Businesses, particularly those involved in manufacturing drug and medical devices, need experienced FDA counsel to help navigate the complex array of regulations and public policy issues that can make or break a new product's commercialization.

The Firm's Health Care Practice offers clients advice in the food and drug area and in biotechnology. Our FDA experience includes taking a company from start to finish through the FDA's pre-market clearance process; assisting companies with product development strategies in order to minimize FDA regulatory costs; giving advice on questions involving the FDA's labeling, advertising and manufacturing requirements; and handling other issues that arise during a product's progression from pre-market clinical testing to post-market commercial distribution.

We have defended companies against FDA enforcement actions and represented client interests in the legislative and regulatory process. We have assisted clients with respect to medical devices, drugs, biologics, food, food additives, cosmetics, animal drugs and other veterinary products. We have also represented companies that develop and market products using recombinant DNA, monoclonal antibodies and other biologically based products and processes generally referred to as biotechnology.

Besides providing assistance in matters before the FDA, we have counseled biotech clients with respect to the Orphan Drug Act, the Administration's multi-agency "coordinated" approach to regulating biotechnology and the role of the courts in protecting both the biotech industry and public from administrative abuses. Finally, we have assisted companies in addressing biotech-related trade problems for food and agricultural products.

Representative Matters:

• Represented the animal health division of a foreign multi-national pharmaceutical company in getting legislation passed by Congress requiring the FDA to expedite approval of a new class of animal drugs that improve food safety
• Prepared dozens of 510(k) applications that won FDA clearance of various medical devices, including a telemedicine product, circulatory assist device, wheelchairs, orthoses and others
• Developed labeling for a range of natural honey-based products in compliance with FDA's nutrition labeling and dietary supplement laws
• Helped a home care company prepare an abbreviated new drug application for a generic respiratory drug
• Advised several pharmacy clients on FDA regulation of compounding practices and advertising under the FDA Modernization Act and relevant case law
• Defended several device and drug vendors against FDA enforcement actions including seizure, product recalls, inspections and civil monetary penalties
• Counseled clinical investigators and sponsors regarding permissible labeling, promotion and charging for investigational drugs and devices