Wiley Rein’s Food & Drug Law Practice has the depth of experience and breadth of resources to effectively handle both complex legal and regulatory challenges, and the more routine but crucial regulatory tasks required of Food and Drug Administration (FDA)-regulated companies in the pharmaceutical, biotechnology, medical device, food, and dietary supplement industries. Our partners have held high-ranking positions in government and have received independent recognition from numerous organizations as leaders in food and drug law. In addition, our team includes a well-balanced group of counsel and associates, which allows us to staff routine matters cost effectively but also bring to bear all necessary resources when handling larger and time-sensitive matters.
We work closely with our clients, and regularly collaborate with other law firms, to develop proactive, strategically focused, bottom line-oriented FDA regulatory strategies to advance clients’ business interests. Our work falls within the following broad categories:
- Product development and approval strategies (New Drug Applications (NDAs), 505(b)(2) NDAs, Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs) (innovator and Biosimilar products), Humanitarian Device Exemptions (HDEs), Investigational Device Exemptions (IDEs), Premarket Approvals (PMAs), Premarket Notifications (510(k)s), food additive petitions, tobacco product applications);
- Competitive regulatory strategies (lifecycle management, Hatch-Waxman patent litigation support);
- Regulatory compliance (Warning Letters, Untitled Letters, Application Policy Letters, Clinical Investigator Disqualification Letters, and Clinical Hold Letters);
- Enforcement and white collar defense;
- Administrative advocacy and litigation before agencies and the courts (FDA meetings, administrative appeals, Citizen Petitions, Administrative Procedure Act (APA) litigation);
- Promotion and advertising compliance and enforcement (FDA and Federal Trade Commission (FTC) regulation of advertising for prescription (Rx) and over-the-counter (OTC) drugs, medical devices, foods, dietary supplements); and
- Transactional support involving FDA regulatory issues (mergers & acquisitions, product acquisitions, licensing agreements, joint ventures, initial public offerings (IPOs), venture funding).
Our Strategic Approach
Our model is to meld the scientific, legal, regulatory, and public policy aspects of the matter at hand into a cogent, responsible, and persuasive position that will convey to the relevant decision makers that our client’s position is both legally correct and appropriate in light of the public interest and the agency’s goals. Wiley Rein attorneys have practiced before FDA and other agencies for decades and enjoy a reputation as firm, effective advocates who have developed relationships of trust with agency leaders and staff. We are prepared to litigate against agencies if necessary and to enlist Congressional assistance where appropriate. Our goal is to provide innovative approaches to difficult issues and prompt, cost-effective resolution of regulatory matters.
The Food & Drug Law Practice offers the experience of seasoned attorneys who both know the law and have helped shape it through groundbreaking litigation, administrative advocacy, and the legislative process. The group is led by practice chair James N. Czaban and founding partner Bert W. Rein, both of whom have been recognized in numerous independent rankings as leaders in Food & Drug Law. We draw support from more than a dozen other partners and associates who have substantial knowledge and experience in FDA-related matters.
Complementary Practice Areas
In keeping with its interdisciplinary approach, Wiley Rein's broad range of capabilities intersect with and enhance the Food & Drug Law Practice. Our complementary practices include:
- Communications (dual Federal Communications Commission (FCC)-FDA regulation of emerging e-health/m-health technologies and First Amendment commercial free speech issues);
- Consumer Product Safety Commission (CPSC) (compliance, enforcement, and recalls);
- Environmental Protection Agency (EPA) (federal and international regulation of chemical substances and consumer products);
- Government Contracts;
- International Trade (customs and country-of-origin matters, European Union (EU) regulation and policies);
- Public Policy (congressional and Executive branch strategies, legislative drafting and advocacy, hearings, stakeholder coalitions); and
- White Collar Defense & Government Investigations (Federal Food, Drug, and Cosmetic Act (FDCA), False Claims Act, and off-label marketing prosecutions).
Product Development and Approval Strategies | Competitive Regulatory Strategies | Regulatory Compliance | Enforcement and White Collar Defense | Administrative Advocacy and Litigation | Promotion and Advertising | Transactional Support | Working with Other Law Firms | Contact Us
Product Development and Approval Strategies
One of the core functions of FDA is to review marketing applications for regulated products to assure their safety, efficacy, and compliance with other regulatory standards. While this is fundamentally a science-based function, the statutory and regulatory rules FDA must follow have proliferated, public and Congressional scrutiny has intensified, and the amount of time, effort, and money required to obtain FDA approval has skyrocketed. Thus, product sponsors frequently encounter situations with FDA that require legal knowledge and specialized advocacy skills to keep an application on, or return it to, a successful approval pathway. We advise and assist companies in their dealings with FDA at all stages of product development and FDA review, covering pre-clinical testing, human safety and efficacy studies, development of appropriate application strategies, and the FDA review process itself.
