View as Web Page


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

If FDA Can Read Your Mind ... What a Tale Your Product Might Tell: FDA Amends Its "Intended Use" Regulations
By: Alan G. Minsk & Seth S. Ray  

In 1970, Gordon Lightfoot released the classic song “If You Could Read My Mind,” where he sings, “If you could read my mind, love, what a tale your thoughts could tell.” Fifty-one years later, the Food and Drug Administration issued a Final Rule to amend its regulations that define “intended use.” The Rule is effective September 1, 2021. This Bulletin summarizes many of the key provisions of the Final Rule and some of the FDA’s responses to comments from the industry. More

OIG Determines a Drug Manufacturer’s Initiative to Cover Certain Patients’ Transportation Costs Poses Low Risk of Fraud and Abuse
By: David M. Blank & Charmaine A. Mech  

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently issued an Advisory Opinion analyzing an arrangement where a drug manufacturer (the “Requestor”) provides financial assistance to cover transportation, lodging, and meal costs for certain patients to obtain a gene therapy drug. In Advisory Opinion No. 21-08, the OIG concluded that the proposed arrangement presented a low risk of fraud and abuse under the federal anti-kickback statute (“AKS”) and civil monetary penalty law (“CMP”), despite the potential transfer of prohibited remuneration from the Requestor to beneficiaries, physicians, and treatment centers. More 

The Times They Are A-Changin’: CMS Solicits Comments to Proposed Changes to the Open Payments Program 
By: Jennifer D. Burgar & Genevieve M. Razick 

Since the April 2013 effective date of the Final Rule implementing the “National Physician Payment Transparency Program: Open Payments” (also known as the federal “Sunshine Law”), CMS has been annually collecting information on drug and medical device manufacturers that meet the definition of an “applicable manufacturer” and certain payments or other transfers of value that these entities make to physicians and teaching hospitals. The Open Payments Program also requires that “applicable manufacturers” and group purchasing organizations (GPOs) disclose annually any ownership or investment interests held in such entities by physicians (or their immediate family members), in addition to reporting information on payments or other transfers of value made to such owners or investors. More > 

Privacy Three-Peat: Colorado Becomes Third State to Enact Comprehensive Data Privacy Law
By: Kevin L. Coy, Montserrat C. Miller, & Erin E. Doyle

On July 7, 2021, Colorado Governor Jared Polis signed into law S.B. 21-190, known as the Colorado Privacy Act (“CPA”). Colorado is now the third U.S. state to enact comprehensive consumer data privacy legislation, following California and Virginia. Like the others, the CPA grants Colorado residents the right to access, correct, and delete their personal data, as well as opt-out of targeted advertising and the sale of their personal data. More >

Stop, Collaborate and Listen (to Four Things About Collaboration Agreements)
By: Joel N. Gossner  

A key part of the life sciences ecosystem, collaboration agreements help make expensive innovation possible. When they’re well-drafted, they can help collaborating parties pool their resources to more efficiently turn ideas into products. When they’re not, they can lead to disputes and slow things down. Thinking through the issues explained here should help make sure your next collaboration agreement helps rather than hurts. More >

AGG Podcasts
AGG Talks: Background Screening

AGG’s Background Screening team launched its podcast series, titled “AGG Talks: Background Screening” on August 13. In its inaugural episode, titled “Redaction of Identifiers by the Courts in Michigan and California Pose Challenges for Background Checks,” AGG partner and co-chair of the Background Screening industry team, Montserrat C. Miller, and Kevin L. Coy, AGG partner and co-chair of the Data Privacy practice, discuss both the Michigan Supreme Court’s Order and the California litigation and their impact on the use of a key identifier, dates of birth, when preparing background check reports. To listen to this episode, please click here.

