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Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice. We are thinking of all of you in these difficult times, and hope all of you and your loved ones are safe.

 
In This Issue
Industry Insights
A Funny Thing Happened on the Way to the Border: Avoidable Mistakes with FDA-Regulated Product Detentions
By: Alan G. Minsk and Carolina M. Wirth
Al Stewart’s 1970s song, “On the Border,” comes to mind every so often when an existing or new client contacts us as their product is stopped at the United States border by the Food and Drug Administration. Lately, during the recent pandemic, we have received more calls where the detentions are often due to what we might call unforced errors. Mistakes, such as the failure to properly list the product or register the manufacturing facility, can cause the product to be “misbranded.” Incomplete or missing paperwork or wrong information on the product label or the lack of a code (e.g., National Drug Code) can cause delays with imports if FDA (or Customs) cannot readily locate the product or manufacturer in a government database. More >
 
Money, Money, Money...It’s A Rich Man’s World: Getting Funding for COVID-19-Related Medical Products
By: Alan G. Minsk and Carolina M. Wirth
While many of us are justifiably focused on the negative aspects of the COVID-19 pandemic, one positive result has been the way in which the life sciences community has answered the call to develop lifesaving medical countermeasures to fight the coronavirus. In the last 4 months, the Food and Drug Administration has authorized an incredible number of products and others are being studied in clinical trials. Despite the urgent need for these products to come to market, some companies do not have the funding necessary to carry out human clinical trials or to eventually obtain approval or clearance from FDA, and must think of creative ways to raise much needed capital. One option that we have discussed with our clients is applying for a government grant to fund their efforts. More >
 
Another Piece to the CBD Puzzle? FDA Submits Report on CBD Sampling Study to Congress 
By: Robert Durkin
On July 8th, the Food and Drug Administration (FDA) submitted a report to the House and Senate Committees on Appropriations detailing the results of a sampling study of the current cannabidiol (CBD) marketplace. FDA conducted the sampling study and submitted its report to Congress pursuant to an ongoing obligation to comply with the Further Consolidated Appropriations Act of 2020 (P.L. 116-94). The purpose of the report was to update Congress on its evaluation regarding the scope of adulterated or misbranded CBD-containing products currently on the market. More > 
 
PhRMA Takes a Stance on Virtual Lunch and Learns During the Emergency Period  
By: Jennifer D. Burgar and Genevieve M. Razick 
We received a number of questions from pharmaceutical and medical device clients over the past several months regarding how to continue “Lunch and Learn” programs for healthcare professionals during the COVID-19 pandemic. With hospitals and doctors’ offices closing their doors to outside visitors in response to the pandemic, sales representatives put a pause on in-person visits. Some of these companies turned to virtual platforms, such as Zoom, to provide needed scientific and clinical information to healthcare professionals during the pandemic. More > 
 
CIA Imposes Requirements for Pharmaceutical Speaker Programs and Events 
By: Sara M. Lord and Genevieve M. Razick
On July 1, 2020, the United States Department of Justice (DOJ) announced two settlements with Novartis Pharmaceuticals Corporation (“Novartis”), resolving allegations that the company had paid illegal kickbacks to physicians in the form of honoraria for speaker programs and other events, and that it had used charitable foundations as vehicles to provide copayments to Medicare patients prescribed Novartis drugs. More >
 
Novartis’ FCPA Settlement and New Compliance Guidance
By: Michael E. Burke and William P. Olsen
In late June, the U.S. Department of Justice (“DOJ”) and Securities and Exchange Commission (“SEC”) announced that Novartis AG and Alcon Pte Ltd, a former subsidiary of the Swiss drug maker, agreed to pay a combined $347 million to resolve allegations that the companies engaged in corrupt conspiracies to bribe public hospitals and clinics in Greece, Vietnam, and South Korea. This settlement was the result of an investigation jointly performed by the DOJ and SEC into alleged criminal and civil violations of the Foreign Corrupt Practices Act (“FCPA”), and takes place against the backdrop of updated FCPA compliance guidance recently issued by DOJ. More >
 