We work closely with clients’ in-house regulatory and scientific personnel and their outside technical consultants to prepare the least burdensome development and approval strategies, and to ensure that the agency’s review of product applications is conducted in conformity with the proper scientific, legal, and regulatory standards. Our work includes:
- Determining appropriate product classifications and approval pathways for drugs, medical devices including in vitro diagnostics (IVD), dietary supplements, food additives, and tobacco products, including:
- NDAs, 505(b)(2) NDAs, ANDAs, or OTC Monograph for drug products,
- BLAs for innovator and Biosimilar biological products,
- PMAs, 510(k)s, or exempt status for devices,
- Petitions or Generally Recognized as Safe (GRAS) self-affirmation for food additives and new dietary ingredient notifications for dietary supplements, and
- Reduced-risk and new tobacco product applications.
- Preparing clients for key FDA meetings (including pre-Investigational New Drug (IND), end-of-phase-2 (EOP-2), Special Protocol Assessment, pre-NDA, and advisory committee meetings), pre-submission meetings for 510(k)’s IDEs, HDEs, and PMAs, as well as day 100 (PMA deficiency) meetings and attending such meetings where appropriate;
- Informed consent and institutional review board (IRB) matters;
- Counseling on 510(k), HDE, IND, IDE, NDA, PMA, and pharmacovigilance/Adverse Drug Reactions (ADR) and Medical Device Reporting (MDR) requirements as well as clinical holds for both drugs and medical devices;
- Counseling on Quality System and Medical Device Good Manufacturing Practices;
- Counseling on how to prepare for FDA inspection both routine and for cause inspections;
- Responding to issued Form FDA 483s and regulatory correspondence such as warning letters and untitled letters;
- Responding to FDA “complete response” letters;
- Development and drafting of prescription and OTC drug labeling;
- Development and implementation of Risk Evaluation and Mitigation Strategies (REMS);
- Clinical and bioequivalence study requirements for drug products;
- Clinical study requirements for medical device products and Clinical Laboratory Improvements Amendments (CLIA) for in vitro diagnostics;
- Counseling with conditions of approval studies and post marketing surveillance studies (522 studies) for medical devices;
- Counseling on voluntary and mandatory recalls of food, drug, and medical device products;
- Appeals of adverse agency decisions during the development and application review processes; and
- Counseling on appropriate corrective action plans when requested by the FDA.
Competitive Regulatory Strategies
The FDCA contains numerous provisions that provide direct incentives for the development of new and improved therapeutic products. These incentives take the form of regulatory market exclusivities and approval process requirements which can shield eligible products from competition for defined periods of time. These include:
- New Chemical Entity (NCE) exclusivity (5 years);
- New clinical trial exclusivity (3 years);
- Orphan Drug Exclusivity (ODE) (7 years);
- Pediatric exclusivity (6 months);
- Biosimilar product interchangeability exclusivity (period varies);
- 30-month stay in generic drug patent litigation; and
- Pediatric Device Consortia Grant Program.
We assist clients in developing advantageous strategies that address these exclusivities in the context of product development efforts and potential generic competition. Our advice draws upon a deep base of specific experience in each of these areas, a nuanced understanding of how each exclusivity operates, and a practical sense of how they may apply in varying circumstances to our clients’ businesses.
More generally, FDA’s extensive product approval regulations and guidances (both substantive and procedural) can also be used strategically vis-à-vis potential competitors, through FDA’s formal Citizen Petition process, during rulemaking proceedings, in confidential interactions with the agency, and, in appropriate circumstances, via litigation against the agency.
In the context of generic drug patent litigation under the Hatch-Waxman amendments, there is a complex overlay of FDA regulatory procedures and requirements, and we regularly support our clients and outside patent counsel in the strategic use of the regulatory scheme to advance the client’s case and achieve the desired regulatory outcome.
The regulation of product advertising and promotion by FDA and FTC also often gives rise to competitive disputes. We represent drug, medical device, and food companies in trade complaints, National Advertising Division (NAD) advertising proceedings, and Lanham Act litigation involving false and misleading product claims and advertising.
