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Effective Strategies for FDA Regulated Businesses

A clear understanding of Food and Drug Administration (FDA) regulatory policies is essential when seeking product approvals, developing an effective life cycle management strategy, and assuring that products are marketed in compliance with federal and state requirements. Our Washington, D.C.-based team of FDA regulatory experts is made up of seasoned lawyers who have served within the FDA, held key positions as policy advisors in Congress, and worked in-house at life sciences companies. As trusted and experienced advisors to many of the world’s leading pharmaceutical, biotechnology, medical device, and other FDA-regulated life sciences companies, we help clients through the entire product life cycle: from the inception of an idea, through development and testing, and all the way to market and beyond.

Our deep understanding of the market and regulatory forces affecting the pharmaceutical, biotechnology, and medical device industries has made us ideally suited to provide counsel to many of the world’s leading life sciences companies.

Integrated Capabilities

Part of our interdisciplinary life sciences group, our FDA regulatory expertise is routinely brought to bear on corporate and transactional matters (e.g., financings, licensing, mergers and acquisitions), government enforcement defense, health care law compliance, intellectual property analyses, intellectual property litigation, and reimbursement determinations. Ropes & Gray is unique in that it is a true “life sciences firm,” offering unmatched breadth and depth of substantive expertise to life sciences companies in an integrated, efficient, and effective manner.

Powerful Knowledge

Our life sciences lawyers and technical advisors possess nearly 150 scientific degrees (including 60 Ph.D.s) in such disciplines as organic chemistry, molecular biology, experimental medicine, cellular biophysics, polymer science, and biomedical engineering. This depth of knowledge enables our team to grasp complex ideas and concepts quickly, identify potential regulatory concerns and advise clients on the technical and scientific detail associated with FDA matters. 

Overview of Capabilities

Our FDA regulatory capabilities include expertise in the following areas, among others:

• Product Development, Approvals, and Competitor Market Entry 
• Post Approval Compliance 
• FDA Enforcement Actions and Litigation 
• Congressional Investigations and Public Policy 
• Due Diligence Reviews and Transactional Integration Support 

PRODUCT DEVELOPMENT, APPROVALS, AND COMPETITOR MARKET ENTRY

Research and Development

We work closely with our clients from the earliest stage of a product’s life cycle — research and development. Our firm’s work representing academic medical centers, research institutes, and universities, in addition to global life sciences companies, gives us a wide range of experience and perspective from which to draw when counseling clients on clinical research and development activities. We regularly counsel FDA regulated companies that sponsor product research as well as clinical sites on compliance with numerous federal laws relating to clinical research, including FDA investigational new drug requirements, human subjects protection requirements, adverse event reporting requirements, clinical trial registration requirements, privacy laws, conflicts of interest, and the proper use of federal research funds. We help clinical sites and research sponsors develop and implement research policies, procedures, and templates to ensure compliance with legal requirements, to protect business interests, and to facilitate research activities.

Product Approvals

Obtaining FDA approval or clearance to market drugs, biologics, medical devices, and food additives — especially those that have encountered difficulties in the approval process — requires experienced counsel. We regularly advise clients on such matters, from the initial development of regulatory approval strategies through implementation of those strategies, including preparing for and participating, in advisory committee proceedings and responding to difficult questions from the FDA.

Competitor Market Entry

Strategic and legal advice is essential on statutory provisions that confer exclusive marketing rights on qualifying products, including the Hatch-Waxman Act, the Orphan Drug Act, the pediatric exclusivity provisions of the Federal Food, Drug, and Cosmetic Act, and the Biologics Price Competition and Innovation Act. We are one of the few firms that has both top-ranked IP and FDA practices, which gives us an in-depth understanding of the relationship between patent and non-patent exclusivity rights.

Please click here for a detailed list of our experience in the area of product development, approvals, and competitor market entry. 

