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美国食品和药物管理局(FDA)监管及合规事务

概述

随着合规压力增加以及制约全球医药行业的法律法规主体不断演变和扩展,制药及生命科学企业需要管理的远远不仅限于他们的产品管道和日常业务相关事务。

乐博的FDA监管及合规事务团队就FDA相关产品的经销和商品化(包括营销与推广)向客户提供全方位的法律及商业事务顾问服务。

我们与医药及生命科学行业的各类客户合作,涵盖制药、生物制剂、医疗设备、保健产品、膳食补充剂以及有机产品等诸多领域。我们就监管事务、合规相关事务以及风险管理战略向客户提供顾问服务;就产品推广及标名相关的法律法规事宜提供建议;就FDA排他性政策向客户提供指导;以及就包括企业诚信协议实施在内的许可交易和监管执行诉讼提供代理服务。

我们的律师洞悉法律的细微变化,我们也深谙生命科学产业市场面临的商业挑战,包括与合规工作相关的商业要务以及担忧。我们的职能不仅仅是提供传统的私人执业服务,在很大程度上类似于公司法务部门的一部分,我们紧密凝聚的团队提供及时、实用的服务,致力于把对监管政策的见解化为切合实际的建议,帮助客户取得成功。

对于从创新型生物科技和医疗设备初创企业、到全球顶尖的医药制造商,以及介于两者之间的各类客户,乐博的律师都作为其信任的商业伙伴和顾问,帮助他们解决产品生命周期的每一阶段所涉及的事宜。我们的核心服务包括:

  • Our work with clients in the drug, biologics and medical device 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. 
    • Clinical Development Strategies and Support. Assisting with clinical trial monitoring and reporting,  responding to suspected unexpected serious adverse reactions (SUSARs) and clinical hold issues, end-of-phase 2 (EOP-2) meetings, and special protocol assessment (SPA) requests, 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.
    • 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. We work collaboratively with clients and their scientific advisers to support the preferred product labeling and to respond to complete response letters (CRLs), 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.
    • Post-Market 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, 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.
    • 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 Federal Trade Commission (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 they 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.
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