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Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from colleagues in other related life science disciplines. 

In This Issue

Industry Insights

There’s No Reply At All: It’s Never a Good Idea to Ignore FDA During an Inspection (and, In Fact, It’s Illegal) 

By: Alan G. Minsk & Robert Durkin 

Rule Number One: If a facility is regulated by the Food and Drug Administration, the agency may inspect it (although there are some boundaries, not discussed here). Rule Number Two: Assuming Rule Number One applies, the facility cannot deny FDA access to those records and information to which it is entitled. In fact, it is a prohibited act. Recently, FDA issued a Warning Letter to a manufacturer of over-the-counter drug products (including hand sanitizers) reminding industry of Rules One and Two. Reading the Warning Letter reminded the author of the 1981 classic rock song by Genesis, “No Reply At All.” More >

And I Won’t Tell No One Your Name: Doesn’t Matter, FDA Reminds IVD Industry of IRB Review in Certain Cases
By: Alan G. Minsk & Laura S. Dona  

The authors doubt the Food and Drug Administration was humming the Goo Goo Dolls 1995 hit, “Name,” when it drafted its letter, dated October 18, 2021, to manufacturers of in vitro diagnostics to remind them that the agency requires Institutional Review Boards to evaluate all clinical investigations of medical devices that involve human subjects, including those that use leftover, de-identified human specimens in FDA-regulated studies. FDA defines “leftover human specimens” as “remnants of specimens collected for routine clinical care or analysis that would otherwise have been discarded.” Even though, as the song lyric goes, “And I won’t tell no one your name,” to FDA, it doesn’t matter. The agency requires IRB oversight and evaluation. The agency said that this requirement includes data used to support an investigational device exemption, a medical device marketing application, or a submission to include IVD technical or analytical studies that use human specimens. More >

Recruitment Incentives in Clinical Trials
By: Neil W. Hoffman Laura S. Dona  

Recruiting a sufficient number of trial participants is a common difficulty for clinical trial sponsors. To obtain such numbers, sponsors may offer financial incentives to investigators or study sites or site personnel to identify and recruit participants. Such arrangements are not expressly precluded by the U.S. Food and Drug Administration (FDA), though it does have certain disclosure requirements that could be applicable. But drug and medical device manufacturers that sponsor clinical trials should be cognizant of potential regulatory risks inherent in such recruitment arrangements. Also, various organizations have called for more governmental regulation of recruitment incentives in clinical trials, so it is possible that we may see increased governmental enforcement in this area going forward. More  

DOJ/FTC Regulatory Update Regarding Pharmaceutical Companies
By: Jeffrey S. Jacobovitz

The Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) have both taken recent activity, which indicates there will be close scrutiny and enforcement of the pharmaceutical industry. The DOJ announced on October 1, 2021, that three generic pharmaceutical companies have agreed to pay over $447 million to resolve False Claim Liability for Price Fixing of Generic Drugs. The three companies, Taro Pharmaceuticals USA, Sandoz Inc., and Apotex Corporation resolved claims arising from a large generic price-fixing case that has involved many generic companies and is still pending. More

Insurance Coverage for Cyberattacks?
By: Lori L. Wright & Rebecca L. Kolb  

With the many recent, high-profile ransomware attacks, many companies are likely assessing their own cybersecurity and risks. Seeing the crippling effect a cyberattack can have on, for example, the nation’s largest infrastructure systems naturally brings to mind the potential impact of a similar attack on one’s own company, which likely leads to questions about available insurance coverage for such attacks. Nearly every industry faces serious risks. For example, a breach in hospitality and retail businesses could expose customers’ credit card information, a breach in education and healthcare risks exposing personal protected information, and a ransomware attack on a manufacturing plant could result in a complete shut down until a ransom is paid. More >  

Attorney Spotlight 



Bob Durkin is of counsel in the firm’s FDA and Healthcare practices and is a Dietary Supplements industry team member. As a former acting Director and Deputy Director of the Office of Dietary Supplement Programs (ODSP) in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), he brings a wealth of knowledge and insight to his legal practice. In working with AGG clients, Bob draws from the extensive experience he gained at the FDA, where he was responsible for performing policy analysis and evaluations related to all aspects of the agency’s dietary supplement programs while also providing skillful advice on compliance and enforcement issues (such as Warning Letters, seizures, injunctions, import detention/refusal, etc.). During this time, he was active in a variety of agency working groups, including Agency-wide Marijuana Working Group, Agency-wide CBD Policy Working Group, and the Agency-wide Investigational New Drug (IND) Policy Working Group. While helping to lead ODSP, Bob successfully led the Office through multiple GAO investigations and supervised both the Good Manufacturing Practice and Labeling Review Staffs. As the agency signing official, Bob reviewed the analysis of and approved the final regulatory determination of over 250 New Dietary Ingredient Determination Notifications.

Industry Recognition

Kevin Bell and Bob Durkin Quoted in NutraIngredients Article Titled “Edibles That Look Like Candy: A Different Kind of Scary This Halloween”

AGG partner and Dietary Supplements team leader, Kevin M. Bell, and AGG attorney and member of the firm’s Dietary Supplements industry team, Bob Durkin, were quoted in a NutraIngredients article titled "Edibles That Look Like Candy: A Different Kind of Scary This Halloween" on October 25. For more information, please click here.

Webinar Recording

And Now There Are Three: A Look at the New California, Colorado and Virginia Privacy Statutes From a Life Science Company Perspective

On October 12, 2021, AGG partner and Food & Drug team leader Alan G. Minsk moderated a webinar as partner and co-chair of the Data Privacy practice Kevin L. Coy and associate in the Data Privacy practice Erin E. Doyle discussed new privacy legislation in Colorado, the Colorado Privacy Act, and how it compares to the California Consumer Privacy Act, the California Privacy Rights Act, and the Virginia Consumer Data Protection Act. To view the recording, please click here.

Upcoming Webinars/Events

Alan Minsk and Brian Teras To Present at “MPTX516: Medical Products and the Law”

Invited by the University of Southern California Department of Regulatory and Quality Sciences, AGG Food & Drug team leader Alan G. Minsk and Corporate & Finance partner Brian A. Teras will be presenting “IP and the Life Science License Deal” in their course “MPTX516: Medical Products and the Law” on November 7. Alan and Brian will discuss transaction types and contract structures, FDA-related regulatory issues, recent transaction trends, and common pitfalls. For more information, please contact Alan or Brian.

2021 AGG Employment Law Seminar (Virtual)

On Tuesday, November 16 from 9:00 AM – 12:00 PM ET, AGG’s Employment Law team will host its annual Employment Law Seminar titled “The World Turned Upside Down: Vaccines, Vacancies, & Other Vexations in the Pandemic Workplace.” This virtual program will take a deep dive into the most pressing workplace issues of the day, including government vaccine mandates, OSHA rules, and the challenges presented by the Great Resignation, an increasingly virtual workforce, and special twists in state law. For more information or to register, please click here.
Alan Minsk To Present to a Biological Client on Cell and Gene Therapy 
Alan G. Minsk will be presenting “Cell and Gene Therapy – From Concept to Clinical Use: Chemistry, Manufacturing and Controls – Regulatory and Common Concerns” to a biological client on December 7 [closed to the public]. For more information, please contact Alan.
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This newsletter is published by Arnall Golden Gregory’s Food & Drug and Government Affairs & Public Policy practices. This information presented provides a general summary of recent legal and regulatory developments. It is not intended to be, and should not be relied upon, as legal advice. For more information on the Food & Drug practice, please contact Alan G. Minsk.

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