FOOD AND DRUG: DESCRIPTION
The Food and Drug practice of McKenna Long & Aldridge includes all aspects of product approvals, federal policy making, science advocacy, enforcement, litigation, and “elevation” of issues to higher regulatory, executive, and congressional levels. Our focus is on foods, dietary supplements, drugs, biologics, medical devices, and all other types of products (e.g. radiological, cosmetics, etc.) and services (e.g., clinical research) subject to FDA authority. We have a reputation for developing multi-faceted, out-of-the-box strategies that may simultaneously involve policy advocacy, congressional support, litigation, coalition building, advocacy with a wide range of stakeholders, and a strong scientific component. We are proud of our ability to craft innovative solutions to difficult problems, yet we are grounded in basic food and drug law and apply our experience in routine and complicated regulatory counseling and enforcement issues.
Our attorneys are also intimately involved with all aspects of food safety and health risk assessment, including risk assessment and management techniques, risk communication, data quality, and new drug issues. We address these issues with both scientists and policy makers, e.g. the Office of Management and Budget, the Office of Science and Technology Policy, and the National Academy of Sciences. Our clients include domestic and international manufacturers, processors, developers and distributors of articles (e.g., foods, cosmetics, medical devices, dietary supplements, biologicals, and electronic products). We also represent clinicians, trade associations, and research institutions subject to regulation by the FDA.
Food Law
MLA lawyers assist clients in all aspects of food law:
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preparing food additive petitions, food contact notifications, and obtaining FDA approval for the use of new food additives and packaging materials
providing opinion letters on whether food ingredients or substances used in food packaging comply with FDA regulations
establishing that food ingredients or packaging materials are “Generally Recognized as Safe”
food labeling
compliance issues, including good manufacturing practice requirements, product recalls, FDA inspection practices, and warning letters
Dietary Supplements
Our work with dietary supplements includes advising clients on:
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the requirements of the Dietary Supplement Health and Education Act, including its provisions on adulteration, good manufacturing practices, new dietary ingredients, and misbranding
labeling requirements for dietary supplements
the types of claims that may be made regarding the supplement on labels and in advertising
testing requirements to establish the safety of a dietary supplement
product liability issues
Drug Biologic Law
Our experience covers decades, from the passage of the Drug Amendments of 1962 to the present. We advise clients on:
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new drug approvals for human and animal use
abbreviated new drug and generic drug approvals
factory inspections and Good Manufacturing Practice approvals
labeling and advertising
over-the-counter drugs
active pharmaceutical ingredients (APIs)
enforcement issues
Medical Device Law
MLA partner Larry Pilot is recognized as an architect of the FDA's present medical device regulatory program, beginning in 1970. He advises clients on all aspects of medical device law:
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device clearances and approvals
due diligence and audits
Warning letters, recalls, and notifications
enforcement
litigation
import/export actions
bioterrorism
product liability prevention and defense
Enforcement Proceedings and Litigation
MLA's Food and Drug practice represents clients in federal enforcement proceedings, including fraud investigations and regulatory hearings involving the FDA, the DEA, the Federal Trade Commission (FTC), and the Department of Justice. We also handle state enforcement matters before parallel state agencies. The firm represents companies in civil and criminal litigation involving these same agencies, such as grand jury proceedings, injunctions, and product seizures.
We assist clients subject to FDA regulation with:
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Complying with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) requirements
Administrative procedures
Litigation (including consent decrees)
Negotiated settlements
Arbitration
Plant inspections
Product recalls
Reconditioning plans
Warning letters
Import/export issues
Crisis Management
We are often asked to assist clients with sudden high-stakes challenges, such as unfavorable media attention, unexpected adverse agency actions, or unfavorable product reviews impacting customer and public opinion. We have worked successfully with the scientific community, federal and state regulators, the media, and public interest, health, environmental, and other nongovernmental organizations to address these issues when they arise. We also assist clients in designing and implementing crisis management plans that allow immediate response to unexpected events.
Elevation to Higher Decision Levels
We are often asked to intervene at higher levels in the federal agencies and with the Executive Office. We do this with due regard for the views of lower-level officials charged to address a matter, and with the expectation that colleagues and friends who have positions of responsibility will expect well-prepared reasons for elevation. Entry may be easy. Informed advocacy is the key.
Strong Scientific and Technical Basis
We maintain very close ties to the scientific, medical, and engineering communities. We are proficient in risk assessment methodology and the basics of the science involved in toxicology, epidemiology, biology, chemistry, pharmacology, and molecular biology. We also work closely with our affiliate, Technology Services Group (TSG), on technical and regulatory matters for our food and drug clients. TSG and its European subsidiary, Technology Sciences Europe, Ltd., have offices in Washington, DC, San Francisco and Davis, CA, Phoenix and Knaresborough, UK.
Business Transactions
Our food and drug lawyers work closely with corporate management in developing short- and long-term regulatory strategies. We are regularly involved in consultation, facility reviews and document drafting for business transactions involving operations regulated by the FDA, USDA, and DEA. For example, we perform due diligence reviews for potential acquirors, and merger candidates, and underwriters contemplating equity financing. We also prepare documents for the acquisition and sale of regulated products, facilities and businesses.
Business relationships among regulated parties often require agreements with special, carefully drawn provisions. Such arrangements include the purchase of unapproved products for use in research projects, contracts for the conduct of research activities, and contracts for the conduct of manufacturing activities. Other common contractual relationships include those with clinical investigators, contract institutional review boards, or contract clinical research organizations. MLA lawyers have drafted and negotiated numerous such agreements.
International
MLA lawyers advise clients on food and drug import and export matters involving FDA and customs issues, including tariff classifications. Our lawyers have counseled clients in administrative proceedings concerning importations, including detentions and liquidated damage claims and penalty proceedings relating to the refusal of admission for FDA-regulated products. We advise clients concerning international regulatory developments, particularly those related to the European Union and China, and we assist clients in obtaining product registrations in Japan and elsewhere.
Our lawyers also have vast experience in international trade issues arising in the fertilizer, pesticide, livestock, and commodity industries. The firm assists clients with the international registration and harmonization of crop protection chemicals and biotechnology products; food labeling requirements; tariff and duty suspension, and pytosanitary and quarantine regulations.