POST APPROVAL COMPLIANCE

Labeling, Advertising, and Other Promotional Activity

Promotional compliance is a key risk area for FDA regulated companies. We regularly review proposed promotional materials and activities for compliance with FDA and other requirements for prescription and over-the-counter drugs, medical devices, cosmetics, and other FDA regulated products. In addition, we help ensure that our client’s competitors’ promotional activities meet applicable standards and requirements.

Good Manufacturing Practices (GMP)

We regularly counsel global pharmaceutical and device companies on manufacturing-related regulatory issues, advise clients on FDA inspections, help clients draft “483” and Warning Letter responses, and, when necessary, assist companies in negotiating with the FDA and the Department of Justice (DOJ) over GMP issues. Our team has negotiated GMP Consent Decrees with the FDA and DOJ and advised clients on implementing Consent Decree requirements. We also have experience advising global pharmaceutical companies with overseas manufacturing facilities or suppliers on how to respond to the threat of FDA Import Alerts relating to alleged GMP deficiencies.

Safety Surveillance and Risk Management

Drug and device safety surveillance and risk management are critical to the long-term success of a product. Our team has extensive experience counseling clients on compliance with adverse event reporting regulations; developing and implementing Risk Evaluation and Mitigation Strategies (REMS), Risk Management Plans (RiskMAPs), and Risk Communications strategies for global pharmaceutical brands; and advising drug and device clients on post-approval labeling changes and product recalls.

Please click here for a detailed list of our experience in the area of post approval compliance.

FDA ENFORCEMENT ACTIONS AND LITIGATION

FDA Enforcement Actions

Our lawyers have a wealth of experience in designing and carrying out plans to address potential FDA enforcement actions. We regularly advise clients on enforcement matters ranging from advisory actions such as FDA Warning Letters to formal actions such as withdrawals of product approvals, product seizures, injunctions and consent decrees, recalls, import alerts, denial of export certificates, civil money penalty hearings, clinical investigator and IRB disqualification hearings, and criminal prosecutions.

Litigation

We are frequently engaged to protect the interests of our clients by bringing legal actions directly against the FDA and other federal and state government agencies. In many cases, these legal actions involve complex scientific and legal challenges to government decisions that can impact our clients’ business or their products. These situations also entail strategic decisions about timing and access to the administrative records that govern federal agency determinations.

Please click here for a detailed list of our experience in the area of FDA enforcement actions and litigation.

CONGRESSIONAL INVESTIGATIONS AND PUBLIC POLICY

Congress represents a crucial component of the regulatory, litigation, and public relations environment for FDA regulated companies. House and Senate oversight committees — as well as individual members of Congress on both sides of the aisle — have launched numerous investigations of pharmaceutical and medical device manufacturers' practices, including research, marketing, and outsourcing.

Our FDA group has decades of experience working on Capitol Hill, drafting legislation, developing public policy positions and lobbying on behalf of clients. This experience extends to working on investigations before the Congressional committees that most frequently investigate life sciences companies, including the U.S. Senate Finance Committee, the House Committee on Oversight and Government Reform, and the Subcommittee on Oversight and Investigations of the House Energy & Commerce Committee. In addition, we routinely respond to subpoenas or informal document requests, represent clients in interviews with Congressional investigative staff, prepare for Congressional hearings, and coordinate these activities to minimize the company's risk of adverse publicity, enforcement action, or litigation exposure.

Please click here for a detailed list of our experience in the area of Congressional investigations and public policy.

DUE DILIGENCE REVIEWS AND TRANSACTIONAL INTEGRATION SUPPORT

We conduct due diligence reviews for FDA regulated companies engaging in mergers, acquisitions, licensing deals, and other corporate transactions. Our experience on FDA regulatory matters allows us to identify and evaluate the significance of regulatory issues that may affect the value of a proposed transaction. Our firm’s unique depth in both life science transactions and FDA regulation enables us to incorporate regulatory diligence findings seamlessly into deal negotiations and deal terms.

Please click here for a detailed list of our experience in the area of due diligence reviews.

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