Food, Drug, and Medical Device Law


Wiley Rein’s Food, Drug, and Medical Device 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 allow 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 technical experts and our clients’ 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 for the marketing of innovator and generic drugs,  Biologics License Applications for innovator and Biosimilar products, Premarket Approval applications and Premarket Notifications for the marketing of medical devices, and Investigational New Drug and Investigational Device Exemption applications for the clinical testing of investigational products).
  • 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.

Our Team

The Food, Drug, and Medical Device 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 former FDA attorney Sonali P. Gunawardhana, who is recognized in numerous independent rankings as a leader in Food, Drug, and Medical Device 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, and Medical Device 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

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.

Regulatory Compliance

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 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;
  • 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;
  • Import and export requirements;  and
  • Change reporting and supplemental application requirements for drugs and devices.


Our practice cuts across all industry sectors regulated by the FDA, including pharmaceuticals and biologics, medical devices and radiation-emitting products (whether for medical or non-medical purposes), and foods and dietary supplements. Many companies are subject to joint or overlapping regulation by FDA, the Federal Trade Commission (FTC), the Consumer Product Safety Commission (CPSC), and analogous state agencies. Below we summarize the nature and scope of the regulatory oversight of these industry sectors and our capabilities in these areas of regulation. 


FDA’s regulatory authority over pharmaceutical products is exercised by FDA’s Center for Drug Evaluation and Research (CDER). CDER reviews applications for new and generic pharmaceuticals, developed current Good Manufacturing Practice (cGMP) regulations for pharmaceutical manufacturing.  The Center also determines which drugs require a prescription, monitors advertising of approved drugs, and collects and analyzes safety data about pharmaceuticals that are already on the market. Its primary objective is to ensure that all prescription and over-the-counter (OTC) medications are safe and effective when used as directed.  Our work for pharmaceutical clients encompasses regulatory strategies at all stages of a product’s lifecycle, from research, development and clinical testing, the FDA approval process, manufacturing compliance and safety monitoring, to marketing and promotional strategies and compliance.

Medical Devices

FDA’s regulatory authority over medical devices is exercised by FDA’s Center for Devices and Radiological Health (CDRH). The basic framework under which FDA oversees medical devices was put in place 40 years ago, when Congress enacted the Medical Device Amendments of 1976 (MDA). The MDA established a flexible framework for FDA's oversight of medical devices and required that FDA tailor its oversight of devices to the degree of risk presented. Medical devices vary according to their intended use and indications. Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers which assist in the conduct of medical testing, implants, and prostheses. The FDA allows for two regulatory pathways that allow the marketing of medical devices. The first and the most common pathway is the so-called 510(k) process (named after the CFR section that describes the process). A new medical device that can be demonstrated to be "substantially equivalent" to a previously legally marketed device can be "cleared" by the FDA for marketing as long as the general and special controls are met. The second regulatory pathway for new medical devices is the Premarket Approval process, which is similar to the pathway for a new drug approval and generally requires clinical trials to be conducted.  We have worked with clients to assist them both through the complex premarket process but also with all compliance requirements in regards to post marketing, including review of proposed promotion and advertising as well as developing comprehensive written responses to regulatory correspondence.  We have also represented our clients in person at various stages of the approval and post marketing process.

Non-Medical Radiation Emitting Devices

FDA’s regulatory authority over radiation emitting devices such as lasers is exercised by FDA’s Center for Devices and Radiological Health (CDRH).  CDRH also regulates non-medical radiation-emitting products such as laser illuminated projectors, toy lasers, baggage x-ray machines and sun lamps. FDA still regulates non-medical lasers based on regulations promulgated in the 1970s, which unfortunately do not reflect the current state of scientific knowledge.  We have worked with clients in these industries to seek “variances” and exemptions from regulatory requirements to reduce the regulatory burden without compromising safety, and have advocated more generally before the FDA and Congress for the development of more appropriate modern regulatory standards for lasers and laser products. 

Personal Care Products

FDA’s regulatory authority also extends to a variety of personal care products, though depending on the use of the product it may share oversight with other regulatory agencies such as the FTC and CPSC.Personal care includes products as diverse as cleansing pads, colognes, cotton swabs, deodorant, eye liner, lipstick, lotion, makeup, nail files, pomade, perfumes, razors, shaving cream, soap, toothpaste, and wet wipes.  Some of these products may fall into two areas of FDA oversight both cosmetic and pharmaceutical depending on the intended use of the product and the claims made about the product.  The Center at the FDA that oversees cosmetic products is the Center for Food Safety and Applied Nutrition (CFSAN) through its Office of Cosmetic Products.  If the personal care product makes a particular disease claim it may also be regulated by CDER as a pharmaceutical product. We have assisted clients navigate the complicated regulatory pathway depending on the instructions for use of the product or advise as how best to comply with both mandatory and voluntary requirements suggested as best practices by the FDA.  

Food and Dietary Supplements

CFSAN is also responsible for the regulation of food and dietary supplements. The FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods. The FDA subdivides substances that it regulates as food into various categories—including foods, food additives, added substances, and dietary supplements.  We have assisted clients in making determinations as to the appropriate pathway to introduce new food and dietary products into the market.  Most food products are not subject to the FDA preapproval process rather they are required to adhere to appropriate labeling requirements and manufacturing processes.   We have assisted clients navigate the myriad of food labeling requirements including allergen labeling and menu labeling requirements.  We have also assisted clients in determining whether the proposed marketed product is in compliance with dietary supplement requirements in terms of labeling and promotion activites.

FDA 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 Food, Drug, and Medical Device Law 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 regulatory compliance for the marketing and advertising of drugs, devices, foods, and consumer products is deep and longstanding. 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.

Clients 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.

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.

Contact Us

Sonali Gunawardhana
202.719.7454 |

Tracy Heinzman
202.719.7106 |

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