AGG Food and Drug Newsletter - July 2019

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice.

Industry Insights

OPDP Sends Second Enforcement Letter of the Year
By: Alan G. Minsk and Seth S. Ray

The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) recently sent an Untitled Letter to the manufacturer of a weight-loss drug for its Internet promotion. According to OPDP, the homepage of the consumer website made false or misleading claims about the efficacy and risks associated with the drug. OPDP found this misleading consumer-directed presentation to be “especially concerning,” because obesity and excessive weight are significant public health concerns that affect millions of people and are associated with numerous co-morbidities. More >

Influencers Take Note: OPDP Issues Untitled Letter Regarding an Interview with a Brand Spokesperson
By: Seth S. Ray, Christine Kirk and Genevieve M. Razick

On June 14, 2019, FDA’s Office of Prescription Drug Promotion (OPDP) issued an Untitled Letter regarding a direct-to-consumer video of an interview featuring a paid company spokesperson. Among other violations, OPDP noted that the video does not present balanced risk and benefit information and that it makes false or misleading claims or representations about the risks and efficacy of the promoted product. More >

HUBs: The Good, The Bad, The Balance
By: Alan G. Minsk and Genevieve M. Razick

While there can be different models, hubs generally serve as a single point-of-contact for manufacturers to ensure efficient medication distribution. They can be standalone entities or partner with specialty pharmacies and perform a number of key functions, i.e., reimbursement services. We have answered a number of questions from pharmaceutical clients on the topic of hubs and regulatory compliance. This Bulletin summarizes, at a very high level, the nature of hubs and hub services, some of the legal issues to consider, and recommendations to minimize risk if a company develops such a program. More >

FCPA Investigations in Brazil are Expanding into Healthcare and Other Industries
By: Michael E. Burke, Sara M. Lord and Adriaen M. Morse Jr.

In the last few weeks, additional investigations by U.S. criminal and civil authorities into potential FCPA violations by multi-national companies in Brazil have come to light. These investigations, which focus on medical equipment sales to Brazilian public health companies in exchange for illegal payoffs to public employees, involve such household names as GE, Johnson & Johnson, Phillips, and Siemens. Brazilian federal prosecutor, Marisa Ferrari told Reuters that the evidence points to widespread bribery and price gouging by companies looking to tap into Brazil’s public healthcare system, characterizing the “scheme” as “truly massive,” and this first investigation as “just a tiny sliver of what is to come.” More >

Supreme Court Settles Debate Over Limitations Period for FCA Relators
By: Aaron M. Danzig and Kara Gordon Silverman

On May 13, 2019, the Supreme Court handed down its decision in Cochise Consultancy, Inc. v. United States ex rel. Hunt, wherein it recognized a prolonged statute of limitations for a qui tam relator bringing an action under the False Claims Act (FCA). The FCA allows an individual, known as a qui tam relator, to bring a civil whistleblower action on behalf of the federal government. The FCA statute of limitations requires that a relator file his or her lawsuit within the later of six years from when the violation occurred or three years after the government knew, or should have known, about the material facts, but not more than 10 years after the violation. In Cochise, the Supreme Court reviewed whether a relator can bring an action more than six years after the alleged violation, but still within three years after the government learned of the violation, regardless of whether the government intervenes in the case. More >

Frequently Asked Questions: EPA’s New Hazardous Waste Pharmaceuticals Rule
By: Brooke F. Dickerson and Jennifer L. Hilliard

Earlier this year, the Environmental Protection Agency (EPA) published its final rule revising management standards for hazardous waste pharmaceuticals, which will take effect August 2019. Healthcare facilities that provide a host of healthcare-related services or distribute, sell or dispense pharmaceuticals, and reverse distributors of pharmaceuticals will need to learn a whole new set of regulations under the Resource Conservation and Recovery Act (RCRA), or risk being assessed steep penalties. Arnall Golden Gregory attorneys Brooke Dickerson and Jennifer Hilliard presented a webinar guiding participants through the new regulatory framework included in these rules and the possible implications for a range of healthcare facilities including: hospitals, health clinics, skilled nursing facilities, long-term care facilities, in-patient hospice facilities, pharmacies, and others. More >

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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