Life Sciences

Our Life Sciences group draws from a diverse range of experience. Whether your business requires the development of a comprehensive compliance program to prevent and defend against claims of off-label promotion, the development of a tax optimization strategy in a global co-development agreement or defense of your products from product liability claims, our lawyers have the ability and experience to meet your needs.

Representative Experience

• Counseled a pharmaceutical client in all phases of global product launch, including clinical trial development, publication plans, FDA dialogue, risk management plan development, product and disease state education, training and promotional strategy.
• Provided advice on issues pertaining to the import and export of controlled substances and raw materials.
• Advised a pharmaceutical client in the application of FDA regulations to product labeling, advertising, and promotional and educational activities, as well as provided advice on limiting liability exposure relating to those communications (including product liability, intellectual property, competition laws, and fraud and abuse laws).
• Represented a pharmaceutical client in multidistrict product liability litigation.
• Represented a pharmaceutical client on a variety of international transactions including an international licensing arrangement for a controlled substance, cost allocation for new product development, and profit sharing arrangements.
• Provided advice on the informed consent process, clinical trial recruitment strategy and related advertising and education.
• Provided advice on the use of coupons and vouchers for prescription drugs.
• Advised a pharmaceutical client on the structure and operation of patient assistance programs.
• Provided advice on DEA, PDMA and licensing restrictions pertaining to prescription drug sampling.
• Advised a pharmaceutical client in the establishment of a compliance program, including structural formation, policy and procedure development, training and advice.
• Established educational and research grant review process for FDA-regulated client.
• Provided advice on issues relating to orphan drug and compassionate use programs.
• Represented medical device, biotech and pharmaceutical clients on acquisitions and asset transfer arrangements.
• Represent clients on acquisitions and asset transfer arrangements.