FDA Regulatory & Compliance

Our work with clients in the drug, biologics, medical device, food/dietary supplement and cosmetic sectors covers all stages of a product’s life cycle, including:

• Early Product Enablement: Advising on the critical, early development-stage gateway activities, including licensing transactions, contract research organizations (CROs) and contract manufacturing organizations (CMOs) agreements, clinical trial agreements, investigational new drug (IND) and investigational device exemption (IDE) development and submission, and pre-IND meetings with the FDA. For entities in the food and cosmetic industries, we also advise on ingredient and formulation requirements, including generally recognized as safe (GRAS) status, food additive requirements, new dietary ingredient (NDI) submissions, California Proposition 65 considerations, and cosmetic International Nomenclature Cosmetic Ingredient (INCI) naming requirements. We also regularly advise clients on DEA- and state-controlled substance laws and regulations for products in the merging cannabis and psychedelics products spaces.
• Clinical Development Strategies and Support: Assisting with clinical trial protocol development, monitoring and reporting, responding to suspected unexpected serious adverse reactions (SUSARs) and clinical hold issues, User Fee Program meetings (including end-of-phase-2 and Special Protocol Assessments), Fast-Track, RMAT, and Priority Review strategies, medical device presubmission meetings, and working with clinical and marketing teams in connection with target product profiles and planned labeling and promotional claims.
• Launch Planning: Assisting with launch planning, including issues ranging from developing and clearing a proprietary name, publishing clinical studies in medical journals and publicizing those publications in compliance with regulatory requirements, discussions with managed care organizations, and full-scale planning for marketing and promotional campaigns.
• Regulatory Pathway to Market: Advising clients on the most appropriate and least burdensome regulatory pathway to market for life sciences and direct-to-consumer companies. For the pharmaceutical and biotech industries, we advise on the premarket application pathway, including requirements for a new drug application (NDA) or biologics license application (BLA). For clients in the device industry, we evaluate whether a product’s technology and proposed labeling claims are ripe for a 510(k) application, de novo classification, premarket approval (PMA) application, or whether the product may be subject to FDA enforcement discretion as a low-risk “general wellness product” or under another of FDA’s many product-specific enforcement discretion policies. We also file 513(g) requests to obtain FDA’s input on medical device classifications. For clients in the food and dietary supplement industries, we evaluate whether the product is most appropriately regulated as a conventional food, a dietary supplement or a medical food, and we advise on the corresponding regulatory requirements. 
• Navigating the Application Process: Providing creative strategies and persuasive advocacy to minimize and mitigate risks of unfavorable FDA positions regarding a sponsor’s chosen regulatory pathway, clinical approach or interpretation of data presented in an application, including NDAs/BLAs, medical device 510(k), de novo and PMA applications. We work collaboratively with clients and their scientific advisers to support preferred product labeling and to respond to complete response letters (CRLs) and medical device requests for additional information (AI requests), including doing so through the formal dispute resolution process. We also help clients leverage the least burdensome regulatory pathways for market access, such as 505(b)(2) new drug applications (NDAs), the newly amended over-the-counter (OTC) drug monograph system, and 510(k) eligibility and exemptions for lower-risk devices.
• Postmarket Compliance: Monitoring ongoing compliance with marketing and promotional laws and regulations under the Federal Food, Drug, and Cosmetic Act (FDCA), the False Claims Act, the Anti-Kickback Statute, the Federal Trade Commission Act (FTC Act), federal and state sunshine laws, and other fraud and abuse laws, including evaluating a wide range of materials, from product advertisements and social media activities to educational presentations and medical abstracts. Assisting companies in developing and implementing effective compliance programs, policies, standard operating procedures, work instructions and guidelines relating to all aspects of distribution and commercialization of FDA-regulated products, including but not limited to current good manufacturing practices (cGMP) requirements. We also help clients navigate product recalls, market withdrawals and FDA import detentions, alerts and refusals.
• Investigations and Enforcement Actions: Conducting internal or independent investigations into alleged violations of FDA and fraud and abuse laws, Foreign Corrupt Practices Act violations, insider trading, money laundering and other fraud-related and white-collar criminal matters. Our lawyers have experience leading anti-kickback, sampling and off-label investigations and assisting life sciences clients with implementation of and compliance audits related to corporate integrity agreements.

In close collaboration with our comprehensive patent litigation team, our FDA team advises pharmaceutical companies on the complex regulatory issues and strategies involving NDAs, 505(b)(2) NDAs and generic drug approvals. We advise and advocate in connection with all types of regulatory exclusivities, including New Chemical Entity (NCE) Exclusivity, Biologics Price Competition and Innovation Act (BPCIA) exclusivities, New Clinical Trial Exclusivity, Orphan Drug Exclusivity, Generating Antibiotic Incentives Now (GAIN) Act Exclusivity, Pediatric Exclusivity and labeling “carve out” issues. Our lawyers have a long history of successful Hatch-Waxman regulatory advocacy in the form of citizen petitions, nonpublic FDA submissions and federal court litigation against the FDA under the Administrative Procedure Act (APA).

An ever-increasing variety of direct-to-consumer products are subject to some level of FDA regulation, from dietary supplements, functional foods and cosmeceuticals to emerging product categories such as health-related mobile apps, OTC hearing aids, cannabinoids and a host of products regulated as medical “devices.” Many of these products are also subject to FTC advertising regulations. Our FDA team members work closely with members of our Advertising and Media practice to guide our clients with practical advice on the FDA compliance complexities that impact their business risk management calculations as they seek to market directly to consumers.

For life sciences companies seeking to merge, go public or enter a licensing agreement, FDA regulatory diligence and strategic negotiation of regulatory deal terms are foundational issues that can make or break the deal. Loeb’s FDA lawyers have supported hundreds of public and private offerings, SPACs, and M&A transactions involving FDA-regulated companies and technologies, and we know how to get to the heart of our clients’ business needs in evaluating the regulatory landscape of a transaction. Our advice is never one-size-fits-all but is tailored to meet the specific needs of specific clients in a specific transactional context. Our depth of experience allows us to offer clients a nuanced understanding of regulatory terms and conditions, the risks and opportunities associated with them and the ability to negotiate for language that clearly and effectively secures our clients’ side of the bargain.

We counsel on compliance with federal and state privacy laws, including the Health Insurance Portability and Accountability Act, the Health Information Technology for Economic and Clinical Health Act, and the General Data Protection Regulation. We offer guidance on privacy considerations related to the use of digital and social media, mobile and internet-based communications, and electronic data collection and optimization strategies.

Regulated entities sometimes wish to challenge FDA policies and decisions that are based on novel interpretations of the law or that are inconsistent with past agency policy and precedents. Successfully pursuing challenges against the FDA requires a deep knowledge of the specific statutory and regulatory bases for the FDA’s authority to act in the relevant circumstances, a seasoned perspective on the internal workings and policy objectives of the agency and its senior officials, and the experience and understanding of how the courts review and decide cases challenging agency actions and decisions. We have fought such challenges to successful conclusions through the use of the citizen petition process, through nonpublic advocacy and negotiation with the agency, and in federal court litigation under the APA. Moreover, our lawyers have actively advised individual clients and industry associations on legislative policy issues and proposed statutory reform provisions during multiple user fee reauthorization cycles, and have also aided clients in congressional advocacy on specific matters and focused policy initiatives. These client services not only offer a pathway to potential business solutions but also provide our team and our clients with a “ground up” understanding of, and the ability to leverage, new laws even before their final enactment.