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

• Freeze-Frame: FDA Issues an Untitled Letter for an Unlawful Instagram Post
• Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices
• You Cannot Do It Any Way You Want It: FDA Issues an Untitled Letter for an Incomplete Journey Forward
• There Is Never a Bad Time To Audit Your Supply Chain
• The Consequences of the Shifting Landscape in Opioid-Related Litigation
• Supreme Court Issues Split Decisions on Federal Vaccine Mandates

Industry Insights

Freeze-Frame: FDA Issues an Untitled Letter for an Unlawful Instagram Post
By: Alan G. Minsk

Does anyone remember the 1980’s song, “Freeze-Frame” by The J. Geils Band? A new year, a new Untitled Letter issued by the Food and Drug Administration’s Office of Prescription Drug Promotion to a prescription drug company. No, OPDP did not send New Year greetings when it found the company’s Instagram ad to be false and misleading about claims made about the product’s benefits and risks. The Untitled Letter, the first for 2022, included a number of issues and concerns raised by OPDP in the past (which we have pointed out in other Bulletins). We will summarize the main points raised by FDA in this most current letter and offer our own recommendations to maximize compliance. More >

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices
By: Alan G. Minsk & Kadeja A. Watts

Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the FD&C [Federal Food, Drug and Cosmetic Act].” The guidance is intended to: (a) help medical device manufacturers provide timely notice about changes in the production of certain products to help prevent or mitigate device shortages; (b) assist industry in understanding how FDA plans to implement Section 506J (21 U.S.C. § 356j) outside of the COVID-19 Public Health Emergency; and (c) serve as the baseline for information about notifications during, or in advance of, any public health emergency. More >

You Cannot Do It Any Way You Want It: FDA Issues an Untitled Letter for an Incomplete Journey Forward
By: Alan G. Minsk & Laura S. Dona

Late last year, the Food and Drug Administration’s Office of Prescription Drug Promotion issued an Untitled Letter to a drug company for unlawful promotion of its biologic product. In particular, OPDP objected to two direct-to-consumer television advertisements about patient “journey forward” experiences, claiming the ads provided false or misleading risk information and failed to submit a Form FDA-2253 at the time of initial publication. Of course, we thought of the 1980 Journey song, “Any Way You Want It.” More >

There Is Never a Bad Time To Audit Your Supply Chain
By: Michael E. Burke

In late December 2021, the United States banned imports of disposable gloves produced in Malaysia by manufacturer Brightway Holdings over allegations of forced labor. Brightway was a supplier of Kimberly-Clark Corporation, and was the fifth Malaysian glove manufacturer to face a Withhold Release Order from U.S. Customs and Border Protection. Supply chain challenges are on the front-pagefront page of many newspapers, and a large number of life sciences have conducted, or are conducting, a supply chain audit on multiple issues. More >

The Consequences of the Shifting Landscape in Opioid-Related Litigation
By: Sara M. Lord

The end of 2021 was marked by several significant developments in the wave of litigation that has resulted from the opioid crisis of the last several years. These developments, however, are sufficiently inconsistent that it is difficult to predict where opioid-related lawsuits will land in 2022. On the one hand, pharmaceutical companies and others have entered into meaningful, large-scale settlements; on the other hand, the same companies and others have resisted efforts to hold them accountable through litigation. Furthermore, in the four instances where trials have concluded, the results have been materially different. More >

Supreme Court Issues Split Decisions on Federal Vaccine Mandates
By: Tenley A. Carp, Edward P. Cadagin, Henry M. Perlowski, & Jennifer L. Hilliard

On January 13, 2022, the U.S. Supreme Court issued split decisions regarding Federal vaccine mandates issued by the Centers for Medicare and Medicaid Services and the Occupational Safety and Health Administration. More >