We draw on extensive industry-specific knowledge and technical background to help life sciences clients create innovative business plans. We are particularly experienced with the biotech, medical device and pharmaceutical industries and their products. Whether you are a new, privately held startup or an established public company, our practical and legal experiences can help you overcome the complex corporate, information technology, intellectual property, litigation and regulatory issues that challenge your business daily. Simply put, we can help you take your ideas to market.
Our Life Sciences group is focused on helping FDA-regulated industries translate their scientific advances to commercial success. A cascade of social, political, scientific, legal and regulatory factors combine to make the life sciences one of the most complex and dynamic business pursuits. Fostering the development of products that improve the condition of living beings also makes the life sciences one of the most rewarding endeavors.
We recognize that business success and the ultimate ability to positively impact public health depend upon efficient, practical approaches. Our experienced professionals help pharmaceutical, medical device, biotechnology, food, medical research and other life science businesses successfully navigate the complex laws and regulations that govern them in order to achieve decisions that advance their business.
People who dedicate their business and professional life to the life sciences need experienced professionals to assist in the practical interpretation of the laws and regulations that establish their operational framework. These decision-makers also need lawyers with the experience to protect and defend their business.
Our practice draws upon experienced professionals with science and industry backgrounds to develop practical, efficient solutions to the challenges faced in the life sciences.
- Corporate lawyers experienced in the areas of research and development, manufacturing and marketing of new products, including clinical trial structuring, investigational new product applications, and compliance issues.
- Corporate lawyers who have successfully negotiated co-development, co-marketing, cost sharing and risk allocation agreements on both national and international levels.
- Litigators who defend companies in criminal and civil investigations and enforcement actions, including extensive experience with the Department of Justice (DOJ), the Office of Inspector General (OIG) and state attorneys general.
- Litigators with experience in complex multijurisdictional tort and contract litigation involving efficacy, labeling and safety claims with respect to pharmaceutical, medical device and biologic products.
- Lawyers experienced with the creation and preservation of intellectual property and the unique challenges of life-cycle management in the pharmaceutical, medical device and biotechnology businesses.
- Lawyers who provide practical advice to maximize business success while complying with state and federal laws that affect life sciences, such as the Prescription Drug Marketing Act, the Prescription Drug User Fee Act, the Medical Device User Fee and Modernization Act, the Controlled Substances Act, the Controlled Substance Import and Export Act, the Medicare Modernization Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the False Claims Act and the Anti-Kickback Act.
- Lawyers with experience in all facets of drug and medical device labeling, packaging, CMC development, cGMP issues, and hearings and negotiations with CDER, CBER, and CDRH.
- Lawyers with extensive government contacts and experience in policy development and lobbying with respect to state and federal legislative and administrative initiatives impacting the life sciences (including tort reform, importation, trade regulation, controlled substance restrictions, Medicare reform, Medicaid reform, and other access, reimbursement and operational hurdles).
- Lawyers with practical real-world experience with bioterrorism issues.
Lawyers in our Life Sciences group are experienced with the impact on business brought by the interplay of state and federal laws, regulations and policies that act upon the life sciences. That's why we do more than just identify risks in business practices. We work with clients to understand their business intimately and bring our experience to assist them in implementing innovative solutions which allow them to do what they do best – deliver products and services that improve the health and well-being of living beings.
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.
- 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.
Our clients include the following life science providers:
- Pharmaceutical companies engaged in branded and generic pharmaceuticals
- Biotechnology innovators creating the next generation of medicines
- Medical device companies
- Animal health companies
- Contract research organizations
- Institutions responsible for medical research and development
- Health-related e-businesses
- Physicians, health plans and hospitals engaged in the life sciences
- Companies engaged in the development of bioterrorism protection
Business Law Update – Summer 2019 - Thompson Hine Newsletter
August 14, 2019