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A Bridge Too Far: Court Vacates FHWA's 2012 Expansion of Its Buy America Waiver

Client Alert | 1 min read | 01.15.16

On December 22, 2015, the U.S. district court for D.C. vacated the Federal Highway Administration's position, set forth in a December 2012 policy memorandum, that exempted manufactured steel products from the FHWA's Buy America restriction if (a) they had less than 90% steel or iron content or (b) they were "miscellaneous steel or iron products" (i.e., off-the-shelf products necessary to "encase, assemble and construct manufactured products"), causing FHWA on January 6 to rescind the policy memorandum, pending further update. The court held that both of FHWA's "clarifications" related to a 1983 public interest waiver exemption for manufactured products other than steel products; were substantive rules requiring notice and comment; and that, in any event, the 90% content rule was arbitrary and capricious under the current record.

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Client Alert | 7 min read | 09.14.26

AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. ...