the biosimilar litigation process has raised strategy questions for prospective biosimilar applicants. This panel features speakers from both FDA’s Center for Biologics Evaluation and Research and the New York Genome Center.

Ethics

An ethics panel designed for attorneys involving early access promises to provide many insights into how human subjects can be protected and potentially benefit when using unapproved medical therapies, which has been a hot topic, where increased drug access has been emphasized.

Drug Law

Following ethics, a drug law panel with the New York Attorney General’s Health Care Bureau Chief will discuss how New York is addressing the opioid drug crisis, and then will include a lively debate between a distinguished academic and former Assistant Director of the U.S. Federal Trade Commission (FTC) (now litigator), considering how generic competition may be encouraged by additional FDA/FTC statutory or regulatory measures. This panel also includes a discussion of a new tactic to avoid potentially certain pharmaceutical patent challenges involving patent ownership by Indian tribes or state entities and the invocation of sovereign immunity.

Medical Device Law

The program concludes with a medical device panel focusing on device and software regulation following the 21st Century Cures Act, safety, privacy and data/cyber-security in an era of digital devices, and FDA’s evolving policy on personalized medicine, featuring a discussion on gene-based tests.

Brian J. Malkin is counsel at Arent Fox.