AGG Talks: Technology

AGG’s Technology team launched its podcast series, titled “AGG Talks: Technology” on August 26. In its inaugural episode, titled "In the Balance: Interoperability and Security," AGG partner and chair of the Technology practice, Lori L.. Wright, focuses on healthcare technology and compliance concerns as she discusses with guest Tina Simpson, a principal with Atrómitos, how an organization can comply with interoperability requirements while still protecting their organizations from ransomware and other unwanted system intrusions. To listen to this episode, please click here.

Industry Activities and Recognition

Alan Minsk Recognized in 2022 Best Lawyers in America Guides for FDA Law

AGG partner and Food and Drug team leader Alan G. Minsk has been recognized by Best Lawyers in America® guides for the fourth year in a row for exceptional service in FDA Law. Along with Alan’s recognition, sixty-six AGG attorneys were also recognized in this year’s Best Lawyers guides. For more information or to view the press release, please click here.


AGG Ranks Fourth (4th) for Deals by Volume in Pharma, Medical and Biotech League Table

AGG earned a notable ranking in Datasite’s half-year pharma, medical and biotech league table for legal advisors. The “Deal Drivers” publications are a series of spotlight reports from around the world, produced in partnership with Mergermarket, a leading M&A intelligence company.

AGG is the only Atlanta-based law firm represented in this league table, ranking fourth (4th) by deal volume with 29 deals with a disclosed value of $220 million. This ranking adds to the recognition that AGG’s Healthcare Private Equity industry team co-chairs and partners, Matthew M. Brohm and Jeff R. Friedman, received earlier this year in Mergermarket’s individual league table for M&A lawyers.
For more information, please click here. To view the press release, please click here.

Webinar Recording Available: Life Science Licensing Deals: (Some) Key Corporate and Regulatory Considerations
On August 12, 2021, AGG partner and Food & Drug team leader Alan G. Minsk and partner Brian Teras discussed corporate and regulatory considerations for life science licensing deals. To listen to the recording, please click here.

Kevin Bell Quoted in Natural Products Insider Article Titled “‘GRAS Loophole’ Rears Head in FDA Supplements Letter”

AGG partner and leader of the Dietary Supplements team, Kevin Bell, was quoted in an article by Natural Products Insider titled “‘GRAS Loophole’ Rears Head in FDA Supplements Letter” on August 12. To read more, please click here.
Upcoming Webinars

Alan Minsk To Present a Webinar For a Medical Device Client

Alan G. Minsk will present an in-house webinar for a medical device client on September 24 on medical device advertising and promotion [closed to the public].


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

On September 30, 2021 from 1:00 PM – 2:00 PM EDT, please join partner and Food and Drug team leader Alan G. Minsk, partner and co-chair of the Data Privacy practice Kevin L. Coy, and associate in the Data Privacy practice Erin E. Doyle for a complimentary webinar as they discuss 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. For more information or to register, please click here.
Upcoming Events

Robert Durkin To Present at USP Dietary Supplements and Herbal Medicines Stakeholder Forum

AGG of counsel and member of the firm’s Dietary Supplements industry team, Robert Durkin, will present at the USP Dietary Supplements and Herbal Medicines Stakeholder Forum on September 14-15. To learn more, please click here.

Alan Minsk To Present at Investigator-Initiated Trials Hosted by Momentum Events

Alan G. Minsk will be presenting “Meeting the Challenges of Investigator-Initiated Trials” on September 20, 2021. Alan will discuss meeting FDA compliance requirements within IITs. For more information about this event, please click here.

Alan Minsk Joins BSI and Israeli Ministry of Health for Roundtable on the Regulatory Perspective of Digital Health at the 2nd Medical Device Research & Development Summit 

Alan G. Minsk will be joining BIS and the Israeli Ministry of Health for a roundtable discussion on the topic “Digital Health: Regulatory Perspective” in Tel-Aviv, Israel, on October 25, 2021, at the 2nd Medical Device Research & Development Summit. This year’s conference will focus on the development of artificial intelligence-based medical devices and the R&D methodologies and their linkage to product development and regulations. For more information about this event, please click here.
Follow AGG:   

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.

Comments | Manage your SubscriptionUnsubscribe at