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.
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 >
