Food & Drug

The firm’s regulatory practice is backed by substantial experience representing clients in matters involving the Food and Drug Administration (FDA). Our attorneys have handled matters including:

Guiding companies through the FDA’s premarket clearance process
Assisting with product development and commercialization strategies to minimize FDA regulatory costs
Providing advice on FDA labeling, advertising and manufacturing requirements
Offering advice and guidance on other issues arising during the progression of a product from premarket clinical testing to postmarket commercial distribution

We assist clients with issues relating to:

Medical devices
Biologics
Food
Food additives
Dietary supplements
Nutritional products
Cosmetics
Animal drugs
Veterinary products

An important component of the firm’s regulatory practice centers on planning and obtaining FDA approval of products. In terms of medical devices, for example, our attorneys have successfully prepared dozens of premarket notification submissions or “510(k)s” on behalf of clients. We have successfully brought to market specialized wheelchairs, circulatory assist devices, cranial headbands, an allergy control device and teleradiology products. Our medical device practice also include assistance on matters involving premarket approval, investigational device exemptions, institutional review boards, humanitarian devices, medical device reporting and the FDA’s quality system regulations.

In the food area, we have advised clients on FDA regulation of various food-related issues such as registration of low-acid canned food establishments, infant formula nutrient requirements, dietary supplement health claims, potential drug status of parenteral and enteral nutrition solutions, and premarket review procedures applicable to food additives generally recognized as safe (GRAF).

Eliminating Roadblocks

A key element of our representation includes responding to and overcoming roadblocks and obstacles in the regulatory arena. If problems arise that involve concerns of a broader public policy nature, we elevate the issues within the FDA as appropriate, to the office of the relevant Center Director, the Office of the Commissioner and/or the Office of the General Counsel. We may also direct our efforts outside of the FDA by targeting the Department of Health and Human Services, the White House and/or Congress.

The following are representative examples of strategies our attorneys successfully employed on behalf of clients:

We represented a veterinary drug manufacturer in an aggressive defense of two poultry products when the FDA and the Centers for Disease Control considered market withdrawals of products perceived to be connected to the problem of drug resistance in farm animals. Our process involved delicate negotiations with the FDA while initiating an educational campaign for members of Congress and the general public.
We persuaded the FDA to expedite approval of a class of veterinary drugs using Congressional report language
Recommending the FDA relax its export requirements for certain HIV diagnostic test kits
Discouraging the FDA from regulating infusion therapy pharmacies as manufacturers

Enforcement and Compliance

A second major area of focus within the firm’s FDA practice includes representing clients regarding FDA enforcement and compliance matters. Among the members of the firm’s Litigation Group is a former supervisory Assistant US Attorney with substantial experience with FDA-related litigation. Our attorneys have undertaken compliance projects in numerous situations, including:

Helping a manufacturer of over-the-counter drugs with a product recall
Reviewing and revising draft labeling for dietary supplements
Assisting manufacturers in responding to adverse inspects (483s) and warning letters
Representing a device manufacturer during a seizure action
Defending employees of a vaccine manufacturer against criminal charges of falsifying data and knowingly violating good manufacturer practices and drug export requirements