We advise companies regarding compliance with FDA regulations, guidances, policies, and procedures regarding foods, drugs, biologics (including biosimilars), medical devices, cosmetics, and tobacco. Our compliance counseling experience spans a broad range of contexts including:
- Development of effective compliance programs under the Office of Inspector General (OIG) Guidance for pharmaceutical and medical device manufacturers, including standard operating procedures (SOPs), employee codes of conduct, internal investigations, and self-reporting;
- Product formulation, labeling and claims including permissible product ingredients, health claims, nutrient content, and “structure/function” claims for foods and dietary supplements;
- OTC monograph requirements for drug product formulation and labeling;
- Product safety monitoring and adverse event reporting;
- Expanded access INDs, Humanitarian Use Device (HUDs), and HDEs;
- Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP);
- Recalls and field corrections;
- Food Safety Modernization Act compliance, involving hazard analysis, preventive control and corrective action plans, supplier verification programs, track-and-trace, and recordkeeping requirements;
- Drug Enforcement Agency (DEA) controlled substance and listed chemical product registration, packaging, security, distribution, recordkeeping, and reporting;
- Tobacco product formulation, reporting, and recordkeeping;
- Informed consent, IRB approval, and clinical trial registration and reporting;
- Pharmaceutical and medical device advertising and promotion (see details below);
- Import and export requirements;
- Acidified and low-acid canned foods;
- Unapproved marketed drugs;
- Pharmacy compounding;
- Permissible food additives and GRAS petitions; and
- Change reporting and supplemental application requirements for drugs and devices.
Enforcement and White Collar Defense
We assist clients with developing strategies and responding to critical “bet the company” issues as well as routine FDA enforcement matters. Our experience includes the following:
- Fashioning appropriate responses to FDA Warning Letters, requests for recall, threatened seizures, or proposed consent decrees. Our experience has included a wide range of FDA-regulated activities such as current Good Manufacturing Practices (cGMP), promotion and advertising, misbranding and adulteration, validity of data submitted to the agency, adverse reaction reporting, and allegations that labeling or advertising make a food, dietary supplement, or cosmetic a “new drug.”
- Advising companies on how to respond to FDA inspections and requests for information.
- Advising companies on how to respond to new internal information that raises concerns. For example, a food or drug company may learn that a particular lot of its product may be adulterated or that there is new adverse reaction data. We are experienced in advising companies as they consider approaching FDA and in negotiating solutions such as a possible recall, if necessary. Our experience in these matters permits us to bring a degree of sophistication to handling the public relations aspects of such situations.
- Assisting management and corporate attorneys in a realistic evaluation of the company’s position and in developing data to respond to the agency’s concerns. We are experienced in developing and presenting the scientific data or considerations in a way that will be most responsive in light of the agency’s concerns and the company’s position.
- Negotiating with FDA to favorably resolve active or threatened enforcement actions.
FDA and the Department of Justice (DOJ) have recently increased their emphasis on bringing strict-liability criminal prosecutions under the Park Doctrine against companies and individual corporate officers for FDA-related violations. Our experience in FDA-related criminal defense work long pre-dates this recent trend, and allows us to effectively represent companies and individuals in FDA criminal enforcement actions. We have represented parties in criminal investigations involving such allegations as falsification of data; failure to properly file adverse reaction reports; improper promotion or advertising of off-label uses; product adulteration, including failure to follow GMPs; and providing illegal gratuities to FDA officials.
Administrative Advocacy and Litigation
In the vast majority of situations, FDA-regulated companies are best served by pursuing carefully developed strategies to work within the framework of FDA policies and decisions in order to achieve the company’s business goals. Facilitating that approach is a hallmark of our firm’s FDA practice. However, given the massive scope of FDA’s regulatory authority and the breadth of its discretionary powers, the potential for arbitrary or unlawful actions by FDA is ever-present, and companies do sometimes find themselves in intractable disputes with the agency. In such cases, litigation against FDA may be the best, or even the only, option.
Wiley Rein and its FDA attorneys have a long history of successful advocacy challenging FDA regulations, policies, and specific administrative decisions. The first stage of such advocacy often involves the use of the Citizen petition process, or other formal communications with the agency. Where the agency refuses to alter its objectionable position, or takes final adverse action against a client, the Administrative Procedure Act allows an aggrieved party to seek judicial review of the matter, and the courts must overturn or set aside FDA action that is arbitrary, capricious, and otherwise contrary to law.
We have achieved successful results for clients in numerous petition proceedings, confidential advocacy and administrative lawsuits, and in many cases our efforts have led to new or revised legal interpretations of the underlying statutory and regulatory provisions. Particular areas of our Citizen petition experience include Hatch-Waxman exclusivity and generic drug approval standards; new drug development policies (including pediatric testing requirements); Rx-to-OTC switches; reduced-risk tobacco products; and regulation of drug marketing.
