Lassman Law+Policy

For pharmaceutical, biotechnology, and medical device companies operating in or engaging with the regulatory landscape of Washington D.C., navigating the intricacies of the Food and Drug Administration (FDA) is a monumental task. The legal and policy framework governing product development, approval, and marketing is exceptionally complex, demanding highly specialized legal counsel. Lassman Law+Policy stands out as a premier boutique law firm in the nation's capital, offering unparalleled expertise specifically in FDA regulatory law. This article provides a comprehensive overview of Lassman Law+Policy, detailing their specialized services, strategic location, and why they are an invaluable resource for life sciences companies and investors in the District of Columbia.

Lassman Law+Policy is a dedicated FDA regulatory law firm located in Washington D.C., founded by Scott M. Lassman. With over 30 years of experience in FDA law and policy, both in-house and in private practice, Scott Lassman has established himself as a recognized expert in this highly nuanced field. The firm's mission is to solve its clients' most complicated FDA-related problems, serving sophisticated pharmaceutical, biotechnology, and medical device companies, as well as investors and industry trade associations.

Scott Lassman's extensive background includes serving as the head FDA regulatory attorney at a major pharmaceutical trade association and chairing the FDA Practice Group at a leading international law firm. This diverse experience provides him with a deep understanding not only of the law itself but also of the FDA's operational procedures, its interpretation of regulations, and the unique needs of corporate clients. He is particularly adept at navigating "legal gray areas," identifying unseen dangers, and leveraging hidden opportunities for his clients. The firm is known for its focused expertise on exclusivity rules, biosimilars, product approval, advertising and promotion, and broader FDA policy matters. Scott Lassman also authors the "Exclusivity Rules" blog, a highly regarded resource that delves into the written and unwritten rules governing FDA's exclusivity decisions. For any entity in Washington D.C. seeking specialized and authoritative counsel in FDA regulatory law, Lassman Law+Policy offers a rare combination of deep knowledge and practical experience.

Location and Accessibility

Lassman Law+Policy's Washington D.C. office is strategically located at 1717 K St NW Suite 900, Washington, DC 20006, USA. This prime address positions the firm directly within the bustling K Street corridor, an area synonymous with influential law firms, corporate headquarters, and policy organizations in the nation's capital. This central location ensures exceptional accessibility for clients located throughout the District of Columbia and the broader metropolitan area.

The office's placement on K Street NW provides convenient access via Washington D.C.'s robust public transportation network. It is situated within close walking distance of several Metro stations, including Farragut North (Red Line) and Farragut West (Blue, Orange, and Silver lines). These stations offer seamless connections from various parts of the city and its surrounding suburbs, making commutes straightforward for clients. Additionally, numerous Metrobus lines operate along the K Street corridor, further enhancing public transit options.

For clients who choose to drive, the location offers direct access to major downtown thoroughfares. While on-street parking can be challenging in this busy commercial district, there are typically several commercial parking garages available in the immediate vicinity of 1717 K Street NW, providing practical parking solutions. This highly accessible and central location underscores Lassman Law+Policy's commitment to providing convenient and efficient service to its specialized clientele in the life sciences sector.

Services Offered

Lassman Law+Policy provides comprehensive legal services with a deep specialization in all aspects of FDA regulatory law. Their focused expertise is designed to address the intricate challenges faced by pharmaceutical, biotechnology, and medical device companies, as well as their investors and representative associations. Key services offered by Lassman Law+Policy include:

• Exclusivity Matters: Advising on the complex array of exclusivity and patent certification provisions that determine product approval and market entry for pharmaceutical and biological products, a core expertise of the firm.

• Drug & Biologic Development: Providing legal counsel throughout the drug and biologic development process, including navigating 505(b)(2) applications and resolving disputes related to product approval programs.

• Biosimilars: Offering specialized guidance on the regulatory pathways and policy issues surrounding biosimilar products.

• Citizen Petitions & Litigation: Utilizing the citizen petition process to request FDA action (or inaction) and, when necessary, engaging in litigation with the FDA under the Administrative Procedure Act (APA) to challenge incorrect agency decisions.

• FDA Policy: Providing insights and advice on proposed FDA legislation, regulations, and guidance documents, actively contributing to policy discussions.

