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
- If FDA Can Read Your Mind ... What a Tale Your Product Might Tell: FDA Amends Its "Intended Use" Regulations
- OIG Determines a Drug Manufacturer’s Initiative to Cover Certain Patients’ Transportation Costs Poses Low Risk of Fraud and Abuse
- The Times They Are A-Changin’: CMS Solicits Comments to Proposed Changes to the Open Payments Program
- Privacy Three-Peat: Colorado Becomes Third State to Enact Comprehensive Data Privacy Law
- Stop, Collaborate and Listen (to Four Things About Collaboration Agreements)
- AGG Podcasts
- Industry Activities and Recognition
- Upcoming Webinars
- Upcoming Events
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’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’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.
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.
Kevin Bell Quoted in Natural Products Insider Article Titled “‘GRAS Loophole’ Rears Head in FDA Supplements Letter”
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
Robert Durkin To Present at USP Dietary Supplements and Herbal Medicines Stakeholder Forum
Alan Minsk To Present at Investigator-Initiated Trials Hosted by Momentum Events
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
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