Mayer Brown’s Food and Drug Administration (FDA) Regulatory practice combines regulatory experience, industry knowledge and scientific capabilities to handle the wide range of regulatory issues facing our clients. From advising on routine matters to bet-the-company crises, we use our know-how and our understanding of our clients’ products and business goals to offer seamless, comprehensive counseling and sophisticated, effective advocacy.
Our team has extensive experience in all areas of drug, biologics, human cell/tissue products, and medical device regulation. We have represented clients in all phases of the product life cycle before the FDA, the Federal Trade Commission (FTC), the Drug Enforcement Agency (DEA), the National Institutes of Health (NIH) and the National Academy of Sciences (NAS), as well as the US State Department, the Commerce Department, the White House and both houses of Congress. We have also represented clients before counterpart agencies outside the United States, such as the National Competent Authorities (NCAs) and the World Health Organization (WHO).
We have represented clients on diverse issues related to product development, clearance and approval, clinical trials, biosafety, licensing agreements, manufacturer and distributor registration, government inspections, product and ingredient notifications and recalls, product corrective actions, regulatory and due diligence audits, labeling and promotion, Good Manufacturing Practices, Good Laboratory Practices and Quality Systems Regulation requirements. Our lawyers have defended clients against FDA enforcement actions, including seizure, product recalls, inspections and civil monetary penalties. We have also brought affirmative actions on behalf of our clients against FDA under the Administrative Procedure Act (APA).
We take a strategic, life-cycle approach to client counseling and advocacy. In addition to working with our clients to establish and maintain compliance with existing laws and regulations, we help them anticipate, adapt to and profit from changes in the legal and regulatory arenas as well as the public policy and legislative landscapes. We help clients craft innovative administrative, legislative or litigation approaches when the law is not clear, where there are seemingly irreconcilable multi-jurisdictional conflicts or where agency action is an issue.
Clients benefit from the perspective, analysis and judgment that we can provide thanks to our combination of education, training, skills and experience. Further, our team members bring extensive outside experience that includes previous positions as industry executives, in-house counsel, government or agency lawyers, physicians, scientists and public policy practitioners. In addition, our team is fully integrated with the myriad of other practice areas in the firm that service the health care and life science industries. Whether your business involves drugs, biologics, human cell/tissue products, medical devices, combination products, or veterinary drugs, our team offers experience and perspective on all of the industries that fall under the jurisdiction of FDA and its counterparts worldwide. Thus, our team is able to draw at once on an immense pool of talent and resources that can be tailored to fit each client’s needs and achieve its goals.
Pharmaceuticals and Biologics
Mayer Brown’s regulatory practitioners counsel and represent firm clients in matters involving the development of pharmaceuticals and biologics, including approval under, and compliance with, the Food, Drug, and Cosmetic Act and the Public Health Safety Act, statutory amendments such as Hatch-Waxman and the Biologics Price Competition and Innovation Act, and the various related regulations. Our team includes practitioners who have decades of regulatory experience, including government service. Team members have also held numerous high-ranking positions in industry and have highly technical medical and scientific education and training, which provides valuable perspective and insight for our clients.
Our work in this area spans every stage of the product life cycle. We advise on and prepare the universe of regulatory submissions pertaining to new product development and approval including the following:
- Investigational New Drug Applications (INDs)
- Preclinical Testing
- Clinical Trials
- Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) protocols
- 505(b)(1) and 505(b)(2) New Drug Applications (NDAs)
- Abbreviated New Drug Applications (ANDAs)
- Biologics License Applications (BLAs)
- 351(k) biosimilar applications
In concert with those processes, we advise on the multitude of available regulatory exclusivities, including those pertaining to New Chemical Entities (NCEs), New Clinical Studies (NCSs), ANDAs, Suitability Petitions, Orphan Drugs, Pediatric Drugs, Biosimilars and Interchangeable Biologics.
We also have extensive experience representing our clients with respect to Orange Book listings, Patent Term Extensions (PTEs), Drug Enforcement Agency (DEA) scheduling, Risk Evaluation and Mitigation Strategies (REMS), citizen petitions, agency meetings and appeals and agreements with third parties and vendors. Further, we assist with post-marketing compliance, including application supplementation, post-marketing surveillance, establishment registration, labeling, product listing, drug master files, Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) compliance and requirements for reporting of adverse events and other information. When necessary, we represent our clients in affirmative or defensive litigation and adversarial proceedings involving private parties and government agencies such as the FDA. We also represent our drug clients before the FTC in advertising cases, including Lanham Act litigation, as well as before the National Advertising Division of the Better Business Bureau (NAD) with respect to challenged advertising claims.
Our lawyers have managed major international inspections for pharmaceutical manufacturers and their API manufacturers, including Chinese API manufacturers. We expect these inspections to increase in frequency and rigor as the FDA’s establishment of international offices continues, and we are well-positioned to help our clients manage these inspections, which are critical to the ability of a manufacturer to maintain ongoing compliance with the requirements of their NDAs.
