In a December 12 speech at the Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference, Food and Drug Administration (FDA) Commissioner Scott Gottlieb set out a number of oversight and enforcement priorities for 2019 and beyond.

While recognizing that many compliance issues with food and drug safety laws and regulations are unintentional and amount to good faith mistakes, Gottlieb stated that in an unfortunate number of cases, the misconduct runs deeper, and is often driven by greed. He was unequivocal in his position that FDA will aggressively pursue instances of intentional adulteration, fraudulent regulatory submissions, the sale of counterfeit, substandard, or unapproved medical products, and fraudulent marketing.

Gottlieb stated that FDA and its enforcement partners were doing “…all we can to take actions that deter future misconduct. That means sending a clear signal to would-be bad actors what whatever he economic incentives for the misconduct – and those incentives may be significant – we have the tools, the resources, and the commitment to identify violations, penalize bad actors, and protect the public health.”

Of particular interest to FDA in 2019 are issues related to drug compounding and over-the-counter, dietary supplements.

In the wake of the New England Compounding Center deaths in 2012,[1] FDA worked with Congress to implement stricter regulation of compounding facilities. Gottlieb noted that while significant progress has been made on bringing the industry into compliance, that a lot more needs to be done, and that compounders can expect “rigorous inspections to help firms understand what needs to be improved and taking swift action when we encounter conditions that put patients in harm’s way. That includes criminal enforcement.” Gottlieb cited the creation of an internal FDA task force assigned to take a “hard look” at compounding enforcement operations. The task force has already implemented new policies that help it swiftly move referrals to the Department of Justice (DOJ) when necessary. Gottlieb also boasted of working with DOJ in reaching multiple consent decrees over the last year and a half, enjoining compounders who persisted in violating the law.

Gottlieb also cited the explosive growth of the dietary supplement industry as cause for concern.  He remarked that the industry’s rate of growth had far outpaced FDA’s ability to manage the ensuing risks to consumers, stating that, “We’ve encountered a range of problematic conduct in this space as well.” He specifically cited the inclusion of dangerous and illegal ingredients (often unidentified in labeling), inadequate manufacturing processes and unproven claims about their ability to treat serious conditions as some of the primary concerns. A Dietary Supplement Working Group was formed in FDA to examine policies and procedures, with the stated goal of “modernizing” FDA’s approach to dietary supplements, including a look at “what more the FDA can be doing within our existing authorities…and what new authorities might make sense.”

The Health Care and Pharmacy Law attorneys at FisherBroyles are always ready and able to assist you with questions of FDA compliance. Questions may be directed to any of the following attorneys:

Brian Dickerson, FisherBroyles Partner
Brian E. Dickerson
brian.dickerson@fisherbroyles.com
202.570.0248

Anthony Calamunci, FisherBroyles Partner
Anthony Calamunci
Anthony.calaunci@fisherbroyles.com
419.376.1776

Nicole Waid, FisherBroyles Partner
Nicole Hughes Waid
nicole.waid@fisherbroyles.com
202.906.9572

Amy Butler, FisherBroyles Partner
Amy Butler
amy.butler@fisherbroyles.com
419.340.8466

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[1] In 2012, 753 people were sickened and 64 died after receiving injections of a contaminated drug produced by the New England Compounding Center.  The Center’s president and chief pharmacist were each ultimately convicted of racketeering and sentenced to significant terms of incarceration, though both escaped conviction on second-degree murder charges.