• Advertising & Promotion: Counseling on compliance with FDA regulations regarding the advertising and promotion of pharmaceutical, biotechnology, and medical device products.

• Corporate Support & Due Diligence: Offering comprehensive support on FDA regulatory law for corporate transactions, including IPOs, mergers, acquisitions, and asset sales, performing regulatory due diligence, drafting relevant documents, and providing regulatory opinions.

Features / Highlights

Lassman Law+Policy distinguishes itself through several key features and highlights that firmly establish its position as a leading FDA regulatory law firm in Washington D.C.:

• Deep FDA Specialization: The firm's exclusive focus on FDA regulatory law means clients benefit from unparalleled depth of knowledge and experience in this highly specialized and complex area, particularly concerning pharmaceutical, biotechnology, and medical device products.

• Recognized Expert Leadership: Scott M. Lassman, the firm's principal, is widely recognized as a top attorney in FDA and Administrative/Regulatory Law, consistently selected to prestigious lists like Super Lawyers and Best Lawyers in America. His extensive experience, including in-house roles, provides a unique understanding of client needs.

• Strategic Use of Citizen Petitions and Litigation: The firm possesses a strong track record of successfully leveraging the Citizen Petition process and, when necessary, litigating against the FDA in federal court under the APA to protect client interests.

• Authority on Exclusivity: Scott Lassman is a leading authority on FDA exclusivity rules, as evidenced by his "Exclusivity Rules" blog and frequent contributions to discussions on this critical aspect of drug and biologic approvals.

• Comprehensive Corporate Transaction Support: Lassman Law+Policy seamlessly integrates with corporate legal teams, providing essential specialized FDA regulatory expertise during major corporate transactions, ensuring regulatory compliance and mitigating risks.

• Client-Centric and Proactive Approach: The firm works intimately with clients to understand their business objectives and provides strategic, proactive advice to navigate the regulatory landscape, avoid pitfalls, and capitalize on opportunities.

Promotions or Special Offers

As a highly specialized professional legal services provider, Lassman Law+Policy does not typically offer public promotions or discounts in the manner of retail businesses. Legal fees for complex FDA regulatory matters are generally structured based on the specific services required, the complexity of the issues, and the time and expertise involved in delivering strategic and effective solutions.

However, prospective clients are strongly encouraged to contact Lassman Law+Policy directly to discuss their specific FDA regulatory needs. During an initial consultation, the firm's professionals can provide an assessment of your situation, discuss potential legal strategies, and transparently outline their fee structure. This direct communication ensures clarity on engagement terms and allows life sciences companies and investors to make informed decisions about their legal representation. The firm’s value is derived from its deep expertise and its ability to achieve favorable outcomes in complex regulatory environments, rather than through generalized promotional offers.

Contact Information

For pharmaceutical, biotechnology, and medical device companies, as well as investors and trade associations in the District of Columbia seeking expert counsel on FDA regulatory matters, Lassman Law+Policy can be reached through the following contact details:

Address: 1717 K St NW Suite 900, Washington, DC 20006, USA

Phone: (202) 248-5426

Mobile Phone: +1 202-248-5426

It is advisable to contact the office by phone to schedule a consultation or to make inquiries, ensuring that your specific FDA regulatory needs are directed to the most appropriate legal professional within their specialized team.

Conclusion: Why this place is suitable for locals

For the vibrant and innovation-driven life sciences community in the District of Columbia, Lassman Law+Policy stands as an exceptionally suitable and indispensable legal partner. Its strategic location on K Street NW provides unparalleled accessibility, placing the firm directly within the nexus of D.C.'s legal and regulatory landscape, including close proximity to the FDA and other federal agencies.

What truly sets Lassman Law+Policy apart is its singular and profound specialization in FDA regulatory law. In a field that demands highly specific knowledge and experience, having a firm dedicated solely to these issues, led by a widely recognized authority like Scott M. Lassman, provides a critical advantage. Whether dealing with intricate exclusivity challenges, complex biosimilar pathways, or navigating FDA policy through citizen petitions and litigation, local pharmaceutical, biotech, and medical device companies can rely on Lassman Law+Policy for strategic, informed, and effective counsel. Their ability to provide both proactive compliance advice and robust advocacy makes them an ideal choice for businesses in D.C. seeking to successfully develop, approve, and market their regulated products in the nation's capital and beyond.