Akin represents pharma, medical device, biotech, and healthcare tech clients in global regulatory and legislative strategies. The ‘client-focused’ team leverages its strong legislative and regulatory knowledge to advise on matters at the intersection of healthcare and emerging technology, including digital health, AI, and related data privacy considerations. Nathan Brown leads the practice from Washington DC, drawing on his governmental experience to advise on regulatory, compliance, and policy matters. He also brings ’cutting-edge knowledge’ in AI and new technology applied to digital health. Also in DC, regulatory lawyer Kelly Cleary has experience in state and federal fraud abuse laws, as well as marketplace regulations under the Patient Protection and Affordable Care Act.
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Testimonials
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‘The team is client-focused, driven, attentive and responsive, with the ability to navigate complex issues.’
‘The healthcare and life science team at Akin has a unique mix of experience in both regulatory and legislative matters that make them exceptional partners and counsel on a range of topics. They provide insights on how proposed regulations intersect legislation moving in Congress. They know the details of emerging technology - particularly AI - and can effectively analyze how new and existing policies will affect this space.’
‘Nathan Brown has been an essential partner on a range of matters. Nate has both agency (FDA) and congressional experience, enabling him to provide insights on all policy matters regardless of their origin. Nate has immersed himself in AI and new technologies, equipping him with knowledge on the cutting edge of these issues. His combined legal/policy knowledge and familiarity with emerging technical matters have been instrumental in offering support on next steps on a range of topics.’
Key clients
- AdvaMed
- Leukemia & Lymphoma Society
- NowDiagnostics, Inc.
- Alliance for Aging Research
- Johnson & Johnson
Work highlights
Represents NowDiagnostics in its FDA-related legal and regulatory needs, including assisting its strategy for obtaining the first ever U.S. authorization for an at-home syphilis test.
Advised AdvaMed and its members on a wide range of legal, regulatory and congressional matters, including the implementation of MDUFA V and of the Food and Drug Omnibus Reform Act of 2022, and deliberations with the FDA and industry regarding sensitive global trade and national security issues relating to medical technologies.
Prepared and filed an amicus brief on behalf of 25 leading patient and provider advocacy organizations, spearheaded by the Leukemia & Lymphoma Society, in the Fifth Circuit litigation over FDA’s approval of the drug mifepristone, which is used for medication abortions.
Lawyers
Leading partners
The strongest partners in their field, leading on market-leading deals and endorsed by peers and clients alike.
Next generation partners
Junior partners with significant recognition from clients and peers in the market and key roles on multiple matters.
Practice head
Nathan Brown
Other key lawyers
Kelly Cleary; John Jacob; Robert Salcido