We work strategically with our clients to assess legislation and proposed rulemaking affecting the industry. We advocate before lawmakers and agency personnel on behalf of our clients and prepare and submit citizen petitions and public comments. Additionally, we work closely with lawyers and others in our firm’s related practices—including Product Liability & Mass Torts, Intellectual Property, Supreme Court & Appellate, Corporate & Securities and Government Relations —to develop regulatory arguments designed to ensure that all critical issues are anticipated and addressed. This integrated, cross-disciplinary focus enables us to help our clients steer clear of inconsistent positions and to identify and implement their most beneficial overall legal and regulatory strategies for the entire product life cycle.
Medical Devices and Combination Products
Mayer Brown’s regulatory practitioners counsel and represent clients in a broad range of regulatory matters involving the development and marketing of medical devices, including compliance with the Food, Drug, and Cosmetic Act and related regulations. Our lawyers have extensive experience with medical devices and combination products, and our team includes medical doctors who have actually used many of these products. This broad industry experience allows us to provide our device clients with the insight and understanding that they need, whether they are startup device companies, universities and academic medical centers, or major multinational device makers.
Our lawyers have worked on matters involving a wide range of medical devices and medical technologies, including:
- Apps, Digital Health and Telemedicine: clinical decision support software and systems, cybersecurity measures and systems, digital data systems, digital treatment plans, Electronic Medical Records (EMR), Health Information Technology (HIT), interoperable devices and systems, electronically controlled mobility devices, electronic vision assistance devices, Medical Device Data Systems (MDDSs), mobile medical apps, personal carry devices, and personal wearable devices.
- Cardiovascular: angioplasty devices, stents (coronary, renal), catheters (ultrasound, imaging, balloon, ablation), pulse oximeters, defibrillators (implantable and AED defibrillators and hospital/EMS defibrillator monitors), pacemakers, defibrillator leads, fall detection/alert devices, infusion pumps, beating heart surgical tools, endovascular coils for aneurysms, linear accelerators and intra-aortic balloons.
- Dental: dental implants, dental attachments and dental positioning adjustment devices.
- Dermatology: microdermabrasion devices and transdermal delivery systems.
- Diagnostic and Imaging: PET scanners, MRI devices, catheters (ultrasound, imaging), ultrasound machines, brain imaging, wireless patient monitors, patient-worn telemetry devices, multi-parameter patient monitors, dockable transport monitors, remote ICU monitoring systems, telemedicine systems, X-ray machines and tubes and diabetes test devices.
- Drug Delivery and Combination Products: drug-coated stents, needles, auto-injectors, epinephrine pens, inhalers, nebulizers, implantable pumps, implantable drug-release devices and needle-free drug delivery platform technologies.
- Machines and Monitors: sleep apnea machines and masks, circulation foot pumps, wireless patient monitors, patient-worn telemetry devices, multi-parameter patient monitors, dockable transport monitors, remote ICU monitoring systems and linear accelerators.
- Ocular: intraocular lenses, ophthalmologic implants and instruments and eye drops.
- Spinal: intervertebral and spinal stabilization implants and instruments (screws, rods, articulating devices), vertebroplasty implants and instrumentation and bone graft materials.
- Surgical: wound healing devices, vascular closure devices, veinous and arterial grafting materials and devices, cannulae, balloon cannulae, ablation devices, orthopedic implants (hip, knee, ankle, wrist) and instrumentation, bioabsorbable implants, tools for beating heart surgery, saphenous vein harvest, extraperitoneal hernia repair, silicone implants, surgical staplers, trocars, surgical microscopes, suture anchors, surgical navigation systems and cochlear implant systems.
- Tissue and Stem Cells: skin grafting, organ and tissue regeneration and transplantation and stem cell therapies.
- Treatment Devices: radiation therapy devices, Gamma Knife machines, nasal cannulae, cancer ablation devices, bone growth stimulator and inhalers.
- Urology: endoscopic catheters, stents and stone extraction devices.
Our group has experience working with a variety of devices and combinations, including all manner of traditional diagnostic and treatment instrumentation and implants, testing assays and imaging technologies, medical apps and software, Medical Device Data Systems (MDDSs), Health Information Technology (HIT) and combination device/drug, device/biologic and drug/biologic products. We advise on and prepare all premarket regulatory submissions, including pre-submissions, Investigational Exemptions (IDEs), Preclinical and Clinical Studies, Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) protocols, 510(k) Notifications, Premarket Approval Applications (PMAs), de novo applications and Humanitarian Device Exemptions (HDEs). We also assist with post-marketing compliance, including supplementation, post-marketing surveillance, establishment registration, product listing, inspections, Medical Device Reporting (MDR) and product recalls.
When necessary, we represent our clients in litigation and adversarial proceedings involving private parties and governmental agencies such as the FDA. We also represent our device and combination product clients before the FTC in advertising cases, including Lanham Act litigation, as well as before the National Advertising Division of the Better Business Bureau (NAD) with respect to challenged advertising claims.
