Our pharmaceutical and health care experience includes:
- Reviewing and evaluating both the environmental management program and the compliance status at each facility of a company engaged in the manufacturing and distribution of cosmetics and pharmaceutical products.
- Representing a group of more than 300 research-based and generic pharmaceutical companies on emerging pharmaceutical product take-back laws and assisting with the preparation of early organizational documents and formal bylaws that address membership criteria and dues, voting structure, board of directors, committees, limitations of liability, and data confidentiality, and preparing vendor contracts, product stewardship plans (including protocols addressing applicable DEA and other requirements), and other regulatory submissions.
- Hosting a roundtable among EHS in-house counsel at leading pharmaceutical companies to assess emerging EHS issues.
- Helping a major global pharmaceutical company evaluate its Regulation on Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) exposure and develop a REACH compliance strategy.
- Representing health care providers in managing alleged waterborne pathogen outbreaks, including in litigation.
- Counseling a Fortune 100 company on emerging new chemical notification and chemical inventory regimes in Europe, Asia, and Latin America.
- Counseling two major pharmaceutical companies on options for securing essential-use exemptions for the continued use of chlorofluorocarbons (CFCs) under the Montreal Protocol and U.S. implementing measures under the Clean Air Act, as well as related matters including disposal of waste products and transfers of CFC stockpiles and allowances.
- Working with a medical device manufacturer on the viability of future product lines using a substance that could qualify as an ozone-depleting substance.
- Representing pharmaceutical production facilities with reuse/recycling operations under the Resource Conservation and Recovery Act (RCRA).
- Providing on-going research, analysis, and advocacy assistance to a number of large pharmaceutical companies about the shifting landscape of national and international climate change requirements.
- Advising a Fortune 100 company on all aspects of Clean Air Act New Source Review permitting for capital projects accompanying the production of major new pharmaceutical products.
- Representing an industry trade association supporting EPA’s Maximum Achievable Control Technology (MACT) regulation for medical waste incinerators against a lawsuit brought by an environmental organization challenging that rule in the D.C. Circuit.
- Advising on Toxic Release Inventory (TRI) reporting obligations under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), including responses to EPA enforcement actions.
- Assisting a major pharmaceutical manufacturer with the development of a continuous release reporting program to ensure compliance with the emergency release reporting requirements of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and EPCRA.
- Advising pharmaceutical industry clients on the requirements of the Toxic Substances Control Act (TSCA), including circumstances (e.g., recycling of pharmaceutical waste streams) under which substances may not be considered “drugs” exempt from TSCA’s chemical regulatory requirements.
- Counseling U.S.-based pharmaceutical companies on the implementation of the Cartagena Protocol on Biosafety.
- Representing pharmaceutical and medical products manufacturers seeking insurance coverage for the defense and settlement of liability claims.
- Counseling a major pharmaceutical company on due diligence issues related to the consideration of new pharmaceutical products based on products that may implicate obligations under international agreements or raise corporate responsibility considerations, including under the Convention on Biological Diversity and the Antarctic Treaty System.