Pharmaceuticals and Biologics
The pharmaceutical industry continues to undergo significant restructuring. During this process, we are assisting pharmaceutical and biotechnology manufacturers and distributors on everything from the development of new products and services to their marketing, promotion, reimbursement and pricing. Through our international offices, we regularly assist with multinational drug development, manufacturing, marketing, licensing and related transactions in Canada, Europe and Asia.
At the development stage, we help clients with both strategic and practical issues. We advise on how to approach the FDA to enable the prompt development and effective marketing of a proposed product. We also assess reimbursement strategies and provide advice regarding any available market exclusivity for the product. We are there to work with clients on the full range of early development, Investigational New Drug Application, New Drug Application, and Biologics License Application processes. The scientific training of our lawyers and professionals is a vital asset and enhances our ability to respond to issues involving novel products and technology.
Once pharmaceutical products are introduced in the marketplace, we help our clients develop promotional, reimbursement, marketing/distribution, and pricing strategies, including developing strategies to establish and extend market exclusivity protection. We advise companies on the proper structuring of various pharmaceutical marketing arrangements and practices in the new managed care environment. We also assist in ongoing compliance activities, advising on such issues as Good Manufacturing Practices, recalls, export/import, and both federal and state distribution issues, including those involving the Prescription Drug Marketing Act and the Controlled Substances Act, and emerging e-commerce issues. As part of our regulatory counseling, we anticipate and seek to manage potential product liability exposure.
When enforcement concerns arise, we help companies based on our extensive involvement in large, complex government investigations and litigation. We have represented several large pharmaceutical companies and distributors in connection with federal and state governmental health fraud investigations of pharmaceutical price and marketing practices. We have also counseled and defended clients with respect to investigations and litigation by the FDA, the Federal Trade Commission, the Health Care Financing Administration, the Office of the Inspector General of the Department of Health and Human Services, the Department of Justice, and state Attorneys General based on state consumer protection statutes. Because of our extensive enforcement counseling, we can effectively and efficiently assist clients in responding to civil and criminal enforcement and less formal compliance matters, such as FDA Form 483, Warning Letter and untitled letter responses.