Some entities known as Alternative Funding Programs (AFPs) are engaged in the unauthorized importation of specialty drugs into the United States and may pose a growing threat to the U.S. drug supply. Article authored by Benjamin B. Correa and Kathy P. Lee.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/03/GLS-Blog_Generic-imagery-12.png606833Benjamin B. Correahttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngBenjamin B. Correa2025-03-26 11:27:022025-03-26 11:27:02Unauthorized Drug Importation by Alternative Funding Programs: What Pharmaceutical Companies Need to Know and Options on How to Respond
A Special Fraud Alert has been issued by the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG), warning that certain marketing arrangements relating to Medicare Advantage beneficiary referrals could potentially result in “abusive arrangements.” Jon Zucker explains.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Jon S. Zuckerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJon S. Zucker2025-01-22 13:43:432025-01-22 13:47:43Referral Payments Targeted in New Special Fraud Alert
For the past two years, clinical trial fraud has been a key enforcement area for the U.S. Department of Justice’s (DOJ) Consumer Protection Branch (CPB). David Ludlow and Julea Lipiz set out considerations for life sciences companies to help mitigate scrutiny of their trial results and related products.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2024/12/MN-24014_GoodLifeSci-Blog-Imagery-Refresh12.jpg606833David J. Ludlowhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngDavid J. Ludlow2024-12-18 09:48:382024-12-18 10:45:08How Life Sciences Companies Can Respond To DOJ’s Focus on Clinical Trial Fraud
AI tools are already advancing patient care by opening up new avenues for drug and product discovery, evaluation, and pharmacovigilance. But they also raise regulatory challenges as our panelists discuss.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Rebecca K. Woodhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngRebecca K. Wood2024-11-27 11:36:522024-11-27 11:37:55The AI Revolution and the FDA: Becky Wood and Deeona Gaskin’s Fireside Chat with Former FDA Commissioner Dr. Scott Gottlieb
A recent SEC enforcement action against Cassava Sciences over misleading statements made to the FDA about clinical trial (CT) results highlights the importance of life sciences companies exercising care in how they disclose FDA-related information to investors. Lara Mehraban explains.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-10.png606833Lara Mehrabanhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngLara Mehraban2024-11-08 09:05:172024-11-08 09:49:14SEC Interest in FDA-Related Disclosures by Life Sciences Companies Highlighted
As the life sciences sector grapples with complex challenges around sustainability and Environmental and Social Governance (ESG) compliance, Generative AI (GenAI) is emerging as a potentially powerful tool for enhancing efficiency and sustainability. Michele Tagliaferri, Eva von Mühlenen, and Anna-Shari Melin explain.(more…)
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Michele Tagliaferrihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMichele Tagliaferri2024-11-05 06:30:332024-11-04 11:17:40Risks and Benefits of Generative AI for Pharma Supply Chain Management
In a recent judgment, the Court of Justice of the European Union (CJEU) has shed light on the scope of the ‘clinical superiority’ criteria providing for a derogation to orphan market exclusivity which is key to protect the orphan molecule from competition for the period of market exclusivity (10 or 12 years as the case may be). Marie Manley, Chris Boyle, and Alix Vermulst examine the impact of this judgment on pharmaceutical companies.
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Unauthorized Drug Importation by Alternative Funding Programs: What Pharmaceutical Companies Need to Know and Options on How to Respond
Some entities known as Alternative Funding Programs (AFPs) are engaged in the unauthorized importation of specialty drugs into the United States and may pose a growing threat to the U.S. drug supply. Article authored by Benjamin B. Correa and Kathy P. Lee.
Benjamin B. Correa
Washington, D.C.
bcorrea@sidley.com
Kathy P. Lee
Washington, D.C.
kathy.lee@sidley.com
Referral Payments Targeted in New Special Fraud Alert
A Special Fraud Alert has been issued by the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG), warning that certain marketing arrangements relating to Medicare Advantage beneficiary referrals could potentially result in “abusive arrangements.” Jon Zucker explains.
Jon S. Zucker
Washington D.C.
jzucker@sidley.com
How Life Sciences Companies Can Respond To DOJ’s Focus on Clinical Trial Fraud
For the past two years, clinical trial fraud has been a key enforcement area for the U.S. Department of Justice’s (DOJ) Consumer Protection Branch (CPB). David Ludlow and Julea Lipiz set out considerations for life sciences companies to help mitigate scrutiny of their trial results and related products.
David J. Ludlow
Washington, D.C.
dludlow@sidley.com
Julea Lipiz
Washington, D.C.
jlipiz@sidley.com
The AI Revolution and the FDA: Becky Wood and Deeona Gaskin’s Fireside Chat with Former FDA Commissioner Dr. Scott Gottlieb
AI tools are already advancing patient care by opening up new avenues for drug and product discovery, evaluation, and pharmacovigilance. But they also raise regulatory challenges as our panelists discuss.
Rebecca K. Wood
Washington, D.C.
rwood@sidley.com
Deeona R. Gaskin
Washington D.C.
dgaskin@sidley.com
SEC Interest in FDA-Related Disclosures by Life Sciences Companies Highlighted
A recent SEC enforcement action against Cassava Sciences over misleading statements made to the FDA about clinical trial (CT) results highlights the importance of life sciences companies exercising care in how they disclose FDA-related information to investors. Lara Mehraban explains.
(more…)
Lara Mehraban
New York
lmehraban@sidley.com
Risks and Benefits of Generative AI for Pharma Supply Chain Management
As the life sciences sector grapples with complex challenges around sustainability and Environmental and Social Governance (ESG) compliance, Generative AI (GenAI) is emerging as a potentially powerful tool for enhancing efficiency and sustainability. Michele Tagliaferri, Eva von Mühlenen, and Anna-Shari Melin explain. (more…)
Michele Tagliaferri
Brussels
mtagliaferri@sidley.com
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com
Anna-Shari Melin
Munich
amelin@sidley.com
European Court of Justice Judgment Relating to Orphan Market Exclusivity
In a recent judgment, the Court of Justice of the European Union (CJEU) has shed light on the scope of the ‘clinical superiority’ criteria providing for a derogation to orphan market exclusivity which is key to protect the orphan molecule from competition for the period of market exclusivity (10 or 12 years as the case may be). Marie Manley, Chris Boyle, and Alix Vermulst examine the impact of this judgment on pharmaceutical companies.
Maria Isabel Manley
London
mmanley@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Alix Vermulst
Brussels
alix.vermulst@sidley.com
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