SEC Disclosure Considerations for Publicly-Traded Life Sciences Companies During the COVID-19 Pandemic
By: Brian A. Teras
As we close in on five months since the beginning of the coronavirus (COVID-19) pandemic in the United States, public companies in the life sciences industry must continually evaluate public disclosures in light of the pandemic’s effect on the company’s operations and financial results. The impact of the pandemic varies from company to company but can include revenue declines, supply-chain disruption, employee restructuring costs, contract terminations or renegotiatons, increased expenses for cleaning measures to address COVID-19 spread concerns, suspended or cancelled clinical trials, and the effects of remote working. As companies prepare earnings releases and 10-Q filings for the 2020 second quarter, the following items should be considered. More >
 
EU-U.S. Privacy Shield Invalidated by European Court of Justice
By: Kevin Coy, Montserrat C. Miller, and Erin E. Doyle
On July 16, 2020, the Court of Justice of the European Union (CJEU) issued its judgment in the so-called “Schrems II” case (click here for the decision and here for the accompanying press release). The Court concludes that (i) the EU-U.S. Privacy Shield program (“Privacy Shield”) does not provide adequate safeguards and the European Commission’s adequacy decision which facilitates the ability of participating companies to transfer personal data from the European Union (EU) to the United States is invalid; and (ii) Standard Contractual Clauses (SCCs) remain a valid mechanism for such transfers, although a case-by-case evaluation of their sufficiency may be required by local data protection authorities as well as controllers and processors. More >
 
Industry Recognition  
Carolina Wirth Spoke at Hall & Wilcox’s “COVID-19 & Therapeutic Goods – An International Perspective” Webinar
Alongside with other international panelists, AGG attorney Carolina M. Wirth spoke at Hall & Wilcox’s “COVID-19 & Therapeutic Goods – An International Perspective” webinar. Carolina discussed USA FDA equity of access, regulatory basics, the process of registration, and off-label use in USA. To view the webinar on-demand, please click here.  
 
Brian Teras Quoted in In Vivo’s “Back to Business: Deal Making on the Other Side of COVID-19” 
AGG partner Brian A. Teras was quoted in an article by In Vivo titled “Back to Business: Deal Making on the Other Side of COVID-19.” The article discussed challenges and opportunities presented to biopharma attorneys by COVID-19. Brian commented on the volatility on biopharma transactions during the pandemic. More > 
 
Upcoming Events

AGG Attorneys to Present “Emergency Management During the COVID-19 Pandemic: How FDA Responds to an Emergency” at FDLI

AGG attorneys Robert Durkin and Genevieve M. Razick will present “Emergency Management During the COVID-19 Pandemic: How FDA Responds to an Emergency” at FDLI’s The Law Over Lunch Series on July 30 from 12:00 PM – 1:00PM EDT. The Series provides FDLI members to proactively engage in topics of interest to the food and drug law community in virtual discussions over lunch. To register for this event, please click here.

 

AGG Partners Kevin Coy, Alan Minsk, and Henry Perlowski to Present “Reopening for Business: Maintaining Employee Confidence and Minimizing Privacy Risks”

Join chair of AGG’s FDA practice team, Alan G. Minsk (as moderator), Kevin Coy and Henry M. Perlowski for a webinar discussing how the COVID-19 pandemic has presented all businesses, including life sciences companies, with unprecedented challenges as they reopen to their employees, customers, and visitors. They will discuss the current regulatory climate of returning to in-person work, best practices in addressing risk associated with returning to in-person work, privacy issues, and data security. To register for this event, please click here.

 

AGG Partner Alan Minsk to Speak at 2020 RAPS Convergence: “AdPromo: Same, Similar, or Superior Claims”

Alan G. Minsk will be speaking at Regulatory Affairs Professionals Society (RAPS)’s virtual event: “2020 RAPS Convergence.” Joined by Jennifer Kelley, MS, RAC, Director of Global Regulatory Affairs at Sanofi, they will discuss CFL and generics/biosimilars promotion and provide commentary and examples to implement them to your organizations at “AdPromo: Same, Similar, or Superior Claims” webinar on September 15, 2020 at 1:00PM – 2:30PM EST. For more information or to register, please click here.  

 
This newsletter is published by Arnall Golden Gregory’s Food and Drug and Government Affairs and 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 about the Food and Drug Practice, please contact Alan Minsk.
 

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