Industries: Life Sciences

FDA Regulatory

Our FDA practice provides counsel where innovation meets regulation. In doing this, our mission is to solve problems, add value, and define strategy by the ultimate goal. Our method is to inform clients, help them adapt, and watch them thrive. We have counseled manufacturers and distributors of medical devices, drugs, food, cosmetics, nutritional supplements, and veterinary products throughout the United States and around the world. The FDA practice represents clients in day-to-day compliance matters involving all areas of government regulation. The team includes not only experienced lawyers who focus their practices exclusively within the FDA, but also:

• Former FDA and NIH members
• An attorney who is also a medical doctor
• A registered nurse
• Pharmacists, engineers, and science professionals
• Former in-house counsel to medical device and drug companies
• Former assistant U.S. attorneys
• A cadre of attorneys active in the tobacco, nutraceuticals, food and beverage, and consumer product industries

As a team, we partner with clients to develop, implement, and monitor regulatory programs from product development through launch, commercialization, and quality management. In addition, we believe that a comprehensive, multidisciplinary approach to life sciences products is the real-world way to navigate clients’ businesses – inside and outside the firm. Internally, McGuireWoods’ larger Life Sciences Industry Group is a one-stop shop for life sciences companies – a single team of interconnected attorneys with deep, varied experience.

Externally, we stay abreast of overt and subtle changes to regulatory policy and procedure, especially in this new era of heightened regulation and enforcement. We are adept at working with the FDA through collaborative mechanisms that, quite frankly, make themselves most available to those studied and experienced in FDA relations. We proudly maintain a positive relationship with the FDA in order to find the most efficient pathways to success. We likewise monitor the product liability landscape because, in the current climate, litigation prevention counseling can be a client’s soundest business investment. Should claims arise, we believe that preventative measures are the most solid foundation on which to build a legal defense.

Our FDA team provides life sciences companies with strategic regulatory guidance and preventative liability consulting. At whatever stage of a client’s business, we can analyze compliance strategy, prepare and file FDA submissions, provide benchmarking audit and analysis of regulatory and liability postures, establish and monitor applicable internal compliance programs, and take the client through implementation.

We can work alone or assemble a tailor-made support team. We have exclusive consulting agreements with former FDA managers; and connections with CROs, VCs and many contract experts in science and technology. We also have a premiere international presence. Through our worldwide offices and international affiliates, we provide among the highest caliber of medical device regulatory and approval services in the world.

FDA Submissions

We draft or review all documents required to obtain approval of new products, as well as provide legal strategy for approval and clearance pathways for FDA applications and notifications.

Marketing & Promotion

We guide our clients in the highly scrutinized area of product promotion, including reviewing advertising/marketing for FDA and FTC compliance, counseling on proper labeling of FDA-regulated products, and counseling on off-label use and promotion.

Compliance Counseling

With respect to day-to-day FDA compliance, we assist with developing standard operating procedures (SOPs) to comply with directives following FDA current good manufacturing practices (cGMP), quality system regulation (QSR), and inspections; HIPAA compliance; clinical trial practices, including foreign trials; facilitating the export/import of FDA-regulated products; entity registration and product listing.

Regulatory & Compliance Analysis

We provide a "reality check" for clients with respect to interpreting FDA issues in today’s environment. We analyze clients’ compliance positions against FDA regulatory requirements and policies. We provide insight into the FDA's likely views of clients’ regulatory positions, including the bases for FDA enforcement actions and appropriate approaches to prevent them. We help clients understand their current compliance positions, and develop regulatory solutions that meet their business needs.

Liability Analysis

We benchmark clients’ risks vis-à-vis the relevant liability landscape. We help clients harmonize their businesses with applicable product liability law by bridging gaps between them and best practices.

Corrective Action Plans

Prompt, comprehensive corrective actions to FDA's compliance communications are essential to our clients’ survival. FDA regulatory counsel assesses FDA's key concerns and underlying issues, and develops a comprehensive plan to address them. We also provide plans for effective communication with the FDA or other appropriate regulatory agencies, and an integrated public relations campaigns.

Litigation

We have handled various types of FDA–related litigation for clients including seizure, injunction and criminal matters. Our team has defended individuals and companies in grand jury investigations, criminal prosecutions, and civil regulatory and enforcement matters in federal and state courts. We have also:

• Represented individuals and companies who were the focus of federal investigations, but subsequently not indicted because of aggressive defense.s
• Defended a mass seizure of a major device manufacturer’s products, saving products worth tens of millions of dollars.
• Represented companies in numerous seizure and injunction actions.
• Created new case law advantageous to claimants in FDA seizure actions.
• Represented major veterinary product manufacturer in contract arbitration.
• Negotiated consent decrees with FDA and DEA, avoiding protracted litigation.
• Assisted major drug manufacturer in negotiating with FDA, avoiding substantial product recall.