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
- Real-World Data or Not So Accurate Data: OPDP Issues Letter to Company for Misplaced Reliance on Real-World Data
- I Can See Clearly Now: FDA Issues Final Guidance on the Form and Content of the Unique Device Identifier
- D. C. Circuit Court of Appeals Overturns FDA Ban on Shock Medical Devices
- Renewed Focus on Cybersecurity May Have Significant Impacts on Previously Shielded Healthcare Companies
- Medicare Home Infusion Therapy Benefit: New Opportunities and New Challenges for Pharmacies
- Is the HIPAA Exemption Enough? A Look at the Impact of New California and Virginia Privacy Laws on Healthcare and Life Sciences Entities
- President Biden’s Executive Order and Impact on Pharmaceutical Companies
- Industry Activities and Recognition
- Upcoming Webinar
Real-World Data or Not So Accurate Data: OPDP Issues Letter to Company for Misplaced Reliance on Real-World Data
By: Alan G. Minsk & Genevieve M. Razick
On July 7, 2021, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an Untitled Letter regarding a professional animated banner. According to OPDP, the banner ad made false or misleading claims and representations regarding the benefits of the prescription drug product. OPDP’s primary concern was the company’s use of a real-world study, which it found had many limitations. It did not raise concerns about the product’s safety. Therefore, the banner ad misbranded the product. This Bulletin will review the Untitled Letter, focusing primarily on the study, and offering our observations. More >
I Can See Clearly Now: FDA Issues Final Guidance on the Form and Content of the Unique Device Identifier
By: Alan G. Minsk & Carolina M. Wirth
Channeling Johnny Nash and the 1972 classic song, “I Can See Clearly Now,” on July 7, 2021, the Food and Drug Administration issued its final guidance titled, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).” The UDI System Final Rule, which was issued almost eight years ago, was intended to create a standardized identification system for medical devices that adequately identifies them through distribution and use. The agency released a draft guidance five years ago. It is FDA’s expectation that the guidance, along with the Final Rule, will assist labelers and FDA-accredited issuing agencies in complying with UDI labeling requirements by clarifying the agency’s interpretation of certain requirements set forth in 21 C.F.R. § 801.40.3 This Bulletin summarizes some of the final guidance’s key provisions and provides background information for context. More >
D. C. Circuit Court of Appeals Overturns FDA Ban on Shock Medical Devices
By: Seth S. Ray
In a 2-1 opinion, decided on July 6, a three-judge panel of the U.S. Court of Appeals for the D.C. Circuit has overturned the Food and Drug Administration’s ban on the use of electric shock medical devices to correct aggressive or self-harming behavior in patients at a school for the disabled. We analyze this case because it has significant implications for FDA’s ability to regulate medical devices based on their specific intended uses. More >
Renewed Focus on Cybersecurity May Have Significant Impacts on Previously Shielded Healthcare Companies
By: Lori L. Wright & Carolina M. Wirth
On May 12, President Biden signed an executive order on improving the nation’s cybersecurity (the “Executive Order”). The Executive Order identified six broad initiatives for the improvement of security within federal government information technology systems and called on various federal departments and agencies to assist in building out actionable steps to achieve the Executive Order goals. More >
Medicare Home Infusion Therapy Benefit: New Opportunities and New Challenges for Pharmacies
By: Jennifer L. Hilliard
More than seven months in from the effective date of the new Medicare Part B Home Infusion Therapy (HIT) services benefit, opportunities abound for pharmacies enrolled as qualified HIT suppliers. But challenges remain, primarily at the state level, as the adaptation of state regulatory structures has lagged despite the enactment of federal legislation establishing the benefit in 2016 and promulgation of final implementing regulations in late 2020. With new payment rates for HIT proposed by the Centers for Medicare and Medicaid Services (CMS) and a new Medicare enrollment protocol for HIT suppliers implemented in June 2021, however, the federal framework for the benefit is fully established and will allow for states to make any further changes to their own licensing and regulatory structures to accommodate the new benefit. More >
