We are proud to be the trusted advisors to medical device, pharmaceutical, biotech, digital health, telehealth, pharmacy, laboratory, animal health, dietary supplement, HCT/P, food, and cosmetic companies. We also counsel companies providing technology and other services targeted to these regulated sectors, as well as industry-active investors, investment banks, and financial services companies. In addition to counseling on traditional FDA and EU regulatory challenges, we can advise on developing areas, such as personalized medicine and gene therapy, novel food and food supplements, software as a medical device, artificial intelligence, and machine learning.
Our team works seamlessly with colleagues around the world to provide 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 Asia and the Middle East to provide strategic cross-border regulatory counsel for clients.
With Reed Smith, our clients have a cross-functional, integrated team able to support all legal needs throughout the product lifecycle. Key areas of our practice include:
Strategic path-to-market guidance
In the United States, 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 product design and development (including device design controls), human factors and usability testing, and preclinical and clinical development, as well as in later-stage marketing application submissions for drug and device companies (510(k), de novo, premarket approval, new drug application (NDA), and biologics license application).
In the EU, we advise on EU market entry strategies and appropriate regulatory pathways, product classification and borderline determination, and various issues that may arise during the marketing approval process. We counsel on marketing authorizations for pharmaceutical companies (including new marketing authorization applications, accelerated approvals, named patients, and compassionate use programs) and medical device companies (including CE mark and notified body assessments).
Clinical research compliance
We have extensive experience with the legal and regulatory requirements related to the research and development of medicinal products in both the United States and the EU.
Our team advises life sciences clients on investigation and research as well as the setup of clinical trials and usability studies, including development and implementation of conflict of interest policies; site and investigator selection; IRB/IEC/REC 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 clinicaltrials.gov and euclinicaltrials.eu; formation and conduct of drug safety monitoring boards; requests and preparation for meetings with the FDA; contract negotiations, including the engagement of CROs and site management organizations (SMOs); and interpretation of study results, including drafting press releases about the data.
Our team helps clients prepare and negotiate all phases of clinical trial agreements, including among study sites, sponsors, and principal investigators, and between sponsors and SMOs or CROs for trials conducted all over the world in a wide range of therapeutic areas.
We 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. Furthermore, we provide guidance and support on the investigation and resolution of alleged research misconduct, deviations, and other noncompliance, as well as with sponsor audits. We are also able to advise on collaborative research that involves entities outside the United States and on ownership and use of data, including data integrity issues.
Manufacturing and distribution supply chain logistics and compliance
We advise clients on compliance considerations for manufacturing, storage, testing, packaging and labeling, and other processes under applicable current good manufacturing and distribution practice (cGMP/GDP) and quality system regulations. We collaborate with clients on contract negotiations and supplier/vendor arrangements. We also assist clients with regulatory seizures, injunctions, prosecutions, and consent decree negotiations, often helping with press releases and other public disclosures about supply chain matters. 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 from state boards of pharmacy and health departments.
Recalls
Clients in the medical device, pharmaceutical, food, and supplement 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, market withdrawal, or other corrective measure is necessary. Our team helps clients execute recalls from start to finish, customizing our approach to the product in question. Our work includes assistance with drafting the recall plan, drafting communications to customers and business stakeholders, and interfacing with the FDA, EMA, notified bodies, and other competent authorities.
Postmarketing surveillance and compliance
Clients regularly consult with our team when questions arise about postmarketing surveillance and compliance program requirements and industry best practices, including adverse event requirements, good pharmacovigilance practices, and medical device vigilance. We advise on procedures for complaint handling, internal evaluation and escalation, analysis of reportability of events or malfunctions, and implementation of corrective and preventive actions, 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 devices (including companion diagnostics), pharmaceuticals, and combination products. We also regularly assist our food, dietary supplement, and cosmetic clients in this area.
Our work runs the gamut of marketing promotion guidance, including, for example, helping companies identify and fill gaps in their advertising and promotional policies and procedures, reviewing product claims (including efficacy, safety, off-label, comparative, and differentiation claims), counseling on labeling and packaging requirements, conducting internal investigations regarding promotional practices, advising on compliant wording for press releases and SEC filings, and proactively addressing competitor activities.
As part of serving as our clients’ advertising counsel, our U.S. 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.
Government inspections, investigations, and enforcement
Clients turn to us when FDA and EU regulatory-related matters are the subject of internal compliance concerns or government inquiries, audits, or investigations (including those involving the FDA’s Office of Criminal Investigations and multi-agency investigations, such as those involving the U.S. Department of Justice), or audits by notified bodies or customer/supplier audits.
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 (including concerns around GxP and adherence to ISO 13485 quality management systems), product safety, adulteration, misbranding, fraudulent misbranding, data integrity, and promotional compliance.
Our team advises on responding to FDA Form 483s, Warning and Untitled Letters, consent decrees, criminal enforcement audits by EU notified bodies, and recalls. We also defend our clients in bet-the-business investigations and enforcement actions. On the U.S. state level, our work includes responding to inquiries and enforcement actions from state boards of pharmacy and health departments.
Regulatory due diligence and deal document negotiation and drafting
Reed Smith boasts highly regarded corporate and private equity teams that regularly guide life sciences and health care companies – and their investors – through mergers, acquisitions, divestitures, investments, strategic alliances, joint ventures, collaboration agreements, and more.
Our FDA and EU regulatory team works hand-in-hand on these deals and transactions to provide tailored regulatory due diligence, to provide assistance with negotiating and drafting specialized terms (in particular definitions and representations and warranties), and to handle change of ownership licensing issues in an efficient manner to minimize disruption to business.
For more information, please visit our Health Care & Life Sciences Transactions page.
State licensing and compliance services
We support clients’ U.S. state licensing needs, including assisting with filings, responding to licensing board requests and compliance communications, and providing strategic licensing analysis and risk mitigation advice in the context of complex distribution networks (including the use of third-party logistics providers in addition to wholesale distributors). We regularly support clients in the preparation of new applications, as well as managing renewals and change of ownership/personnel applications, leveraging highly experienced paraprofessionals to provide efficient and practical approaches with the oversight of our attorneys. We also assist with National Association of Boards of Pharmacy Verified-Accredited Wholesale Distributor accreditation matters.
Regulatory support in litigation
Our litigation colleagues in both the United States and the EU defend clients in disputes that hinge on allegations of non-compliance with the FDA, related U.S. state authorities, or related EU regulations. These include labeling challenges; claims made under U.S. state consumer protection statutes, including California’s Consumers Legal Remedies Act; National Advertising Division actions; and similar disputes and litigation in EU Member States.
Our FDA and EU regulatory lawyers work seamlessly with our litigators in these matters, providing the deep regulatory analysis and experience necessary to defend against these claims.
