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- Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices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
- Attorney Spotlight
- Industry Activities
- Upcoming Events
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Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices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 In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the FD&C [Federal Food, Drug and Cosmetic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 >
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Kevin L. Coy is a partner in AGG’s Washington D.C. office and co-chairs the Data Privacy practice. With an established reputation in privacy law and an understanding that security is critical to a successful business environment, organizations seek Kevin’s counsel on domestic and international privacy law and policy matters and strategies to protect personal information. Kevin’s legal advice also addresses online privacy, privacy statements, and compliance programs, as well as privacy impact assessments. When data security and breach notification issues present themselves, he guides clients through their response to difficult data security incidents. |
Jeff R. Friedman and Matthew M. Brohm, AGG partners and co-chairs of the Healthcare Private Equity team, were quoted in an article in PitchBook titled “PitchBook Analyst Note: Established Private Healthcare Provider Plays.” This article details trends and strategies in behavioral health, dentistry, dermatology, and vision. To read more, please click here.
Kevin M. Bell, co-chair of AGG’s Intellectual Property practice and Dietary Supplements industry team, was quoted in a WholeFoods Magazine article titled “Industry Members Call FDA Inaction ‘Disheartening,’” discussing a panel Kevin spoke on regarding FDA’s actions surrounding intellectual property during the New York State Bar Association’s 2022 Annual Meeting. To read the full article, please click here.
Jeffrey S. Jacobovitz, AGG Litigation partner and vice chair of the ABA Antitrust U.S. Policy and Comments Committee, will moderate an American Bar Association panel titled “Summary of Recent Proposed Antitrust Legislation” on February 7, 2022, at 12 p.m. EST. During the presentation, panelists will discuss the flurry of recent proposals to amend antitrust laws. These bills are intended to meet competition challenges and focus on high tech. To learn more and register, please click here.
Alan G. Minsk, leader of AGG’s Food & Drug team, will speak at the Investigator-Initiated Trials Summit on February 8, 2022, at 8:45 a.m EST. Alan will present “Master Class: Review the Challenges of Meeting FDA and Non-FDA Compliance Requirements,” which will highlight some of the FDA and non-FDA issues to help organizations make a more educated decision before supporting an IIT. To learn more and register, please click here.
Alan G. Minsk will speak at Georgia Bio’s virtual Compliance Framework Strategy for 2022 on February 15, 2022, at 9 a.m EST. Alan will join a panel of professionals with compliance experience in the life sciences and healthcare industries and share best practices concerning the culture of compliance, FDA & OIG priorities, and how to build an ethics and compliance program. To learn more and register, please click here.
Alan G. Minsk will present a guest lecture on FDA regulation of pharmaceuticals to students at the Georgia Institute of Technology on March 15, 2022. For more information, please contact Alan.