We have been retained to mount major court challenges requiring innovative approaches to FDA interpretations of its statutory authority. In litigation against FDA, our attorneys have successfully asserted that FDA regulations, guidances, and policies are inconsistent with the Constitution, particularly the First Amendment, that FDA’s actions were without legal authority under the FDCA, and that the agency’s actions were inconsistent with the underlying Congressional intent and therefore unlawful.
Our attorneys have also represented clients in numerous Supreme Court cases involving food and drug regulatory issues, including Wyeth v. Levine (federal preemption of state failure-to-warn laws for FDA-approved prescription drugs); Merck v. Integra (patent infringement safe harbor for pre-clinical drug research); Mylan v. Daiichi Sankyo (obviousness test for drug patent invalidity claims); Sorrell v. IMS (use of prescriber data in drug marketing); and Granholm v. Heald (regulation of interstate wine shipments).
Promotion and Advertising
Our practice in food and drug marketing and advertising is deep and longstanding. Our attorneys have:
- Served as legal counsel on the promotional review committees of several prominent pharmaceutical companies;
- Testified at FDA hearings on the use of the internet and social media for promoting FDA-regulated products;
- Lectured widely authored treatises on FDA regulation of drug marketing;
- Served as lead counsel in a First Amendment challenge to FDA’s off-label reprint guidances (Washington Legal Foundation v. Shalala); and
- Represented companies under investigation for off-label promotion of prescription drug products.
We regularly counsel drug and device clients on the permissible boundaries of promotional claims and marketing activities for specific products, represent companies who have received FDA warning or untitled letters, and negotiate for the termination of investigations, or limitations to proposed consent decrees, involving criminal enforcement actions arising from the promotion of prescription drugs and medical devices. Current areas of special focus for our clients include:
- The Office of Prescription Drug Promotion's (OPDP)—formerly known as The Division of Drug Marketing, Advertising, and Communications (DDMAC)—efforts to establish social media policies for prescription drug advertising;
- Use of reprints and continuing medical education (CME) materials discussing off-label uses;
- Engaging medical thought leaders for promotion-related activities;
- Criminal prosecution of companies and individuals for alleged promotional violations; and
- Compliance with the PhRMA and AdvaMed codes, OIG Guidance, and state law restrictions on pharmaceutical promotion.
Food, dietary supplement, and OTC drug companies come to us for advice on labeling and advertising claims compliance, for risk assessments for proposed promotional strategies, and for representation in FTC, NAD, and Lanham Act disputes involving allegations of false or misleading advertising. A key focus of this work involves advice on health-related claims and the type and quality of substantiation required, and strategic guidance on the appropriate use and development of survey evidence for purposes of supporting or attacking claims.
We represent pharmaceutical, biotechnology, medical device, and food companies, as well as investment banks and venture capitalists, in connection with the FDA regulatory aspects of commercial transactions, including
- Mergers and acquisitions;
- Product in-licensing and out-licensing;
- Joint ventures;
- Co-promotion agreements;
- Venture-backed financing;
- Public offerings; and
- Clinical trial agreements.
Our work includes conducting and managing regulatory due diligence (often in collaboration with outside consultants), and drafting and negotiating deal terms (such as regulatory milestones, scope of licensed assets, allocation of regulatory responsibilities, and ownership and rights of reference to clinical data).
We also provide advice on Securities and Exchange Commission (SEC)-related disclosures including regulatory risk disclosures in S-1s, 10-Ks and 10-Qs, and company press releases for material events involving FDA-regulatory issues.
Working with Other Law Firms
We are one of relatively few firms with significant FDA regulatory capabilities, and as such we are often sought out by other law firms to collaborate with them in the representation of their clients in FDA-related matters. We have developed a reputation for honesty, integrity, and trust among our law firm peers, as we honor their existing client relationships while affording them and their clients the same degree of care, attention, and thoroughness that we give to our own clients.
FDA Issues REMS-Drug Generic Access Guidance; Antitrust Issues Remain Key Factor
By James N. Czaban
December 5, 2014
Pushback Prompts FDA To Propose New Food Safety Rules
By Sonali P. Gunawardhana and James N. Czaban
November 18, 2014 | Law360
US regulators react to cyber threats to medical devices
By Sonali P. Gunawardhana and Megan L. Brown
November 2014 | eHealth Law & Policy Journal
RECENT NEWSSonali Gunawardhana Discusses FDA Consent Decree on Food Additives Oversight
October 30, 2014
Ralph Caccia Offers Compliance Tips for Medical Device Manufacturers
October 16, 2014