Pharmaceutical, medical device, biotechnology, health care, technology, food/dietary supplement, and other life sciences companies are among the most heavily regulated entities in the world. King & Spalding’s FDA & Life Sciences group serves every aspect of this specialized and intensely-regulated industry: from day-to-day advice and counseling, to managing large scale government fraud or FDA investigations and everything in between. We are dedicated life sciences specialists because the complexity of the industry and our clients demand it. Federal, state and international government regulation (and associated scrutiny and enforcement) continue to expand, and as the regulatory framework becomes even more complex, companies need external counsel who are more than just specialists with expertise in these new developments. Successful ventures need to understand how the new regulations and developments fit within the broader regulatory framework—and how these changes impact business and industry practices. King & Spalding’s widely recognized FDA & Life Sciences group is well positioned to meet these demands.
With more than 35 lawyers and professionals in the U.S. and Europe devoting their time exclusively to FDA matters, as well as U.S. and EU health care and related regulatory matters for life sciences companies, King & Spalding’s FDA & Life Sciences group provides sophisticated regulatory counseling to more than 200 large, mid-cap, and start-up medical device, drug, biotech, food, and tissue product manufacturers, as well as distributors, health care providers, and technology ventures. We serve the needs of these companies at every stage of the product life cycle. From early research and development, clinical testing, and product and ingredient clearance/approval, to manufacturing operations, sales and marketing, product labeling and claims, and drug pricing and reimbursement, we regularly advise FDA-and EU-regulated manufacturers, pharmacies, and investors on complex matters involving:
- Department of Health and Human Services (HHS), including
- Food and Drug Administration (FDA)
- Centers for Medicare and Medicaid Services (CMS)
- Office of the Inspector General (OIG)
- Office for Civil Rights (OCR)
- Health Resources and Services Administration (HRSA)
- U.S. Congress
- U.S. Department of Justice (DOJ)
- U.S. Attorney’s Offices
- Drug Enforcement Administration (DEA)
- U.S. Department of Veterans Affairs (VA)
- State Boards of Pharmacy
- State Attorney General Offices
- European Commission
- European Medicines Agency (EMA)
- Notified Bodies in the European Union
- European Food Safety Authority (EFSA)
- European National Competent Authorities
The team also frequently conducts due diligence evaluations of medical product and food companies’ regulatory compliance for other companies, investment banks, private equity funds, and venture capital firms. Additionally, we provide regulatory expertise in complex litigation matters.
An Elite Team
Ranked by Chambers USA, The Legal 500, U.S. News & World Report and LMG Life Sciences as among the nation’s best, King & Spalding’s FDA & Life Sciences team includes a deep bench of lawyers and other professionals with expertise and experience in the areas of federal, state, and international regulation that affect the life sciences industry. Eleven members of the team have previously served at FDA in the Office of Chief Counsel, the Office of Regulatory Affairs, the Center for Drug Evaluation and Research’s Office of Regulatory Policy, the Center for Devices and Radiological Health’s (CDRH) Office of Compliance, and CDRH’s Office of Device Evaluation (ODE). One team member served as Acting General Counsel in the HHS Office of General Counsel, and several others have served at OIG and DOJ (and in various positions within the federal government). Others have held executive positions in biotech and medical device companies, bringing additional deep and practical understanding of the industry.
In addition, the FDA & Life Sciences group’s non-lawyer professionals provide integrated medical and technical assessments and recommendations, which are routinely required in complex regulatory matters, including FDA interfaces and preparation for meetings and submissions, quality system audits and mock inspections, and crisis-management situations. These individuals include a former deputy associate commissioner for regulatory affairs in CDRH; three quality system consultants who previously served as FDA investigators; a national expert in pharmaceutical, biologics, and medical device quality and manufacturing processes; a former ODE senior scientific reviewer; a former chief of the neurodiagnostic and neurosurgical devices branch of the neurological and physical medicine devices division in ODE; and a board-certified cardiologist who is a former Harvard University Professor of Medicine and who previously was the chief medical officer for a medical device manufacturer and a member of an FDA advisory committee.
Our FDA & Life Sciences group also calls upon the expertise of lawyers in several related areas within the firm, particularly those in our health care industry practice as well as those in the product liability, civil and criminal litigation, mergers and acquisitions, intellectual property, international trade, government investigations and government advocacy and public policy practices. Altogether, more than 200 King & Spalding lawyers devote at least 50% of their practice exclusively to the issues of the life sciences industry.
Thought Leaders to the Life Sciences Industry
King & Spalding’s FDA & Life Sciences group offers a wide range of educational seminars and conferences to clients. This includes the annual Pharmaceutical University, a one-day, dual-track conference providing insight into and analysis of a number of key legal/regulatory issues of importance to manufacturers of pharmaceutical and biological products, as well as the annual Medical Device Summit, a two-day conference addressing compliance, fraud and abuse, and FDA regulatory developments of interest to medical technology manufacturers. We also host periodic seminars, roundtables, audio conferences and webinars designed to keep clients informed of key developments in the life sciences industry as well as publish client alerts on new regulatory developments.
- Named “Law Firm of the Year” for FDA law by U.S. News & World Report and Best Lawyers in 2013. The firm also was awarded a national tier 1 ranking in the FDA Law category for a fourth consecutive year.
- Ranked number 1 in Modern Healthcare’s list of “largest healthcare law firms” each year from 2007-2013,” with more AHLA members than any other law firm.
- Named FDA medical device firm of the year at the LMG Life Sciences Awards in 2013.
- ‘Highly recommended’ in the area of FDA-medical device regulatory work in the 2013 edition of LMG Life Sciences. Ten King & Spalding lawyers were identified as “life sciences stars.”
- One of very few firms ranked among the best in the U.S. for both pharmaceutical/medical products and food and beverages by both Chambers USA and The Legal 500.
- Identified among the top 10 lobbying practices in the U.S. in the 2013 edition of the National Law Journal’s Influence 50 survey.
What others say about our FDA & Life Sciences Practice
- “Sources say: ‘Strong technical knowledge, excellent customer service and broad skills.’” — Chambers USA 2013
- “King & Spalding LLP is ‘among the top firms in its field’; and ‘has the depth and breadth of expertise to assist with issues ranging from medical device regulation, drug regulation, import, customs and other US government topics. Its service is above excellent’.” — The Legal 500 2013
- “The firm has excellent connections to the government and is very well respected and trusted by regulators, the DOJ and the OIG, which is essential when negotiating with governmental authorities.” — Senior vice president and general counsel at a top 20 pharmaceutical company
- “King & Spalding is a huge reservoir of legal talent for FDA issues.” — CEO and president of a biotechnology company
- “King & Spalding has exceptional talent and delivers consistently high quality results. They are the undisputed leaders in the medical device regulatory sphere, and their drugs/biologics and other FDA regulatory practice areas are also top-notch. They are the best I’ve seen at conducting highly professional and timely privileged investigations and audits.” — Vice president, FDA / regulatory law, of a multinational biopharmaceutical company