Life Sciences — Regulatory

Pharmaceutical and medical device companies face regulatory risks and challenges that are unique to the products they make, the facilities where they manufacture them, and the ways in which they deliver them to market. We work with clients on their most difficult challenges, helping them develop and enhance compliance programs to meet applicable regulatory requirements, including U.S. Food and Drug Administration (FDA) investigational new drug (IND), premarket notification 510(k), and marketing and labeling requirements. With our focus on diligence and risk mitigation, Crowell helps clients avoid litigation and enforcement actions.

We also advise clients on a variety of regulatory and fraud and abuse issues, including Medicaid "best price" and other statutory pricing requirements, federal and state anti-kickback and consumer protection laws, development and implementation of formularies, legal risks associated with potential conflicts of interest in business relationships, and DEA investigations of pharmacy drug handling and recordkeeping. Our lawyers also develop compliance programs and policies, and regularly conduct internal investigations and compliance reviews.

EU Regulatory Framework 

Our team has a detailed understanding of the EU regulatory framework relating to the life sciences and biotechnology sectors. We advise and litigate on all regulatory issues, including marketing authorizations, pricing, and reimbursement decisions, legislative reforms, off-label use questions, and parallel import. We also advise clients on the marketing and advertising of medicinal products, including compliance with the applicable rules and codes of conduct, restrictions regarding promotional offers and hospitality towards health care providers, internal audits, and drafting of company guidelines.

We have represented clients in regulatory matters before the Belgian administrative and civil courts and assisted clients in procedures before the European Medicines Agency (EMA), the Ethical Health platform Mdeon, the Deontological and Pharmaceutical Ethics Committee, and other regulatory and legislative bodies.