PRESCRIPTION OTC DRUGS AND BIOLOGICS

Thompson Coburn, having represented drug and biologic companies ranging from emerging technology to specialty pharma to the larger companies in the industry, understands that these companies are constantly under scrutiny and often targets of product liability litigation. This portion of the life science industry is heavily regulated making the cost to get to market and maintain market share difficult. Complying with Good Manufacturing Practices, working with clinical trial sites and Institutional Review Boards, and achieving approval to market is time-consuming and costly.

Our attorneys work with clients to navigate the regulatory waters consistent with their business strategies. For emerging technology and specialty pharma, we negotiate sensible and fair licensing agreements, negotiate with capital sources and provide intellectual property counseling. We have assisted our clients in:

• Filing New Drug Applications
• Filing Investigational New Drug Applications
• Filing for Orphan Designation
• Drafting and reviewing clinical trial agreements, protocols and informed consents, as well as advising the client on IRB interactions
• Complying with the Compounding Quality Act
• Negotiating regional and global licenses
• Reviewing BLA filings for sufficiency prior to filing
• Negotiating clinical trial agreements
• Negotiating tech-transfer agreements between research/academia and commercial entities
• Implementing strategies related to the detention of regulated products
• Responding to FDA 483 Inspection Reports and implementing corrective action plans where necessary
• Civil investigations and disputes with the FDA and FTC, including fraud and marketing claims
• Product liability cases regarding failure to warn, duty to warn, negligent manufacture and strict liability
• DEA licensing/registration issues
• FDA- and DEA-enforced pharmaceutical disposal matters
• Negotiating tech-transfer agreements between research/academia and commercial entities
• Compliance with the OTC monograph