Developing an FDA regulated product, obtaining the necessary approval or clearance, and marketing the product can present a daunting array of challenges and opportunities. Reed Smith’s FDA Counseling & Litigation team focuses on the FDA regulation of drug, medical device, biologic, and biotechnology products, through the entire product life cycle. Our team advises clients on viable pathways to expedite development and review of new products and to obtain approvals or clearances with market protections wherever available and possible. After approval or clearance, we help clients develop and maintain compliant advertising and promotional strategies. In addition, we provide in-depth counsel on compliance and enforcement matters, such as adverse event and medical device reporting and inspections, and assist in responding to FDA’s 483s, Warning and Untitled Letters, and initiating and managing recalls. We help clients communicate with FDA, comment on proposed rules and guidances, and develop long-term strategies to better inform agency policy.
We represent a variety of medical device and drug companies with a wide array of products. We have experience in key areas of policy and regulatory development, such as combination drug and diagnostic products, laboratory developed tests, genetic tests, emerging biotechnologies, and personalized medicine. We also have significant experience with medical device data systems and hospital information systems.
Our Team
Members of our Life Sciences Health Industry team include a registered nurse and former federal prosecutors who are intimately familiar with FDA and U.S. Department of Justice investigations and enforcement matters. Our team also includes other recognized leaders in the life sciences industry, along with noted attorneys in the areas of administrative law litigation, transactions, intellectual property, product liability and advertising. An international leader in the life sciences industry, Reed Smith represents many of the world’s largest pharmaceutical and biotechnology companies and medical device manufacturers.
Risk Assessment and Management
The members of our FDA team partner with clients from product development to product delivery to identify and manage risks. We understand the broad spectrum of risks presented by:
- FDA regulatory requirements and enforcement actions
- Health care regulatory and legislative mandates
- Fraud and abuse rules and OIG compliance
- Securities and Exchange Commission (“SEC”) regulations
- Import and export enforcement
- Product liability actions
We conduct comprehensive reviews, assessments, audits and compliance-gap analyses of compliance and risks related to:
- Manufacturing, storage, maintenance and other processes and compliance with applicable Current Good Manufacturing Practice and the Quality System Regulations
- Compliance infrastructure and function
- Clinical trial issues, including safety reports
- Safety Surveillance Adverse Event and Medical Device Reporting
- Labeling, advertisement and promotional materials, including multi-media and Internet advertisements
- Import, export, and U.S. Customs requirements
- Reimbursement, coverage, and payment analysis (Medicare, Medicaid, commercial insurer, managed care)
- SEC filings and transactions due diligence
Regulatory Compliance and Enforcement Counseling
We provide critical advice and legal support involving:
- Compliance with regulatory requirements applicable to product manufacture, distribution, marketing and promotional activities
- FDA inspections
- "483" Inspectional Observations, Warning Letters or Notice of Violation Letters
- Recall activities
- FDA-initiated seizures, injunctions, and prosecutions
- Consent decree negotiations
- News releases and other public disclosures during a product recall, FDA enforcement action, or other crisis
Led by former prosecutors and experienced trial lawyers, our litigation team handles civil and criminal charges arising from FDA-related matters. For example, we:
- Defend product liability suits
- Investigate, counsel and defend against white collar criminal investigations and prosecutions, as well as civil charges under the False Claims Act, including qui tam actions
- Investigate, counsel and defend against other civil and administrative charges concerning fraud, FDA’s Application Integrity Policy, and governmental debarment or exclusion issues
- Defend against prosecution under federal and state privacy laws