Is the HIPAA Exemption Enough? A Look at the Impact of New California and Virginia Privacy Laws on Healthcare and Life Sciences Entities
By: Kevin L. Coy & Erin E. Doyle
With the recent enactment of Virginia’s Consumer Data Privacy Act (VCDPA), and similar bills under consideration in several state legislatures, healthcare and life sciences companies are considering how these new laws are likely to impact their operations. The VCDPA follows the California Consumer Privacy Act (CCPA), the first “general” data privacy law in the U.S., which has been in effect since January 1, 2020. The VCDPA is similar, though not identical, to the CCPA and will take effect January 1, 2023, the same day that the California Privacy Rights Act (CPRA), which California voters adopted through a ballot initiative in November 2020, will replace and expand the CCPA. These new laws regulate the processing of personal information about state residents, require businesses to provide public-facing privacy notices, and give individuals the right to access, correct, delete, and limit the sale or sharing of their personal information. More >
President Biden’s Executive Order and Impact on Pharmaceutical Companies
By: Jeffrey S. Jacobovitz
On July 9, 2021, President Biden issued an “Executive Order on Promoting Competition in the American Economy.” The Order focuses on antitrust issues and contains provisions directly affecting pharmaceutical companies and pharmaceutical pricing. More >
AGG Welcomes Former Federal Prosecutor David Blank to Washington, D.C. Office
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AGG is pleased to welcome David M. Blank to the Washington, D.C. office. David, a partner in the firm’s healthcare and litigation practices, counsels individuals and entities through government investigations, advises on corporate compliance and governance matters, and litigates civil and criminal healthcare fraud matters. His practice is built on a foundation of knowledge developed through a distinguished career in the federal government. He draws extensively from this knowledge base in private practice, representing clients in criminal, civil, and administrative proceedings and internal investigations and counseling clients on regulatory compliance. David has a depth of experience working across a spectrum of healthcare-related issues for clients, including physician practice groups, healthcare technology companies, pharmaceutical manufacturers, pharmacies, assisted living facilities, home health providers, and others. Prior to working in private practice, David served as senior counsel for more than a decade for the United States Department of Health and Human Services, Office of Inspector General (OIG), where he represented the agency in healthcare fraud and abuse matters involving the federal False Claims Act (including the Anti-Kickback Statute and Stark Law), Civil Monetary Penalties Law (CMPL), and federal program exclusion authorities. |
Kevin Bell and Robert Durkin Spoke at the 2021 Dietary Supplements Regulatory Summit Hosted by the Natural Products Association
AGG attorneys and members of the firm’s Dietary Supplements industry team, Kevin Bell and Robert Durkin, spoke at the 2021 Dietary Supplements Regulatory Summit hosted by the Natural Products Association on July 13. To read more, please click here.
Robert Durkin and Ed Marshall Will Present at the Merchant Acquirers’ Committee’s MAC Level Up 21 Event on the Topic “In the Weeds on Cannabis and Payments”
Robert Durkin Quoted in an Article by Whole Foods Magazine Titled “3 Takeaways From the 2021 Dietary Supplements Regulatory Summit”
AGG attorney Robert Durkin was quoted in an article by Whole Foods Magazine titled “3 Takeaways From the 2021 Dietary Supplements Regulatory Summit” on July 21. To read more, please click here.
Life Science Licensing Deals: (Some) Key Corporate and Regulatory Considerations
On Tuesday, August 10 from 1:00 PM - 2:00 PM EDT, join AGG partner and Food & Drug team leader, Alan Minsk, and AGG Corporate partner, Brian Teras, for a complimentary webinar as they review corporate and regulatory considerations for life science licensing deals. This webinar will focus on a variety of topics, including transaction types and structures, FDA-related regulatory issues, recent transaction trends, and common pitfalls. To register, please click here.
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