Clients turn to Reed Smith’s highly regarded FDA attorneys for help in achieving and maintaining compliant operations as they seek to develop and commercialize products and services in a business environment that is evolving on a real-time basis. Our team can counsel clients on traditional FDA-related challenges, such as inspections and investigations, as well as on developing areas, such as personalized medicine and gene therapy, software as a medical device (SaMD), artificial intelligence (AI), and machine learning (ML).
Innovative, future-focused life sciences and health care companies require strategic insights on a wide array of FDA and related regulatory matters to assess opportunities and risks, advocate for solutions that benefit patients or customers, and develop tailored risk mitigation strategies. We are proud to be the trusted advisors of numerous companies in the pharmaceutical, biologic, compounding, medical device, digital health, telehealth, pharmacy, laboratory, animal health, dietary supplement, food, and cosmetic spaces. We also counsel companies providing technology and services targeted to these regulated sectors.
Additionally, we regularly provide tailored regulatory due diligence advice and counseling to life sciences and health companies seeking strategic growth – whether through a range of collaboration agreements, mergers, acquisitions, divestitures, or financing opportunities – as well as to investors and investment banks and financial services companies that are active in the life sciences and health care sectors.
In addition to our knowledge of and focus on these issues at the federal level, we also assist life sciences and health care clients with related matters at the state level, typically involving state boards of pharmacy and health departments.
Our team includes a partner who was formerly a registered nurse; lawyers with advanced degrees in public health, global health, pharmacy, and business administration; and lawyers with backgrounds in science and computer science, giving us a unique perspective into our life sciences and health care clients and their needs.
Additionally and importantly, our team works seamlessly with colleagues around the world to provide our clients with comprehensive services and counseling. For example, we draft specialized manufacturing and quality agreements with our corporate colleagues, collaborate with our international trade colleagues to assist clients with import and export issues, and work with colleagues in Europe and Asia to provide strategic cross border regulatory counsel for clients whose needs require interactions with or advice on FDA’s equivalent organizations around the world.
Strategic path-to-market guidance. We advise clients on viable designations, expedited programs and accelerated pathways, and emergency use authorizations with the aim of aiding efforts to bring important technologies to patients. We serve as strategic advisors for innovative medical science and technology clients, helping them navigate challenges that may arise in the context of human factors and usability testing and preclinical and clinical development, as well as in later marketing application submissions for drug and device companies (510(k), de novo, premarket approval (PMA), new drug application (NDA), biologics license application (BLA)).
Clinical research compliance. We have extensive experience with the legal and regulatory requirements related to the research and development of medicinal products. Our team regularly advises life sciences clients on investigation and research and the setup of clinical trials, including site and investigator selection, IRB/IEC engagement and submission of study materials, human subject protections and informed consent (including FDA and the Common Rule requirements as applicable), patient recruitment and enrollment, registration of trials on www.clinicaltrials.gov, formation and conduct of drug safety monitoring boards, and contract negotiations, including the engagement of contract research organizations (CROs) and site management organizations (SMOs).
In conjunction with corporate colleagues who focus on life sciences and health care contracts, our team helps clients prepare and negotiate all phases of clinical trial agreements including among sponsors, principal investigators, and sites and between sponsors and SMOs or CROs for trials conducted all over the world in a wide range of therapeutic areas.
We also assist with the conduct and monitoring of studies under applicable requirements, including good clinical practice (GCP), good laboratory practice (GLP), and good manufacturing practice (GMP). We advise on specimen collection, including storage for use in future research and the requirements, standards, and licensure related to the formation and conduct of biorepositories. And, we provide guidance and support on the investigation and resolution of research misconduct, deviations, and other noncompliance, as well as with sponsor audits and with FDA inspections, investigations, and enforcement activities (including clinical holds). We are also able to advise on collaborative research that involves entities outside the United States and ownership and use of data, including data integrity issues.
Manufacturing and distribution supply chain logistics and compliance. We regularly advise wholesalers, distributors, and third-party logistics providers (3PLs) on compliance with legislative and regulatory mandates and evolving policy and enforcement priorities. On a federal level, this involves helping clients navigate FDA, Drug Enforcement Administration (DEA), Nuclear Regulatory Commission (NRC), and Customs & Border Protection (CBP) regulatory requirements and respond to inspections and enforcement actions. We regularly advise on implementation of, and compliance with, the Drug Quality and Security Act’s (DQSA’s) Drug Supply Chain Security Act (DSCSA). And we provide guidance on import and export issues (including those involving the Automated Commercial Environment (ACE), detentions, and seizures). We have helped clients with FDA holds and detentions, and have successfully advocated for the release of clients’ products. On the state level, our work includes advising on regulatory requirements and responding to inquiries and enforcement actions from state boards of pharmacy and health departments. We also help clients to gain, maintain, and – in the context of a transaction – transfer National Association of Boards of Pharmacy Verified-Accredited Wholesale Distributors® (VAWD®) accreditation.
We advise clients on compliance considerations for manufacturing, storage, testing, packaging and labeling, and other processes under applicable current good manufacturing practice (cGMP) and the quality system regulations (QSR). We assist clients with regulatory inspections and corrective actions (including responding to state agency inquiries and FDA Form 483s and Warning Letters), enforcement actions, regulatory seizures, injunctions, prosecutions, and consent decree negotiations. We also assist with press releases and other public disclosures about supply chain matters.
