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

• FDA Allows Sponsors to Modify the Conduct of Clinical Trials During the COVID-19 Pandemic
• A Guide to FDA’s Evolving Interpretation of How Sponsors Can Demonstrate Substantial Evidence of Effectiveness for Human Drug and Biological Products
• Drug Company Refuses to Take it Easy and Prevails in Court Case Against FDA Relating to Orphan Drug Exclusivity
• In the Midst of the COVID-19 Pandemic, FDA Issues Much Needed Guidance on the Distribution of Face Masks and Respirators
• A Little Help from Our Friends: FDA Issues a Final Guidance Document on the 510(k) Third-Party Review Program (3P510k)
• FDA Decision to Suspend On-Site Inspections Shifts Safety Guarantees to Manufacturers
• Proceed at Your Own Risk: FDA Issues Final Rule Requiring New Warnings for Cigarette Packages and Advertisements
• Latest News & Insights Related to the 2019 Novel Coronavirus (COVID-19)
• Upcoming Events

FDA Allows Sponsors to Modify the Conduct of Clinical Trials During the COVID-19 Pandemic
By: Seth S. Ray

On March 18, the Food and Drug Administration issued a guidance for industry, investigators, and Institutional Review Boards on the “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.” FDA recognizes that that the COVID-19 pandemic may affect the conduct of clinical trials of investigational human drugs, medical devices, and biological products. More >

A Guide to FDA’s Evolving Interpretation of How Sponsors Can Demonstrate Substantial Evidence of Effectiveness for Human Drug and Biological Products
By: Seth S. Ray

A new drug’s effectiveness must be established by “substantial evidence,” which is defined in Section 505(d) of the Federal Food, Drug, and Cosmetic Act (FDCA). FDA has interpreted the law as generally requiring at least two adequate and well-controlled clinical investigations, each convincing on its own, to establish effectiveness. Nevertheless, under specific circumstances, the agency has been flexible, relying on a single large multicenter trial or previous findings of effectiveness. More >

Drug Company Refuses to Take it Easy and Prevails in Court Case Against FDA Relating to Orphan Drug Exclusivity
By: Alan G. Minsk and Genevieve M. Razick

On March 13, 2020, Eagle Pharmaceuticals, Inc. refused to “take it easy" against the Food and Drug Administration when it took a stand and prevailed in a court case against the agency concerning the then-clinically superior FDA regulatory requirement for orphan drug exclusivity determinations. However, as will be discussed, the decision may have limited applicability. More >

In the Midst of the COVID-19 Pandemic, FDA Issues Much Needed Guidance on the Distribution of Face Masks and Respirators
By: Carolina M. Wirth

The novel Coronavirus (COVID-19) has presented many challenges to our healthcare industry, including a shortage of personal protective equipment (PPE). Over the last couple of weeks, we have seen an increased in the number of efforts to provide PPE to our doctors and nurses on the frontline of this crisis, from fashion designers pledging to make masks over Instagram to efforts on Facebook to make face masks to be donated to local hospitals without much guidance from the Food and Drug Administration. With the mounting pressure to increase the availability of face masks for health care providers and consumers, FDA released a new guidance document on Wednesday, March 25, 2020.  More >

A Little Help from Our Friends: FDA Issues a Final Guidance Document on the 510(k) Third-Party Review Program (3P510k) 
By: Carolina M. Wirth and Genevieve M. Razick

On March 12, 2020, the Food and Drug Administration issued a final guidance on its Third-Party (3P510k) Review Program titled, Guidance for Industry, Food and Drug Administration Staff and Third-Party Review Organizations. Under the 3P510k Review Program, FDA recognizes certain third parties (3P510k Review Organizations) to review premarket notification submissions (510(k) submissions) for low to moderate risk and less complex medical devices and to recommend a device classification. The 3P510k Review Program also serves as a voluntary alternative review process so that manufacturers of eligible devices (to be discussed) have an avenue to seek a more rapid 510(k) review decision. More >

FDA Decision to Suspend On-Site Inspections Shifts Safety Guarantees to Manufacturers
By: Kevin M. Bell, Robert Durkin, and Carolina M. Wirth

The Natural Products Association (NPA) and Arnall Golden Gregory (AGG) hosted a panel discussion on March 18th and explained FDA’s briefing for food stakeholders that took place that day, potential future guidance, and how to stay ahead of the curve, pending legislation affecting life science industries, state-level activity and real-time intel on supply chain issues out of China. As a result, a press release was sent out to report on the FDA’s decision to suspend routine plant inspections amid COVID-19. More >

Proceed at Your Own Risk: FDA Issues Final Rule Requiring New Warnings for Cigarette Packages and Advertisements
By: Carolina M. Wirth

In a world where the Coronavirus has taken over all of our day-to-day lives, other parts of the Food and Drug Administration continue to focus on initiatives that “promote greater public understanding [of the] negative health consequences of smoking.” Almost 11 years since the passing of the Family Smoking Prevention and Tobacco Control Act, on March 17, 2020, FDA issued a Final Rule that requires new health warnings on cigarette packages and advertisements. More >

Latest News & Insights Related to the 2019 Novel Coronavirus (COVID-19)

AGG is closely monitoring the outbreak of the Coronavirus disease (COVID-19). We will continue to provide timely legal updates on myriad issues that are affecting our clients across a broad range of industries and geographies. While these articles are not FDA-related issues, we are committed to sharing our insights with our clients to help them navigate issues that are critical to their most immediate business and legal needs, while assessing any long-term impacts. These are but some of the many articles AGG has prepared for clients relating to COVID-19. To access AGG’s complete collection of articles, news alerts, and presentations, please click here.  

• OCR Issues HIPAA Telehealth FAQs
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• Your Event is Cancelled Because of COVID-19: Breach of Contract or Excused Performance?
• HIPAA Waivers and Compliance in COVID-19 Pandemic
• Coronavirus and the Workplace
• Is the Coronavirus a Force Majeure that Excuses Performance of A Contract?