Based in Washington, D.C., the Regulatory and Government Affairs Group combines highly sophisticated technical expertise, a deep knowledge of the industries in which our clients operate and the legal and political skills needed to help clients navigate the labyrinth of government regulations that affect their businesses, both in the U.S. and in foreign markets. The multidisciplinary professionals in the Group work closely with the firm’s other practice areas to help clients navigate federal and state regulatory challenges. We work with clients to achieve and maintain market access for their goods, limit potential exposure to liability, maximize business opportunities and help manage crisis situations.
Our Regulatory attorneys have experience practicing before a wide range of federal agencies, including the following:
Consumer Product Safety Commission (CPSC)
Department of Commerce/Bureau of Industry and Security (BIS)
Department of Commerce/National Oceanic and Atmospheric Administration (NOAA)
Department of Commerce/National Telecommunications and Information Administration (NTIA)
Department of Defense (DoD)
Department of Homeland Security/U.S. Customs and Border Protection (CBP)
Department of Labor/Occupational, Safety and Health Administration (OSHA)
Department of State/Directorate of Defense Trade Controls (DDTC)
Department of the Treasury/Office of Foreign Assets Control (OFAC)
Federal Aviation Administration (FAA)
Federal Communications Commission (FCC)
Federal Trade Commission (FTC)
Food and Drug Administration (FDA)
National Aeronautics and Space Administration (NASA)
As you tour our website, you will see the different regulatory areas in which we work and will meet the people who do the work.
REGULATORY AND GOVERNMENT AFFAIRS PRACTICE AREAS
Fish & Richardson has significant expertise representing clients on a variety of regulatory and government affairs matters. The cornerstones of our practice are quality, accessibility, responsiveness, and reliability. The attorneys at Fish & Richardson work closely with in-house legal, technical, business, and marketing personnel on a daily basis. This work typically involves tight deadlines and demanding schedules. Our goal is to achieve 100% client satisfaction with each engagement, which contributes to the long-term nature of our client relationships. We assist clients primarily in the following areas:
Advertising & Marketing
Communications & Spectrum Regulation
Drug & Medical Device Regulation
Export Controls, Foreign Policy & National Security Issues
Government Contracts
Occupational Safety & Health
Satellites & Space Systems
Advertising & Marketing
We provide advice to in-house counsel and marketing personnel concerning advertising and marketing issues. This includes, for example, compliance with federal and state laws concerning spam and e-mail marketing, telemarketing, sweepstakes and contests, deceptive practices, product claim substantiation, "free" offers, and customer testimonials. We regularly pre-screen advertising copy including print, television and radio advertisements, telephone scripts, and web site materials for compliance with such laws.
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Communications & Spectrum Regulation
Our Communications & Spectrum Regulation practice is devoted to a broad range of federal, state and international telecommunications law and policy. We have the extensive experience necessary to meet the ever-changing business, regulatory and technological needs of our clients. Our work regularly brings us before the Federal Communications Commission ("FCC"), the National Telecommunications and Information Administration ("NTIA") and state regulatory commissions. We are unique in that we are able to draw upon the firm's unsurpassed technical expertise which includes many attorneys with Ph.Ds and other advanced degrees in science or engineering, including communications and electrical engineering. Further, in conjunction with the firm's Complex Litigation Practice, our communications practitioners also have extensive state and federal appellate litigation experience.
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Drug & Medical Device Regulation
Our Drug and Medical Device practice delivers regulatory know-how with value added by the scientific expertise of our intellectual property practice. Unlike most "FDA practices," we have a unique technical capacity that comes from our world-class patent practice. One-stop shopping for both patents and regulatory work saves client resources because clients need not teach their technology twice.
We have experience in a wide range of FDA regulation of various products, including small molecule drugs, biologics, homeopathics, and medical devices. We counsel clients in areas such as gene and cell therapies, antihypertensives, ophthalmics, anti-inflammatories, immunologics, antibiotics, anti-anxiety medications, hormone therapies, and medical gases. Our medical device practice covers products such as research and screening technologies, dental devices, implants, imaging agents, medical telemetry, PARS, catheters, cardiovascular devices, microwave therapies, pressure monitors, oximeters, and various types of drug delivery technologies. We also are experienced in a broad range of radiological health technologies including x-ray, MRI, PET, and medical lasers.
One of our unique specialties is advising on the interrelationship between patent and drug laws to protect patent exclusivity for products worldwide. In the United States, this means understanding the complex relationship between U.S. patent laws and the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act"). We advise and counsel clients on the scope and application of the 271(e)(1) safe harbor from patent infringement; Orange Book practice and patent litigation under 271(e)(2); marketing exclusivities for pioneers and generics; and patent term extensions.
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Export Controls, Foreign Policy & National Security Issues
U.S. companies are subject to restrictions on the transfer - be it a one-time shipment or disclosure or the sale of an entire company - of hardware, software, technical data and services to foreign persons, including foreign employees, subsidiaries, vendors, suppliers, joint venture partners and investors, whether located in the U.S. or abroad. These restrictions arise under U.S. laws and regulations that govern exports and imports and implement U.S. and U.N. embargoes and sanctions and include the International Traffic in Arms Regulations ("ITAR") administered by the State Department's Directorate of Defense Trade Controls, the Export Administration Regulations ("EAR") administered by the Commerce Department's Bureau of Industry and Security, and the various foreign assets and transactions control regulations administered by the Treasury Department's Office of Foreign Assets Control ("OFAC").
U.S. companies also must comply with U.S. Anti-Boycott rules, Exon-Florio limits, Foreign Ownership Control and Influence ("FOCI") restrictions and the Foreign Corrupt Practices Act ("FCPA").
We routinely help clients assess their export control and trade compliance practices, identify licensing needs and apply for licenses, establish and implement compliance programs and policies, train senior management, staff and other employees, perform audits, advise on discreet questions that arise in the normal course of business and represent them before federal agencies and judicial bodies with respect to actual or alleged events of non-compliance.
For examples of the technologies with which we are experienced and the types of trade compliance projects in which we have been or are involved, please click on the following links:
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Government Contracts
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Occupational Safety & Health
We routinely counsel clients on federal and state Occupational Safety and Health Administration ("OSHA") compliance in the area of electrical safety. We have represented Nationally Recognized Test Laboratories ("NRTLs") seeking OSHA accreditation and in response to audit and enforcements matters. We also represent clients filing Complaints About State Program Administrations ("CASPA") before OSHA. In addition, we pursue state violations of federal OSHA standards at the state regulatory level.
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Satellites & Space Systems
Our clients appreciate that we combine our legal training and skills with an in-depth knowledge of the satellite and space industries. Many of our attorneys worked in the aerospace sector, at companies and at government agencies, before entering private practice. This background gives us the legal and technical know-how to get the job done - a rare combination of talent and experience not found in many law firms. Moreover, because our knowledge of and experience in this area is so extensive, we regularly advise clients not only on traditional regulatory matters, but also on contracts, risk management and insurance, legislative and policy matters, and corporate and finance issues unique to these complex industries. Our clients tell us that this cross-functional approach is efficient and highly effective.
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OUR ATTORNEYS
Donna A. Balaguer
Keith A. Barritt
Kerri Griffin
Edwin N. Lavergne
Terry G. Mahn
Jay S. Newman
Franceska O. Schroeder
Ramon K. Tabtiang
Joseph Taylor (Admitted only in Maryland)
Robert J. Ungar
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Regulatory and Government Affairs