Recalls. Clients in the food, pharmaceutical, and medical device industries have turned to our team when faced with potential recall situations. We are often called in from the start to help conduct health hazard evaluations and root cause analyses to determine whether and to what extent a recall or market withdrawal is necessary. Once a recall or withdrawal is determined to be necessary, our team helps clients execute recalls from start to finish, including assistance with drafting the recall plan, drafting communications to customers, and interfacing with the FDA.
When facing a recall situation, it is critical that life sciences and health companies engage counsel with extensive recall experience. Recall strategies must be customized to the product in question and consequently should be prepared by a counsel who understand the unique legal and regulatory requirements and obligations for such products: For example, recall strategies and logistics for a traditional medical device and a digital health product will be different, and must be prepared by a counsel that understand such differences.
Postmarketing surveillance. Clients regularly consult with our team when questions arise about postmarketing surveillance program requirements and industry best practices, including drug and biologic adverse event requirements and good pharmacovigilance practices and medical device reporting (MDR) requirements. We also advise on procedures for complaint handling, internal evaluation and escalation, and analysis of reportability of events or malfunctions, in addition to supporting decision-making around potential recalls or corrections.
Advertising, labeling, and promotion. We regularly assist clients with advertising and promotional review matters for drugs, biologics, devices (including companion diagnostics), and combination products. We also regularly assist our food, dietary supplement, and cosmetic clients in this area. Our work runs the gamut, for example, helping companies identify and fill gaps in their advertising and promotional policies and procedures, serving on promotional and medical review committees, conducting internal investigations regarding promotional practices, responding to governmental enforcement actions, and proactively addressing competitor activities. As part of serving as our clients’ advertising counsel, our team routinely works closely with our FTC and data privacy groups to address broader but related issues as they arise in the normal course of advertising concept reviews and final copy review and approval.
State licensure compliance. Life sciences companies must contend with a complex national patchwork of U.S. state licensing regulations. Pharmaceutical and medical device manufacturers, pharmacies, outsourcing facilities, wholesalers, and distributors are often required to be licensed by various state health agencies in the states in which they maintain facilities or even simply where they dispense or distribute products. State licensure and registration requirements can extend to research institutions, laboratories, and similar facilities. Our team has worked with state health departments and state boards of pharmacy across the country on state licensing matters, and we bring years of experience advising on these issues and have established relationships and credibility with many such boards. This experience includes assisting with state agency inspections, drafting and managing state licensing application processes for clients (including new applications, renewals, and change of ownership/personnel applications), addressing state board inquiries relating to licenses held by clients, and litigating state licensing administrative matters. We also assist food clients with state licensure issues and compliance.
Government inspections, investigations and enforcement. When FDA-related matters are the subject of internal compliance concerns or government inquiries, audits, or investigations, we bring a breadth and depth of experience based on years of advising companies ranging from start-ups to large multinational manufacturers. We regularly work in coordination with our clients’ in-house legal, compliance, regulatory, and quality teams to assess and address potential areas of noncompliance, such as product quality, product safety, data integrity, and promotional compliance. Our team advises on inspections, responding to FDA Form 483s, Warning and Untitled Letters, and, as discussed above, recalls. We also defend our clients in bet-the-business FDA investigations, FDA compliance conferences (e.g., regulatory meetings), and FDA enforcement actions.
Regulatory due diligence. Reed Smith boasts highly regarded corporate and private equity teams that regularly guide life sciences and health companies – and their investors – through mergers, acquisitions, divestitures, strategic alliances, joint ventures, collaboration agreements, and more. Our FDA team works hand-in-hand on these deals and transactions to provide tailored regulatory due diligence. Other firms often lack this FDA regulatory experience, and our team is regularly hired by competing firms who need assistance with these specific aspects of the deals they are handling for their clients. We have provided regulatory due diligence on some of the industry’s largest and most novel deals, and we keep our finger on the pulse of pending or potential new regulations, giving us awareness of what regulations could impact deals both now and in the future. Through our regulatory due diligence services, we counsel clients to identify key issues and strategies to mitigate regulatory risk and liabilities, and we develop integration plans for post-closing, providing our clients with a detailed review of legal requirements, contracts, marketing approvals, compliance plans, audits, investigations, and policies and procedures.
Controlled substance controls and compliance. Pharmaceutical wholesalers and distributors shipping controlled substances and pharmacies and outsourcing facilities dispensing these substances to consumers need to be compliant with a variety of federal and state laws. Our team assists clients in obtaining the necessary registrations with DEA and appropriate state agencies. We help clients stay up-to-date on state laws, which can be stricter than the federal Controlled Substances Act (CSA). We advise on federal and state requirements surrounding storage, handling, transport, dispensing, and record keeping. And we assist clients with federal and state inspections. With the passage of the 2018 Farm Bill, we also have been advising product manufacturers, distributors, and retailers on the unique FDA regulatory compliance considerations surrounding cannabidiol (CBD) products.
Notice-and-comment rulemaking and Administrative Procedure Act litigation. We regularly track proposed rules and guidances important to the industry and assist clients with offering comments. We have also successfully represented clients in Administrative Procedure Act litigation adverse to FDA.