Mayer Brown’s lawyers have decades of experience managing bet-the-company crises such as medical device recalls, detentions of product by FDA and Customs, Import Alerts, 483 responses, Warning Letter responses and consent decrees involving FDA and the Department of Justice. We have been involved on behalf of our clients in numerous recalls and enforcement actions, a critical aspect of our practice in view of the heightened enforcement environment for medical device manufacturers, both at the federal and state level, as well as internationally. We work with our clients to develop strategies not only for managing existing issues, but also establishing regulatory procedures to prevent future incidents. We also have significant experience helping our clients develop global regulatory systems and strategies to promote corporate-wide uniformity and compliance.
We work strategically with our clients to assess legislation, policy shifts and proposed rulemaking affecting their businesses, and we identify and execute the best actions to influence these processes for the benefit of our clients. Our efforts include advocating our clients’ positions with lawmakers and agency personnel as well as preparing and submitting citizen petitions and public comments. Additionally, we work closely with lawyers and others in our firm’s related practices—including Product Liability & Mass Torts, Intellectual Property, Supreme Court & Appellate, Corporate & Securities and Government Relations—to develop regulatory arguments designed to ensure that all critical issues are anticipated and addressed. This integrated, cross-disciplinary focus enables us to help our clients steer clear of inconsistent positions and to identify and implement their most beneficial overall legal and regulatory strategies for the entire product life cycle.
Mayer Brown’s regulatory practitioners counsel clients on all areas of the FDA's regulatory authority over veterinary drug products under the Food, Drug and Cosmetic Act and related regulations. We have assisted our clients with respect to New Animal Drug Applications (NADAs), Abbreviated New Animal Drug Applications (ANADAs), Conditional Approvals (CNADAs), designing and conducting clinical studies for new animal drugs, Green Book listings, exclusivity issues under the Generic Animal Drug and Patent Restoration Act (GADPTRA) and responding to FDA warning letters and enforcement actions. We also represent our veterinary drug clients before the FTC in advertising cases, including Lanham Act litigation, as well as before the National Advertising Division of the Better Business Bureau (NAD) with respect to challenged advertising claims.
FDA Regulation of Pharmaceuticals and Biologics
- Assisted several pharmaceutical manufacturers in successfully resolving issues that delayed approval of applications.
- Managed five successful international Active Pharmaceutical Ingredient (API) inspections by the FDA and international counterparts.
- Counseled a pharmaceutical company in obtaining FDA approval of a new drug for opioid maintenance therapy.
- Counseled a professional sports league on intellectual property licensing and HIPAA compliance involving a system for monitoring medications prescribed to patient-players.
- Counseled a private equity firm on scientific, intellectual property, contractual and FDA issues pertaining to a new drug to treat Hepatitis C.
- Counseled a national patient advocacy organization on proposed federal legislation for biologics regulation.
- Counseled a pharmacy client on FDA regulation of compounding practices under the FDA Modernization Act; provided relevant guidance.
- Counseled a startup company on FDA regulation of promotion and practice of stem cell therapy under the FD&C Act and PHS Act; provided relevant guidance.
- Counseled various pharmaceutical companies, universities and physician practice groups on design of clinical study protocols and handling of irregularities in conduct of clinical studies.
- Counseled various pharmaceutical companies, universities and physician practice groups on scope of permissible off-label promotion and use of drugs.
- Counseled pharmaceutical clients regarding labeling of drug products.
- Worked with clients regarding the development and distribution of drugs and biologics.
- Conducted due diligence in numerous acquisition transactions pertaining to drugs and biologics.
FDA Regulation of Medical Devices and Combination Products
- Assisted several medical device manufacturers in resolving approval problems with the FDA involving 510k and PMA submissions.
- Successfully managed numerous medical device recalls and remediation efforts, working with clients, customers and managing crisis and media relations teams.
- Counseled a medical device company on intellectual property, FDA and product liability issues involving a new cardiac rhythm monitoring and assessment system.
- Counseled a medical device company in obtaining FDA clearance of a device used for skin treatments.
- Counseled a medical device company in obtaining FDA clearance of a device used for tracking and dispensing prescription drugs.
- Counseled a physician practice group on IP and FDA issues pertaining to medical devices for joint replacement.
- Worked with clients to develop and prepare 510(k) applications to secure FDA clearance of medical devices.
- Counseled device makers regarding labeling of medical devices.
- Counseled various device makers, universities and physician practice groups on scope of permissible off-label promotion and use of medical devices.
- Worked with companies regarding the development and distribution of medical devices.
- Conducted due diligence in numerous acquisition transactions pertaining to medical devices.
Labeling, Promotion and False Advertising
- Counseled and represented drug and medical device clients in various transactional, administrative and litigation matters involving issues or allegations of off-label drug and medical device promotion.
- Counseled and represented drug and medical device clients in proceedings before the National Advertising Division (NAD) of the Council of Better Business Bureaus in adversarial matters involving allegations of false advertising.
- Counseled drug and medical device clients in matters pertaining to Federal Trade Commission (FTC) regulation of advertising and promotion.
- Counseled one of the world’s largest medical device companies in developing a new label and advertising strategy and program for an entire line of medical devices directed at the consumer market.